Skip to main content

We've saved some files called cookies on your device. These cookies are:

  • essential for the site to work
  • to help improve our website by collecting and reporting information on how you use it

We would also like to save some cookies to help tailor communications.

BETA
You're viewing an updated version of this service - your feedback will help us to improve it.

Contract Notice

Virknings- og sikkerhedsundersøgelser om lægemidler.

  • First published: 14 December 2017
  • Last modified: 14 December 2017
  • Version: N/A
  • This file may not be fully accessible.

  •  

Information icon

The buyer is not using this website to administer the notice.

To record your interest or obtain additional information or documents please find instructions within the Full Notice Text. (NOTE: Contract Award Notices and Prior Information Notices do not normally require a response)

Information icon
You are viewing an expired notice.

Contents

Summary

OCID:
Published by:
European Medicines Agency (EMA) (Det Europæiske Lægemiddelagentur)
Authority ID:
AA21400
Publication date:
14 December 2017
Deadline date:
02 February 2018
Notice type:
Contract Notice
Has documents:
No
Has SPD:
No
Has Carbon Reduction Plan:
N/A

Abstract

En fuldstændig beskrivelse findes i del 3.2 af de tekniske specifikationer (udbudsdokumenterne).

Full notice text

Contract notice

Section I: Contracting authority

I.1) Name and addresses

Det Europæiske Lægemiddelagentur

30 Churchill Place

London

E14 5EU

UK

E-mail: pass.tender@ema.europa.eu

NUTS: UKI4

Internet address(es)

Main address: http://www.ema.europa.eu/ema/index.jsp?curl=pages/about_us/general/general_content_000259.jsp&mid=WC0b01ac0580029487

Address of the buyer profile: http://www.ema.europa.eu/ema/index.jsp?curl=pages/about_us/general/general_content_000259.jsp&mid=WC0b01ac0580029487

I.1) Name and addresses

Europäische Arzneimittel-Agentur

30 Churchill Place

London

E14 5EU

UK

E-mail: pass.tender@ema.europa.eu

NUTS: UKI4

Internet address(es)

Main address: http://www.ema.europa.eu/ema/index.jsp?curl=pages/about_us/general/general_content_000259.jsp&mid=WC0b01ac0580029487

Address of the buyer profile: http://www.ema.europa.eu/ema/index.jsp?curl=pages/about_us/general/general_content_000259.jsp&mid=WC0b01ac0580029487

I.1) Name and addresses

European Medicines Agency

30 Churchill Place

London

E14 5EU

UK

E-mail: pass.tender@ema.europa.eu

NUTS: UKI4

Internet address(es)

Main address: http://www.ema.europa.eu/ema/index.jsp?curl=pages/about_us/general/general_content_000259.jsp&mid=WC0b01ac0580029487

Address of the buyer profile: http://www.ema.europa.eu/ema/index.jsp?curl=pages/about_us/general/general_content_000259.jsp&mid=WC0b01ac0580029487

I.1) Name and addresses

Agencia Europea de Medicamentos

30 Churchill Place

London

E14 5EU

UK

E-mail: pass.tender@ema.europa.eu

NUTS: UKI4

Internet address(es)

Main address: http://www.ema.europa.eu/ema/index.jsp?curl=pages/about_us/general/general_content_000259.jsp&mid=WC0b01ac0580029487

Address of the buyer profile: http://www.ema.europa.eu/ema/index.jsp?curl=pages/about_us/general/general_content_000259.jsp&mid=WC0b01ac0580029487

I.1) Name and addresses

Euroopan lääkevirasto

30 Churchill Place

London

E14 5EU

UK

E-mail: pass.tender@ema.europa.eu

NUTS: UKI4

Internet address(es)

Main address: http://www.ema.europa.eu/ema/index.jsp?curl=pages/about_us/general/general_content_000259.jsp&mid=WC0b01ac0580029487

Address of the buyer profile: http://www.ema.europa.eu/ema/index.jsp?curl=pages/about_us/general/general_content_000259.jsp&mid=WC0b01ac0580029487

I.1) Name and addresses

Agence européenne des médicaments

30 Churchill Place

London

E14 5EU

UK

E-mail: pass.tender@ema.europa.eu

NUTS: UKI4

Internet address(es)

Main address: http://www.ema.europa.eu/ema/index.jsp?curl=pages/about_us/general/general_content_000259.jsp&mid=WC0b01ac0580029487

Address of the buyer profile: http://www.ema.europa.eu/ema/index.jsp?curl=pages/about_us/general/general_content_000259.jsp&mid=WC0b01ac0580029487

I.1) Name and addresses

¿¿¿¿pa¿¿¿¿ ¿¿¿a¿¿sµ¿¿ Fa¿µ¿¿¿¿

30 Churchill Place

London

E14 5EU

UK

E-mail: pass.tender@ema.europa.eu

NUTS: UKI4

Internet address(es)

Main address: http://www.ema.europa.eu/ema/index.jsp?curl=pages/about_us/general/general_content_000259.jsp&mid=WC0b01ac0580029487

Address of the buyer profile: http://www.ema.europa.eu/ema/index.jsp?curl=pages/about_us/general/general_content_000259.jsp&mid=WC0b01ac0580029487

I.1) Name and addresses

Agenzia europea per i medicinali

30 Churchill Place

London

E14 5EU

UK

E-mail: pass.tender@ema.europa.eu

NUTS: UKI4

Internet address(es)

Main address: http://www.ema.europa.eu/ema/index.jsp?curl=pages/about_us/general/general_content_000259.jsp&mid=WC0b01ac0580029487

Address of the buyer profile: http://www.ema.europa.eu/ema/index.jsp?curl=pages/about_us/general/general_content_000259.jsp&mid=WC0b01ac0580029487

I.1) Name and addresses

Europees Geneesmiddelenbureau

30 Churchill Place

London

E14 5EU

UK

E-mail: pass.tender@ema.europa.eu

NUTS: UKI4

Internet address(es)

Main address: http://www.ema.europa.eu/ema/index.jsp?curl=pages/about_us/general/general_content_000259.jsp&mid=WC0b01ac0580029487

Address of the buyer profile: http://www.ema.europa.eu/ema/index.jsp?curl=pages/about_us/general/general_content_000259.jsp&mid=WC0b01ac0580029487

I.1) Name and addresses

Agência Europeia de Medicamentos

30 Churchill Place

London

E14 5EU

UK

E-mail: pass.tender@ema.europa.eu

NUTS: UKI4

Internet address(es)

Main address: http://www.ema.europa.eu/ema/index.jsp?curl=pages/about_us/general/general_content_000259.jsp&mid=WC0b01ac0580029487

Address of the buyer profile: http://www.ema.europa.eu/ema/index.jsp?curl=pages/about_us/general/general_content_000259.jsp&mid=WC0b01ac0580029487

I.1) Name and addresses

Europeiska läkemedelsmyndigheten

30 Churchill Place

London

E14 5EU

UK

E-mail: pass.tender@ema.europa.eu

NUTS: UKI4

Internet address(es)

Main address: http://www.ema.europa.eu/ema/index.jsp?curl=pages/about_us/general/general_content_000259.jsp&mid=WC0b01ac0580029487

Address of the buyer profile: http://www.ema.europa.eu/ema/index.jsp?curl=pages/about_us/general/general_content_000259.jsp&mid=WC0b01ac0580029487

I.1) Name and addresses

Evropská agentura pro lécivé prípravky

30 Churchill Place

London

E14 5EU

UK

E-mail: pass.tender@ema.europa.eu

NUTS: UKI4

Internet address(es)

Main address: http://www.ema.europa.eu/ema/index.jsp?curl=pages/about_us/general/general_content_000259.jsp&mid=WC0b01ac0580029487

Address of the buyer profile: http://www.ema.europa.eu/ema/index.jsp?curl=pages/about_us/general/general_content_000259.jsp&mid=WC0b01ac0580029487

I.1) Name and addresses

Euroopa Ravimiamet

30 Churchill Place

London

E14 5EU

UK

E-mail: pass.tender@ema.europa.eu

NUTS: UKI4

Internet address(es)

Main address: http://www.ema.europa.eu/ema/index.jsp?curl=pages/about_us/general/general_content_000259.jsp&mid=WC0b01ac0580029487

Address of the buyer profile: http://www.ema.europa.eu/ema/index.jsp?curl=pages/about_us/general/general_content_000259.jsp&mid=WC0b01ac0580029487

I.1) Name and addresses

Európai Gyógyszerügynökség

30 Churchill Place

London

E14 5EU

UK

E-mail: pass.tender@ema.europa.eu

NUTS: UKI4

Internet address(es)

Main address: http://www.ema.europa.eu/ema/index.jsp?curl=pages/about_us/general/general_content_000259.jsp&mid=WC0b01ac0580029487

Address of the buyer profile: http://www.ema.europa.eu/ema/index.jsp?curl=pages/about_us/general/general_content_000259.jsp&mid=WC0b01ac0580029487

I.1) Name and addresses

Europos vaistu agentura

30 Churchill Place

London

E14 5EU

UK

E-mail: pass.tender@ema.europa.eu

NUTS: UKI4

Internet address(es)

Main address: http://www.ema.europa.eu/ema/index.jsp?curl=pages/about_us/general/general_content_000259.jsp&mid=WC0b01ac0580029487

Address of the buyer profile: http://www.ema.europa.eu/ema/index.jsp?curl=pages/about_us/general/general_content_000259.jsp&mid=WC0b01ac0580029487

I.1) Name and addresses

Eiropas Zalu agentura

30 Churchill Place

London

E14 5EU

UK

E-mail: pass.tender@ema.europa.eu

NUTS: UKI4

Internet address(es)

Main address: http://www.ema.europa.eu/ema/index.jsp?curl=pages/about_us/general/general_content_000259.jsp&mid=WC0b01ac0580029487

Address of the buyer profile: http://www.ema.europa.eu/ema/index.jsp?curl=pages/about_us/general/general_content_000259.jsp&mid=WC0b01ac0580029487

I.1) Name and addresses

L-Agenzija Ewropea ghall-Medicini

30 Churchill Place

London

E14 5EU

UK

E-mail: pass.tender@ema.europa.eu

NUTS: UKI4

Internet address(es)

Main address: http://www.ema.europa.eu/ema/index.jsp?curl=pages/about_us/general/general_content_000259.jsp&mid=WC0b01ac0580029487

Address of the buyer profile: http://www.ema.europa.eu/ema/index.jsp?curl=pages/about_us/general/general_content_000259.jsp&mid=WC0b01ac0580029487

I.1) Name and addresses

Europejska Agencja Leków

30 Churchill Place

London

E14 5EU

UK

E-mail: pass.tender@ema.europa.eu

NUTS: UKI4

Internet address(es)

Main address: http://www.ema.europa.eu/ema/index.jsp?curl=pages/about_us/general/general_content_000259.jsp&mid=WC0b01ac0580029487

Address of the buyer profile: http://www.ema.europa.eu/ema/index.jsp?curl=pages/about_us/general/general_content_000259.jsp&mid=WC0b01ac0580029487

I.1) Name and addresses

Európska agentúra pre lieky

30 Churchill Place

London

E14 5EU

UK

E-mail: pass.tender@ema.europa.eu

NUTS: UKI4

Internet address(es)

Main address: http://www.ema.europa.eu/ema/index.jsp?curl=pages/about_us/general/general_content_000259.jsp&mid=WC0b01ac0580029487

Address of the buyer profile: http://www.ema.europa.eu/ema/index.jsp?curl=pages/about_us/general/general_content_000259.jsp&mid=WC0b01ac0580029487

I.1) Name and addresses

Evropska agencija za zdravila

30 Churchill Place

London

E14 5EU

UK

E-mail: pass.tender@ema.europa.eu

NUTS: UKI4

Internet address(es)

Main address: http://www.ema.europa.eu/ema/index.jsp?curl=pages/about_us/general/general_content_000259.jsp&mid=WC0b01ac0580029487

Address of the buyer profile: http://www.ema.europa.eu/ema/index.jsp?curl=pages/about_us/general/general_content_000259.jsp&mid=WC0b01ac0580029487

I.1) Name and addresses

An Ghníomhaireacht Leigheasra Eorpach

30 Churchill Place

London

E14 5EU

UK

E-mail: pass.tender@ema.europa.eu

NUTS: UKI4

Internet address(es)

Main address: http://www.ema.europa.eu/ema/index.jsp?curl=pages/about_us/general/general_content_000259.jsp&mid=WC0b01ac0580029487

Address of the buyer profile: http://www.ema.europa.eu/ema/index.jsp?curl=pages/about_us/general/general_content_000259.jsp&mid=WC0b01ac0580029487

I.1) Name and addresses

¿¿¿¿¿¿¿¿¿¿ ¿¿¿¿¿¿¿ ¿¿ ¿¿¿¿¿¿¿¿¿¿¿

30 Churchill Place

London

E14 5EU

UK

E-mail: pass.tender@ema.europa.eu

NUTS: UKI4

Internet address(es)

Main address: http://www.ema.europa.eu/ema/index.jsp?curl=pages/about_us/general/general_content_000259.jsp&mid=WC0b01ac0580029487

Address of the buyer profile: http://www.ema.europa.eu/ema/index.jsp?curl=pages/about_us/general/general_content_000259.jsp&mid=WC0b01ac0580029487

I.1) Name and addresses

Agen¿ia Europeana pentru Medicamente

30 Churchill Place

London

E14 5EU

UK

E-mail: pass.tender@ema.europa.eu

NUTS: UKI4

Internet address(es)

Main address: http://www.ema.europa.eu/ema/index.jsp?curl=pages/about_us/general/general_content_000259.jsp&mid=WC0b01ac0580029487

Address of the buyer profile: http://www.ema.europa.eu/ema/index.jsp?curl=pages/about_us/general/general_content_000259.jsp&mid=WC0b01ac0580029487

I.1) Name and addresses

Europska agencija za lijekove

30 Churchill Place

London

E14 5EU

UK

E-mail: pass.tender@ema.europa.eu

NUTS: UKI4

Internet address(es)

Main address: http://www.ema.europa.eu/ema/index.jsp?curl=pages/about_us/general/general_content_000259.jsp&mid=WC0b01ac0580029487

Address of the buyer profile: http://www.ema.europa.eu/ema/index.jsp?curl=pages/about_us/general/general_content_000259.jsp&mid=WC0b01ac0580029487

I.3) Communication

The procurement documents are available for unrestricted and full direct access, free of charge at:

https://etendering.ted.europa.eu/cft/cft-display.html?cftId=2506


Additional information can be obtained from the abovementioned address


Tenders or requests to participate must be sent to the abovementioned address


I.4) Type of the contracting authority

European institution/agency or international organisation

European institution/agency or international organisation

European institution/agency or international organisation

European institution/agency or international organisation

European institution/agency or international organisation

European institution/agency or international organisation

European institution/agency or international organisation

European institution/agency or international organisation

European institution/agency or international organisation

European institution/agency or international organisation

European institution/agency or international organisation

European institution/agency or international organisation

European institution/agency or international organisation

European institution/agency or international organisation

European institution/agency or international organisation

European institution/agency or international organisation

European institution/agency or international organisation

European institution/agency or international organisation

European institution/agency or international organisation

European institution/agency or international organisation

European institution/agency or international organisation

European institution/agency or international organisation

European institution/agency or international organisation

European institution/agency or international organisation

I.5) Main activity

General public services

General public services

General public services

General public services

General public services

General public services

General public services

General public services

General public services

General public services

General public services

General public services

General public services

General public services

General public services

General public services

General public services

General public services

General public services

General public services

General public services

General public services

General public services

General public services

Section II: Object

II.1) Scope of the procurement

II.1.1) Title

Virknings- og sikkerhedsundersøgelser om lægemidler.

Reference number: EMA/2017/09/PE

II.1.2) Main CPV code

73000000

 

II.1.3) Type of contract

Services

II.1.4) Short description

Undersøgelser i effektivitet og farmakoepidemiologi efter godkendelse med henblik på at generere data og oplysninger til støtte for den lovgivningsmæssige beslutningsproces. Forskningen vil også fokusere på effektiviteten af trufne lovgivningsmæssige foranstaltninger og indvirkningen af relevant lovgivning. Omfanget af emner, der skal undersøges, er begrænset til områder, der er af stor relevans for den offentlige sundhed, og som har indvirkning på Europa. Anvendelsesområdet i henseende til finansiering dækker både nationalt og centralt godkendte produkter, herunder vacciner. Resultaterne fra denne forskning vil efterfølgende blive vurderet af det ansvarlige agenturudvalg med hensyn til behovet for regulatoriske handlinger, og yderligere forskning kan efterfølgende blive udført for at måle effektiviteten af de regulatoriske handlinger, der blev udført.

Forskningen kan vedrøre fire forskellige partier, med maksimalt fem rammeaftaler for partierne 1, 2 og 3 og maksimalt 8 rammeaftaler for parti 4.

II.1.5) Estimated total value

Value excluding VAT: 5 000 000.00  EUR

II.1.6) Information about lots

This contract is divided into lots: Yes

Tenders may be submitted for all lots

II.2) Description

Lot No: 1

II.2.1) Title

Brugen af innovative metoder til at optimere nytten af sparsomme data til at støtte benefit/risk-vurderingen

II.2.2) Additional CPV code(s)

73210000

II.2.3) Place of performance

NUTS code:

UKI4

II.2.4) Description of the procurement

En fuldstændig beskrivelse findes i del 3.2 af de tekniske specifikationer (udbudsdokumenterne).

II.2.5) Award criteria

Price is not the only award criterion and all criteria are stated only in the procurement documents

II.2.6) Estimated value

Value excluding VAT: 400 000.00  EUR

II.2.7) Duration of the contract, framework agreement or dynamic purchasing system

Duration in months: 48

This contract is subject to renewal: No

II.2.9) Information about the limits on the number of candidates to be invited

II.2.10) Information about variants

Variants will be accepted: No

II.2.11) Information about options

Options: No

II.2.13) Information about European Union funds

The procurement is related to a project and/or programme financed by European Union funds: No

II.2.14) Additional information

Bemærk venligst, at der maksimalt påtænkes 5 rammeaftaler til parti 1.

Lot No: 2

II.2.1) Title

Kvalitativ forskning

II.2.2) Additional CPV code(s)

73210000

II.2.3) Place of performance

NUTS code:

UKI4

II.2.4) Description of the procurement

En fuldstændig beskrivelse findes i del 3.2 af de tekniske specifikationer (udbudsdokumenterne).

II.2.5) Award criteria

Price is not the only award criterion and all criteria are stated only in the procurement documents

II.2.6) Estimated value

Value excluding VAT: 600 000.00  EUR

II.2.7) Duration of the contract, framework agreement or dynamic purchasing system

Duration in months: 48

This contract is subject to renewal: No

II.2.9) Information about the limits on the number of candidates to be invited

II.2.10) Information about variants

Variants will be accepted: No

II.2.11) Information about options

Options: No

II.2.13) Information about European Union funds

The procurement is related to a project and/or programme financed by European Union funds: No

II.2.14) Additional information

Bemærk venligst, at der maksimalt påtænkes 5 rammeaftaler til parti 2.

Lot No: 3

II.2.1) Title

Farmakoepidemiologisk forskning — hurtige, beskrivende undersøgelser

II.2.2) Additional CPV code(s)

73210000

II.2.3) Place of performance

NUTS code:

UKI4

II.2.4) Description of the procurement

En fuldstændig beskrivelse findes i del 3.2 af de tekniske specifikationer (udbudsdokumenterne).

II.2.5) Award criteria

Price is not the only award criterion and all criteria are stated only in the procurement documents

II.2.6) Estimated value

Value excluding VAT: 1 000 000.00  EUR

II.2.7) Duration of the contract, framework agreement or dynamic purchasing system

Duration in months: 48

This contract is subject to renewal: No

II.2.9) Information about the limits on the number of candidates to be invited

II.2.10) Information about variants

Variants will be accepted: No

II.2.11) Information about options

Options: No

II.2.13) Information about European Union funds

The procurement is related to a project and/or programme financed by European Union funds: No

II.2.14) Additional information

Bemærk venligst, at der maksimalt påtænkes 5 rammeaftaler til parti 3.

Lot No: 4

II.2.1) Title

Farmakoepidemiologisk forskning — associationsundersøgelser, inklusiv graviditets- og amningsundersøgelser.

II.2.2) Additional CPV code(s)

73210000

II.2.3) Place of performance

NUTS code:

UKI4

II.2.4) Description of the procurement

En fuldstændig beskrivelse findes i del 3.2 af de tekniske specifikationer (udbudsdokumenterne).

II.2.5) Award criteria

Price is not the only award criterion and all criteria are stated only in the procurement documents

II.2.6) Estimated value

Value excluding VAT: 3 000 000.00  EUR

II.2.7) Duration of the contract, framework agreement or dynamic purchasing system

Duration in months: 48

This contract is subject to renewal: No

II.2.9) Information about the limits on the number of candidates to be invited

II.2.10) Information about variants

Variants will be accepted: No

II.2.11) Information about options

Options: No

II.2.13) Information about European Union funds

The procurement is related to a project and/or programme financed by European Union funds: No

II.2.14) Additional information

Bemærk venligst, at der maksimalt påtænkes 8 rammeaftaler til parti 4.

Section II: Object

II.1) Scope of the procurement

II.1.1) Title

Wirksamkeits- und Sicherheitsstudien zu Arzneimitteln.

Reference number: EMA/2017/09/PE

II.1.2) Main CPV code

73000000

 

II.1.3) Type of contract

Services

II.1.4) Short description

Wirksamkeits- und Pharmakoepidemiologie-Studien nach der Zulassung zur Erzeugung von Daten und Informationen zur Unterstützung der regulatorischen Entscheidungsfindung. Bei der Forschung kann auch ein Schwerpunkt auf die Wirksamkeit der getroffenen regulatorischen Maßnahmen und auf die Auswirkungen der einschlägigen Rechtsvorschriften gelegt werden. Die Bandbreite der Forschungsthemen beschränkt sich auf solche mit hoher Relevanz für die öffentliche Gesundheit und Auswirkungen für Europa. In den Geltungsbereich der Förderung fallen sowohl national als auch zentral zugelassene Produkte, einschließlich Impfstoffe. Die Ergebnisse dieser Forschung werden anschließend vom verantwortlichen Gremium der Agentur hinsichtlich der Notwendigkeit von Regulierungsmaßnahmen bewertet, und es können anschließend weitere Untersuchungen durchgeführt werden, um die Wirksamkeit gesetzgeberischer Maßnahmen zu messen.

Die Forschung kann sich auf vier verschiedene Lose beziehen, mit maximal fünf Rahmenverträgen für die Lose 1, 2 und 3 und maximal 8 Rahmenverträgen für Los 4.

II.1.5) Estimated total value

Value excluding VAT: 5 000 000.00  EUR

II.1.6) Information about lots

This contract is divided into lots: Yes

Tenders may be submitted for all lots

II.2) Description

Lot No: 1

II.2.1) Title

Einsatz innovativer Methoden zur Optimierung des Nutzens von spärlichen Daten zur Unterstützung der Nutzen-Risiko-Bewertung

II.2.2) Additional CPV code(s)

73210000

II.2.3) Place of performance

NUTS code:

UKI4

II.2.4) Description of the procurement

Die vollständige Beschreibung finden Sie in Abschnitt 3.2 der technischen Spezifikationen (Beschaffungsdokumente).

II.2.5) Award criteria

Price is not the only award criterion and all criteria are stated only in the procurement documents

II.2.6) Estimated value

Value excluding VAT: 400 000.00  EUR

II.2.7) Duration of the contract, framework agreement or dynamic purchasing system

Duration in months: 48

This contract is subject to renewal: No

II.2.9) Information about the limits on the number of candidates to be invited

II.2.10) Information about variants

Variants will be accepted: No

II.2.11) Information about options

Options: No

II.2.13) Information about European Union funds

The procurement is related to a project and/or programme financed by European Union funds: No

II.2.14) Additional information

Bitte beachten Sie, dass für Los 1 maximal 5 Rahmenverträge vorgesehen sind.

Lot No: 2

II.2.1) Title

Qualitative Forschung

II.2.2) Additional CPV code(s)

73210000

II.2.3) Place of performance

NUTS code:

UKI4

II.2.4) Description of the procurement

Die vollständige Beschreibung finden Sie in Abschnitt 3.2 der technischen Spezifikationen (Beschaffungsdokumente).

II.2.5) Award criteria

Price is not the only award criterion and all criteria are stated only in the procurement documents

II.2.6) Estimated value

Value excluding VAT: 600 000.00  EUR

II.2.7) Duration of the contract, framework agreement or dynamic purchasing system

Duration in months: 48

This contract is subject to renewal: No

II.2.9) Information about the limits on the number of candidates to be invited

II.2.10) Information about variants

Variants will be accepted: No

II.2.11) Information about options

Options: No

II.2.13) Information about European Union funds

The procurement is related to a project and/or programme financed by European Union funds: No

II.2.14) Additional information

Bitte beachten Sie, dass für Los 2 maximal 5 Rahmenverträge vorgesehen sind.

Lot No: 3

II.2.1) Title

Pharmakoepidemiologische Forschung - schnelle deskriptive Studien

II.2.2) Additional CPV code(s)

73210000

II.2.3) Place of performance

NUTS code:

UKI4

II.2.4) Description of the procurement

Die vollständige Beschreibung finden Sie in Abschnitt 3.2 der technischen Spezifikationen (Beschaffungsdokumente).

II.2.5) Award criteria

Price is not the only award criterion and all criteria are stated only in the procurement documents

II.2.6) Estimated value

Value excluding VAT: 1 000 000.00  EUR

II.2.7) Duration of the contract, framework agreement or dynamic purchasing system

Duration in months: 48

This contract is subject to renewal: No

II.2.9) Information about the limits on the number of candidates to be invited

II.2.10) Information about variants

Variants will be accepted: No

II.2.11) Information about options

Options: No

II.2.13) Information about European Union funds

The procurement is related to a project and/or programme financed by European Union funds: No

II.2.14) Additional information

Bitte beachten Sie, dass für Los 3 maximal 5 Rahmenverträge vorgesehen sind.

Lot No: 4

II.2.1) Title

Pharmakoepidemiologische Forschung — Assoziationsstudien, einschließlich Schwangerschaft und Stillforschung.

II.2.2) Additional CPV code(s)

73210000

II.2.3) Place of performance

NUTS code:

UKI4

II.2.4) Description of the procurement

Die vollständige Beschreibung finden Sie in Abschnitt 3.2 der technischen Spezifikationen (Beschaffungsdokumente).

II.2.5) Award criteria

Price is not the only award criterion and all criteria are stated only in the procurement documents

II.2.6) Estimated value

Value excluding VAT: 3 000 000.00  EUR

II.2.7) Duration of the contract, framework agreement or dynamic purchasing system

Duration in months: 48

This contract is subject to renewal: No

II.2.9) Information about the limits on the number of candidates to be invited

II.2.10) Information about variants

Variants will be accepted: No

II.2.11) Information about options

Options: No

II.2.13) Information about European Union funds

The procurement is related to a project and/or programme financed by European Union funds: No

II.2.14) Additional information

Bitte beachten Sie, dass für Los 4 maximal 8 Rahmenverträge vorgesehen sind.

Section II: Object

II.1) Scope of the procurement

II.1.1) Title

Efficacy and safety studies on medicines.

Reference number: EMA/2017/09/PE

II.1.2) Main CPV code

73000000

 

II.1.3) Type of contract

Services

II.1.4) Short description

Post-authorisation effectiveness and pharmacoepidemiology studies to generate data and information to support regulatory decision-making. Research may also focus on the effectiveness of regulatory measures taken and on the impact of relevant legislation. The range of research topics is limited to those with high public health relevance and with a European impact. The scope of the funding covers both nationally and centrally authorised products, including vaccines. The results obtained from this research will subsequently be assessed by the responsible agency committee regarding the need for regulatory action and further research may subsequently also be conducted to measure the effectiveness of regulatory actions taken.

The research may concern four different lots, with a maximum of five framework contracts for lots 1, 2 and 3 and a maximum of 8 framework contracts for lot 4.

II.1.5) Estimated total value

Value excluding VAT: 5 000 000.00  EUR

II.1.6) Information about lots

This contract is divided into lots: Yes

Tenders may be submitted for all lots

II.2) Description

Lot No: 1

II.2.1) Title

Use of innovative methods to optimise the utility of sparse data to support benefit /risk assessment

II.2.2) Additional CPV code(s)

73210000

II.2.3) Place of performance

NUTS code:

UKI4

II.2.4) Description of the procurement

For full description please see section 3.2 of the technical specifications (procurement documents).

II.2.5) Award criteria

Price is not the only award criterion and all criteria are stated only in the procurement documents

II.2.6) Estimated value

Value excluding VAT: 400 000.00  EUR

II.2.7) Duration of the contract, framework agreement or dynamic purchasing system

Duration in months: 48

This contract is subject to renewal: No

II.2.9) Information about the limits on the number of candidates to be invited

II.2.10) Information about variants

Variants will be accepted: No

II.2.11) Information about options

Options: No

II.2.13) Information about European Union funds

The procurement is related to a project and/or programme financed by European Union funds: No

II.2.14) Additional information

Please note that a maximum of 5 framework contracts is foreseen for lot 1.

Lot No: 2

II.2.1) Title

Qualitative research

II.2.2) Additional CPV code(s)

73210000

II.2.3) Place of performance

NUTS code:

UKI4

II.2.4) Description of the procurement

For full description please see section 3.2 of the technical specifications (procurement documents).

II.2.5) Award criteria

Price is not the only award criterion and all criteria are stated only in the procurement documents

II.2.6) Estimated value

Value excluding VAT: 600 000.00  EUR

II.2.7) Duration of the contract, framework agreement or dynamic purchasing system

Duration in months: 48

This contract is subject to renewal: No

II.2.9) Information about the limits on the number of candidates to be invited

II.2.10) Information about variants

Variants will be accepted: No

II.2.11) Information about options

Options: No

II.2.13) Information about European Union funds

The procurement is related to a project and/or programme financed by European Union funds: No

II.2.14) Additional information

Please note that a maximum of 5 framework contracts is foreseen for lot 2.

Lot No: 3

II.2.1) Title

Pharmacoepidemiology research — rapid descriptive studies

II.2.2) Additional CPV code(s)

73210000

II.2.3) Place of performance

NUTS code:

UKI4

II.2.4) Description of the procurement

For full description please see section 3.2 of the technical specifications (procurement documents).

II.2.5) Award criteria

Price is not the only award criterion and all criteria are stated only in the procurement documents

II.2.6) Estimated value

Value excluding VAT: 1 000 000.00  EUR

II.2.7) Duration of the contract, framework agreement or dynamic purchasing system

Duration in months: 48

This contract is subject to renewal: No

II.2.9) Information about the limits on the number of candidates to be invited

II.2.10) Information about variants

Variants will be accepted: No

II.2.11) Information about options

Options: No

II.2.13) Information about European Union funds

The procurement is related to a project and/or programme financed by European Union funds: No

II.2.14) Additional information

Please note that a maximum of 5 framework contracts is foreseen for lot 3.

Lot No: 4

II.2.1) Title

Pharmacoepidemiology research — association studies, including pregnancy and breastfeeding research.

II.2.2) Additional CPV code(s)

73210000

II.2.3) Place of performance

NUTS code:

UKI4

II.2.4) Description of the procurement

For full description please see section 3.2 of the technical specifications (procurement documents).

II.2.5) Award criteria

Price is not the only award criterion and all criteria are stated only in the procurement documents

II.2.6) Estimated value

Value excluding VAT: 3 000 000.00  EUR

II.2.7) Duration of the contract, framework agreement or dynamic purchasing system

Duration in months: 48

This contract is subject to renewal: No

II.2.9) Information about the limits on the number of candidates to be invited

II.2.10) Information about variants

Variants will be accepted: No

II.2.11) Information about options

Options: No

II.2.13) Information about European Union funds

The procurement is related to a project and/or programme financed by European Union funds: No

II.2.14) Additional information

Please note that a maximum of 8 framework contracts is foreseen for lot 4.

Section II: Object

II.1) Scope of the procurement

II.1.1) Title

Estudios de eficacia y seguridad de medicamentos.

Reference number: EMA/2017/09/PE

II.1.2) Main CPV code

73000000

 

II.1.3) Type of contract

Services

II.1.4) Short description

Estudios farmacoepidemiológicos y de eficacia posteriores a la autorización para generar datos e información que apoyen la adopción de decisiones reguladoras. La investigación también se podrá centrar en la eficacia de las medidas reguladoras tomadas y en las repercusiones de la legislación pertinente. El ámbito de los temas de investigación se limita a aquellos temas que sean de gran relevancia para la salud pública y con impacto a nivel europeo. El ámbito de la financiación cubre los productos autorizados tanto centralmente como nacionalmente, incluidas las vacunas. El comité de la agencia responsable evaluará los resultados obtenidos en esta investigación para valorar la necesidad de acción reguladora, y también se podrán llevar a cabo más investigaciones para determinar la eficacia de las acciones reguladoras tomadas.

La investigación puede incluir 4 lotes distintos, con un máximo de 5 contratos marco para los lotes 1, 2 y 3, y un máximo de 8 contratos marco para el lote 4.

II.1.5) Estimated total value

Value excluding VAT: 5 000 000.00  EUR

II.1.6) Information about lots

This contract is divided into lots: Yes

Tenders may be submitted for all lots

II.2) Description

Lot No: 1

II.2.1) Title

Utilización de métodos innovadores para optimizar la utilidad de los datos escasos para reforzar la evaluación de beneficios/riesgos

II.2.2) Additional CPV code(s)

73210000

II.2.3) Place of performance

NUTS code:

UKI4

II.2.4) Description of the procurement

Para una descripción pormenorizada, véase el apartado 3.2 de las especificaciones (documentos del concurso).

II.2.5) Award criteria

Price is not the only award criterion and all criteria are stated only in the procurement documents

II.2.6) Estimated value

Value excluding VAT: 400 000.00  EUR

II.2.7) Duration of the contract, framework agreement or dynamic purchasing system

Duration in months: 48

This contract is subject to renewal: No

II.2.9) Information about the limits on the number of candidates to be invited

II.2.10) Information about variants

Variants will be accepted: No

II.2.11) Information about options

Options: No

II.2.13) Information about European Union funds

The procurement is related to a project and/or programme financed by European Union funds: No

II.2.14) Additional information

Téngase en cuenta que se prevé un máximo de 5 contratos marco para el lote 1.

Lot No: 2

II.2.1) Title

Investigación cualitativa

II.2.2) Additional CPV code(s)

73210000

II.2.3) Place of performance

NUTS code:

UKI4

II.2.4) Description of the procurement

Para una descripción pormenorizada, véase el apartado 3.2 de las especificaciones (documentos del concurso).

II.2.5) Award criteria

Price is not the only award criterion and all criteria are stated only in the procurement documents

II.2.6) Estimated value

Value excluding VAT: 600 000.00  EUR

II.2.7) Duration of the contract, framework agreement or dynamic purchasing system

Duration in months: 48

This contract is subject to renewal: No

II.2.9) Information about the limits on the number of candidates to be invited

II.2.10) Information about variants

Variants will be accepted: No

II.2.11) Information about options

Options: No

II.2.13) Information about European Union funds

The procurement is related to a project and/or programme financed by European Union funds: No

II.2.14) Additional information

Téngase en cuenta que se prevé un máximo de 5 contratos marco para el lote 2.

Lot No: 3

II.2.1) Title

Investigación farmacoepidemiológica: estudios descriptivos rápidos

II.2.2) Additional CPV code(s)

73210000

II.2.3) Place of performance

NUTS code:

UKI4

II.2.4) Description of the procurement

Para una descripción pormenorizada, véase el apartado 3.2 de las especificaciones (documentos del concurso).

II.2.5) Award criteria

Price is not the only award criterion and all criteria are stated only in the procurement documents

II.2.6) Estimated value

Value excluding VAT: 1 000 000.00  EUR

II.2.7) Duration of the contract, framework agreement or dynamic purchasing system

Duration in months: 48

This contract is subject to renewal: No

II.2.9) Information about the limits on the number of candidates to be invited

II.2.10) Information about variants

Variants will be accepted: No

II.2.11) Information about options

Options: No

II.2.13) Information about European Union funds

The procurement is related to a project and/or programme financed by European Union funds: No

II.2.14) Additional information

Téngase en cuenta que se prevé un máximo de 5 contratos marco para el lote 3.

Lot No: 4

II.2.1) Title

Investigación farmacoepidemiológica: estudios de asociación, incluyendo investigación sobre embarazo y lactancia.

II.2.2) Additional CPV code(s)

73210000

II.2.3) Place of performance

NUTS code:

UKI4

II.2.4) Description of the procurement

Para una descripción pormenorizada, véase el apartado 3.2 de las especificaciones (documentos del concurso).

II.2.5) Award criteria

Price is not the only award criterion and all criteria are stated only in the procurement documents

II.2.6) Estimated value

Value excluding VAT: 3 000 000.00  EUR

II.2.7) Duration of the contract, framework agreement or dynamic purchasing system

Duration in months: 48

This contract is subject to renewal: No

II.2.9) Information about the limits on the number of candidates to be invited

II.2.10) Information about variants

Variants will be accepted: No

II.2.11) Information about options

Options: No

II.2.13) Information about European Union funds

The procurement is related to a project and/or programme financed by European Union funds: No

II.2.14) Additional information

Téngase en cuenta que se prevé un máximo de 8 contratos marco para el lote 4.

Section II: Object

II.1) Scope of the procurement

II.1.1) Title

Lääkkeiden tehokkuutta ja turvallisuutta koskevat tutkimukset.

Reference number: EMA/2017/09/PE

II.1.2) Main CPV code

73000000

 

II.1.3) Type of contract

Services

II.1.4) Short description

Sopimuksen kohteena on myyntiluvan myöntämisen jälkeistä tehokkuutta ja farmakoepidemiologiaa koskeva tutkimus sellaisten tietojen tuottamiseksi, joiden avulla tuetaan sääntelyyn liittyvää päätöksentekoa. Tutkimuksessa voidaan keskittyä myös toteutettujen sääntelytoimenpiteiden tehokkuuteen ja asiaankuuluvan lainsäädännön vaikutuksiin. Tutkimusaiheet rajoitetaan koskemaan kansanterveyden kannalta erittäin tärkeitä kysymyksiä, joilla on vaikutuksia Euroopassa. Rahoitus kattaa sekä kansallisesti että keskitetysti hyväksytyt valmisteet, myös rokotteet. Tämän jälkeen asiasta vastaava virastokomitea arvioi tutkimuksesta saatuja tietoja sääntelytoimien tarpeellisuuden kannalta, ja myös täydentäviä tutkimuksia voidaan suorittaa suoritettujen sääntelytoimien tehokkuuden mittaamiseksi.

Tutkimus voi koskea neljää eri erää, ja puitesopimuksia tehdään enintään 4 erien 1, 2 ja 3 osalta ja enintään 8 erän 4 osalta.

II.1.5) Estimated total value

Value excluding VAT: 5 000 000.00  EUR

II.1.6) Information about lots

This contract is divided into lots: Yes

Tenders may be submitted for all lots

II.2) Description

Lot No: 1

II.2.1) Title

Innovatiivisten menetelmien käyttö parhaan mahdollisen hyödyn saamiseksi vähäisistä tiedoista hyötyjä/riskejä koskevan arvioinnin tueksi

II.2.2) Additional CPV code(s)

73210000

II.2.3) Place of performance

NUTS code:

UKI4

II.2.4) Description of the procurement

Katso täydellinen kuvaus tarjouseritelmien kohdasta 3.2 (hankinta-asiakirjat).

II.2.5) Award criteria

Price is not the only award criterion and all criteria are stated only in the procurement documents

II.2.6) Estimated value

Value excluding VAT: 400 000.00  EUR

II.2.7) Duration of the contract, framework agreement or dynamic purchasing system

Duration in months: 48

This contract is subject to renewal: No

II.2.9) Information about the limits on the number of candidates to be invited

II.2.10) Information about variants

Variants will be accepted: No

II.2.11) Information about options

Options: No

II.2.13) Information about European Union funds

The procurement is related to a project and/or programme financed by European Union funds: No

II.2.14) Additional information

Tarjoajia pyydetään huomioimaan, että erästä 1 on tarkoitus tehdä enintään 5 puitesopimusta.

Lot No: 2

II.2.1) Title

Laadullinen tutkimus

II.2.2) Additional CPV code(s)

73210000

II.2.3) Place of performance

NUTS code:

UKI4

II.2.4) Description of the procurement

Katso täydellinen kuvaus tarjouseritelmien kohdasta 3.2 (hankinta-asiakirjat).

II.2.5) Award criteria

Price is not the only award criterion and all criteria are stated only in the procurement documents

II.2.6) Estimated value

Value excluding VAT: 600 000.00  EUR

II.2.7) Duration of the contract, framework agreement or dynamic purchasing system

Duration in months: 48

This contract is subject to renewal: No

II.2.9) Information about the limits on the number of candidates to be invited

II.2.10) Information about variants

Variants will be accepted: No

II.2.11) Information about options

Options: No

II.2.13) Information about European Union funds

The procurement is related to a project and/or programme financed by European Union funds: No

II.2.14) Additional information

Tarjoajia pyydetään huomioimaan, että erästä 2 on tarkoitus tehdä enintään 5 puitesopimusta.

Lot No: 3

II.2.1) Title

Farmakoepidemiologiaa koskeva tutkimus – nopeat kuvailevat tutkimukset

II.2.2) Additional CPV code(s)

73210000

II.2.3) Place of performance

NUTS code:

UKI4

II.2.4) Description of the procurement

Katso täydellinen kuvaus tarjouseritelmien kohdasta 3.2 (hankinta-asiakirjat).

II.2.5) Award criteria

Price is not the only award criterion and all criteria are stated only in the procurement documents

II.2.6) Estimated value

Value excluding VAT: 1 000 000.00  EUR

II.2.7) Duration of the contract, framework agreement or dynamic purchasing system

Duration in months: 48

This contract is subject to renewal: No

II.2.9) Information about the limits on the number of candidates to be invited

II.2.10) Information about variants

Variants will be accepted: No

II.2.11) Information about options

Options: No

II.2.13) Information about European Union funds

The procurement is related to a project and/or programme financed by European Union funds: No

II.2.14) Additional information

Tarjoajia pyydetään huomioimaan, että erästä 3 on tarkoitus tehdä enintään 5 puitesopimusta.

Lot No: 4

II.2.1) Title

Farmakoepidemiologiaa koskeva tutkimus – assosiaatiotutkimukset, mukaan luettuina raskautta ja imetystä koskeva tutkimus.

II.2.2) Additional CPV code(s)

73210000

II.2.3) Place of performance

NUTS code:

UKI4

II.2.4) Description of the procurement

Katso täydellinen kuvaus tarjouseritelmien kohdasta 3.2 (hankinta-asiakirjat).

II.2.5) Award criteria

Price is not the only award criterion and all criteria are stated only in the procurement documents

II.2.6) Estimated value

Value excluding VAT: 3 000 000.00  EUR

II.2.7) Duration of the contract, framework agreement or dynamic purchasing system

Duration in months: 48

This contract is subject to renewal: No

II.2.9) Information about the limits on the number of candidates to be invited

II.2.10) Information about variants

Variants will be accepted: No

II.2.11) Information about options

Options: No

II.2.13) Information about European Union funds

The procurement is related to a project and/or programme financed by European Union funds: No

II.2.14) Additional information

Tarjoajia pyydetään huomioimaan, että erästä 4 on tarkoitus tehdä enintään 8 puitesopimusta.

Section II: Object

II.1) Scope of the procurement

II.1.1) Title

Études sur l’efficacité et la sécurité des médicaments.

Reference number: EMA/2017/09/PE

II.1.2) Main CPV code

73000000

 

II.1.3) Type of contract

Services

II.1.4) Short description

Efficacité post-autorisation et études pharmaco-épidémiologiques afin de générer des données et des informations pour soutenir la prise de décision réglementaire. La recherche pourra également se focaliser sur l’efficacité des mesures réglementaires prises et sur l’impact de la législation applicable. Les sujets d'étude sont limités à ceux qui présentent un intérêt élevé pour la santé publique et qui ont un impact à l'échelle européenne. Le champ d’application du fond couvre les produits autorisés au niveau national ainsi qu’au niveau central, y compris les vaccins. Les résultats de cette recherche seront par la suite évalués par le comité de l’agence compétente quant à la nécessité d’actions réglementaires et d’autres recherches pourront également être menées par la suite afin d’évaluer l’efficacité des actions réglementaires prises.

La recherche pourra porter sur quatre lots différents, avec un maximum de cinq contrats-cadres pour les lots 1, 2 et 3 et un maximum de 8 contrats-cadres pour le lot 4.

II.1.5) Estimated total value

Value excluding VAT: 5 000 000.00  EUR

II.1.6) Information about lots

This contract is divided into lots: Yes

Tenders may be submitted for all lots

II.2) Description

Lot No: 1

II.2.1) Title

Utilisation des méthodes innovantes pour optimiser l’utilité des données éparses afin d’assurer l’appui à l’évaluation des bénéfices/risques

II.2.2) Additional CPV code(s)

73210000

II.2.3) Place of performance

NUTS code:

UKI4

II.2.4) Description of the procurement

Pour une description complète, voir la section 3.2 des spécifications techniques (dossier d’appel d’offres).

II.2.5) Award criteria

Price is not the only award criterion and all criteria are stated only in the procurement documents

II.2.6) Estimated value

Value excluding VAT: 400 000.00  EUR

II.2.7) Duration of the contract, framework agreement or dynamic purchasing system

Duration in months: 48

This contract is subject to renewal: No

II.2.9) Information about the limits on the number of candidates to be invited

II.2.10) Information about variants

Variants will be accepted: No

II.2.11) Information about options

Options: No

II.2.13) Information about European Union funds

The procurement is related to a project and/or programme financed by European Union funds: No

II.2.14) Additional information

Il convient de noter qu’un maximum de 5 contrats-cadres est prévu pour le lot 1.

Lot No: 2

II.2.1) Title

Recherche qualitative

II.2.2) Additional CPV code(s)

73210000

II.2.3) Place of performance

NUTS code:

UKI4

II.2.4) Description of the procurement

Pour une description complète, voir la section 3.2 des spécifications techniques (dossier d’appel d’offres).

II.2.5) Award criteria

Price is not the only award criterion and all criteria are stated only in the procurement documents

II.2.6) Estimated value

Value excluding VAT: 600 000.00  EUR

II.2.7) Duration of the contract, framework agreement or dynamic purchasing system

Duration in months: 48

This contract is subject to renewal: No

II.2.9) Information about the limits on the number of candidates to be invited

II.2.10) Information about variants

Variants will be accepted: No

II.2.11) Information about options

Options: No

II.2.13) Information about European Union funds

The procurement is related to a project and/or programme financed by European Union funds: No

II.2.14) Additional information

Il convient de noter qu’un maximum de 5 contrats-cadres est prévu pour le lot 2.

Lot No: 3

II.2.1) Title

Recherche pharmaco-épidémiologique — études descriptives rapides

II.2.2) Additional CPV code(s)

73210000

II.2.3) Place of performance

NUTS code:

UKI4

II.2.4) Description of the procurement

Pour une description complète, voir la section 3.2 des spécifications techniques (dossier d’appel d’offres).

II.2.5) Award criteria

Price is not the only award criterion and all criteria are stated only in the procurement documents

II.2.6) Estimated value

Value excluding VAT: 1 000 000.00  EUR

II.2.7) Duration of the contract, framework agreement or dynamic purchasing system

Duration in months: 48

This contract is subject to renewal: No

II.2.9) Information about the limits on the number of candidates to be invited

II.2.10) Information about variants

Variants will be accepted: No

II.2.11) Information about options

Options: No

II.2.13) Information about European Union funds

The procurement is related to a project and/or programme financed by European Union funds: No

II.2.14) Additional information

Il convient de noter qu’un maximum de 5 contrats-cadres est prévu pour le lot 3.

Lot No: 4

II.2.1) Title

Recherche pharmaco-épidémiologique — études d’association, y compris la recherche sur la grossesse et l’allaitement.

II.2.2) Additional CPV code(s)

73210000

II.2.3) Place of performance

NUTS code:

UKI4

II.2.4) Description of the procurement

Pour une description complète, voir la section 3.2 des spécifications techniques (dossier d’appel d’offres).

II.2.5) Award criteria

Price is not the only award criterion and all criteria are stated only in the procurement documents

II.2.6) Estimated value

Value excluding VAT: 3 000 000.00  EUR

II.2.7) Duration of the contract, framework agreement or dynamic purchasing system

Duration in months: 48

This contract is subject to renewal: No

II.2.9) Information about the limits on the number of candidates to be invited

II.2.10) Information about variants

Variants will be accepted: No

II.2.11) Information about options

Options: No

II.2.13) Information about European Union funds

The procurement is related to a project and/or programme financed by European Union funds: No

II.2.14) Additional information

Il convient de noter qu’un maximum de 8 contrats-cadres est prévu pour le lot 4.

Section II: Object

II.1) Scope of the procurement

II.1.1) Title

¿e¿¿te¿ ap¿te¿esµat¿¿¿t¿ta¿ ¿a¿ asf¿¿e¿a¿ fa¿µ¿¿¿¿.

Reference number: EMA/2017/09/PE

II.1.2) Main CPV code

73000000

 

II.1.3) Type of contract

Services

II.1.4) Short description

¿ete¿¿¿¿t¿¿¿¿ µe¿¿te¿ ap¿te¿esµat¿¿¿t¿ta¿ ¿a¿ fa¿µa¿¿ep¿d¿µ¿¿¿¿¿¿a¿ ¿¿a t¿¿ pa¿a¿¿¿¿ ded¿µ¿¿¿¿ ¿a¿ p¿¿¿¿f¿¿¿¿¿ s¿et¿¿¿ µe t¿¿ ¿p¿st¿¿¿¿¿ t¿¿ ¿¿¿¿¿ ap¿f¿se¿¿ se ¿¿¿µ¿st¿¿¿ ¿¿µata. ¿ ¿¿e¿¿a µp¿¿e¿ ep¿s¿¿ ¿a ep¿¿e¿t¿¿¿e¿ st¿¿ ap¿te¿esµat¿¿¿t¿ta t¿¿ ¿¿f¿¿¿t¿¿ ¿¿¿µ¿st¿¿¿¿ µ¿t¿¿¿ ¿a¿ st¿¿ a¿t¿¿t¿p¿ t¿¿ s¿et¿¿¿¿ ¿¿µ¿¿es¿a¿. ¿¿ e¿¿¿¿ ¿eµ¿t¿¿ ¿¿e¿¿a¿ pe¿¿¿¿¿¿eta¿ se a¿t¿ p¿¿ s¿et¿¿¿¿ta¿ se µe¿¿¿¿ ßa¿µ¿ µe t¿ d¿µ¿s¿a ¿¿e¿a ¿a¿ ¿¿¿¿¿ a¿t¿¿t¿p¿ se e¿¿¿pa¿¿¿ ep¿ped¿. ¿¿ e¿¿¿¿ t¿¿ ¿¿¿µat¿d¿t¿s¿¿ ¿a¿¿pte¿ t¿s¿ e¿¿¿¿¿ ¿s¿ ¿a¿ p¿¿¿¿¿ta µe ¿de¿a ¿¿¿¿¿f¿¿¿a¿ µ¿s¿ ¿e¿t¿¿¿¿¿ d¿ad¿¿as¿a¿, s¿µpe¿¿¿aµßa¿¿µ¿¿¿¿ t¿¿ eµß¿¿¿¿¿. ¿a ap¿te¿¿sµata p¿¿ ¿a p¿¿¿¿¿¿¿¿ ap¿ t¿¿ ¿¿e¿¿a a¿t¿ ¿a a¿¿¿¿¿¿¿¿¿¿¿ e¿ t¿¿ ¿st¿¿¿¿ ap¿ t¿¿ a¿µ¿d¿a ep¿t¿¿p¿ t¿¿ ¿¿¿a¿¿sµ¿¿ s¿et¿¿¿ µe t¿¿ a¿¿¿¿¿ ¿¿¿µ¿st¿¿¿¿ d¿¿s¿¿ ¿a¿, st¿ s¿¿¿¿e¿a, µp¿¿e¿ ¿a d¿e¿a¿¿e¿ pe¿a¿t¿¿¿ ¿¿e¿¿a ¿¿a t¿ µ¿t¿¿s¿ t¿¿ ap¿te¿esµat¿¿¿t¿ta¿ t¿¿ ¿¿f¿¿¿t¿¿ ¿¿¿µ¿st¿¿¿¿ d¿¿se¿¿.

¿ ¿¿e¿¿a µp¿¿e¿ ¿a af¿¿¿ t¿sse¿¿¿ d¿af¿¿et¿¿¿¿ pa¿t¿de¿, µe p¿¿te s¿µß¿se¿¿-p¿a¿s¿a ¿at¿ a¿¿tat¿ ¿¿¿¿ ¿¿a t¿¿ pa¿t¿de¿ 1, 2 ¿a¿ 3 ¿a¿ 8 s¿µß¿se¿¿-p¿a¿s¿a ¿at¿ a¿¿tat¿ ¿¿¿¿ ¿¿a t¿¿ pa¿t¿da 4.

II.1.5) Estimated total value

Value excluding VAT: 5 000 000.00  EUR

II.1.6) Information about lots

This contract is divided into lots: Yes

Tenders may be submitted for all lots

II.2) Description

Lot No: 1

II.2.1) Title

¿¿¿s¿ ¿a¿¿¿t¿µ¿¿ µe¿¿d¿¿ ¿¿a t¿ ße¿t¿st¿p¿¿¿s¿ t¿¿ ¿¿¿s¿µ¿t¿ta¿ t¿¿ a¿a¿¿¿ ded¿µ¿¿¿¿ st¿¿ st¿¿¿¿¿ t¿¿ a¿¿¿¿¿¿¿s¿¿ t¿¿ s¿¿s¿¿ ¿f¿¿¿¿¿/¿¿¿d¿¿¿¿

II.2.2) Additional CPV code(s)

73210000

II.2.3) Place of performance

NUTS code:

UKI4

II.2.4) Description of the procurement

G¿a p¿¿¿¿ pe¿¿¿¿af¿, a¿at¿¿¿te st¿ tµ¿µa 3.2 t¿¿ te¿¿¿¿¿¿ p¿¿d¿a¿¿af¿¿ (¿¿¿¿afa d¿a¿¿¿¿sµ¿¿).

II.2.5) Award criteria

Price is not the only award criterion and all criteria are stated only in the procurement documents

II.2.6) Estimated value

Value excluding VAT: 400 000.00  EUR

II.2.7) Duration of the contract, framework agreement or dynamic purchasing system

Duration in months: 48

This contract is subject to renewal: No

II.2.9) Information about the limits on the number of candidates to be invited

II.2.10) Information about variants

Variants will be accepted: No

II.2.11) Information about options

Options: No

II.2.13) Information about European Union funds

The procurement is related to a project and/or programme financed by European Union funds: No

II.2.14) Additional information

S¿µe¿¿ste ¿t¿ ¿¿a t¿¿ pa¿t¿da 1 p¿¿ß¿¿p¿¿ta¿ 5 s¿µß¿se¿¿-p¿a¿s¿a ¿at¿ a¿¿tat¿ ¿¿¿¿.

Lot No: 2

II.2.1) Title

¿¿¿¿t¿¿¿ ¿¿e¿¿a

II.2.2) Additional CPV code(s)

73210000

II.2.3) Place of performance

NUTS code:

UKI4

II.2.4) Description of the procurement

G¿a p¿¿¿¿ pe¿¿¿¿af¿, a¿at¿¿¿te st¿ tµ¿µa 3.2 t¿¿ te¿¿¿¿¿¿ p¿¿d¿a¿¿af¿¿ (¿¿¿¿afa d¿a¿¿¿¿sµ¿¿).

II.2.5) Award criteria

Price is not the only award criterion and all criteria are stated only in the procurement documents

II.2.6) Estimated value

Value excluding VAT: 600 000.00  EUR

II.2.7) Duration of the contract, framework agreement or dynamic purchasing system

Duration in months: 48

This contract is subject to renewal: No

II.2.9) Information about the limits on the number of candidates to be invited

II.2.10) Information about variants

Variants will be accepted: No

II.2.11) Information about options

Options: No

II.2.13) Information about European Union funds

The procurement is related to a project and/or programme financed by European Union funds: No

II.2.14) Additional information

S¿µe¿¿ste ¿t¿ ¿¿a t¿¿ pa¿t¿da 2 p¿¿ß¿¿p¿¿ta¿ 5 s¿µß¿se¿¿-p¿a¿s¿a ¿at¿ a¿¿tat¿ ¿¿¿¿.

Lot No: 3

II.2.1) Title

Fa¿µa¿¿ep¿d¿µ¿¿¿¿¿¿¿¿ ¿¿e¿¿a — ta¿e¿e¿ pe¿¿¿¿af¿¿¿¿ µe¿¿te¿

II.2.2) Additional CPV code(s)

73210000

II.2.3) Place of performance

NUTS code:

UKI4

II.2.4) Description of the procurement

G¿a p¿¿¿¿ pe¿¿¿¿af¿, a¿at¿¿¿te st¿ tµ¿µa 3.2 t¿¿ te¿¿¿¿¿¿ p¿¿d¿a¿¿af¿¿ (¿¿¿¿afa d¿a¿¿¿¿sµ¿¿).

II.2.5) Award criteria

Price is not the only award criterion and all criteria are stated only in the procurement documents

II.2.6) Estimated value

Value excluding VAT: 1 000 000.00  EUR

II.2.7) Duration of the contract, framework agreement or dynamic purchasing system

Duration in months: 48

This contract is subject to renewal: No

II.2.9) Information about the limits on the number of candidates to be invited

II.2.10) Information about variants

Variants will be accepted: No

II.2.11) Information about options

Options: No

II.2.13) Information about European Union funds

The procurement is related to a project and/or programme financed by European Union funds: No

II.2.14) Additional information

S¿µe¿¿ste ¿t¿ ¿¿a t¿¿ pa¿t¿da 3 p¿¿ß¿¿p¿¿ta¿ 5 s¿µß¿se¿¿-p¿a¿s¿a ¿at¿ a¿¿tat¿ ¿¿¿¿.

Lot No: 4

II.2.1) Title

Fa¿µa¿¿ep¿d¿µ¿¿¿¿¿¿¿¿ ¿¿e¿¿a — µe¿¿te¿ s¿s¿¿t¿s¿¿ s¿µpe¿¿¿aµßa¿¿µ¿¿¿¿ t¿¿ ¿¿e¿¿a¿ s¿et¿¿¿ µe t¿¿ e¿¿¿µ¿s¿¿¿ ¿a¿ t¿ ¿¿¿asµ¿.

II.2.2) Additional CPV code(s)

73210000

II.2.3) Place of performance

NUTS code:

UKI4

II.2.4) Description of the procurement

G¿a p¿¿¿¿ pe¿¿¿¿af¿, a¿at¿¿¿te st¿ tµ¿µa 3.2 t¿¿ te¿¿¿¿¿¿ p¿¿d¿a¿¿af¿¿ (¿¿¿¿afa d¿a¿¿¿¿sµ¿¿).

II.2.5) Award criteria

Price is not the only award criterion and all criteria are stated only in the procurement documents

II.2.6) Estimated value

Value excluding VAT: 3 000 000.00  EUR

II.2.7) Duration of the contract, framework agreement or dynamic purchasing system

Duration in months: 48

This contract is subject to renewal: No

II.2.9) Information about the limits on the number of candidates to be invited

II.2.10) Information about variants

Variants will be accepted: No

II.2.11) Information about options

Options: No

II.2.13) Information about European Union funds

The procurement is related to a project and/or programme financed by European Union funds: No

II.2.14) Additional information

S¿µe¿¿ste ¿t¿ ¿¿a t¿¿ pa¿t¿da 4 p¿¿ß¿¿p¿¿ta¿ 8 s¿µß¿se¿¿-p¿a¿s¿a ¿at¿ a¿¿tat¿ ¿¿¿¿.

Section II: Object

II.1) Scope of the procurement

II.1.1) Title

Studi sull'efficacia e la sicurezza dei farmaci.

Reference number: EMA/2017/09/PE

II.1.2) Main CPV code

73000000

 

II.1.3) Type of contract

Services

II.1.4) Short description

Studi sulla farmacoepidemiologia e l'efficacia post-autorizzazione allo scopo di produrre dati e informazioni onde sostenere il processo decisionale regolamentare. La ricerca può anche riguardare l'efficacia delle misure regolamentari adottate e l'impatto della legislazione pertinente. La gamma delle tematiche di ricerca sarà limitata a quelle con elevata rilevanza sulla sanità pubblica e con un impatto europeo. Lo scopo del finanziamento riguarda prodotti autorizzati a livello nazionale e centrale, compresi i vaccini. I risultati ottenuti dalla ricerca in oggetto verranno successivamente valutati dalla commissione dell'agenzia responsabile in merito alla necessità di un'azione normativa e potranno essere successivamente condotte ulteriori ricerche per misurare l'efficacia delle azioni normative intraprese.

La ricerca potrà interessare quattro lotti diversi, con un massimo di cinque contratti quadro per i lotti 1, 2 e 3 e un massimo di 8 contratti quadro per il lotto 4.

II.1.5) Estimated total value

Value excluding VAT: 5 000 000.00  EUR

II.1.6) Information about lots

This contract is divided into lots: Yes

Tenders may be submitted for all lots

II.2) Description

Lot No: 1

II.2.1) Title

Utilizzo di metodi innovativi per ottimizzare l'utilità di dati sparsi per sostenere la valutazione del rapporto rischio/beneficio

II.2.2) Additional CPV code(s)

73210000

II.2.3) Place of performance

NUTS code:

UKI4

II.2.4) Description of the procurement

Per una descrizione completa, consultare la sezione 3.2 delle specifiche tecniche (documenti di gara).

II.2.5) Award criteria

Price is not the only award criterion and all criteria are stated only in the procurement documents

II.2.6) Estimated value

Value excluding VAT: 400 000.00  EUR

II.2.7) Duration of the contract, framework agreement or dynamic purchasing system

Duration in months: 48

This contract is subject to renewal: No

II.2.9) Information about the limits on the number of candidates to be invited

II.2.10) Information about variants

Variants will be accepted: No

II.2.11) Information about options

Options: No

II.2.13) Information about European Union funds

The procurement is related to a project and/or programme financed by European Union funds: No

II.2.14) Additional information

Si prega di notare che è previsto un massimo di 5 contratti quadro per il lotto 1.

Lot No: 2

II.2.1) Title

Ricerca qualitativa

II.2.2) Additional CPV code(s)

73210000

II.2.3) Place of performance

NUTS code:

UKI4

II.2.4) Description of the procurement

Per una descrizione completa, consultare la sezione 3.2 delle specifiche tecniche (documenti di gara).

II.2.5) Award criteria

Price is not the only award criterion and all criteria are stated only in the procurement documents

II.2.6) Estimated value

Value excluding VAT: 600 000.00  EUR

II.2.7) Duration of the contract, framework agreement or dynamic purchasing system

Duration in months: 48

This contract is subject to renewal: No

II.2.9) Information about the limits on the number of candidates to be invited

II.2.10) Information about variants

Variants will be accepted: No

II.2.11) Information about options

Options: No

II.2.13) Information about European Union funds

The procurement is related to a project and/or programme financed by European Union funds: No

II.2.14) Additional information

Si prega di notare che è previsto un massimo di 5 contratti quadro per il lotto 2.

Lot No: 3

II.2.1) Title

Ricerca sulla farmacoepidemiologia: studi descrittivi rapidi

II.2.2) Additional CPV code(s)

73210000

II.2.3) Place of performance

NUTS code:

UKI4

II.2.4) Description of the procurement

Per una descrizione completa, consultare la sezione 3.2 delle specifiche tecniche (documenti di gara).

II.2.5) Award criteria

Price is not the only award criterion and all criteria are stated only in the procurement documents

II.2.6) Estimated value

Value excluding VAT: 1 000 000.00  EUR

II.2.7) Duration of the contract, framework agreement or dynamic purchasing system

Duration in months: 48

This contract is subject to renewal: No

II.2.9) Information about the limits on the number of candidates to be invited

II.2.10) Information about variants

Variants will be accepted: No

II.2.11) Information about options

Options: No

II.2.13) Information about European Union funds

The procurement is related to a project and/or programme financed by European Union funds: No

II.2.14) Additional information

Si prega di notare che è previsto un massimo di 5 contratti quadro per il lotto 3.

Lot No: 4

II.2.1) Title

Ricerca farmacoepidemiologia: studi di associazione, compresa la ricerca sulla gravidanza e l'allattamento al seno.

II.2.2) Additional CPV code(s)

73210000

II.2.3) Place of performance

NUTS code:

UKI4

II.2.4) Description of the procurement

Per una descrizione completa, consultare la sezione 3.2 delle specifiche tecniche (documenti di gara).

II.2.5) Award criteria

Price is not the only award criterion and all criteria are stated only in the procurement documents

II.2.6) Estimated value

Value excluding VAT: 3 000 000.00  EUR

II.2.7) Duration of the contract, framework agreement or dynamic purchasing system

Duration in months: 48

This contract is subject to renewal: No

II.2.9) Information about the limits on the number of candidates to be invited

II.2.10) Information about variants

Variants will be accepted: No

II.2.11) Information about options

Options: No

II.2.13) Information about European Union funds

The procurement is related to a project and/or programme financed by European Union funds: No

II.2.14) Additional information

Si prega di notare che è previsto un massimo di 8 contratti quadro per il lotto 4.

Section II: Object

II.1) Scope of the procurement

II.1.1) Title

Onderzoeken betreffende de doeltreffendheid en veiligheid van geneesmiddelen.

Reference number: EMA/2017/09/PE

II.1.2) Main CPV code

73000000

 

II.1.3) Type of contract

Services

II.1.4) Short description

Doeltreffendheids- en farmaco-epidemiologisch onderzoeken (na toelating) voor het genereren van gegevens en informatie ter ondersteuning van besluitvorming inzake regulering. Het onderzoek kan zich tevens toespitsen op de doeltreffendheid van de regulerende maatregelen en de effecten van relevante wetgeving. De onderzoeksonderwerpen zijn beperkt tot deze met grote relevantie voor de volksgezondheid en met een effect in Europa. Het bereik van de financiering dekt zowel nationaal als centraal vergunde producten, met inbegrip van vaccins. De resultaten die door dit onderzoek worden bekomen, zullen vervolgens worden beoordeeld door de verantwoordelijke commissie van het bureau met betrekking tot de behoefte aan regelgevende actie en daarna kan ook verder onderzoek worden uitgevoerd om de doeltreffendheid van de ondernomen regelgevende acties te meten.

Het onderzoek kan betrekking hebben op 4 verschillende percelen, met maximaal 5 raamovereenkomsten voor percelen 1, 2 en 3 en maximaal 8 raamovereenkomsten voor perceel 4.

II.1.5) Estimated total value

Value excluding VAT: 5 000 000.00  EUR

II.1.6) Information about lots

This contract is divided into lots: Yes

Tenders may be submitted for all lots

II.2) Description

Lot No: 1

II.2.1) Title

Gebruik van innovatieve methoden voor de optimalisering van de bruikbaarheid van schaarse gegevens ter ondersteuning van voordelen-/risicobeoordelingen

II.2.2) Additional CPV code(s)

73210000

II.2.3) Place of performance

NUTS code:

UKI4

II.2.4) Description of the procurement

Zie sectie 3.2 van de technische specificaties (aanbestedingsstukken) voor de volledige beschrijving.

II.2.5) Award criteria

Price is not the only award criterion and all criteria are stated only in the procurement documents

II.2.6) Estimated value

Value excluding VAT: 400 000.00  EUR

II.2.7) Duration of the contract, framework agreement or dynamic purchasing system

Duration in months: 48

This contract is subject to renewal: No

II.2.9) Information about the limits on the number of candidates to be invited

II.2.10) Information about variants

Variants will be accepted: No

II.2.11) Information about options

Options: No

II.2.13) Information about European Union funds

The procurement is related to a project and/or programme financed by European Union funds: No

II.2.14) Additional information

Gelieve op te merken dat er maximaal 5 raamovereenkomsten zijn voorzien voor perceel 1.

Lot No: 2

II.2.1) Title

Kwalitatief onderzoek

II.2.2) Additional CPV code(s)

73210000

II.2.3) Place of performance

NUTS code:

UKI4

II.2.4) Description of the procurement

Zie sectie 3.2 van de technische specificaties (aanbestedingsstukken) voor de volledige beschrijving.

II.2.5) Award criteria

Price is not the only award criterion and all criteria are stated only in the procurement documents

II.2.6) Estimated value

Value excluding VAT: 600 000.00  EUR

II.2.7) Duration of the contract, framework agreement or dynamic purchasing system

Duration in months: 48

This contract is subject to renewal: No

II.2.9) Information about the limits on the number of candidates to be invited

II.2.10) Information about variants

Variants will be accepted: No

II.2.11) Information about options

Options: No

II.2.13) Information about European Union funds

The procurement is related to a project and/or programme financed by European Union funds: No

II.2.14) Additional information

Gelieve op te merken dat er maximaal 5 raamovereenkomsten zijn voorzien voor perceel 2.

Lot No: 3

II.2.1) Title

Farmaco-epidemiologisch onderzoek — snelle beschrijvende onderzoeken

II.2.2) Additional CPV code(s)

73210000

II.2.3) Place of performance

NUTS code:

UKI4

II.2.4) Description of the procurement

Zie sectie 3.2 van de technische specificaties (aanbestedingsstukken) voor de volledige beschrijving.

II.2.5) Award criteria

Price is not the only award criterion and all criteria are stated only in the procurement documents

II.2.6) Estimated value

Value excluding VAT: 1 000 000.00  EUR

II.2.7) Duration of the contract, framework agreement or dynamic purchasing system

Duration in months: 48

This contract is subject to renewal: No

II.2.9) Information about the limits on the number of candidates to be invited

II.2.10) Information about variants

Variants will be accepted: No

II.2.11) Information about options

Options: No

II.2.13) Information about European Union funds

The procurement is related to a project and/or programme financed by European Union funds: No

II.2.14) Additional information

Gelieve op te merken dat er maximaal 5 raamovereenkomsten zijn voorzien voor perceel 3.

Lot No: 4

II.2.1) Title

Farmaco-epidemiologisch onderzoek — aanverwante onderzoeken, met inbegrip van onderzoek inzake zwangerschap en borstvoeding.

II.2.2) Additional CPV code(s)

73210000

II.2.3) Place of performance

NUTS code:

UKI4

II.2.4) Description of the procurement

Zie sectie 3.2 van de technische specificaties (aanbestedingsstukken) voor de volledige beschrijving.

II.2.5) Award criteria

Price is not the only award criterion and all criteria are stated only in the procurement documents

II.2.6) Estimated value

Value excluding VAT: 3 000 000.00  EUR

II.2.7) Duration of the contract, framework agreement or dynamic purchasing system

Duration in months: 48

This contract is subject to renewal: No

II.2.9) Information about the limits on the number of candidates to be invited

II.2.10) Information about variants

Variants will be accepted: No

II.2.11) Information about options

Options: No

II.2.13) Information about European Union funds

The procurement is related to a project and/or programme financed by European Union funds: No

II.2.14) Additional information

Gelieve op te merken dat er maximaal 8 raamovereenkomsten zijn voorzien voor perceel 4.

Section II: Object

II.1) Scope of the procurement

II.1.1) Title

Estudos no domínio da eficácia e segurança sobre medicamentos.

Reference number: EMA/2017/09/PE

II.1.2) Main CPV code

73000000

 

II.1.3) Type of contract

Services

II.1.4) Short description

Investigação no domínio da farmacoepidemiologia e eficácia após autorização para geração de dados e informação de apoio na tomada de decisão regulamentar. A investigação pode ainda centrar-se na eficácia das medidas regulamentares adotadas e no impacto da legislação relevante. A abrangência dos tópicos está limitada aos que tenham uma relevância significativa para a saúde pública e um impacto europeu. O âmbito do financiamento cobre produtos autorizados a níveis nacional e central, incluindo as vacinas. Os resultados obtidos a partir desta pesquisa serão posteriormente avaliados pela comissão da agência responsável sobre a necessidade de uma ação regulamentar e também podem ser realizadas investigações adicionais para medir a eficácia das ações regulamentares tomadas.

A investigação pode referir-se a quatro lotes diferentes, com um máximo de cinco contratos-quadro para os lotes 1, 2 e 3 e um máximo de 8 contratos-quadro para o lote 4.

II.1.5) Estimated total value

Value excluding VAT: 5 000 000.00  EUR

II.1.6) Information about lots

This contract is divided into lots: Yes

Tenders may be submitted for all lots

II.2) Description

Lot No: 1

II.2.1) Title

Utilização de métodos inovadores para otimizar a utilidade de dados escassos de apoio à avaliação dos riscos e benefícios

II.2.2) Additional CPV code(s)

73210000

II.2.3) Place of performance

NUTS code:

UKI4

II.2.4) Description of the procurement

Para obter uma descrição completa, consulte a ponto 3.2 das especificações técnicas (documentos da adjudicação).

II.2.5) Award criteria

Price is not the only award criterion and all criteria are stated only in the procurement documents

II.2.6) Estimated value

Value excluding VAT: 400 000.00  EUR

II.2.7) Duration of the contract, framework agreement or dynamic purchasing system

Duration in months: 48

This contract is subject to renewal: No

II.2.9) Information about the limits on the number of candidates to be invited

II.2.10) Information about variants

Variants will be accepted: No

II.2.11) Information about options

Options: No

II.2.13) Information about European Union funds

The procurement is related to a project and/or programme financed by European Union funds: No

II.2.14) Additional information

Importa notar que está previsto um máximo de 5 contratos-quadro para o lote 1.

Lot No: 2

II.2.1) Title

Investigação qualitativa

II.2.2) Additional CPV code(s)

73210000

II.2.3) Place of performance

NUTS code:

UKI4

II.2.4) Description of the procurement

Para obter uma descrição completa, consulte a ponto 3.2 das especificações técnicas (documentos da adjudicação).

II.2.5) Award criteria

Price is not the only award criterion and all criteria are stated only in the procurement documents

II.2.6) Estimated value

Value excluding VAT: 600 000.00  EUR

II.2.7) Duration of the contract, framework agreement or dynamic purchasing system

Duration in months: 48

This contract is subject to renewal: No

II.2.9) Information about the limits on the number of candidates to be invited

II.2.10) Information about variants

Variants will be accepted: No

II.2.11) Information about options

Options: No

II.2.13) Information about European Union funds

The procurement is related to a project and/or programme financed by European Union funds: No

II.2.14) Additional information

Importa notar que está previsto um máximo de 5 contratos-quadro para o lote 2.

Lot No: 3

II.2.1) Title

Investigação em farmacoepidemiologia — estudos descritivos rápidos

II.2.2) Additional CPV code(s)

73210000

II.2.3) Place of performance

NUTS code:

UKI4

II.2.4) Description of the procurement

Para obter uma descrição completa, consulte a ponto 3.2 das especificações técnicas (documentos da adjudicação).

II.2.5) Award criteria

Price is not the only award criterion and all criteria are stated only in the procurement documents

II.2.6) Estimated value

Value excluding VAT: 1 000 000.00  EUR

II.2.7) Duration of the contract, framework agreement or dynamic purchasing system

Duration in months: 48

This contract is subject to renewal: No

II.2.9) Information about the limits on the number of candidates to be invited

II.2.10) Information about variants

Variants will be accepted: No

II.2.11) Information about options

Options: No

II.2.13) Information about European Union funds

The procurement is related to a project and/or programme financed by European Union funds: No

II.2.14) Additional information

Importa notar que está previsto um máximo de 5 contratos-quadro para o lote 3.

Lot No: 4

II.2.1) Title

Investigação em farmacoepidemiologia — estudos de associação, incluindo investigação sobre gravidez e amamentação.

II.2.2) Additional CPV code(s)

73210000

II.2.3) Place of performance

NUTS code:

UKI4

II.2.4) Description of the procurement

Para obter uma descrição completa, consulte a ponto 3.2 das especificações técnicas (documentos da adjudicação).

II.2.5) Award criteria

Price is not the only award criterion and all criteria are stated only in the procurement documents

II.2.6) Estimated value

Value excluding VAT: 3 000 000.00  EUR

II.2.7) Duration of the contract, framework agreement or dynamic purchasing system

Duration in months: 48

This contract is subject to renewal: No

II.2.9) Information about the limits on the number of candidates to be invited

II.2.10) Information about variants

Variants will be accepted: No

II.2.11) Information about options

Options: No

II.2.13) Information about European Union funds

The procurement is related to a project and/or programme financed by European Union funds: No

II.2.14) Additional information

Importa notar que está previsto um máximo de 8 contratos-quadro para o lote 4.

Section II: Object

II.1) Scope of the procurement

II.1.1) Title

Studier avseende läkemedels effektivitet och säkerhet.

Reference number: EMA/2017/09/PE

II.1.2) Main CPV code

73000000

 

II.1.3) Type of contract

Services

II.1.4) Short description

Effektivitetsforskning och farmakoepidemiologiforskning efter godkännande för försäljning i syfte att generera data och information till stöd för beslutsfattande beträffande föreskrifter. Forskningen kan även inriktas på effektiviteten av vidtagna reglerande åtgärder och på effekterna av relevant lagstiftning. Forskningsämnenas omfattning är begränsad till områden som är av stor relevans för folkhälsan och som har betydelse för Europa. Finansieringens omfattning täcker både nationellt och centralt godkända produkter, inbegripet vacciner. Resultaten från denna forskning kommer sedan att bedömas av den ansvariga kommittén avseende behovet för lagstiftningsåtgärder och vidare forskning kan också senare utföras för att mäta effektiviteten av de tagna lagstiftningsåtgärderna.

Forskningen kan gälla 4 olika delar, med högst 5 ramavtal för del 1, 2 och 3 och högst 8 ramavtal för del 4.

II.1.5) Estimated total value

Value excluding VAT: 5 000 000.00  EUR

II.1.6) Information about lots

This contract is divided into lots: Yes

Tenders may be submitted for all lots

II.2) Description

Lot No: 1

II.2.1) Title

Användning av innovativa idéer för att optimera användbarheten av glesa data för att stödja nytto-/riskbedömning

II.2.2) Additional CPV code(s)

73210000

II.2.3) Place of performance

NUTS code:

UKI4

II.2.4) Description of the procurement

För en fullständig beskrivning se sektion 3.2 i de tekniska specifikationerna (upphandlingsdokumenten).

II.2.5) Award criteria

Price is not the only award criterion and all criteria are stated only in the procurement documents

II.2.6) Estimated value

Value excluding VAT: 400 000.00  EUR

II.2.7) Duration of the contract, framework agreement or dynamic purchasing system

Duration in months: 48

This contract is subject to renewal: No

II.2.9) Information about the limits on the number of candidates to be invited

II.2.10) Information about variants

Variants will be accepted: No

II.2.11) Information about options

Options: No

II.2.13) Information about European Union funds

The procurement is related to a project and/or programme financed by European Union funds: No

II.2.14) Additional information

Observera att högst 5 ramavtal förutses för del 1.

Lot No: 2

II.2.1) Title

Kvalitativ forskning

II.2.2) Additional CPV code(s)

73210000

II.2.3) Place of performance

NUTS code:

UKI4

II.2.4) Description of the procurement

För en fullständig beskrivning se sektion 3.2 i de tekniska specifikationerna (upphandlingsdokumenten).

II.2.5) Award criteria

Price is not the only award criterion and all criteria are stated only in the procurement documents

II.2.6) Estimated value

Value excluding VAT: 600 000.00  EUR

II.2.7) Duration of the contract, framework agreement or dynamic purchasing system

Duration in months: 48

This contract is subject to renewal: No

II.2.9) Information about the limits on the number of candidates to be invited

II.2.10) Information about variants

Variants will be accepted: No

II.2.11) Information about options

Options: No

II.2.13) Information about European Union funds

The procurement is related to a project and/or programme financed by European Union funds: No

II.2.14) Additional information

Observera att högst 5 ramavtal förutses för del 2.

Lot No: 3

II.2.1) Title

Farmakoepidemiologiforskning – snabbdeskriptiva studier

II.2.2) Additional CPV code(s)

73210000

II.2.3) Place of performance

NUTS code:

UKI4

II.2.4) Description of the procurement

För en fullständig beskrivning se sektion 3.2 i de tekniska specifikationerna (upphandlingsdokumenten).

II.2.5) Award criteria

Price is not the only award criterion and all criteria are stated only in the procurement documents

II.2.6) Estimated value

Value excluding VAT: 1 000 000.00  EUR

II.2.7) Duration of the contract, framework agreement or dynamic purchasing system

Duration in months: 48

This contract is subject to renewal: No

II.2.9) Information about the limits on the number of candidates to be invited

II.2.10) Information about variants

Variants will be accepted: No

II.2.11) Information about options

Options: No

II.2.13) Information about European Union funds

The procurement is related to a project and/or programme financed by European Union funds: No

II.2.14) Additional information

Observera att högst 5 ramavtal förutses för del 3.

Lot No: 4

II.2.1) Title

Farmakoepidemiologiforskning – associeringsstudier, inklusive forskning kring graviditet och amning.

II.2.2) Additional CPV code(s)

73210000

II.2.3) Place of performance

NUTS code:

UKI4

II.2.4) Description of the procurement

För en fullständig beskrivning se sektion 3.2 i de tekniska specifikationerna (upphandlingsdokumenten).

II.2.5) Award criteria

Price is not the only award criterion and all criteria are stated only in the procurement documents

II.2.6) Estimated value

Value excluding VAT: 3 000 000.00  EUR

II.2.7) Duration of the contract, framework agreement or dynamic purchasing system

Duration in months: 48

This contract is subject to renewal: No

II.2.9) Information about the limits on the number of candidates to be invited

II.2.10) Information about variants

Variants will be accepted: No

II.2.11) Information about options

Options: No

II.2.13) Information about European Union funds

The procurement is related to a project and/or programme financed by European Union funds: No

II.2.14) Additional information

Observera att högst 8 ramavtal förutses för del 4.

Section II: Object

II.1) Scope of the procurement

II.1.1) Title

Studie úcinnosti a bezpecnosti lécivých prípravku.

Reference number: EMA/2017/09/PE

II.1.2) Main CPV code

73000000

 

II.1.3) Type of contract

Services

II.1.4) Short description

Studie zamerená na úcinnost a farmakoepidemiologii v návaznosti na schvalování léciv s cílem získat údaje a informace na podporu rozhodování v oblasti regulace. Výzkum se muže zamerit také na úcinnost prijatých regulacních opatrení a na dopad príslušné legislativy. Rozsah témat výzkumu se omezuje na ta s velkým významem pro verejné zdravotnictví a s evropským dopadem. Rozsah financování zahrnuje národne i centrálne schvalované výrobky, vcetne vakcín. Výsledky získané v tomto výzkumu budou následne hodnoceny odpovedným výborem agentury, co se týce potreby regulacních opatrení, a muže být následne proveden další výzkum s cílem posoudit efektivitu prijatých regulacních opatrení.

Výzkum se muže týkat ctyr ruzných položek. Na položky c. 1, 2 a 3 muže být uzavreno maximálne pet rámcových smluv a na položku c. 4 maximálne 8 rámcových smluv.

II.1.5) Estimated total value

Value excluding VAT: 5 000 000.00  EUR

II.1.6) Information about lots

This contract is divided into lots: Yes

Tenders may be submitted for all lots

II.2) Description

Lot No: 1

II.2.1) Title

Využití inovativních metod s cílem optimalizovat užitecnost nízkého množství údaju za úcelem podpory hodnocení rizik / výhod

II.2.2) Additional CPV code(s)

73210000

II.2.3) Place of performance

NUTS code:

UKI4

II.2.4) Description of the procurement

Celý popis viz oddíl 3.2 technické specifikace (zadávací dokumentace).

II.2.5) Award criteria

Price is not the only award criterion and all criteria are stated only in the procurement documents

II.2.6) Estimated value

Value excluding VAT: 400 000.00  EUR

II.2.7) Duration of the contract, framework agreement or dynamic purchasing system

Duration in months: 48

This contract is subject to renewal: No

II.2.9) Information about the limits on the number of candidates to be invited

II.2.10) Information about variants

Variants will be accepted: No

II.2.11) Information about options

Options: No

II.2.13) Information about European Union funds

The procurement is related to a project and/or programme financed by European Union funds: No

II.2.14) Additional information

Upozornujeme, že pro položku c. 1 se predpokládá maximálne 5 rámcových smluv.

Lot No: 2

II.2.1) Title

Kvalitativní výzkum

II.2.2) Additional CPV code(s)

73210000

II.2.3) Place of performance

NUTS code:

UKI4

II.2.4) Description of the procurement

Celý popis viz oddíl 3.2 technické specifikace (zadávací dokumentace).

II.2.5) Award criteria

Price is not the only award criterion and all criteria are stated only in the procurement documents

II.2.6) Estimated value

Value excluding VAT: 600 000.00  EUR

II.2.7) Duration of the contract, framework agreement or dynamic purchasing system

Duration in months: 48

This contract is subject to renewal: No

II.2.9) Information about the limits on the number of candidates to be invited

II.2.10) Information about variants

Variants will be accepted: No

II.2.11) Information about options

Options: No

II.2.13) Information about European Union funds

The procurement is related to a project and/or programme financed by European Union funds: No

II.2.14) Additional information

Upozornujeme, že pro položku c. 2 se predpokládá maximálne 5 rámcových smluv.

Lot No: 3

II.2.1) Title

Farmakoepidemiologický výzkum – rychlá popisná studie

II.2.2) Additional CPV code(s)

73210000

II.2.3) Place of performance

NUTS code:

UKI4

II.2.4) Description of the procurement

Celý popis viz oddíl 3.2 technické specifikace (zadávací dokumentace).

II.2.5) Award criteria

Price is not the only award criterion and all criteria are stated only in the procurement documents

II.2.6) Estimated value

Value excluding VAT: 1 000 000.00  EUR

II.2.7) Duration of the contract, framework agreement or dynamic purchasing system

Duration in months: 48

This contract is subject to renewal: No

II.2.9) Information about the limits on the number of candidates to be invited

II.2.10) Information about variants

Variants will be accepted: No

II.2.11) Information about options

Options: No

II.2.13) Information about European Union funds

The procurement is related to a project and/or programme financed by European Union funds: No

II.2.14) Additional information

Upozornujeme, že pro položku c. 3 se predpokládá maximálne 5 rámcových smluv.

Lot No: 4

II.2.1) Title

Farmakoepidemiologický výzkum – pridružená studie, vcetne výzkumu v oblasti tehotenství a kojení.

II.2.2) Additional CPV code(s)

73210000

II.2.3) Place of performance

NUTS code:

UKI4

II.2.4) Description of the procurement

Celý popis viz oddíl 3.2 technické specifikace (zadávací dokumentace).

II.2.5) Award criteria

Price is not the only award criterion and all criteria are stated only in the procurement documents

II.2.6) Estimated value

Value excluding VAT: 3 000 000.00  EUR

II.2.7) Duration of the contract, framework agreement or dynamic purchasing system

Duration in months: 48

This contract is subject to renewal: No

II.2.9) Information about the limits on the number of candidates to be invited

II.2.10) Information about variants

Variants will be accepted: No

II.2.11) Information about options

Options: No

II.2.13) Information about European Union funds

The procurement is related to a project and/or programme financed by European Union funds: No

II.2.14) Additional information

Upozornujeme, že pro položku c. 4 se predpokládá maximálne 8 rámcových smluv.

Section II: Object

II.1) Scope of the procurement

II.1.1) Title

Ravimite tõhususe ja ohutuse uuringud.

Reference number: EMA/2017/09/PE

II.1.2) Main CPV code

73000000

 

II.1.3) Type of contract

Services

II.1.4) Short description

Loasaamisjärgne mõjusus ja farmako-epidemioloogilised uuringud regulatiivsete otsuste langetamise toetamiseks mõeldud andmete ja teabe koostamiseks. Uuringutes võidakse keskenduda ka võetud regulatiivsete meetmete mõjususele ja asjakohaste õigusaktide mõjule. Uurimisteemade ulatus on piiratud üksnes teemadega, mis on rahvatervise jaoks väga olulised ja mille mõju avaldub Euroopa tasandil. Rahastamise ulatus hõlmab nii riikliku kui ka keskse loaga tooteid, sh vaktsiine. Uuringu tulemusi regulatiivmeetmete vajaduse seisukohast hindab seejärel ameti vastutav komisjon ning samuti võidakse teostada täiendavaid uuringuid, et mõõta võetud regulatiivmeetmete tõhusust.

Uuringud võivad puudutada nelja erinevat osa, kusjuures 1., 2. ja 3. osa kohta sõlmitakse maksimaalselt viis raamlepingut ning 4. osa kohta maksimaalselt 8 raamlepingut.

II.1.5) Estimated total value

Value excluding VAT: 5 000 000.00  EUR

II.1.6) Information about lots

This contract is divided into lots: Yes

Tenders may be submitted for all lots

II.2) Description

Lot No: 1

II.2.1) Title

Innovaatiliste meetodite kasutamine hõredate andmete kasutamise optimeerimiseks, eesmärgiga toetada kasu-riskihindamist

II.2.2) Additional CPV code(s)

73210000

II.2.3) Place of performance

NUTS code:

UKI4

II.2.4) Description of the procurement

Täieliku kirjelduse kohta vt tehnilise iseloomustuse punkti 3.2 (hankedokumendid).

II.2.5) Award criteria

Price is not the only award criterion and all criteria are stated only in the procurement documents

II.2.6) Estimated value

Value excluding VAT: 400 000.00  EUR

II.2.7) Duration of the contract, framework agreement or dynamic purchasing system

Duration in months: 48

This contract is subject to renewal: No

II.2.9) Information about the limits on the number of candidates to be invited

II.2.10) Information about variants

Variants will be accepted: No

II.2.11) Information about options

Options: No

II.2.13) Information about European Union funds

The procurement is related to a project and/or programme financed by European Union funds: No

II.2.14) Additional information

Pange tähele, et 1. osa kohta on ette nähtud maksimaalselt 5 raamlepingut.

Lot No: 2

II.2.1) Title

Kvalitatiivsed uuringud

II.2.2) Additional CPV code(s)

73210000

II.2.3) Place of performance

NUTS code:

UKI4

II.2.4) Description of the procurement

Täieliku kirjelduse kohta vt tehnilise iseloomustuse punkti 3.2 (hankedokumendid).

II.2.5) Award criteria

Price is not the only award criterion and all criteria are stated only in the procurement documents

II.2.6) Estimated value

Value excluding VAT: 600 000.00  EUR

II.2.7) Duration of the contract, framework agreement or dynamic purchasing system

Duration in months: 48

This contract is subject to renewal: No

II.2.9) Information about the limits on the number of candidates to be invited

II.2.10) Information about variants

Variants will be accepted: No

II.2.11) Information about options

Options: No

II.2.13) Information about European Union funds

The procurement is related to a project and/or programme financed by European Union funds: No

II.2.14) Additional information

Pange tähele, et 2. osa kohta on ette nähtud maksimaalselt 5 raamlepingut.

Lot No: 3

II.2.1) Title

Farmako-epidemioloogilised uuringud – kirjeldavad kiiruuringud

II.2.2) Additional CPV code(s)

73210000

II.2.3) Place of performance

NUTS code:

UKI4

II.2.4) Description of the procurement

Täieliku kirjelduse kohta vt tehnilise iseloomustuse punkti 3.2 (hankedokumendid).

II.2.5) Award criteria

Price is not the only award criterion and all criteria are stated only in the procurement documents

II.2.6) Estimated value

Value excluding VAT: 1 000 000.00  EUR

II.2.7) Duration of the contract, framework agreement or dynamic purchasing system

Duration in months: 48

This contract is subject to renewal: No

II.2.9) Information about the limits on the number of candidates to be invited

II.2.10) Information about variants

Variants will be accepted: No

II.2.11) Information about options

Options: No

II.2.13) Information about European Union funds

The procurement is related to a project and/or programme financed by European Union funds: No

II.2.14) Additional information

Pange tähele, et 3. osa kohta on ette nähtud maksimaalselt 5 raamlepingut.

Lot No: 4

II.2.1) Title

Farmakoepidemioloogilised uuringud – assotsiatsiooniuuringud, sh rasedust ja rinnaga toitmist käsitlevad uuringud.

II.2.2) Additional CPV code(s)

73210000

II.2.3) Place of performance

NUTS code:

UKI4

II.2.4) Description of the procurement

Täieliku kirjelduse kohta vt tehnilise iseloomustuse punkti 3.2 (hankedokumendid).

II.2.5) Award criteria

Price is not the only award criterion and all criteria are stated only in the procurement documents

II.2.6) Estimated value

Value excluding VAT: 3 000 000.00  EUR

II.2.7) Duration of the contract, framework agreement or dynamic purchasing system

Duration in months: 48

This contract is subject to renewal: No

II.2.9) Information about the limits on the number of candidates to be invited

II.2.10) Information about variants

Variants will be accepted: No

II.2.11) Information about options

Options: No

II.2.13) Information about European Union funds

The procurement is related to a project and/or programme financed by European Union funds: No

II.2.14) Additional information

Pange tähele, et 4. osa kohta on ette nähtud maksimaalselt 8 raamlepingut.

Section II: Object

II.1) Scope of the procurement

II.1.1) Title

Gyógyszerekre vonatkozó hatékonysági és biztonságossági vizsgálatok.

Reference number: EMA/2017/09/PE

II.1.2) Main CPV code

73000000

 

II.1.3) Type of contract

Services

II.1.4) Short description

Engedélyezés utáni gyógyszerhatékonysági és farmakoepidemiológiai vizsgálatok adatok és információk eloállításához a szabályozási döntéshozatal támogatása céljából. A kutatás a szabályozói intézkedések hatékonyságára és a vonatkozó jogszabályok hatására is összpontosíthat. A kutatási témák a közegészségügyi szempontból nagy jelentoségu és európai hatású témákra korlátozódnak. A finanszírozás mind a nemzetileg, mind a központilag engedélyezett termékekre, többek között a vakcinákra is kiterjed. A kutatásból származó eredményeket a késobbiekben értékelni fogja a felelos ügynökség bizottsága szabályozási intézkedés szükségességét illetoen, valamint további kutatás is végezheto a késobbiekben a szabályozási intézkedések hatékonyságának felmérése céljából.

A kutatás 4 különbözo tételre vonatkozhat, az 1., 2. és 3. tétel esetében legfeljebb 5, a 4. tétel esetében pedig legfeljebb 8 keretszerzodés megkötésével.

II.1.5) Estimated total value

Value excluding VAT: 5 000 000.00  EUR

II.1.6) Information about lots

This contract is divided into lots: Yes

Tenders may be submitted for all lots

II.2) Description

Lot No: 1

II.2.1) Title

Innovatív módszerek alkalmazása a kevés rendelkezésre álló adat hasznosságának optimalizálására az elony/kockázat értékelésének támogatása céljából

II.2.2) Additional CPV code(s)

73210000

II.2.3) Place of performance

NUTS code:

UKI4

II.2.4) Description of the procurement

A teljes leírást lásd a muszaki dokumentáció (közbeszerzési dokumentáció) 3.2. szakaszában.

II.2.5) Award criteria

Price is not the only award criterion and all criteria are stated only in the procurement documents

II.2.6) Estimated value

Value excluding VAT: 400 000.00  EUR

II.2.7) Duration of the contract, framework agreement or dynamic purchasing system

Duration in months: 48

This contract is subject to renewal: No

II.2.9) Information about the limits on the number of candidates to be invited

II.2.10) Information about variants

Variants will be accepted: No

II.2.11) Information about options

Options: No

II.2.13) Information about European Union funds

The procurement is related to a project and/or programme financed by European Union funds: No

II.2.14) Additional information

Felhívjuk a figyelmet, hogy az 1. tétel esetében legfeljebb 5 keretszerzodés megkötését tervezik.

Lot No: 2

II.2.1) Title

Minoségi kutatás

II.2.2) Additional CPV code(s)

73210000

II.2.3) Place of performance

NUTS code:

UKI4

II.2.4) Description of the procurement

A teljes leírást lásd a muszaki dokumentáció (közbeszerzési dokumentáció) 3.2. szakaszában.

II.2.5) Award criteria

Price is not the only award criterion and all criteria are stated only in the procurement documents

II.2.6) Estimated value

Value excluding VAT: 600 000.00  EUR

II.2.7) Duration of the contract, framework agreement or dynamic purchasing system

Duration in months: 48

This contract is subject to renewal: No

II.2.9) Information about the limits on the number of candidates to be invited

II.2.10) Information about variants

Variants will be accepted: No

II.2.11) Information about options

Options: No

II.2.13) Information about European Union funds

The procurement is related to a project and/or programme financed by European Union funds: No

II.2.14) Additional information

Felhívjuk a figyelmet, hogy a 2. tétel esetében legfeljebb 5 keretszerzodés megkötését tervezik.

Lot No: 3

II.2.1) Title

Farmakoepidemiológiai kutatás – gyors leíró jellegu vizsgálatok

II.2.2) Additional CPV code(s)

73210000

II.2.3) Place of performance

NUTS code:

UKI4

II.2.4) Description of the procurement

A teljes leírást lásd a muszaki dokumentáció (közbeszerzési dokumentáció) 3.2. szakaszában.

II.2.5) Award criteria

Price is not the only award criterion and all criteria are stated only in the procurement documents

II.2.6) Estimated value

Value excluding VAT: 1 000 000.00  EUR

II.2.7) Duration of the contract, framework agreement or dynamic purchasing system

Duration in months: 48

This contract is subject to renewal: No

II.2.9) Information about the limits on the number of candidates to be invited

II.2.10) Information about variants

Variants will be accepted: No

II.2.11) Information about options

Options: No

II.2.13) Information about European Union funds

The procurement is related to a project and/or programme financed by European Union funds: No

II.2.14) Additional information

Felhívjuk a figyelmet, hogy a 3.tétel esetében legfeljebb 5 keretszerzodés megkötését tervezik.

Lot No: 4

II.2.1) Title

Farmakoepidemiológiai kutatás – kapcsolati vizsgálatok, ideértve a terhességi és szoptatási kutatásokat is.

II.2.2) Additional CPV code(s)

73210000

II.2.3) Place of performance

NUTS code:

UKI4

II.2.4) Description of the procurement

A teljes leírást lásd a muszaki dokumentáció (közbeszerzési dokumentáció) 3.2. szakaszában.

II.2.5) Award criteria

Price is not the only award criterion and all criteria are stated only in the procurement documents

II.2.6) Estimated value

Value excluding VAT: 3 000 000.00  EUR

II.2.7) Duration of the contract, framework agreement or dynamic purchasing system

Duration in months: 48

This contract is subject to renewal: No

II.2.9) Information about the limits on the number of candidates to be invited

II.2.10) Information about variants

Variants will be accepted: No

II.2.11) Information about options

Options: No

II.2.13) Information about European Union funds

The procurement is related to a project and/or programme financed by European Union funds: No

II.2.14) Additional information

Felhívjuk a figyelmet, hogy a 4. tétel esetében legfeljebb 8 keretszerzodés megkötését tervezik.

Section II: Object

II.1) Scope of the procurement

II.1.1) Title

Vaistu veiksmingumo ir saugumo tyrimai.

Reference number: EMA/2017/09/PE

II.1.2) Main CPV code

73000000

 

II.1.3) Type of contract

Services

II.1.4) Short description

Poregistraciniai veiksmingumo ir farmakoepidemiologijos tyrimai duomenims ir informacijai surinkti siekiant remti reguliavimo sprendimu priemima. Moksliniais tyrimais taip pat gali buti atkreipiamas demesys i reguliavimo priemoniu, kuriu buvo imtasi, veiksminguma ir i tinkamu teises aktu poveiki. Tyrimu temos yra ribotos tiems, kuriems visuomenes sveikata yra itin svarbi ir kurie turi itakos Europos mastu. Finansavimas vykdomas vaistams, iskaitant vakcinas, kuriu rinkodaros leidimas išduotas taikant nacionaline ir centralizuota procedura. Šio tyrimo metu gauti rezultatai bus ivertinti atsakingo agenturos komiteto reguliavimo priemoniu poreikio atžvilgiu, o veliau galimai bus atlikti tolesni tyrimai, skirti ivertinti priimtu reguliavimo priemoniu veiksminguma.

Tyrimas gali buti padalintas i keturias skirtingas dalis, skiriant ne daugiau kaip 5 preliminariasias sutartis 1, 2 ir 3 dalims ir ne daugiau kaip 8 preliminariasias sutartis 4 daliai.

II.1.5) Estimated total value

Value excluding VAT: 5 000 000.00  EUR

II.1.6) Information about lots

This contract is divided into lots: Yes

Tenders may be submitted for all lots

II.2) Description

Lot No: 1

II.2.1) Title

Naujovišku metodu naudojimas, siekiant optimizuoti negausiu duomenu, skirtu paremti naudos ir rizikos vertinima, naudinguma

II.2.2) Additional CPV code(s)

73210000

II.2.3) Place of performance

NUTS code:

UKI4

II.2.4) Description of the procurement

Išsamu aprašyma rasite techniniu specifikaciju 3.2 dalyje (pirkimu dokumentai).

II.2.5) Award criteria

Price is not the only award criterion and all criteria are stated only in the procurement documents

II.2.6) Estimated value

Value excluding VAT: 400 000.00  EUR

II.2.7) Duration of the contract, framework agreement or dynamic purchasing system

Duration in months: 48

This contract is subject to renewal: No

II.2.9) Information about the limits on the number of candidates to be invited

II.2.10) Information about variants

Variants will be accepted: No

II.2.11) Information about options

Options: No

II.2.13) Information about European Union funds

The procurement is related to a project and/or programme financed by European Union funds: No

II.2.14) Additional information

Atkreipkite demesi, kad 1 daliai yra numatytos ne daugiau nei 5 preliminariosios sutartys.

Lot No: 2

II.2.1) Title

Kokybinis tyrimas

II.2.2) Additional CPV code(s)

73210000

II.2.3) Place of performance

NUTS code:

UKI4

II.2.4) Description of the procurement

Išsamu aprašyma rasite techniniu specifikaciju 3.2 dalyje (pirkimu dokumentai).

II.2.5) Award criteria

Price is not the only award criterion and all criteria are stated only in the procurement documents

II.2.6) Estimated value

Value excluding VAT: 600 000.00  EUR

II.2.7) Duration of the contract, framework agreement or dynamic purchasing system

Duration in months: 48

This contract is subject to renewal: No

II.2.9) Information about the limits on the number of candidates to be invited

II.2.10) Information about variants

Variants will be accepted: No

II.2.11) Information about options

Options: No

II.2.13) Information about European Union funds

The procurement is related to a project and/or programme financed by European Union funds: No

II.2.14) Additional information

Atkreipkite demesi, kad 2 daliai yra numatytos ne daugiau nei 5 preliminariosios sutartys.

Lot No: 3

II.2.1) Title

Farmakoepidemiologiniai tyrimai – greiti aprašomieji tyrimai

II.2.2) Additional CPV code(s)

73210000

II.2.3) Place of performance

NUTS code:

UKI4

II.2.4) Description of the procurement

Išsamu aprašyma rasite techniniu specifikaciju 3.2 dalyje (pirkimu dokumentai).

II.2.5) Award criteria

Price is not the only award criterion and all criteria are stated only in the procurement documents

II.2.6) Estimated value

Value excluding VAT: 1 000 000.00  EUR

II.2.7) Duration of the contract, framework agreement or dynamic purchasing system

Duration in months: 48

This contract is subject to renewal: No

II.2.9) Information about the limits on the number of candidates to be invited

II.2.10) Information about variants

Variants will be accepted: No

II.2.11) Information about options

Options: No

II.2.13) Information about European Union funds

The procurement is related to a project and/or programme financed by European Union funds: No

II.2.14) Additional information

Atkreipkite demesi, kad 3 daliai yra numatytos ne daugiau nei 5 preliminariosios sutartys.

Lot No: 4

II.2.1) Title

Farmakopepidemiologiniai tyrimai – asociaciju tyrimai, iskaitant neštumo ir žindymo tyrimus.

II.2.2) Additional CPV code(s)

73210000

II.2.3) Place of performance

NUTS code:

UKI4

II.2.4) Description of the procurement

Išsamu aprašyma rasite techniniu specifikaciju 3.2 dalyje (pirkimu dokumentai).

II.2.5) Award criteria

Price is not the only award criterion and all criteria are stated only in the procurement documents

II.2.6) Estimated value

Value excluding VAT: 3 000 000.00  EUR

II.2.7) Duration of the contract, framework agreement or dynamic purchasing system

Duration in months: 48

This contract is subject to renewal: No

II.2.9) Information about the limits on the number of candidates to be invited

II.2.10) Information about variants

Variants will be accepted: No

II.2.11) Information about options

Options: No

II.2.13) Information about European Union funds

The procurement is related to a project and/or programme financed by European Union funds: No

II.2.14) Additional information

Atkreipkite demesi, kad 4 daliai yra numatytos ne daugiau nei 8 preliminariosios sutartys.

Section II: Object

II.1) Scope of the procurement

II.1.1) Title

Zalu efektivitates un drošuma petijumi.

Reference number: EMA/2017/09/PE

II.1.2) Main CPV code

73000000

 

II.1.3) Type of contract

Services

II.1.4) Short description

Pecregistracijas izpete attieciba uz iedarbigumu un farmakoepidemiologiju noluka iegut datus un informaciju, ko varetu izmantot reglamentejošu lemumu pienemšana. Var but japeta ari istenoto reglamentejošo pasakumu iedarbigums un attiecigo tiesibu aktu ietekme. Petniecibas tematu klasta ir ieklauti tie temati, kas ir ipaši svarigi sabiedribas veselibai un kam ir ietekme Eiropas meroga. Finansejuma ir ietverti gan valstis, gan centralizeti atlauti produkti, tostarp vakcinas. Petijumu rezultatus novertes agenturas atbildiga komiteja, nosakot vajadzibu veikt regulativas darbibas; var tikt veikti ari papildu petijumi, lai apzinatu veikto regulativo darbibu efektivitati.

Petijumi var but saistiti ar 4 dažadam dalam, nosledzot ne vairak ka 5 pamatnoligumus par 1., 2. un 3. dalu un ne vairak ka 8 pamatnoligumus par 4. dalu.

II.1.5) Estimated total value

Value excluding VAT: 5 000 000.00  EUR

II.1.6) Information about lots

This contract is divided into lots: Yes

Tenders may be submitted for all lots

II.2) Description

Lot No: 1

II.2.1) Title

Inovativu metožu izmantošana, lai optimizetu datu derigumu ieguvumu/risku novertešanai

II.2.2) Additional CPV code(s)

73210000

II.2.3) Place of performance

NUTS code:

UKI4

II.2.4) Description of the procurement

Pilnu aprakstu ludzam skatit tehnisko specifikaciju (iepirkuma dokumentu) 3.2. iedala.

II.2.5) Award criteria

Price is not the only award criterion and all criteria are stated only in the procurement documents

II.2.6) Estimated value

Value excluding VAT: 400 000.00  EUR

II.2.7) Duration of the contract, framework agreement or dynamic purchasing system

Duration in months: 48

This contract is subject to renewal: No

II.2.9) Information about the limits on the number of candidates to be invited

II.2.10) Information about variants

Variants will be accepted: No

II.2.11) Information about options

Options: No

II.2.13) Information about European Union funds

The procurement is related to a project and/or programme financed by European Union funds: No

II.2.14) Additional information

Ludzam nemt vera, ka par 1. dalu planots noslegt ne vairak ka 5 pamatnoligumus.

Lot No: 2

II.2.1) Title

Kvalitativais petijums

II.2.2) Additional CPV code(s)

73210000

II.2.3) Place of performance

NUTS code:

UKI4

II.2.4) Description of the procurement

Pilnu aprakstu ludzam skatit tehnisko specifikaciju (iepirkuma dokumentu) 3.2. iedala.

II.2.5) Award criteria

Price is not the only award criterion and all criteria are stated only in the procurement documents

II.2.6) Estimated value

Value excluding VAT: 600 000.00  EUR

II.2.7) Duration of the contract, framework agreement or dynamic purchasing system

Duration in months: 48

This contract is subject to renewal: No

II.2.9) Information about the limits on the number of candidates to be invited

II.2.10) Information about variants

Variants will be accepted: No

II.2.11) Information about options

Options: No

II.2.13) Information about European Union funds

The procurement is related to a project and/or programme financed by European Union funds: No

II.2.14) Additional information

Ludzam nemt vera, ka par 2. dalu planots noslegt ne vairak ka 5 pamatnoligumus.

Lot No: 3

II.2.1) Title

Farmakoepidemiologiska petnieciba — atri aprakstošie petijumi

II.2.2) Additional CPV code(s)

73210000

II.2.3) Place of performance

NUTS code:

UKI4

II.2.4) Description of the procurement

Pilnu aprakstu ludzam skatit tehnisko specifikaciju (iepirkuma dokumentu) 3.2. iedala.

II.2.5) Award criteria

Price is not the only award criterion and all criteria are stated only in the procurement documents

II.2.6) Estimated value

Value excluding VAT: 1 000 000.00  EUR

II.2.7) Duration of the contract, framework agreement or dynamic purchasing system

Duration in months: 48

This contract is subject to renewal: No

II.2.9) Information about the limits on the number of candidates to be invited

II.2.10) Information about variants

Variants will be accepted: No

II.2.11) Information about options

Options: No

II.2.13) Information about European Union funds

The procurement is related to a project and/or programme financed by European Union funds: No

II.2.14) Additional information

Ludzam nemt vera, ka par 3. dalu planots noslegt ne vairak ka 5 pamatnoligumus.

Lot No: 4

II.2.1) Title

Farmakoepidemiologiska petnieciba — asociacijas petijumi, tostarp grutniecibas un zidišanas petijumi.

II.2.2) Additional CPV code(s)

73210000

II.2.3) Place of performance

NUTS code:

UKI4

II.2.4) Description of the procurement

Pilnu aprakstu ludzam skatit tehnisko specifikaciju (iepirkuma dokumentu) 3.2. iedala.

II.2.5) Award criteria

Price is not the only award criterion and all criteria are stated only in the procurement documents

II.2.6) Estimated value

Value excluding VAT: 3 000 000.00  EUR

II.2.7) Duration of the contract, framework agreement or dynamic purchasing system

Duration in months: 48

This contract is subject to renewal: No

II.2.9) Information about the limits on the number of candidates to be invited

II.2.10) Information about variants

Variants will be accepted: No

II.2.11) Information about options

Options: No

II.2.13) Information about European Union funds

The procurement is related to a project and/or programme financed by European Union funds: No

II.2.14) Additional information

Ludzam nemt vera, ka par 4. dalu planots noslegt ne vairak ka 8 pamatnoligumus.

Section II: Object

II.1) Scope of the procurement

II.1.1) Title

Studji ta' effikacja u sikurezza dwar il-medicini.

Reference number: EMA/2017/09/PE

II.1.2) Main CPV code

73000000

 

II.1.3) Type of contract

Services

II.1.4) Short description

Studji dwar l-effettività wara l-awtorizzazzjoni u dwar il-farmakoepidemjologija biex jigu ggenerati dejta u taghrif ghal appogg fit-tehid ta' decizjonijiet regolatorji. Ir-ricerka tista' tiffoka wkoll fuq l-effettività ta' mizuri regolatorji mehuda u fuq l-impatt ta' legizlazzjoni rilevanti. Il-firxa ta' suggetti ta' ricerka hija limitata ghal dawk b'rilevanza gholja ghas-sahha pubblika u b'impatt Ewropew. L-ghan tal-iffinanzjar ikopri prodotti awtorizzati kemm f'livell nazzjonali kif ukoll centrali, inkluz vaccini. Ir-rizultati li jinkisbu minn din ir-ricerka sussegwentement ser jigu vvalutati mill-kumitat responsabbli tal-agenzija rigward il-htiega ta' azzjoni regolatorja u wara dan tista' ssir aktar ricerka sabiex titqies l-effettività tal-azzjonijiet regolatorji li jkunu ttiehdu.

Ir-ricerka tista' tikkoncerna erba' lottijiet differenti, b'massimu ta' hames oqfsa ta' kuntratt ghal-lottijiet 1, 2 u 3, u massimu ta' 8 oqfsa ta' kuntratt ghal-lott 4.

II.1.5) Estimated total value

Value excluding VAT: 5 000 000.00  EUR

II.1.6) Information about lots

This contract is divided into lots: Yes

Tenders may be submitted for all lots

II.2) Description

Lot No: 1

II.2.1) Title

L-uzu ta' metodi innovattivi ghall-ottimizzazzjoni ta' dejta limitata biex tappogga l-valutazzjoni tal-beneficcju/tar-riskju

II.2.2) Additional CPV code(s)

73210000

II.2.3) Place of performance

NUTS code:

UKI4

II.2.4) Description of the procurement

Ghal deskrizzjoni shiha jekk joghgbok ara t-Taqsima 3.2 tal-ispecifikazzjonijiet teknici (dokumenti tal-ksib).

II.2.5) Award criteria

Price is not the only award criterion and all criteria are stated only in the procurement documents

II.2.6) Estimated value

Value excluding VAT: 400 000.00  EUR

II.2.7) Duration of the contract, framework agreement or dynamic purchasing system

Duration in months: 48

This contract is subject to renewal: No

II.2.9) Information about the limits on the number of candidates to be invited

II.2.10) Information about variants

Variants will be accepted: No

II.2.11) Information about options

Options: No

II.2.13) Information about European Union funds

The procurement is related to a project and/or programme financed by European Union funds: No

II.2.14) Additional information

Jekk joghgbok innota li huwa previst massimu ta' 5 oqfsa ta' kuntratt ghal-lott 1.

Lot No: 2

II.2.1) Title

Ricerka kwalitattiva

II.2.2) Additional CPV code(s)

73210000

II.2.3) Place of performance

NUTS code:

UKI4

II.2.4) Description of the procurement

Ghal deskrizzjoni shiha jekk joghgbok ara t-Taqsima 3.2 tal-ispecifikazzjonijiet teknici (dokumenti tal-ksib).

II.2.5) Award criteria

Price is not the only award criterion and all criteria are stated only in the procurement documents

II.2.6) Estimated value

Value excluding VAT: 600 000.00  EUR

II.2.7) Duration of the contract, framework agreement or dynamic purchasing system

Duration in months: 48

This contract is subject to renewal: No

II.2.9) Information about the limits on the number of candidates to be invited

II.2.10) Information about variants

Variants will be accepted: No

II.2.11) Information about options

Options: No

II.2.13) Information about European Union funds

The procurement is related to a project and/or programme financed by European Union funds: No

II.2.14) Additional information

Jekk joghgbok innota li huwa previst massimu ta' 5 oqfsa ta' kuntratt ghal-lott 2.

Lot No: 3

II.2.1) Title

Ricerka farmakopidemjologika — studji deskrittivi rapidi

II.2.2) Additional CPV code(s)

73210000

II.2.3) Place of performance

NUTS code:

UKI4

II.2.4) Description of the procurement

Ghal deskrizzjoni shiha jekk joghgbok ara t-Taqsima 3.2 tal-ispecifikazzjonijiet teknici (dokumenti tal-ksib).

II.2.5) Award criteria

Price is not the only award criterion and all criteria are stated only in the procurement documents

II.2.6) Estimated value

Value excluding VAT: 1 000 000.00  EUR

II.2.7) Duration of the contract, framework agreement or dynamic purchasing system

Duration in months: 48

This contract is subject to renewal: No

II.2.9) Information about the limits on the number of candidates to be invited

II.2.10) Information about variants

Variants will be accepted: No

II.2.11) Information about options

Options: No

II.2.13) Information about European Union funds

The procurement is related to a project and/or programme financed by European Union funds: No

II.2.14) Additional information

Jekk joghgbok innota li huwa previst massimu ta' 5 oqfsa ta' kuntratt ghal-lott 3.

Lot No: 4

II.2.1) Title

Ricerka farmakoepidemjologika — studji ta' assocjazzjoni, inkluz ricerka dwar tqala u treddigh.

II.2.2) Additional CPV code(s)

73210000

II.2.3) Place of performance

NUTS code:

UKI4

II.2.4) Description of the procurement

Ghal deskrizzjoni shiha jekk joghgbok ara t-Taqsima 3.2 tal-ispecifikazzjonijiet teknici (dokumenti tal-ksib).

II.2.5) Award criteria

Price is not the only award criterion and all criteria are stated only in the procurement documents

II.2.6) Estimated value

Value excluding VAT: 3 000 000.00  EUR

II.2.7) Duration of the contract, framework agreement or dynamic purchasing system

Duration in months: 48

This contract is subject to renewal: No

II.2.9) Information about the limits on the number of candidates to be invited

II.2.10) Information about variants

Variants will be accepted: No

II.2.11) Information about options

Options: No

II.2.13) Information about European Union funds

The procurement is related to a project and/or programme financed by European Union funds: No

II.2.14) Additional information

Jekk joghgbok innota li huwa previst massimu ta' 8 oqfsa ta' kuntratt ghal-lott 4.

Section II: Object

II.1) Scope of the procurement

II.1.1) Title

Badanie skutecznosci i bezpieczenstwa leków.

Reference number: EMA/2017/09/PE

II.1.2) Main CPV code

73000000

 

II.1.3) Type of contract

Services

II.1.4) Short description

Badanie skutecznosci i farmakoepidemiologiczne po wydaniu zatwierdzenia w celu opracowania danych i informacji na potrzeby wsparcia regulacyjnego procesu decyzyjnego. Badanie moze równiez koncentrowac sie na skutecznosci podjetych srodków regulacyjnych i wplywie odpowiednich przepisów prawa. Zakres tematyczny jest ograniczony i obejmuje jedynie zagadnienia o duzym znaczeniu dla zdrowia publicznego oraz wywierajace wplyw w wymiarze europejskim. Zakres finansowania obejmuje zarówno produkty zatwierdzone na poziomie krajowym, jak i centralnym, miedzy innymi szczepionki. Wyniki niniejszego badania zostana nastepnie ocenione przez wlasciwa komisje agencji pod katem koniecznosci podjecia dzialan regulacyjnych. Nastepnie moze zostac przeprowadzone kolejne badanie w celu oceny skutecznosci podjetych dzialan regulacyjnych.

Badanie moze dotyczyc 4 róznych czesci, podpisanych moze zostac nie wiecej niz 5 umów ramowych dla czesci 1, 2 i 3 oraz nie wiecej niz 8 umów ramowych dla czesci 4.

II.1.5) Estimated total value

Value excluding VAT: 5 000 000.00  EUR

II.1.6) Information about lots

This contract is divided into lots: Yes

Tenders may be submitted for all lots

II.2) Description

Lot No: 1

II.2.1) Title

Wykorzystywanie innowacyjnych metod w celu optymalizacji wykorzystania rzadkich danych do wsparcia oceny korzysci/ryzyka

II.2.2) Additional CPV code(s)

73210000

II.2.3) Place of performance

NUTS code:

UKI4

II.2.4) Description of the procurement

Pelen opis dostepny w sekcji 3.2 specyfikacji technicznej (dokumenty zamówienia).

II.2.5) Award criteria

Price is not the only award criterion and all criteria are stated only in the procurement documents

II.2.6) Estimated value

Value excluding VAT: 400 000.00  EUR

II.2.7) Duration of the contract, framework agreement or dynamic purchasing system

Duration in months: 48

This contract is subject to renewal: No

II.2.9) Information about the limits on the number of candidates to be invited

II.2.10) Information about variants

Variants will be accepted: No

II.2.11) Information about options

Options: No

II.2.13) Information about European Union funds

The procurement is related to a project and/or programme financed by European Union funds: No

II.2.14) Additional information

Dla czesci 1 przewiduje sie nie wiecej niz 5 umów ramowych.

Lot No: 2

II.2.1) Title

Badania jakosciowe

II.2.2) Additional CPV code(s)

73210000

II.2.3) Place of performance

NUTS code:

UKI4

II.2.4) Description of the procurement

Pelen opis dostepny w sekcji 3.2 specyfikacji technicznej (dokumenty zamówienia).

II.2.5) Award criteria

Price is not the only award criterion and all criteria are stated only in the procurement documents

II.2.6) Estimated value

Value excluding VAT: 600 000.00  EUR

II.2.7) Duration of the contract, framework agreement or dynamic purchasing system

Duration in months: 48

This contract is subject to renewal: No

II.2.9) Information about the limits on the number of candidates to be invited

II.2.10) Information about variants

Variants will be accepted: No

II.2.11) Information about options

Options: No

II.2.13) Information about European Union funds

The procurement is related to a project and/or programme financed by European Union funds: No

II.2.14) Additional information

Dla czesci 2 przewiduje sie nie wiecej niz 5 umów ramowych.

Lot No: 3

II.2.1) Title

Badanie farmakoepidemiologiczne — szybkie badania opisowe

II.2.2) Additional CPV code(s)

73210000

II.2.3) Place of performance

NUTS code:

UKI4

II.2.4) Description of the procurement

Pelen opis dostepny w sekcji 3.2 specyfikacji technicznej (dokumenty zamówienia).

II.2.5) Award criteria

Price is not the only award criterion and all criteria are stated only in the procurement documents

II.2.6) Estimated value

Value excluding VAT: 1 000 000.00  EUR

II.2.7) Duration of the contract, framework agreement or dynamic purchasing system

Duration in months: 48

This contract is subject to renewal: No

II.2.9) Information about the limits on the number of candidates to be invited

II.2.10) Information about variants

Variants will be accepted: No

II.2.11) Information about options

Options: No

II.2.13) Information about European Union funds

The procurement is related to a project and/or programme financed by European Union funds: No

II.2.14) Additional information

Dla czesci 3 przewiduje sie nie wiecej niz 5 umów ramowych.

Lot No: 4

II.2.1) Title

Badanie farmakoepidemiologiczne — badania asocjacyjne, w tym badania dotyczace ciazy i karmienia piersia.

II.2.2) Additional CPV code(s)

73210000

II.2.3) Place of performance

NUTS code:

UKI4

II.2.4) Description of the procurement

Pelen opis dostepny w sekcji 3.2 specyfikacji technicznej (dokumenty zamówienia).

II.2.5) Award criteria

Price is not the only award criterion and all criteria are stated only in the procurement documents

II.2.6) Estimated value

Value excluding VAT: 3 000 000.00  EUR

II.2.7) Duration of the contract, framework agreement or dynamic purchasing system

Duration in months: 48

This contract is subject to renewal: No

II.2.9) Information about the limits on the number of candidates to be invited

II.2.10) Information about variants

Variants will be accepted: No

II.2.11) Information about options

Options: No

II.2.13) Information about European Union funds

The procurement is related to a project and/or programme financed by European Union funds: No

II.2.14) Additional information

Dla czesci 4 przewiduje sie nie wiecej niz 8 umów ramowych.

Section II: Object

II.1) Scope of the procurement

II.1.1) Title

Štúdie o úcinnosti a bezpecnosti liekov.

Reference number: EMA/2017/09/PE

II.1.2) Main CPV code

73000000

 

II.1.3) Type of contract

Services

II.1.4) Short description

Poregistracné farmakoepidemiologické štúdie a štúdie úcinnosti s cielom vygenerovat údaje a informácie na podporu prijímania regulacných rozhodnutí. Výskum môže byt tiež zameraný na úcinnost prijatých regulacných opatrení a na vplyv príslušných právnych predpisov. Rozsah výskumných tém je obmedzený na tie, ktoré sú velmi významné z hladiska verejného zdravia a ktoré majú európsky dosah. Rozsah financných prostriedkov zahrna vnútroštátne, ako aj centrálne povolené lieky vrátane vakcín. Výsledky získané na základe tohto výskumu následne posúdi príslušný výbor agentúry, pokial ide o potrebu regulacných opatrení, a následne sa môže vykonat další výskum na hodnotenie úcinnosti prijatých regulacných opatrení.

Výskum sa môže týkat 4 rôznych castí s maximálne 5 rámcovými zmluvami pre casti 1, 2 a 3 a maximálne 8 rámcovými zmluvami pre cast 4.

II.1.5) Estimated total value

Value excluding VAT: 5 000 000.00  EUR

II.1.6) Information about lots

This contract is divided into lots: Yes

Tenders may be submitted for all lots

II.2) Description

Lot No: 1

II.2.1) Title

Použitie inovatívnych metód na optimalizáciu užitocnosti nedostatocných údajov na podporu hodnotenia prínosu/rizika

II.2.2) Additional CPV code(s)

73210000

II.2.3) Place of performance

NUTS code:

UKI4

II.2.4) Description of the procurement

Úplný opis nájdete v oddiele 3.2 technických špecifikácií (sútažné podklady).

II.2.5) Award criteria

Price is not the only award criterion and all criteria are stated only in the procurement documents

II.2.6) Estimated value

Value excluding VAT: 400 000.00  EUR

II.2.7) Duration of the contract, framework agreement or dynamic purchasing system

Duration in months: 48

This contract is subject to renewal: No

II.2.9) Information about the limits on the number of candidates to be invited

II.2.10) Information about variants

Variants will be accepted: No

II.2.11) Information about options

Options: No

II.2.13) Information about European Union funds

The procurement is related to a project and/or programme financed by European Union funds: No

II.2.14) Additional information

Upozornujeme, že pre cast 1 sa predpokladá najviac 5 rámcových zmlúv.

Lot No: 2

II.2.1) Title

Kvalitatívny výskum

II.2.2) Additional CPV code(s)

73210000

II.2.3) Place of performance

NUTS code:

UKI4

II.2.4) Description of the procurement

Úplný opis nájdete v oddiele 3.2 technických špecifikácií (sútažné podklady).

II.2.5) Award criteria

Price is not the only award criterion and all criteria are stated only in the procurement documents

II.2.6) Estimated value

Value excluding VAT: 600 000.00  EUR

II.2.7) Duration of the contract, framework agreement or dynamic purchasing system

Duration in months: 48

This contract is subject to renewal: No

II.2.9) Information about the limits on the number of candidates to be invited

II.2.10) Information about variants

Variants will be accepted: No

II.2.11) Information about options

Options: No

II.2.13) Information about European Union funds

The procurement is related to a project and/or programme financed by European Union funds: No

II.2.14) Additional information

Upozornujeme, že pre cast 2 sa predpokladá najviac 5 rámcových zmlúv.

Lot No: 3

II.2.1) Title

Farmakoepidemiologický výskum – rýchle popisné (deskriptívne) štúdie

II.2.2) Additional CPV code(s)

73210000

II.2.3) Place of performance

NUTS code:

UKI4

II.2.4) Description of the procurement

Úplný opis nájdete v oddiele 3.2 technických špecifikácií (sútažné podklady).

II.2.5) Award criteria

Price is not the only award criterion and all criteria are stated only in the procurement documents

II.2.6) Estimated value

Value excluding VAT: 1 000 000.00  EUR

II.2.7) Duration of the contract, framework agreement or dynamic purchasing system

Duration in months: 48

This contract is subject to renewal: No

II.2.9) Information about the limits on the number of candidates to be invited

II.2.10) Information about variants

Variants will be accepted: No

II.2.11) Information about options

Options: No

II.2.13) Information about European Union funds

The procurement is related to a project and/or programme financed by European Union funds: No

II.2.14) Additional information

Upozornujeme, že pre cast 3 sa predpokladá najviac 5 rámcových zmlúv.

Lot No: 4

II.2.1) Title

Farmakoepidemiologický výskum – súvisiace štúdie vrátane výskumu týkajúceho sa tehotenstva a dojcenia.

II.2.2) Additional CPV code(s)

73210000

II.2.3) Place of performance

NUTS code:

UKI4

II.2.4) Description of the procurement

Úplný opis nájdete v oddiele 3.2 technických špecifikácií (sútažné podklady).

II.2.5) Award criteria

Price is not the only award criterion and all criteria are stated only in the procurement documents

II.2.6) Estimated value

Value excluding VAT: 3 000 000.00  EUR

II.2.7) Duration of the contract, framework agreement or dynamic purchasing system

Duration in months: 48

This contract is subject to renewal: No

II.2.9) Information about the limits on the number of candidates to be invited

II.2.10) Information about variants

Variants will be accepted: No

II.2.11) Information about options

Options: No

II.2.13) Information about European Union funds

The procurement is related to a project and/or programme financed by European Union funds: No

II.2.14) Additional information

Upozornujeme, že pre cast 4 sa predpokladá najviac 8 rámcových zmlúv.

Section II: Object

II.1) Scope of the procurement

II.1.1) Title

Raziskave zdravil glede ucinkovitosti in varnosti.

Reference number: EMA/2017/09/PE

II.1.2) Main CPV code

73000000

 

II.1.3) Type of contract

Services

II.1.4) Short description

Raziskave na podrocju ucinkovitosti in farmakoepidemiologije po izdaji dovoljenja za ustvarjanje podatkov in informacij v podporo regulativnemu odlocanju. Raziskave so lahko osredotocene tudi na ucinkovitost sprejetih regulativnih ukrepov in ucinek ustrezne zakonodaje. Obseg raziskovalnih tem je omejen na tiste z visoko pomembnostjo za javno zdravje in z evropskim ucinkom. Obseg financiranja zajema nacionalno in centralno odobrena zdravila, vkljucno s cepivi. Rezultate, pridobljene s temi raziskavami, bo pristojni odbor agencije naknadno ocenil glede potrebe po regulativnem ukrepu, nato pa se lahko izvede tudi nadaljnje raziskave za merjenje ucinkovitosti sprejetih regulativnih ukrepov.

Raziskava se lahko nanaša na 4 razlicne serije, z najvec 5 okvirnimi narocili za sklope 1, 2 in 3 ter najvec 8 okvirnimi narocili za sklop 4.

II.1.5) Estimated total value

Value excluding VAT: 5 000 000.00  EUR

II.1.6) Information about lots

This contract is divided into lots: Yes

Tenders may be submitted for all lots

II.2) Description

Lot No: 1

II.2.1) Title

Uporaba inovativnih metod za optimiziranje uporabnosti redkih podatkov za podporo ocene koristi/tveganja

II.2.2) Additional CPV code(s)

73210000

II.2.3) Place of performance

NUTS code:

UKI4

II.2.4) Description of the procurement

Za popoln opis glejte oddelek 3.2 tehnicnih specifikacij (razpisna dokumentacija).

II.2.5) Award criteria

Price is not the only award criterion and all criteria are stated only in the procurement documents

II.2.6) Estimated value

Value excluding VAT: 400 000.00  EUR

II.2.7) Duration of the contract, framework agreement or dynamic purchasing system

Duration in months: 48

This contract is subject to renewal: No

II.2.9) Information about the limits on the number of candidates to be invited

II.2.10) Information about variants

Variants will be accepted: No

II.2.11) Information about options

Options: No

II.2.13) Information about European Union funds

The procurement is related to a project and/or programme financed by European Union funds: No

II.2.14) Additional information

Upoštevajte, da je za sklop 1 predvidenih najvec 5 okvirnih narocil.

Lot No: 2

II.2.1) Title

Kvalitativna raziskava

II.2.2) Additional CPV code(s)

73210000

II.2.3) Place of performance

NUTS code:

UKI4

II.2.4) Description of the procurement

Za popoln opis glejte oddelek 3.2 tehnicnih specifikacij (razpisna dokumentacija).

II.2.5) Award criteria

Price is not the only award criterion and all criteria are stated only in the procurement documents

II.2.6) Estimated value

Value excluding VAT: 600 000.00  EUR

II.2.7) Duration of the contract, framework agreement or dynamic purchasing system

Duration in months: 48

This contract is subject to renewal: No

II.2.9) Information about the limits on the number of candidates to be invited

II.2.10) Information about variants

Variants will be accepted: No

II.2.11) Information about options

Options: No

II.2.13) Information about European Union funds

The procurement is related to a project and/or programme financed by European Union funds: No

II.2.14) Additional information

Upoštevajte, da je za sklop 2 predvidenih najvec 5 okvirnih narocil.

Lot No: 3

II.2.1) Title

Farmakoepidemiološke raziskave – hitre opisne študije

II.2.2) Additional CPV code(s)

73210000

II.2.3) Place of performance

NUTS code:

UKI4

II.2.4) Description of the procurement

Za popoln opis glejte oddelek 3.2 tehnicnih specifikacij (razpisna dokumentacija).

II.2.5) Award criteria

Price is not the only award criterion and all criteria are stated only in the procurement documents

II.2.6) Estimated value

Value excluding VAT: 1 000 000.00  EUR

II.2.7) Duration of the contract, framework agreement or dynamic purchasing system

Duration in months: 48

This contract is subject to renewal: No

II.2.9) Information about the limits on the number of candidates to be invited

II.2.10) Information about variants

Variants will be accepted: No

II.2.11) Information about options

Options: No

II.2.13) Information about European Union funds

The procurement is related to a project and/or programme financed by European Union funds: No

II.2.14) Additional information

Upoštevajte, da je za sklop 3 predvidenih najvec 5 okvirnih narocil.

Lot No: 4

II.2.1) Title

Farmakoepidemiološke raziskave – asociacijske študije, vkljucno z raziskavami nosecnosti in dojenja.

II.2.2) Additional CPV code(s)

73210000

II.2.3) Place of performance

NUTS code:

UKI4

II.2.4) Description of the procurement

Za popoln opis glejte oddelek 3.2 tehnicnih specifikacij (razpisna dokumentacija).

II.2.5) Award criteria

Price is not the only award criterion and all criteria are stated only in the procurement documents

II.2.6) Estimated value

Value excluding VAT: 3 000 000.00  EUR

II.2.7) Duration of the contract, framework agreement or dynamic purchasing system

Duration in months: 48

This contract is subject to renewal: No

II.2.9) Information about the limits on the number of candidates to be invited

II.2.10) Information about variants

Variants will be accepted: No

II.2.11) Information about options

Options: No

II.2.13) Information about European Union funds

The procurement is related to a project and/or programme financed by European Union funds: No

II.2.14) Additional information

Upoštevajte, da je za sklop 4 predvidenih najvec 8 okvirnih narocil.

Section II: Object

II.1) Scope of the procurement

II.1.1) Title

Staidéir éifeachtúlachta agus sábháilteachta i leith cógas leighis.

Reference number: EMA/2017/09/PE

II.1.2) Main CPV code

73000000

 

II.1.3) Type of contract

Services

II.1.4) Short description

Taighde iar-údaracháin um éifeachtacht agus um staidéir chógas-eipidéimeolaíochta chun sonraí agus faisnéis a ghiniúint chun tacú le cinnteoireacht rialála. Féadfar an taighde a dhíriú freisin ar éifeachtacht na mbeart rialála a glacadh agus ar thionchar na reachtaíochta ábhartha. Tá raon na n-ábhar taighde teoranta dóibh siúd lena mbaineann ábharthacht mhór maidir le sláinte phoiblí agus le tionchar Eorpach. Cumhdaítear le raon feidhme an chistithe idir tháirgí údaraithe go náisiúnta agus go lárnach, lena n-áirítear vacsaíní. Déanfaidh coiste na gníomhaireachta freagraí measúnú ar na torthaí a fhaightear ón taighde seo ina dhiaidh sin maidir leis an éileamh do ghníomhaíocht rialála, agus féadfar tuilleadh taighde a stiúradh ina dhiaidh sin chun éifeachtacht na gníomhaíochta rialála glactha a thomhas.

Féadfar an taighde a dhéanamh i leith ceithre bheart éagsúla, le cúig chreatchonradh ar a uasmhéad i leith beart 1, 2 agus 3; agus le 8 gcreatchonradh ar a uasmhéad do bheart 4.

II.1.5) Estimated total value

Value excluding VAT: 5 000 000.00  EUR

II.1.6) Information about lots

This contract is divided into lots: Yes

Tenders may be submitted for all lots

II.2) Description

Lot No: 1

II.2.1) Title

Leas a bhaint as modhanna nuálacha chun fónamh na sonraí tearca a bharrfheabhsú chun tacú leis an measúnú tairbhe/riosca

II.2.2) Additional CPV code(s)

73210000

II.2.3) Place of performance

NUTS code:

UKI4

II.2.4) Description of the procurement

Féach cuid 3.2 de na sonraíochtaí teicniúla le haghaidh tuairisce iomláine (doiciméid soláthair).

II.2.5) Award criteria

Price is not the only award criterion and all criteria are stated only in the procurement documents

II.2.6) Estimated value

Value excluding VAT: 400 000.00  EUR

II.2.7) Duration of the contract, framework agreement or dynamic purchasing system

Duration in months: 48

This contract is subject to renewal: No

II.2.9) Information about the limits on the number of candidates to be invited

II.2.10) Information about variants

Variants will be accepted: No

II.2.11) Information about options

Options: No

II.2.13) Information about European Union funds

The procurement is related to a project and/or programme financed by European Union funds: No

II.2.14) Additional information

Tabhair faoi deara gurb é 5 chreatchonradh an t-uasmhéid a shamhlaítear do bheart 1.

Lot No: 2

II.2.1) Title

Taighde cáilíochtúil

II.2.2) Additional CPV code(s)

73210000

II.2.3) Place of performance

NUTS code:

UKI4

II.2.4) Description of the procurement

Féach cuid 3.2 de na sonraíochtaí teicniúla le haghaidh tuairisce iomláine (doiciméid soláthair).

II.2.5) Award criteria

Price is not the only award criterion and all criteria are stated only in the procurement documents

II.2.6) Estimated value

Value excluding VAT: 600 000.00  EUR

II.2.7) Duration of the contract, framework agreement or dynamic purchasing system

Duration in months: 48

This contract is subject to renewal: No

II.2.9) Information about the limits on the number of candidates to be invited

II.2.10) Information about variants

Variants will be accepted: No

II.2.11) Information about options

Options: No

II.2.13) Information about European Union funds

The procurement is related to a project and/or programme financed by European Union funds: No

II.2.14) Additional information

Tabhair faoi deara gurb é 5 chreatchonradh an t-uasmhéid a shamhlaítear do bheart 2.

Lot No: 3

II.2.1) Title

Taighde cógas-eipidéimeolaíochta — mearstaidéir thuairisciúla

II.2.2) Additional CPV code(s)

73210000

II.2.3) Place of performance

NUTS code:

UKI4

II.2.4) Description of the procurement

Féach cuid 3.2 de na sonraíochtaí teicniúla le haghaidh tuairisce iomláine (doiciméid soláthair).

II.2.5) Award criteria

Price is not the only award criterion and all criteria are stated only in the procurement documents

II.2.6) Estimated value

Value excluding VAT: 1 000 000.00  EUR

II.2.7) Duration of the contract, framework agreement or dynamic purchasing system

Duration in months: 48

This contract is subject to renewal: No

II.2.9) Information about the limits on the number of candidates to be invited

II.2.10) Information about variants

Variants will be accepted: No

II.2.11) Information about options

Options: No

II.2.13) Information about European Union funds

The procurement is related to a project and/or programme financed by European Union funds: No

II.2.14) Additional information

Tabhair faoi deara gurb é 5 chreatchonradh an t-uasmhéid a shamhlaítear do bheart 3.

Lot No: 4

II.2.1) Title

Taighde cógas-eipidéimeolaíochta — staidéir chomhbhainteacha, lena n-áirítear taighde um thoircheas agus beathú cíche.

II.2.2) Additional CPV code(s)

73210000

II.2.3) Place of performance

NUTS code:

UKI4

II.2.4) Description of the procurement

Féach cuid 3.2 de na sonraíochtaí teicniúla le haghaidh tuairisce iomláine (doiciméid soláthair).

II.2.5) Award criteria

Price is not the only award criterion and all criteria are stated only in the procurement documents

II.2.6) Estimated value

Value excluding VAT: 3 000 000.00  EUR

II.2.7) Duration of the contract, framework agreement or dynamic purchasing system

Duration in months: 48

This contract is subject to renewal: No

II.2.9) Information about the limits on the number of candidates to be invited

II.2.10) Information about variants

Variants will be accepted: No

II.2.11) Information about options

Options: No

II.2.13) Information about European Union funds

The procurement is related to a project and/or programme financed by European Union funds: No

II.2.14) Additional information

Tabhair faoi deara gurb é 8 gcreatchonradh an t-uasmhéid a shamhlaítear do bheart 4.

Section II: Object

II.1) Scope of the procurement

II.1.1) Title

¿¿¿¿¿¿¿¿¿¿ ¿¿ ¿¿¿¿¿¿¿¿¿¿ ¿ ¿¿¿¿¿¿¿¿¿¿¿ ¿¿ ¿¿¿¿¿¿¿¿¿¿¿.

Reference number: EMA/2017/09/PE

II.1.2) Main CPV code

73000000

 

II.1.3) Type of contract

Services

II.1.4) Short description

¿¿¿¿¿¿¿¿¿¿ ¿¿ ¿¿¿¿¿¿¿¿¿¿¿ ¿ ¿¿¿¿¿¿¿¿¿¿¿¿¿¿¿¿¿¿¿¿ ¿¿¿¿ ¿¿¿¿¿¿¿¿¿¿ ¿¿ ¿¿¿¿¿¿¿¿¿¿ ¿ ¿¿¿ ¿¿¿¿¿¿¿¿¿¿ ¿¿ ¿¿¿¿¿ ¿ ¿¿¿¿¿¿¿¿¿¿ ¿ ¿¿¿¿¿¿¿¿ ¿¿ ¿¿¿¿¿¿¿¿¿¿¿¿¿ ¿¿¿¿¿¿¿ ¿¿ ¿¿¿¿¿¿¿. ¿¿¿¿¿¿¿¿¿¿¿ ¿¿¿¿ ¿¿ ¿¿ ¿¿¿¿¿¿¿¿¿¿¿ ¿¿¿¿ ¿ ¿¿¿¿¿ ¿¿¿¿¿¿¿¿¿¿¿¿¿ ¿¿ ¿¿¿¿¿¿¿¿¿¿¿¿ ¿¿¿¿¿¿¿¿¿¿¿ ¿¿¿¿¿ ¿ ¿¿¿¿¿ ¿¿¿¿¿¿¿¿¿¿¿¿¿ ¿¿ ¿¿¿¿¿¿¿¿¿¿¿ ¿¿¿¿¿¿¿¿¿¿¿¿¿¿¿. ¿¿¿¿¿¿¿¿ ¿¿ ¿¿¿¿¿¿¿¿¿¿¿¿¿¿¿¿¿ ¿¿¿¿ ¿ ¿¿¿¿¿¿¿¿¿ ¿¿ ¿¿¿¿, ¿¿¿¿¿ ¿¿ ¿¿ ¿ ¿¿¿¿¿¿ ¿¿¿¿¿¿¿¿ ¿¿ ¿¿¿¿¿¿¿¿¿¿¿¿ ¿¿¿¿¿¿¿¿¿¿¿¿¿¿ ¿ ¿¿ ¿ ¿¿¿¿¿¿¿¿¿¿¿¿ ¿¿¿¿¿¿¿¿¿¿¿. ¿¿¿¿¿¿¿¿ ¿¿ ¿¿¿¿¿¿¿¿¿¿¿¿¿ ¿¿¿¿¿¿¿ ¿¿¿¿¿¿¿¿¿ ¿¿¿¿¿¿¿¿, ¿¿¿¿¿¿¿¿¿¿¿ ¿¿¿¿¿¿¿, ¿¿ ¿¿¿¿¿¿¿¿¿¿ ¿ ¿¿¿¿¿¿¿¿¿ ¿¿¿¿. ¿¿¿¿¿¿¿¿¿¿ ¿¿¿¿¿¿¿¿¿ ¿¿ ¿¿¿¿ ¿¿¿¿¿¿¿¿¿ ¿¿ ¿¿¿¿¿ ¿¿¿¿¿¿¿¿¿¿¿¿ ¿¿¿¿¿¿¿ ¿¿ ¿¿¿¿¿¿¿¿¿ ¿¿ ¿¿¿¿¿¿¿¿¿¿¿¿¿ ¿¿¿¿¿¿¿ ¿¿¿¿¿¿¿ ¿¿¿¿¿¿¿¿¿¿¿¿¿¿ ¿¿ ¿¿¿¿¿¿¿¿¿¿¿ ¿¿¿¿¿¿¿¿ ¿ ¿¿¿¿¿¿¿¿¿¿¿¿ ¿¿¿¿¿ ¿¿ ¿¿¿¿¿ ¿¿¿¿¿¿¿¿¿ ¿¿¿¿¿¿¿¿¿¿¿¿ ¿¿¿¿¿¿¿¿¿¿ ¿¿ ¿¿¿¿¿¿¿¿¿ ¿¿ ¿¿¿¿¿¿¿¿¿¿¿¿¿ ¿¿ ¿¿¿¿¿¿¿¿¿¿¿¿ ¿¿¿¿¿¿¿¿¿¿¿ ¿¿¿¿¿¿¿¿.

¿¿¿¿¿¿¿¿¿¿¿ ¿¿¿¿ ¿¿ ¿¿ ¿¿¿¿¿¿ ¿¿ ¿¿¿¿¿¿ ¿¿¿¿¿¿¿¿ ¿¿¿¿¿¿¿¿¿ ¿¿¿¿¿¿¿ ¿ ¿¿¿¿¿¿¿¿ ¿¿¿ ¿¿¿¿¿¿¿ ¿¿¿¿¿¿¿¿ ¿¿ ¿¿¿¿¿¿¿¿¿ ¿¿¿¿¿¿¿ 1, 2 ¿ 3 ¿ ¿¿¿¿¿¿¿¿ 8 ¿¿¿¿¿¿¿ ¿¿¿¿¿¿¿¿ ¿¿ ¿¿¿¿¿¿¿¿¿ ¿¿¿¿¿¿¿ 4.

II.1.5) Estimated total value

Value excluding VAT: 5 000 000.00  EUR

II.1.6) Information about lots

This contract is divided into lots: Yes

Tenders may be submitted for all lots

II.2) Description

Lot No: 1

II.2.1) Title

¿¿¿¿¿¿¿¿¿¿ ¿¿ ¿¿¿¿¿¿¿¿¿¿ ¿¿¿¿¿¿ ¿¿ ¿¿¿¿¿¿¿¿¿¿¿¿ ¿¿ ¿¿¿¿¿¿¿ ¿¿ ¿¿¿¿¿¿¿ ¿¿¿¿¿ ¿¿ ¿¿¿¿¿¿¿¿¿¿¿ ¿¿ ¿¿¿¿¿¿¿¿ ¿¿¿¿¿ / ¿¿¿¿

II.2.2) Additional CPV code(s)

73210000

II.2.3) Place of performance

NUTS code:

UKI4

II.2.4) Description of the procurement

¿¿ ¿¿¿¿¿ ¿¿¿¿¿¿¿¿, ¿¿¿¿ ¿¿¿¿¿ ¿¿¿¿¿¿ 3.2 ¿¿ ¿¿¿¿¿¿¿¿¿¿¿¿ ¿¿¿¿¿¿¿¿¿¿¿¿ (¿¿¿¿¿¿¿¿¿ ¿¿ ¿¿¿¿¿¿¿¿¿¿ ¿¿¿¿¿¿¿).

II.2.5) Award criteria

Price is not the only award criterion and all criteria are stated only in the procurement documents

II.2.6) Estimated value

Value excluding VAT: 400 000.00  EUR

II.2.7) Duration of the contract, framework agreement or dynamic purchasing system

Duration in months: 48

This contract is subject to renewal: No

II.2.9) Information about the limits on the number of candidates to be invited

II.2.10) Information about variants

Variants will be accepted: No

II.2.11) Information about options

Options: No

II.2.13) Information about European Union funds

The procurement is related to a project and/or programme financed by European Union funds: No

II.2.14) Additional information

¿¿¿¿, ¿¿¿¿¿¿¿¿ ¿¿¿¿¿¿¿¿, ¿¿ ¿¿ ¿¿¿¿¿¿¿¿¿ ¿¿¿¿¿¿¿ 1 ¿¿ ¿¿¿¿¿¿¿¿¿¿ ¿¿¿¿¿¿¿¿ 5 ¿¿¿¿¿¿¿ ¿¿¿¿¿¿¿¿.

Lot No: 2

II.2.1) Title

¿¿¿¿¿¿¿¿¿¿ ¿¿¿¿¿¿¿¿¿¿

II.2.2) Additional CPV code(s)

73210000

II.2.3) Place of performance

NUTS code:

UKI4

II.2.4) Description of the procurement

¿¿ ¿¿¿¿¿ ¿¿¿¿¿¿¿¿, ¿¿¿¿ ¿¿¿¿¿ ¿¿¿¿¿¿ 3.2 ¿¿ ¿¿¿¿¿¿¿¿¿¿¿¿ ¿¿¿¿¿¿¿¿¿¿¿¿ (¿¿¿¿¿¿¿¿¿ ¿¿ ¿¿¿¿¿¿¿¿¿¿ ¿¿¿¿¿¿¿).

II.2.5) Award criteria

Price is not the only award criterion and all criteria are stated only in the procurement documents

II.2.6) Estimated value

Value excluding VAT: 600 000.00  EUR

II.2.7) Duration of the contract, framework agreement or dynamic purchasing system

Duration in months: 48

This contract is subject to renewal: No

II.2.9) Information about the limits on the number of candidates to be invited

II.2.10) Information about variants

Variants will be accepted: No

II.2.11) Information about options

Options: No

II.2.13) Information about European Union funds

The procurement is related to a project and/or programme financed by European Union funds: No

II.2.14) Additional information

¿¿¿¿, ¿¿¿¿¿¿¿¿ ¿¿¿¿¿¿¿¿, ¿¿ ¿¿ ¿¿¿¿¿¿¿¿¿ ¿¿¿¿¿¿¿ 2 ¿¿ ¿¿¿¿¿¿¿¿¿¿ ¿¿¿¿¿¿¿¿ 5 ¿¿¿¿¿¿¿ ¿¿¿¿¿¿¿¿.

Lot No: 3

II.2.1) Title

¿¿¿¿¿¿¿¿¿¿ ¿¿ ¿¿¿¿¿¿¿¿¿¿¿¿¿¿¿¿¿¿¿¿ – ¿¿¿¿¿¿¿¿¿¿¿¿¿¿ ¿¿¿¿¿¿¿¿¿¿ ¿¿¿¿¿¿¿¿¿¿

II.2.2) Additional CPV code(s)

73210000

II.2.3) Place of performance

NUTS code:

UKI4

II.2.4) Description of the procurement

¿¿ ¿¿¿¿¿ ¿¿¿¿¿¿¿¿, ¿¿¿¿ ¿¿¿¿¿ ¿¿¿¿¿¿ 3.2 ¿¿ ¿¿¿¿¿¿¿¿¿¿¿¿ ¿¿¿¿¿¿¿¿¿¿¿¿ (¿¿¿¿¿¿¿¿¿ ¿¿ ¿¿¿¿¿¿¿¿¿¿ ¿¿¿¿¿¿¿).

II.2.5) Award criteria

Price is not the only award criterion and all criteria are stated only in the procurement documents

II.2.6) Estimated value

Value excluding VAT: 1 000 000.00  EUR

II.2.7) Duration of the contract, framework agreement or dynamic purchasing system

Duration in months: 48

This contract is subject to renewal: No

II.2.9) Information about the limits on the number of candidates to be invited

II.2.10) Information about variants

Variants will be accepted: No

II.2.11) Information about options

Options: No

II.2.13) Information about European Union funds

The procurement is related to a project and/or programme financed by European Union funds: No

II.2.14) Additional information

¿¿¿¿, ¿¿¿¿¿¿¿¿ ¿¿¿¿¿¿¿¿, ¿¿ ¿¿ ¿¿¿¿¿¿¿¿¿ ¿¿¿¿¿¿¿ 3 ¿¿ ¿¿¿¿¿¿¿¿¿¿ ¿¿¿¿¿¿¿¿ 5 ¿¿¿¿¿¿¿ ¿¿¿¿¿¿¿¿.

Lot No: 4

II.2.1) Title

¿¿¿¿¿¿¿¿¿¿ ¿¿ ¿¿¿¿¿¿¿¿¿¿¿¿¿¿¿¿¿¿¿¿ - ¿¿¿¿¿¿¿¿¿¿ ¿¿ ¿¿¿¿¿¿¿¿¿, ¿¿¿¿¿¿¿¿¿¿¿ ¿¿¿¿¿¿¿¿¿¿¿ ¿¿ ¿¿¿¿¿¿¿¿¿¿ ¿ ¿¿¿¿¿¿¿.

II.2.2) Additional CPV code(s)

73210000

II.2.3) Place of performance

NUTS code:

UKI4

II.2.4) Description of the procurement

¿¿ ¿¿¿¿¿ ¿¿¿¿¿¿¿¿, ¿¿¿¿ ¿¿¿¿¿ ¿¿¿¿¿¿ 3.2 ¿¿ ¿¿¿¿¿¿¿¿¿¿¿¿ ¿¿¿¿¿¿¿¿¿¿¿¿ (¿¿¿¿¿¿¿¿¿ ¿¿ ¿¿¿¿¿¿¿¿¿¿ ¿¿¿¿¿¿¿).

II.2.5) Award criteria

Price is not the only award criterion and all criteria are stated only in the procurement documents

II.2.6) Estimated value

Value excluding VAT: 3 000 000.00  EUR

II.2.7) Duration of the contract, framework agreement or dynamic purchasing system

Duration in months: 48

This contract is subject to renewal: No

II.2.9) Information about the limits on the number of candidates to be invited

II.2.10) Information about variants

Variants will be accepted: No

II.2.11) Information about options

Options: No

II.2.13) Information about European Union funds

The procurement is related to a project and/or programme financed by European Union funds: No

II.2.14) Additional information

¿¿¿¿, ¿¿¿¿¿¿¿¿ ¿¿¿¿¿¿¿¿, ¿¿ ¿¿ ¿¿¿¿¿¿¿¿¿ ¿¿¿¿¿¿¿ 4 ¿¿ ¿¿¿¿¿¿¿¿¿¿ ¿¿¿¿¿¿¿¿ 8 ¿¿¿¿¿¿¿ ¿¿¿¿¿¿¿¿.

Section II: Object

II.1) Scope of the procurement

II.1.1) Title

Studii de eficacitate ¿i siguran¿a privind medicamentele.

Reference number: EMA/2017/09/PE

II.1.2) Main CPV code

73000000

 

II.1.3) Type of contract

Services

II.1.4) Short description

Studii în domeniul eficacita¿ii ¿i al farmacoepidemiologiei ulterior autorizarii pentru generarea de date ¿i de informa¿ii pentru sus¿inerea procesului decizional în materie de reglementare. Cercetarea se poate axa, de asemenea, pe eficacitatea masurilor de reglementare adoptate ¿i pe impactul legisla¿iei relevante. Gama de subiecte este limitata la cele de înalta relevan¿a pentru sanatatea publica ¿i cu impact la nivel european. Finan¿area acopera produse autorizate atât la nivel na¿ional, cât ¿i central, incluzând vaccinurile. Rezultatele ob¿inute în urma acestei cercetari vor fi ulterior evaluate de comitetul competent al agen¿iei cu privire la necesitatea unei ac¿iuni de reglementare ¿i pot fi efectuate ulterior cercetari suplimentare pentru a masura eficacitatea masurilor de reglementare luate.

Cercetarea poate viza patru loturi diferite, cu maximum cinci contracte-cadru pentru loturile 1, 2 ¿i 3 ¿i maximum 8 contracte-cadru pentru lotul 4.

II.1.5) Estimated total value

Value excluding VAT: 5 000 000.00  EUR

II.1.6) Information about lots

This contract is divided into lots: Yes

Tenders may be submitted for all lots

II.2) Description

Lot No: 1

II.2.1) Title

Utilizarea metodelor inovatoare pentru a optimiza utilitatea datelor rare pentru a sprijini evaluarea raportului beneficiu / risc

II.2.2) Additional CPV code(s)

73210000

II.2.3) Place of performance

NUTS code:

UKI4

II.2.4) Description of the procurement

Pentru descrierea completa, a se vedea sec¿iunea 3.2 din specifica¿iile tehnice (documentele de achizi¿ie).

II.2.5) Award criteria

Price is not the only award criterion and all criteria are stated only in the procurement documents

II.2.6) Estimated value

Value excluding VAT: 400 000.00  EUR

II.2.7) Duration of the contract, framework agreement or dynamic purchasing system

Duration in months: 48

This contract is subject to renewal: No

II.2.9) Information about the limits on the number of candidates to be invited

II.2.10) Information about variants

Variants will be accepted: No

II.2.11) Information about options

Options: No

II.2.13) Information about European Union funds

The procurement is related to a project and/or programme financed by European Union funds: No

II.2.14) Additional information

Va rugam sa ¿ine¿i cont de faptul ca pentru lotul 1 este prevazut un maxim de 5 contracte-cadru.

Lot No: 2

II.2.1) Title

Cercetare calitativa

II.2.2) Additional CPV code(s)

73210000

II.2.3) Place of performance

NUTS code:

UKI4

II.2.4) Description of the procurement

Pentru descrierea completa, a se vedea sec¿iunea 3.2 din specifica¿iile tehnice (documentele de achizi¿ie).

II.2.5) Award criteria

Price is not the only award criterion and all criteria are stated only in the procurement documents

II.2.6) Estimated value

Value excluding VAT: 600 000.00  EUR

II.2.7) Duration of the contract, framework agreement or dynamic purchasing system

Duration in months: 48

This contract is subject to renewal: No

II.2.9) Information about the limits on the number of candidates to be invited

II.2.10) Information about variants

Variants will be accepted: No

II.2.11) Information about options

Options: No

II.2.13) Information about European Union funds

The procurement is related to a project and/or programme financed by European Union funds: No

II.2.14) Additional information

Va rugam sa ¿ine¿i cont de faptul ca pentru lotul 2 este prevazut un maxim de 5 contracte-cadru.

Lot No: 3

II.2.1) Title

Cercetari farmacoepidemiologice - studii descriptive rapide

II.2.2) Additional CPV code(s)

73210000

II.2.3) Place of performance

NUTS code:

UKI4

II.2.4) Description of the procurement

Pentru descrierea completa, a se vedea sec¿iunea 3.2 din specifica¿iile tehnice (documentele de achizi¿ie).

II.2.5) Award criteria

Price is not the only award criterion and all criteria are stated only in the procurement documents

II.2.6) Estimated value

Value excluding VAT: 1 000 000.00  EUR

II.2.7) Duration of the contract, framework agreement or dynamic purchasing system

Duration in months: 48

This contract is subject to renewal: No

II.2.9) Information about the limits on the number of candidates to be invited

II.2.10) Information about variants

Variants will be accepted: No

II.2.11) Information about options

Options: No

II.2.13) Information about European Union funds

The procurement is related to a project and/or programme financed by European Union funds: No

II.2.14) Additional information

Va rugam sa ¿ine¿i cont de faptul ca pentru lotul 3 este prevazut un maxim de 5 contracte-cadru.

Lot No: 4

II.2.1) Title

Cercetarea farmacoepidemiologica - studii de asociere, inclusiv cercetarea privind sarcina ¿i alaptarea.

II.2.2) Additional CPV code(s)

73210000

II.2.3) Place of performance

NUTS code:

UKI4

II.2.4) Description of the procurement

Pentru descrierea completa, a se vedea sec¿iunea 3.2 din specifica¿iile tehnice (documentele de achizi¿ie).

II.2.5) Award criteria

Price is not the only award criterion and all criteria are stated only in the procurement documents

II.2.6) Estimated value

Value excluding VAT: 3 000 000.00  EUR

II.2.7) Duration of the contract, framework agreement or dynamic purchasing system

Duration in months: 48

This contract is subject to renewal: No

II.2.9) Information about the limits on the number of candidates to be invited

II.2.10) Information about variants

Variants will be accepted: No

II.2.11) Information about options

Options: No

II.2.13) Information about European Union funds

The procurement is related to a project and/or programme financed by European Union funds: No

II.2.14) Additional information

Va rugam sa ¿ine¿i cont de faptul ca pentru lotul 4 este prevazut un maxim de 8 contracte-cadru.

Section II: Object

II.1) Scope of the procurement

II.1.1) Title

Studije djelotvornosti i sigurnosti lijekova.

Reference number: EMA/2017/09/PE

II.1.2) Main CPV code

73000000

 

II.1.3) Type of contract

Services

II.1.4) Short description

Studije djelotvornosti i farmakoepidemiološke studije nakon izdavanja odobrenja kako bi se prikupili podaci i informacije koji bi podržali regulatorno odlucivanje. Istraživanje se takoder može usmjeriti na ucinkovitost poduzetih regulatornih mjera i na ucinak relevantnog zakonodavstva. Raspon tema je ogranicen na one od velike važnosti za javno zdravlje i s europskim ucinkom. Opseg financiranja pokriva nacionalno i centralno odobrene proizvode, ukljucujuci i cjepiva. Rezultate dobivene ovim istraživanjem naknadno ce ocijeniti nadležni odbor agencije u pogledu potrebe za regulatornim radnjama te je moguca i naknadna provedba daljnjeg istraživanja za mjerenje ucinkovitosti poduzetih regulatornih radnji.

Istraživanje se može odnositi na 4 razlicite grupe, s maksimalno 5 okvirnih ugovora za grupe 1, 2 i 3 i maksimalno 8 okvirnih ugovora za grupu 4.

II.1.5) Estimated total value

Value excluding VAT: 5 000 000.00  EUR

II.1.6) Information about lots

This contract is divided into lots: Yes

Tenders may be submitted for all lots

II.2) Description

Lot No: 1

II.2.1) Title

Upotrebna inovativnih metoda za optimiziranje korisnosti male kolicine podataka za podršku procjene koristi/rizika

II.2.2) Additional CPV code(s)

73210000

II.2.3) Place of performance

NUTS code:

UKI4

II.2.4) Description of the procurement

Cjelovit opis potražite u odjeljku 3.2 tehnickih specifikacija (dokumentacija o nabavi).

II.2.5) Award criteria

Price is not the only award criterion and all criteria are stated only in the procurement documents

II.2.6) Estimated value

Value excluding VAT: 400 000.00  EUR

II.2.7) Duration of the contract, framework agreement or dynamic purchasing system

Duration in months: 48

This contract is subject to renewal: No

II.2.9) Information about the limits on the number of candidates to be invited

II.2.10) Information about variants

Variants will be accepted: No

II.2.11) Information about options

Options: No

II.2.13) Information about European Union funds

The procurement is related to a project and/or programme financed by European Union funds: No

II.2.14) Additional information

Napominjemo da je predvideno maksimalno 5 okvirnih ugovora za grupu 1.

Lot No: 2

II.2.1) Title

Kvalitativno istraživanje

II.2.2) Additional CPV code(s)

73210000

II.2.3) Place of performance

NUTS code:

UKI4

II.2.4) Description of the procurement

Cjelovit opis potražite u odjeljku 3.2 tehnickih specifikacija (dokumentacija o nabavi).

II.2.5) Award criteria

Price is not the only award criterion and all criteria are stated only in the procurement documents

II.2.6) Estimated value

Value excluding VAT: 600 000.00  EUR

II.2.7) Duration of the contract, framework agreement or dynamic purchasing system

Duration in months: 48

This contract is subject to renewal: No

II.2.9) Information about the limits on the number of candidates to be invited

II.2.10) Information about variants

Variants will be accepted: No

II.2.11) Information about options

Options: No

II.2.13) Information about European Union funds

The procurement is related to a project and/or programme financed by European Union funds: No

II.2.14) Additional information

Napominjemo da je predvideno maksimalno 5 okvirnih ugovora za grupu 2.

Lot No: 3

II.2.1) Title

Farmakoepidemiološko istraživanje — brze opisne studije

II.2.2) Additional CPV code(s)

73210000

II.2.3) Place of performance

NUTS code:

UKI4

II.2.4) Description of the procurement

Cjelovit opis potražite u odjeljku 3.2 tehnickih specifikacija (dokumentacija o nabavi).

II.2.5) Award criteria

Price is not the only award criterion and all criteria are stated only in the procurement documents

II.2.6) Estimated value

Value excluding VAT: 1 000 000.00  EUR

II.2.7) Duration of the contract, framework agreement or dynamic purchasing system

Duration in months: 48

This contract is subject to renewal: No

II.2.9) Information about the limits on the number of candidates to be invited

II.2.10) Information about variants

Variants will be accepted: No

II.2.11) Information about options

Options: No

II.2.13) Information about European Union funds

The procurement is related to a project and/or programme financed by European Union funds: No

II.2.14) Additional information

Napominjemo da je predvideno maksimalno 5 okvirnih ugovora za grupu 3.

Lot No: 4

II.2.1) Title

Farmakoepidemiološko istraživanje — povezane studije, ukljucujuci istraživanje trudnoce i dojenja.

II.2.2) Additional CPV code(s)

73210000

II.2.3) Place of performance

NUTS code:

UKI4

II.2.4) Description of the procurement

Cjelovit opis potražite u odjeljku 3.2 tehnickih specifikacija (dokumentacija o nabavi).

II.2.5) Award criteria

Price is not the only award criterion and all criteria are stated only in the procurement documents

II.2.6) Estimated value

Value excluding VAT: 3 000 000.00  EUR

II.2.7) Duration of the contract, framework agreement or dynamic purchasing system

Duration in months: 48

This contract is subject to renewal: No

II.2.9) Information about the limits on the number of candidates to be invited

II.2.10) Information about variants

Variants will be accepted: No

II.2.11) Information about options

Options: No

II.2.13) Information about European Union funds

The procurement is related to a project and/or programme financed by European Union funds: No

II.2.14) Additional information

Napominjemo da je predvideno maksimalno 8 okvirnih ugovora za grupu 4.

Section III: Legal, economic, financial and technical information

III.1) Conditions for participation

III.1.1) Suitability to pursue the professional activity, including requirements relating to enrolment on professional or trade registers

List and brief description of conditions:

Se internetadressen anført i del I.3.

Siehe die in Abschnitt I.3 angegebene Internetadresse.

See internet address provided in Section I.3.

Véase la dirección de internet que figura en el apartado I.3.

katso kohdassa I.3 annettu internetosoite.

Voir adresse internet indiquée dans la Section I.3.

¿¿¿pe d¿ad¿¿t¿a¿¿ d¿e¿¿¿¿s¿ p¿¿ pa¿¿¿eta¿ st¿ tµ¿µa I.3.

Cfr. indirizzo Internet indicato alla sezione I.3).

zie het internetadres vermeld in I.3.

Ver endereço Internet disponibilizado no ponto I.3.

Se internetadressen som anges i punkt I.3.

Viz internetová adresa uvedená v cásti I.3.

Vt punktis I.3 nimetatud internetiaadressi.

Lásd az I.3. szakaszban megadott internetcímet.

Žr. interneto adresa, nurodyta I.3 dalyje.

Skatit interneta adresi, kas mineta I.3. iedala.

Ara l-indirizz tal-Internet ipprovdut fit-Taqsima I.3.

Zob. adres internetowy w pkt I.3.

Pozri internetovú adresu uvedenú v oddiele I.3.

Glejte internetni naslov v oddelku I.3.

Féach an seoladh idirlín atá curtha ar fáil in Alt I.3.

¿¿. ¿¿¿¿¿¿¿¿ ¿¿¿¿¿¿, ¿¿¿¿¿¿¿ ¿ ¿¿¿¿¿¿ I.3.

A se vedea adresa de internet indicata la punctul I.3.

Vidjeti internetsku adresu navedenu u odjeljku I.3.

III.1.2) Economic and financial standing

Selection criteria as stated in the procurement documents


III.1.3) Technical and professional ability

Selection criteria as stated in the procurement documents


III.2) Conditions related to the contract

III.2.2) Contract performance conditions

Se internetadressen anført i del I.3.

Siehe die in Abschnitt I.3 angegebene Internetadresse.

See internet address provided in Section I.3.

Véase la dirección de internet que figura en el apartado I.3.

katso kohdassa I.3 annettu internetosoite.

Voir adresse internet indiquée dans la Section I.3.

¿¿¿pe d¿ad¿¿t¿a¿¿ d¿e¿¿¿¿s¿ p¿¿ pa¿¿¿eta¿ st¿ tµ¿µa I.3.

Cfr. indirizzo Internet indicato alla sezione I.3).

zie het internetadres vermeld in I.3.

Ver endereço Internet disponibilizado no ponto I.3.

Se internetadressen som anges i punkt I.3.

Viz internetová adresa uvedená v cásti I.3.

Vt punktis I.3 nimetatud internetiaadressi.

Lásd az I.3. szakaszban megadott internetcímet.

Žr. interneto adresa, nurodyta I.3 dalyje.

Skatit interneta adresi, kas mineta I.3. iedala.

Ara l-indirizz tal-Internet ipprovdut fit-Taqsima I.3.

Zob. adres internetowy w pkt I.3.

Pozri internetovú adresu uvedenú v oddiele I.3.

Glejte internetni naslov v oddelku I.3.

Féach an seoladh idirlín atá curtha ar fáil in Alt I.3.

¿¿. ¿¿¿¿¿¿¿¿ ¿¿¿¿¿¿, ¿¿¿¿¿¿¿ ¿ ¿¿¿¿¿¿ I.3.

A se vedea adresa de internet indicata la punctul I.3.

Vidjeti internetsku adresu navedenu u odjeljku I.3.

III.2.3) Information about staff responsible for the performance of the contract

Obligation to indicate the names and professional qualifications of the staff assigned to performing the contract

Section IV: Procedure

IV.1) Description

IV.1.1) Type of procedure

Open procedure

IV.1.3) Information about a framework agreement or a dynamic purchasing system

The procurement involves the establishment of a framework agreement with several operators.

Envisaged maximum number of participants to the framework agreement: 8

IV.1.8) Information about Government Procurement Agreement (GPA)

The procurement is covered by the Government Procurement Agreement: No

IV.2) Administrative information

IV.2.2) Time limit for receipt of tenders or requests to participate

Date: 02/02/2018

Local time: 12:00

IV.2.4) Languages in which tenders or requests to participate may be submitted

EN

BG

DA

DE

EL

ET

FI

FR

GA

HR

HU

IT

LV

LT

MT

NL

PL

PT

RO

SK

SL

ES

SV

CS

EN

BG

DA

DE

EL

ET

FI

FR

GA

HR

HU

IT

LV

LT

MT

NL

PL

PT

RO

SK

SL

ES

SV

CS

EN

BG

DA

DE

EL

ET

FI

FR

GA

HR

HU

IT

LV

LT

MT

NL

PL

PT

RO

SK

SL

ES

SV

CS

EN

BG

DA

DE

EL

ET

FI

FR

GA

HR

HU

IT

LV

LT

MT

NL

PL

PT

RO

SK

SL

ES

SV

CS

EN

BG

DA

DE

EL

ET

FI

FR

GA

HR

HU

IT

LV

LT

MT

NL

PL

PT

RO

SK

SL

ES

SV

CS

EN

BG

DA

DE

EL

ET

FI

FR

GA

HR

HU

IT

LV

LT

MT

NL

PL

PT

RO

SK

SL

ES

SV

CS

EN

BG

DA

DE

EL

ET

FI

FR

GA

HR

HU

IT

LV

LT

MT

NL

PL

PT

RO

SK

SL

ES

SV

CS

EN

BG

DA

DE

EL

ET

FI

FR

GA

HR

HU

IT

LV

LT

MT

NL

PL

PT

RO

SK

SL

ES

SV

CS

EN

BG

DA

DE

EL

ET

FI

FR

GA

HR

HU

IT

LV

LT

MT

NL

PL

PT

RO

SK

SL

ES

SV

CS

EN

BG

DA

DE

EL

ET

FI

FR

GA

HR

HU

IT

LV

LT

MT

NL

PL

PT

RO

SK

SL

ES

SV

CS

EN

BG

DA

DE

EL

ET

FI

FR

GA

HR

HU

IT

LV

LT

MT

NL

PL

PT

RO

SK

SL

ES

SV

CS

EN

BG

DA

DE

EL

ET

FI

FR

GA

HR

HU

IT

LV

LT

MT

NL

PL

PT

RO

SK

SL

ES

SV

CS

EN

BG

DA

DE

EL

ET

FI

FR

GA

HR

HU

IT

LV

LT

MT

NL

PL

PT

RO

SK

SL

ES

SV

CS

EN

BG

DA

DE

EL

ET

FI

FR

GA

HR

HU

IT

LV

LT

MT

NL

PL

PT

RO

SK

SL

ES

SV

CS

EN

BG

DA

DE

EL

ET

FI

FR

GA

HR

HU

IT

LV

LT

MT

NL

PL

PT

RO

SK

SL

ES

SV

CS

EN

BG

DA

DE

EL

ET

FI

FR

GA

HR

HU

IT

LV

LT

MT

NL

PL

PT

RO

SK

SL

ES

SV

CS

EN

BG

DA

DE

EL

ET

FI

FR

GA

HR

HU

IT

LV

LT

MT

NL

PL

PT

RO

SK

SL

ES

SV

CS

EN

BG

DA

DE

EL

ET

FI

FR

GA

HR

HU

IT

LV

LT

MT

NL

PL

PT

RO

SK

SL

ES

SV

CS

EN

BG

DA

DE

EL

ET

FI

FR

GA

HR

HU

IT

LV

LT

MT

NL

PL

PT

RO

SK

SL

ES

SV

CS

EN

BG

DA

DE

EL

ET

FI

FR

GA

HR

HU

IT

LV

LT

MT

NL

PL

PT

RO

SK

SL

ES

SV

CS

EN

BG

DA

DE

EL

ET

FI

FR

GA

HR

HU

IT

LV

LT

MT

NL

PL

PT

RO

SK

SL

ES

SV

CS

EN

BG

DA

DE

EL

ET

FI

FR

GA

HR

HU

IT

LV

LT

MT

NL

PL

PT

RO

SK

SL

ES

SV

CS

EN

BG

DA

DE

EL

ET

FI

FR

GA

HR

HU

IT

LV

LT

MT

NL

PL

PT

RO

SK

SL

ES

SV

CS

EN

BG

DA

DE

EL

ET

FI

FR

GA

HR

HU

IT

LV

LT

MT

NL

PL

PT

RO

SK

SL

ES

SV

CS

IV.2.6) Minimum time frame during which the tenderer must maintain the tender

Duration in months: 9 (from the date stated for receipt of tender)

IV.2.7) Conditions for opening of tenders

Date: 08/02/2018

Local time: 10:00

Place:

Det Europæiske Lægemiddelagentur, 30 Churchill Place, Canary Wharf, London, E14 5EU, Det Forenede Kongerige.

Europäische Arzneimittel-Agentur, 30 Churchill Place, Canary Wharf, London, E14 5EU, Vereinigtes Königreich.

European Medicines Agency, 30 Churchill Place, Canary Wharf, London, E14 5EU, United Kingdom.

Agencia Europea de Medicamentos, 30 Churchill Place, Canary Wharf, London, E14 5EU, Reino Unido.

Euroopan lääkevirasto, 30 Churchill Place, Canary Wharf, London, E14 5EU, Yhdistynyt kuningaskunta.

Agence européenne des médicaments, 30 Churchill Place, Canary Wharf, London, E14 5EU, Royaume-Uni.

¿¿¿¿pa¿¿¿¿ ¿¿¿a¿¿sµ¿¿ Fa¿µ¿¿¿¿, 30 Churchill Place, Canary Wharf, London, E14 5EU, ¿¿¿µ¿¿¿ ¿as¿¿e¿¿.

Agenzia europea per i medicinali, 30 Churchill Place, Canary Wharf, London, E14 5EU, Regno Unito.

Europees Geneesmiddelenbureau, 30 Churchill Place, Canary Wharf, London, E14 5EU, Verenigd Koninkrijk.

Agência Europeia de Medicamentos, 30 Churchill Place, Canary Wharf, London, E14 5EU, Reino Unido.

Europeiska läkemedelsmyndigheten, 30 Churchill Place, Canary Wharf, London, E14 5EU, Storbritannien.

Evropská agentura pro lécivé prípravky, 30 Churchill Place, Canary Wharf, London, E14 5EU, Spojené království.

Euroopa Ravimiamet, 30 Churchill Place, Canary Wharf, London, E14 5EU, Ühendkuningriik.

Európai Gyógyszerügynökség, 30 Churchill Place, Canary Wharf, London, E14 5EU, Egyesült Királyság.

Europos Vaistu Agentura, 30 Churchill Place, Canary Wharf, London, E14 5EU, Jungtine Karalyste.

Eiropas Zalu agentura, 30 Churchill Place, Canary Wharf, London, E14 5EU, Apvienota Karaliste.

L-Agenzija Ewropea tal-Medicini, 30 Churchill Place, Canary Wharf, London E14 5EU, ir-Renju Unit.

Europejska Agencja Leków, 30 Churchill Place, Canary Wharf, London, E14 5EU, Zjednoczone Królestwo.

Európska agentúra pre lieky, 30 Churchill Place, Canary Wharf, London, E14 5EU, Spojené královstvo.

Evropska agencija za zdravila, 30 Churchill Place, Canary Wharf, London, E14 5EU, Združeno kraljestvo.

An Ghníomhaireacht Leigheasra Eorpach, 30 Churchill Place, Canary Wharf, London, E14 5EU, An Ríocht Aontaithe.

¿¿¿¿¿¿¿¿¿¿ ¿¿¿¿¿¿¿ ¿¿ ¿¿¿¿¿¿¿¿¿¿¿, 30 Churchill Place, Canary Wharf, London, E14 5EU, ¿¿¿¿¿¿¿¿¿ ¿¿¿¿¿¿¿¿.

Agen¿ia Europeana pentru Medicamente, 30 Churchill Place, Canary Wharf, London, E14 5EU, Regatul Unit.

Europska agencija za lijekove, 30 Churchill Place, Canary Wharf, London, E14 5EU, Ujedinjena Kraljevina.

Information about authorised persons and opening procedure:

Højst 1 repræsentant pr. tilbudsgiver kan overvære åbningen af buddene. Af sikkerhedsmæssige årsager skal tilbudsgivere registrere sig inden for den fastsatte frist (se venligst opfordringen til afgivelse af bud) for at få tilladelse til at overvære åbningen af buddene.

Maximal 1 Vertreter je Bieter darf an der Öffnung der Angebote teilnehmen. Aus Sicherheitsgründen müssen sich die Bieter innerhalb der Frist anmelden (siehe die Aufforderung zur Angebotsabgabe), um an der Öffnung teilnehmen zu dürfen.

Maximum of 1 representative per tenderer is permitted to be present at the opening. For security reasons, tenderers must register within the given deadline (please see the invitation to tender letter) to be allowed to attend the opening session.

Podrá estar presente en la apertura de las ofertas 1 representante por licitador como máximo. Por razones de seguridad, los candidatos deben registrarse dentro del plazo fijado (véase la carta de la invitación a licitar) para que se les permita asistir a la sesión de apertura.

Tarjousten avaustilaisuuteen voi osallistua 1 edustaja jokaiselta tarjoajalta. Turvallisuussyistä tarjoajien on rekisteröidyttävä annettuun määräaikaan (katso tarjouspyyntökirje) mennessä voidakseen osallistua avaustilaisuuteen.

1 représentant par soumissionnaire au maximum sera autorisé à assister à l'ouverture des offres. Pour des raisons de sécurité, les soumissionnaires doivent s'inscrire avant la date limite (voir lettre d'invitation à soumissionner) afin d'être autorisés à assister à la séance d'ouverture des offres.

St¿ ¿¿¿¿¿µa t¿¿ p¿¿sf¿¿¿¿ ep¿t¿¿peta¿ ¿a pa¿aste¿ 1 ¿at' a¿¿tat¿ ¿¿¿¿ e¿p¿¿s¿p¿¿ a¿¿ ¿p¿¿¿f¿¿. G¿a ¿¿¿¿¿¿ asf¿¿e¿a¿, ¿¿ ¿p¿¿¿f¿¿¿ p¿¿pe¿ ¿a e¿¿¿af¿¿¿ e¿t¿¿ t¿¿ ¿¿¿s¿e¿sa¿ p¿¿¿esµ¿a¿ (ß¿¿pe t¿¿ ep¿st¿¿¿ p¿¿s¿¿¿s¿¿ ¿p¿ß¿¿¿¿ p¿¿sf¿¿¿¿) p¿¿¿e¿µ¿¿¿¿ ¿a t¿¿¿ ep¿t¿ape¿ ¿a pa¿ast¿¿¿ st¿ s¿¿ed¿¿as¿ ¿¿a t¿ ¿¿¿¿¿µa t¿¿ p¿¿sf¿¿¿¿.

1 rappresentante per ogni offerente potrà essere presente all'apertura delle offerte. Per motivi di sicurezza, gli offerenti dovranno registrarsi entro il termine stabilito (cfr. lettera di invito a presentare offerta) per essere autorizzati ad assistere all'apertura delle offerte.

per inschrijver mag maximaal 1 vertegenwoordiger de opening van de inschrijvingen bijwonen. Om veiligheidsredenen moeten inschrijvers zich binnen de gestelde termijn (zie de uitnodiging tot inschrijving) melden om tot de opening te worden toegelaten.

No máximo, 1 representante por proponente está autorizado a assistir à abertura das propostas. Por motivos de segurança, os proponentes devem registar-se no prazo estabelecido (consultar a carta de convite à apresentação de propostas) para serem autorizados a participar na sessão de abertura.

Högst 1 företrädare per anbudsgivare tillåts närvara vid anbudsöppningen. Av säkerhetsskäl ska anbudsgivare registrera sig inom den angivna tidsfristen (se anbudsinfordran) för att få närvara vid mötet för öppnande av anbud.

Úcast pri otevírání nabídek je povolena maximálne 1 zástupci každého uchazece. Aby se uchazeci mohli zúcastnit otevírání nabídek, musí se z bezpecnostních duvodu zaregistrovat behem stanovené lhuty (viz dokumentaci výzvy k úcasti v nabídkovém rízení).

Avamisest võib osa võtta maksimaalselt 1 esindaja pakkuja kohta. Turvalisusega seotud kaalutlustel peavad pakkujad pakkumiste avamisel osalemise loa saamiseks end esitatud tähtpäevaks registreerima (vt pakkumiskutse kirja).

A tenderbontáson ajánlattevonként legfeljebb1 képviselo részvétele engedélyezett. Az ajánlattevoknek annak érdekében, hogy részt vehessenek a tenderbontáson, biztonsági okokból egy adott határidon belül (lásd az ajánlati felhívást) regisztrálniuk kell.

Voku su pasiulymais atplešimo proceduroje leidžiama dalyvauti ne daugiau nei po 1 kiekvieno konkurso dalyvio atstova. Noredami dalyvauti voku su pasiulymais atplešimo proceduroje, saugumo sumetimais konkurso dalyviai privalo užsiregistruoti per nurodyta termina (žr. kvietima pateikti pasiulymus).

atveršana var piedalities ne vairak ka 1 katra pretendenta parstavis. Drošibas apsverumu del, lai varetu apmeklet atveršanas sanaksmi, pretendentiem jaregistrejas lidz noteiktajam terminam (ludzam skatit uzaicinajuma uz konkursu vestuli).

Mhux aktar minn rapprezentant 1 ghal kull min jitfa' offerta jista' jkun prezenti ghall-ftuh. Ghal ragunijiet ta' sigurtà, dawk li jitfghu l-offerti ghandhom jirregistraw sad-data tal-gheluq moghtija (jekk joghgbok ara l-ittra tal-istedina ghall-offerti) biex jithallew jattendu ghas-sessjoni tal-ftuh.

w otwarciu ofert moze uczestniczyc 1 przedstawiciel kazdego oferenta. Ze wzgledów bezpieczenstwa oferenci musza zarejestrowac sie w podanym terminie (zob. zaproszenie do skladania ofert), aby móc uczestniczyc w sesji otwarcia ofert.

Na otváraní obálok s ponukami sa môže zúcastnit maximálne 1 zástupca za každého uchádzaca. Z bezpecnostných dôvodov sa uchádzaci musia zaregistrovat v stanovenej lehote (pozri výzvu na predloženie ponúk), aby sa mohli zúcastnit na otváraní ponúk.

Pri odpiranju ponudb je lahko navzoc najvec 1 zastopnik na ponudnika. Da bi se lahko ponudniki udeležili odpiranja ponudb, se morajo iz varnostnih razlogov prijaviti v dolocenem roku (glejte povabilo k oddaji ponudb).

Tá cead ag 1 ionadaí in aghaidh an tairgeora ar a mhéad bheith i láthair ag an oscailt. Ar chúiseanna slándála, ní mór do thairgeoirí clárú roimh an spriocdháta atá tugtha (féach ar litir an chuiridh chun tairisceana) ionas go ligfear dóibh freastal ar an seisiún oscailte.

¿¿ ¿¿¿¿¿¿¿¿¿¿ ¿¿ ¿¿¿¿¿¿¿¿ ¿¿¿¿ ¿¿ ¿¿¿¿¿¿¿¿¿ ¿¿ ¿¿¿¿¿¿¿¿ 1 ¿¿¿¿¿¿¿¿¿¿¿¿ ¿¿ ¿¿¿¿¿¿¿. ¿¿ ¿¿¿¿¿¿¿¿¿¿¿ ¿¿ ¿¿¿¿¿¿¿¿¿, ¿¿¿¿¿¿¿¿¿¿ ¿¿¿¿¿¿ ¿¿ ¿¿ ¿¿¿¿¿¿¿¿¿¿¿ ¿ ¿¿¿¿¿¿¿ ¿¿ ¿¿¿¿¿¿¿ ¿¿¿¿¿ ¿¿¿¿ (¿¿¿¿, ¿¿¿¿¿ ¿¿¿¿¿¿¿ ¿¿ ¿¿¿¿¿¿¿¿ ¿¿ ¿¿¿¿¿¿¿ ¿ ¿¿¿¿), ¿¿ ¿¿ ¿¿¿¿¿ ¿¿ ¿¿¿¿¿¿¿¿¿¿ ¿¿ ¿¿¿¿¿¿¿¿¿¿¿ ¿¿ ¿¿¿¿¿¿¿¿.

La deschidere poate participa maximum 1 reprezentant din partea fiecarui ofertant. Din motive de securitate, ofertan¿ii trebuie sa se înregistreze în termenul indicat (a se vedea scrisoarea de invita¿ie la licita¿ie) pentru a li se permite participarea la ¿edin¿a de deschidere.

Otvaranju ponuda smije prisustvovati najviše 1 predstavnik po ponuditelju. Iz sigurnosnih razloga, ponuditelji se moraju registrirati u danom roku (molimo pogledajte pismo poziva za nadmetanje) kako bi mogli prisustvovati javnom otvaranju ponuda.

Section VI: Complementary information

VI.1) Information about recurrence

This is a recurrent procurement: Yes

VI.3) Additional information

Bemærk venligst, at der kun kan afgives 1 bud pr. tilbudsgiver.

Bitte beachten Sie, dass nur 1 Angebot pro Bieter pro Los eingereicht werden kann.

Please note only 1 tender per tenderer per lot may be submitted.

Solo se podrá presentar 1 oferta por licitador y por lote.

Tarjoajia pyydetään ottamaan huomioon, että ne voivat jättää ainoastaan 1 tarjouksen kustakin erästä.

Il convient de noter que 1 seule offre pourra être présentée par soumissionnaire.

S¿µe¿¿¿eta¿ ¿t¿ ep¿t¿¿peta¿ ¿ ¿p¿ß¿¿¿ µ¿¿¿¿ 1 p¿¿sf¿¿¿¿ a¿¿ ¿p¿¿¿f¿¿ a¿¿ pa¿t¿da.

Si noti che può essere presentata 1 sola offerta da parte di ciascun offerente per lotto.

Gelieve op te merken dat er per perceel slechts 1 inschrijving per inschrijver mag worden ingediend.

Importa notar que apenas poderá ser apresentada 1 proposta por proponente e por lote.

Observera att endast 1 anbud kan lämnas per anbudsgivare och del.

Upozornujeme, že každý uchazec smí podat pouze 1 nabídku na položku.

Pange tähele, et pakkuja kohta võib esitada osa kohta ainult 1 pakkumise.

Felhívjuk figyelmüket, hogy pályázónként minden tételre csak 1 pályázatot lehet benyújtani.

Prašome atkreipti demesi, kad konkurso dalyvis gali pateikti tik 1 pasiulyma vienai daliai.

Ludzam nemt vera, ka pretendents par katru dalu var iesniegt tikai 1 piedavajumu.

Jekk joghgbok innota li tista' tintbaghat offerta 1 ghal kull min jitfa' offerta, ghal kull lott.

Pragniemy zwrócic uwage na fakt, ze oferenci moga skladac tylko 1 oferte na kazda czesc zamówienia.

Pripomíname, že jeden uchádzac môže predložit len 1 ponuku za cast.

Upoštevajte, da lahko posamezni ponudnik odda samo 1 ponudbo na sklop.

Tabhair faoi deara nach féidir ach 1 tairiscint amháin a chur isteach in aghaidh an tairgeora le haghaidh gach birt.

¿¿¿¿, ¿¿¿¿¿¿¿¿ ¿¿¿¿¿¿¿¿, ¿¿ ¿¿¿¿ 1 ¿¿¿¿¿¿ ¿¿¿¿ ¿¿ ¿¿¿¿ ¿¿¿¿¿¿¿¿ ¿¿ ¿¿¿¿¿¿¿ ¿¿ ¿¿¿¿¿¿¿¿¿ ¿¿¿¿¿¿¿.

A se avea în vedere faptul ca fiecare ofertant poate depune numai 1 oferta pentru fiecare lot.

Napominjemo da se može podnijeti samo 1 ponuda po ponuditelju po grupi.

VI.4) Procedures for review

VI.4.1) Review body

Retten

Rue du Fort Niedergrünewald

Luxembourg

2925

LU

Telephone: +352 4303-1

E-mail: generalcourt.registry@curia.europa.eu

Fax: +352 4303-2100

Internet address(es)

URL: http://curia.europa.eu

VI.4.3) Review procedure

Precise information on deadline(s) for review procedures:

De kan fremsætte bemærkninger vedrørende tildelingsproceduren til den ordregivende myndighed anført i punkt I.1.

Hvis De mener, at der har været tale om fejl og forsømmelser, kan De indgive en klage til Den Europæiske Ombudsmand i 2 år efter, De har fået kendskab til de forhold, som klagen vedrører (se http://www.ombudsman.europa.eu). En klage bevirker ikke, at perioden for indgivelse af en klage afbrydes, eller at der påbegyndes en ny periode for indgivelse af klage.

Senest 2 måneder efter underrettelsen om tildeling kan De indgive klage til det organ, der er omhandlet i punkt VI.4.1.

Bemerkungen zum Vergabeverfahren können an den in Abschnitt I.1 angegebenen öffentlichen Auftraggeber übermittelt werden.

Bei Verdacht auf Missstände in der Verwaltungstätigkeit kann beim Europäischen Bürgerbeauftragten eine Beschwerde eingereicht werden, und zwar innerhalb von 2 Jahren ab dem Zeitpunkt der Kenntnisnahme der Tatsachen, auf denen die Beschwerde beruht (siehe http://www.ombudsman.europa.eu). Eine solche Beschwerde bewirkt weder die Unterbrechung des Zeitraums für die Einlegung von Rechtsbehelfen noch den Beginn eines neuen Zeitraums für die Einlegung von Rechtsbehelfen.

Rechtsbehelfe können innerhalb von 2 Monaten nach der Mitteilung der Vergabeentscheidung bei der unter VI.4.1 genannten Stelle eingelegt werden.

You may submit any observations concerning the award procedure to the contracting authority indicated under heading I.1.

If you believe that there was maladministration, you may lodge a complaint to the European Ombudsman within 2 years of the date when you became aware of the facts on which the complaint is based (see http://www.ombudsman.europa.eu ). Such complaint does not have as an effect either to suspend the time limit to launch an appeal or to open a new period for lodging an appeal.

Within 2 months of the notification of the award decision you may lodge an appeal to the body referred to in VI.4.1.

Puede comunicar cualquier observación relativa al procedimiento de adjudicación al órgano de contratación indicado en el apartado I.1.

Si considera que se ha realizado una mala administración, puede presentar una reclamación ante el Defensor del Pueblo Europeo en un plazo de 2 años a partir de la fecha en la que tuvo conocimiento de los hechos en que se basa la reclamación (consulte http://www.ombudsman.europa.eu). Dicha reclamación no tendrá como efecto la suspensión del plazo para presentar un recurso ni la apertura de un nuevo plazo de presentación de recursos.

En un plazo de 2 meses a partir de la fecha de notificación de la decisión de adjudicación, puede presentar un recurso ante la instancia indicada en el apartado VI.4.1.

Mahdollisia sopimuksentekomenettelyä koskevia huomautuksia voidaan lähettää kohdassa I.1 ilmoitetulle hankintaviranomaiselle.

Siinä tapauksessa, että tarjoaja kokee hallinnollisen epäkohdan aiheutuneen, asiasta voidaan tehdä valitus Euroopan oikeusasiamiehelle 2 vuoden kuluessa siitä päivämäärästä, jona valituksen perusteena olevat seikat havaittiin (katso http://www.ombudsman.europa.eu). Kyseinen valitus ei pidennä muutoksenhakupyyntöjen jättämisen määräaikaa, eikä sen vuoksi muutoksenhakupyynnön jättämiselle määrätä uutta määräaikaa.

Muutoksenhakupyynnöt on jätettävä kohdassa VI.4.1 mainitulle elimelle 2 kuukauden kuluessa sopimuksentekoa koskevan päätöksen ilmoittamisesta.

Toute observation concernant la procédure d'attribution peut être adressée au pouvoir adjudicateur indiqué au point I.1.

Si le soumissionnaire estime que la gestion a été défaillante, il peut déposer une plainte auprès du Médiateur européen dans un délai de 2 ans à compter de la date à laquelle il a eu connaissance des faits sur lesquels porte la plainte (voir http://www.ombudsman.europa.eu). L'introduction d'une telle plainte n'a pour effet ni la suspension du délai de recours, ni l'ouverture d'un nouveau délai de recours.

Les recours peuvent être déposés auprès de l'organe visé au point VI.4.1 dans les 2 mois à compter de la notification de la décision d'attribution.

¿¿ ¿p¿¿¿f¿¿¿ µp¿¿¿¿¿ ¿a ¿p¿ß¿¿¿¿¿ t¿¿¿¿ pa¿at¿¿¿se¿¿ s¿et¿¿¿ µe t¿ d¿ad¿¿as¿a a¿¿¿es¿¿ st¿¿ a¿a¿¿t¿¿sa a¿¿¿ p¿¿ a¿af¿¿eta¿ st¿ s¿µe¿¿ I.1.

¿¿¿ p¿ste¿ete p¿¿ ¿p¿¿¿e ¿¿t¿µa ¿a¿¿¿ d¿¿¿¿¿s¿¿, µp¿¿e¿te ¿a ¿p¿ß¿¿ete ¿ata¿¿e¿¿a st¿¿ ¿¿¿¿pa¿¿ ¿¿aµes¿¿aß¿t¿ e¿t¿¿ 2 et¿¿ ap¿ t¿¿ ¿µe¿¿µ¿¿¿a ¿at¿ t¿¿ ¿p¿¿a ¿¿ßate ¿¿¿s¿ t¿¿ ¿e¿¿¿¿t¿¿ sta ¿p¿¿a ßas¿¿eta¿ ¿ ¿ata¿¿e¿¿a (ß¿¿pe http://www.ombudsman.europa.eu). ¿ e¿ ¿¿¿¿ ¿ata¿¿e¿¿a de¿ ¿¿e¿ ¿¿ ap¿t¿¿esµa ¿¿te t¿¿ a¿ast¿¿¿ t¿¿ p¿¿¿esµ¿a¿ ¿¿a t¿¿ ¿p¿ß¿¿¿ p¿¿sf¿¿¿¿ ¿¿te t¿¿ ¿¿a¿¿¿ ¿¿a¿ pe¿¿¿d¿¿ ¿¿a t¿¿ ¿p¿ß¿¿¿ p¿¿sf¿¿¿¿.

¿¿t¿¿ 2 µ¿¿¿¿ ap¿ t¿¿ ¿¿¿¿¿p¿¿¿s¿ t¿¿ ap¿fas¿¿ a¿¿¿es¿¿ µp¿¿e¿te ¿a ¿p¿ß¿¿ete p¿¿sf¿¿¿ st¿¿ f¿¿¿a p¿¿ a¿af¿¿eta¿ st¿ s¿µe¿¿ VI.4.1.

Si possono presentare osservazioni relative alla procedura di aggiudicazione all'amministrazione aggiudicatrice indicata al punto I.1).

Se, a parere del ricorrente, vi è stata cattiva amministrazione, questi potrà presentare una denuncia al Mediatore europeo nel termine di 2 anni dalla data in cui è venuto a conoscenza dei fatti a cui si riferisce la denuncia (cfr. http://www.ombudsman.europa.eu). Tale denuncia non produce né l'effetto di sospendere il termine ultimo per la presentazione di ricorsi né di aprirne uno nuovo.

Entro 2 mesi dalla notifica della decisione di aggiudicazione si può presentare ricorso all'organismo di cui al punto VI.4.1).

eventuele opmerkingen in verband met de gunningsprocedure mogen worden verstuurd naar de aanbestedende dienst vermeld in I.1.

Indien u van mening bent dat er sprake is van onbehoorlijk bestuur, dan mag u binnen 2 jaar na de datum waarop u de desbetreffende feiten, waarop deze klacht is gebaseerd, te weten bent gekomen een klacht indienen bij de Europese Ombudsman (ga naar http://www.ombudsman.europa.eu). Dergelijke klacht leidt niet tot een opschorting van de termijn voor het instellen van een beroep, noch tot de opening van een nieuwe termijn voor het instellen van een beroep.

Binnen 2 maanden na de kennisgeving van het gunningsbesluit kan een beroep worden ingesteld bij de dienst vermeld in VI.4.1.

Pode apresentar quaisquer observações relativas ao procedimento de adjudicação à entidade adjudicante indicada no ponto I.1.

Caso acredite na existência de má administração, pode apresentar uma queixa ao Provedor de Justiça Europeu num prazo de 2 anos a contar da data em que tomou conhecimento dos factos em que se baseia a queixa (consultar http://www.ombudsman.europa.eu). A queixa em questão não tem como efeito a suspensão do prazo para interpor um recurso nem a abertura de um novo período de interposição de recursos.

Num prazo de 2 meses a contar da notificação da decisão de adjudicação, pode apresentar um recurso ao organismo indicado no ponto VI.4.1.

Anmärkningar om tilldelningsförfarandet kan lämnas till den upphandlande myndighet som anges i punkt I.1.

Vid misstanke om ett administrativt missförhållande kan ett klagomål framföras till Europeiska ombudsmannen inom 2 år från det datum då de fakta som klagomålet bygger på blev kända (se http://www.ombudsman.europa.eu). Sådana klagomål leder varken till att tidsfristen för begäran om överprövning skjuts upp eller till att en ny period för begäran om överprövning inleds.

En begäran om överprövning kan lämnas till det organ som nämns i punkt VI.4.1 inom 2 månader efter meddelandet om beslutet om tilldelning.

Veškeré pripomínky týkající se zadávacího rízení mužete predložit verejnému zadavateli uvedenému v bode I.1.

Pokud si myslíte, že došlo k nesprávnému administrativnímu postupu, mužete podat stížnost evropskému verejnému ochránci práv ve lhute 2 let od data, kdy jste se dozvedeli o skutecnostech, na nichž se stížnost zakládá (viz http://www.ombudsman.europa.eu). Taková stížnost nebude mít za následek ani pozastavení lhuty, ani zapocetí nové lhuty pro podání odvolání.

Ve lhute 2 mesícu od oznámení rozhodnutí o zadání zakázky mužete podat odvolání k orgánu uvedenému v bode VI.4.1.

Lepingu sõlmimise menetluse kohta võib esitada tähelepanekuid punktis I.1 nimetatud hankijale.

Juhul kui kogetakse halduslikku omavoli, võib Euroopa Ombudsmanile esitada kaebuse 2 aasta jooksul päevast, mil saadakse teada faktid, millel kaebus põhineb (vt http://www.ombudsman.europa.eu). Selline kaebus ei too kaasa apellatsioonide esitamise tähtaja peatamist ega uue tähtaja määramist.

Punktis VI.4.1 nimetatud organile võib apellatsioone esitada 2 kuu jooksul lepingu sõlmimise otsusest teavitamisest.

Az odaítélési eljárással kapcsolatban az I.1. pontban feltüntetett ajánlatkéronek nyújthatja be észrevételeit.

Amennyiben az ajánlattevo úgy véli, hogy hivatali visszásságra került sor, panaszt tehet az európai ombudsmannál attól a naptól számított 2 éven belül, hogy a panaszra okot adó tényrol tudomást szerzett (lásd a http://www.ombudsman.europa.eu oldalon). A benyújtott panasz nem eredményezi sem a fellebbezési idoszak meghosszabbítását, sem új idoszak megnyitását.

Jogorvoslati kérelem benyújtására az odaítélési határozatra vonatkozó értesítést követo 2 hónapon belül van lehetoség a VI.4.1. pontban feltüntetett jogorvoslati szervnek.

Galite pateikti bet kokias pastabas del sutarties skyrimo proceduros I.1 dalyje nurodytai perkanciajai organizacijai.

Jeigu manote, kad buvo blogai administruojama, galite pateikti skunda Europos ombudsmenui per 2 metus nuo dienos, kai tapo žinomi faktai, kuriais grindžiamas skundas (žr. http://www.ombudsman.europa.eu). Del tokio skundo nebus sustabdytas apeliaciju teikimo laikotarpis ar pradetas naujas apeliaciju teikimo laikotarpis.

Per 2 menesius nuo sprendimo paskirti sutarti galima pateikti apeliacija VI.4.1 dalyje nurodytai institucijai.

piezimes par pieškiršanas proceduru var iesniegt I.1. iedala minetajai ligumsledzejai iestadei.

Ja uzskatat, ka pielauta administrativa klume, varat iesniegt sudzibu Eiropas Ombudam 2 gadu laika no dienas, kad esat uzzinajis par faktiem, uz kuriem balstita sudziba (sk. http://www.ombudsman.europa.eu). Šadas sudzibas iesniegšana nevar ne atlikt parsudzibu iesniegšanas terminu, ne ari noteikt jaunu periodu parsudzibu iesniegšanai.

Parsudzibu var iesniegt VI.4.1. iedala minetajai strukturai 2 menešu laika no pieškiršanas lemuma pazinošanas.

Tista' tissottometti kwalunkwe osservazzjonijiet dwar il-procedura tal-ghoti lill-awtorità li qieghda tohrog il-kuntratt indikata taht it-titlu l.1.

Jekk temmen li kien hemm amministrazzjoni hazina, tista' tressaq ilment lill-Ombudsman Ewropew fi zmien sentejn (2) mid-data li fiha sirt taf dwar il-fatti li fuqhom huwa bbazat l-ilment (ara http://www.ombudsman.europa.eu). Ilment bhal dan mhux se jwassal biex jew ikun sospiz il-limitu taz-zmien ghat-tressiq ta' appell jew biex jinfetah perijodu gdid ghat-tressiq ta' appell.

Fi zmien xahrejn (2) min-notifika dwar id-decizjoni tal-ghoti inti tista' tressaq appell quddiem il-korp li ghalih hemm referenza f'VI.4.1.

uwagi dotyczace procedury udzielania zamówienia mozna przesylac do instytucji zamawiajacej wskazanej w pkt I.1.

W przypadku stwierdzenia niewlasciwego administrowania istnieje mozliwosc zlozenia skargi do Europejskiego Rzecznika Praw Obywatelskich w ciagu 2 lat od powziecia wiadomosci o faktach bedacych podstawa skargi (zob. http://www.ombudsman.europa.eu). Taka skarga nie skutkuje zawieszeniem ani rozpoczeciem na nowo biegu terminu skladania odwolan.

Odwolanie do organu, o którym mowa w pkt VI.4.1, mozna zlozyc w ciagu 2 miesiecy od zawiadomienia o decyzji o udzieleniu zamówienia.

Prípadné pripomienky týkajúce sa výberového konania môžete predložit obstarávatelovi uvedenému v bode I.1.

Ak sa domnievate, že došlo k nesprávnemu úradnému postupu, môžete podat stažnost európskemu ombudsmanovi do 2 rokov od dátumu, ked ste sa dozvedeli o skutocnosti, na ktorej sa táto stažnost zakladá (pozri http://www.ombudsman.europa.eu ). Takáto stažnost nebude mat za následok prerušenie, ani zacatie novej lehoty na predloženie odvolania.

Odvolanie môžete podat orgánu uvedenému v bode VI.4.1 do 2 mesiacov od oznámenia o pridelení obstarávania.

Morebitne pripombe v zvezi s postopkom oddaje narocila lahko pošljete narocniku na naslov iz oddelka I.1.

Ce menite, da je prišlo do nepravilnosti, lahko vložite pritožbo pri Evropskem varuhu clovekovih pravic v 2 letih od datuma, ko ste bili obvešceni o dejstvih, ki predstavljajo podlago za pritožbo (glejte http://www.ombudsman.europa.eu). Takšna pritožba ne vpliva na zadržanje navedenega obdobja za sprožitev pritožbe ali na zacetek novega obdobja za vložitev pritožb.

Pritožbo lahko vložite v 2 mesecih od obvestila o sklepu o oddaji narocila pri organu iz oddelka VI.4.1.

Is féidir leat aon tuairimí maidir leis an nós imeachta dámhachtana a chur isteach chuig an údarás conarthach atá léirithe faoi cheannteideal I.1.

Má chreideann tú go raibh míriarachán i gceist, féadfaidh tú gearán a chur chuig an Ombudsman Eorpach laistigh de 2 bhliain ón dáta a d'éirigh tú feasach ar na fíricí a bhfuil an gearán bunaithe orthu (féach http://www.ombudsman.europa.eu). Ní dhéanfar an teorainn ama chun achomharc a sheoladh a chur ar fionraí ná tréimhse nua a oscailt le haghaidh achomharc a dhéanamh mar gheall ar ghearán den sórt sin.

Laistigh de 2 mhí óna gcuirtear cinneadh na dámhachtana in iúl is féidir leat achomharc a thaisceadh leis an gcomhlacht dá dtagraítear in VI.4.1.

¿¿¿¿¿¿ ¿¿ ¿¿¿¿¿¿¿¿ ¿¿¿¿¿¿¿¿ ¿¿¿¿¿¿¿¿¿ ¿¿¿¿¿¿¿ ¿¿¿¿¿¿¿¿¿¿¿ ¿¿ ¿¿¿¿¿¿¿¿¿ ¿¿ ¿¿¿¿¿¿¿¿¿¿ ¿¿¿¿¿, ¿¿¿¿¿¿¿ ¿ ¿¿¿¿¿ I.1.

¿¿¿ ¿¿¿¿¿¿¿, ¿¿ ¿ ¿¿¿¿¿ ¿¿¿¿ ¿¿¿¿¿¿¿¿¿¿, ¿¿¿ ¿¿¿¿¿¿ ¿¿ ¿¿¿¿¿¿¿¿ ¿¿¿¿¿ ¿¿ ¿¿¿¿¿¿¿¿¿¿¿ ¿¿¿¿¿¿¿¿¿ ¿ ¿¿¿¿¿¿¿ ¿¿ 2 ¿¿¿¿¿¿ ¿¿ ¿¿¿¿¿¿, ¿¿ ¿¿¿¿¿ ¿¿¿ ¿¿¿¿¿¿ ¿¿ ¿¿¿¿¿¿¿, ¿¿ ¿¿¿¿¿ ¿¿ ¿¿¿¿¿¿¿¿ ¿¿¿¿¿¿¿ (¿¿.: http://www.ombudsman.europa.eu). ¿¿¿¿¿¿ ¿¿¿¿¿ ¿¿¿¿ ¿¿¿¿ ¿¿ ¿¿¿¿ ¿¿¿¿¿ ¿¿ ¿¿¿¿¿¿¿ ¿¿ ¿¿¿¿¿, ¿¿¿¿ ¿¿ ¿¿¿¿¿¿ ¿¿ ¿¿¿¿¿¿¿¿¿ ¿¿ ¿¿¿ ¿¿¿¿ ¿¿ ¿¿¿¿¿¿¿¿ ¿¿ ¿¿¿¿¿.

¿ ¿¿¿¿¿¿¿ ¿¿ 2 ¿¿¿¿¿¿ ¿¿ ¿¿¿¿¿¿¿¿¿¿¿¿¿ ¿¿ ¿¿¿¿¿¿¿¿¿ ¿¿ ¿¿¿¿¿¿¿¿¿, ¿¿¿ ¿¿¿¿¿¿ ¿¿ ¿¿¿¿¿¿¿¿ ¿¿¿¿¿ ¿¿ ¿¿¿¿¿¿, ¿¿¿¿¿¿¿ ¿ ¿¿¿¿¿ VI.4.1.

Eventualele observa¿ii privind procedura de atribuire se pot depune la autoritatea contractanta indicata la punctul I.1.

În cazul unei presupuse administrari necorespunzatoare, se poate depune o plângere la Ombudsmanul European în termen de 2 ani de la data la care s-a luat cuno¿tin¿a de faptele pe care se bazeaza plângerea (a se vedea http://www.ombudsman.europa.eu). O astfel de plângere nu are drept efect suspendarea termenului sau deschiderea unui nou termen pentru utilizarea cailor de atac.

În termen de 2 luni de la notificarea deciziei de atribuire, se poate depune o plângere la organismul men¿ionat la punctul VI.4.1.

Primjedbe u vezi s postupkom sklapanja ugovora možete dostaviti javnom narucitelju iz tocke I.1.

Ako smatrate da je došlo do nepravilnosti, pritužbu možete podnijeti Europskom ombudsmanu u roku od 2 godine od datuma kad ste doznali za okolnosti koje su uzrok pritužbi (vidi http://www.ombudsman.europa.eu). Takvom se pritužbom ne obustavlja vremenski rok za ulaganje žalbe i ne otvara se novo razdoblje za ulaganje žalbe.

U roku od 2 mjeseca od slanja obavijesti o sklapanju ugovora žalbu možete podnijeti tijelu navedenom u tocki VI.4.1.

VI.4.4) Service from which information about the review procedure may be obtained

Det Europæiske Lægemiddelagentur

30 Churchill Place

London

E14 5EU

UK

Telephone: +44 2036606000

E-mail: info@ema.europa.eu

Fax: +44 2036605555

Internet address(es)

URL: http://www.ema.europa.eu/ema/

VI.5) Date of dispatch of this notice

04/12/2017

Coding

Commodity categories

ID Title Parent category
73000000 Research and development services and related consultancy services Research and Development
73210000 Research consultancy services Research and development consultancy services

Delivery locations

ID Description
100 UK - All

Alert region restrictions

The buyer has restricted the alert for this notice to suppliers based in the following regions.

ID Description
There are no alert restrictions for this notice.

About the buyer

Main contact:
pass.tender@ema.europa.eu
Admin contact:
N/a
Technical contact:
N/a
Other contact:
N/a

Further information

Date Details
No further information has been uploaded.

0800 222 9004

Lines are open 8:30am to 5pm Monday to Friday.

Rydym yn croesawu galwadau'n Gymraeg.

We welcome calls in Welsh.