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Contract Award Notice

Virknings- og sikkerhedsundersøgelser om lægemidler

  • First published: 04 March 2019
  • Last modified: 04 March 2019
  • Version: N/A
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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)

Contents

Summary

OCID:
Published by:
Det Europæiske Lægemiddelagentur
Authority ID:
AA72635
Publication date:
04 March 2019
Deadline date:
-
Notice type:
Contract Award 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 award notice

Results of the procurement procedure

Section I: Contracting entity

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

Ευρωπαϊκός Οργανισμός Φαρμάκων

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 (EMA)

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 léčivé přípravky

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 vaistų agentūra

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 Zāļu aģentūra

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-Aġenzija Ewropea għall-Mediċini

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

Европейска агенция по лекарствата

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

Agenția Europeană 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.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 4 forskellige partier, med maksimalt 5 rammeaftaler for partierne 1, 2 og 3 og maksimalt 8 rammeaftaler for parti 4.

II.1.6) Information about lots

This contract is divided into lots: Yes

II.1.7) Total value of the procurement

Value excluding VAT: 5 000 000.00  EUR

II.2) Description

Lot No: 4

II.2.1) Title

Farmakoepidemiologisk forskning — associationsundersøgelser, inklusive 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

Quality criterion: Caseundersøgelse / Weighting: 30

Quality criterion: Forskningsteam og -opgaver / Weighting: 20

Quality criterion: Projektstyring og kommunikation / Weighting: 20

Price / Weighting:  30

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.1.6) Information about lots

This contract is divided into lots: Yes

II.1.7) Total value of the procurement

Value excluding VAT: 5 000 000.00  EUR

II.2) Description

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

Quality criterion: Fallstudie / Weighting: 30

Quality criterion: Forschungsteam und Aufgaben / Weighting: 20

Quality criterion: Projektmanagement und Kommunikation / Weighting: 20

Price / Weighting:  30

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 eight framework contracts for lot 4.

II.1.6) Information about lots

This contract is divided into lots: Yes

II.1.7) Total value of the procurement

Value excluding VAT: 5 000 000.00  EUR

II.2) Description

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

Quality criterion: Case study / Weighting: 30

Quality criterion: Research Team and Tasks / Weighting: 20

Quality criterion: Project management and communication / Weighting: 20

Price / Weighting:  30

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 eight 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 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 una 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.1.6) Information about lots

This contract is divided into lots: Yes

II.1.7) Total value of the procurement

Value excluding VAT: 5 000 000.00  EUR

II.2) Description

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 de contratación).

II.2.5) Award criteria

Quality criterion: Estudio de caso / Weighting: 30

Quality criterion: Tareas y equipo de investigación / Weighting: 20

Quality criterion: Gestión del proyecto y comunicación / Weighting: 20

Price / Weighting:  30

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 lääke-epidemiologiaa koskevat tutkimukset sääntelyyn liittyvän päätöksenteon tueksi tarvittavien tietojen tuottamiseksi. Tutkimuksessa voidaan keskittyä myös toteutettujen sääntelytoimenpiteiden tehokkuuteen ja asiaankuuluvan lainsäädännön vaikutuksiin. Tutkimusaiheet rajoitetaan koskemaan kansanterveyden kannalta erittäin tärkeitä kysymyksiä ja sellaisia kysymyksiä, joilla on vaikutuksia Euroopassa. Rahoitus kattaa sekä kansallisesti että keskitetysti hyväksytyt valmisteet ja myös rokotteet. Tämän jälkeen viraston asiasta vastaava komitea arvioi tutkimustuloksia sääntelytoimien tarpeellisuuden kannalta, jolloin myös täydentäviä tutkimuksia voidaan suorittaa suoritettujen sääntelytoimien tehokkuuden mittaamiseksi.

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

II.1.6) Information about lots

This contract is divided into lots: Yes

II.1.7) Total value of the procurement

Value excluding VAT: 5 000 000.00  EUR

II.2) Description

Lot No: 4

II.2.1) Title

Lääke-epidemiologinen tutkimus – assosiaatiotutkimukset sekä 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

Quality criterion: tapaustutkimus / Weighting: 30

Quality criterion: tutkimustyöryhmä ja tehtävät / Weighting: 20

Quality criterion: hankkeen johtaminen ja viestintä / Weighting: 20

Price / Weighting:  30

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 kahdeksan 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 5 contrats-cadres pour les lots 1, 2 et 3 et un maximum de 8 contrats-cadres pour le lot 4.

II.1.6) Information about lots

This contract is divided into lots: Yes

II.1.7) Total value of the procurement

Value excluding VAT: 5 000 000.00  EUR

II.2) Description

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

Quality criterion: Étude de cas / Weighting: 30

Quality criterion: Tâches et équipe de recherche / Weighting: 20

Quality criterion: Gestion du projet et communication / Weighting: 20

Price / Weighting:  30

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

Μελέτες αποτελεσματικότητας και ασφάλειας φαρμάκων

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

Μετεγκριτικές μελέτες αποτελεσματικότητας και φαρμακοεπιδημιολογίας για την παραγωγή δεδομένων και πληροφοριών σχετικά με την υποστήριξη της λήψης αποφάσεων σε ρυθμιστικά θέματα. Η έρευνα μπορεί επίσης να επικεντρωθεί στην αποτελεσματικότητα των ληφθέντων ρυθμιστικών μέτρων και στον αντίκτυπο της σχετικής νομοθεσίας. Το εύρος θεμάτων έρευνας περιορίζεται σε αυτά που σχετίζονται σε μεγάλο βαθμό με τη δημόσια υγεία και έχουν αντίκτυπο σε ευρωπαϊκό επίπεδο. Το εύρος της χρηματοδότησης καλύπτει τόσο εθνικά όσο και προϊόντα με άδεια κυκλοφορίας μέσω κεντρικής διαδικασίας, συμπεριλαμβανομένων των εμβολίων. Τα αποτελέσματα που θα προκύψουν από την έρευνα αυτή θα αξιολογηθούν εκ των υστέρων από την αρμόδια επιτροπή του οργανισμού σχετικά με την ανάγκη ρυθμιστικής δράσης και, στη συνέχεια, μπορεί να διεξαχθεί περαιτέρω έρευνα για τη μέτρηση της αποτελεσματικότητας των ληφθέντων ρυθμιστικών δράσεων.

Η έρευνα μπορεί να αφορά τέσσερις διαφορετικές παρτίδες, με πέντε συμβάσεις-πλαίσια κατ' ανώτατο όριο για τις παρτίδες 1, 2 και 3 και οκτώ συμβάσεις-πλαίσια κατ' ανώτατο όριο για την παρτίδα 4.

II.1.6) Information about lots

This contract is divided into lots: Yes

II.1.7) Total value of the procurement

Value excluding VAT: 5 000 000.00  EUR

II.2) Description

Lot No: 4

II.2.1) Title

Φαρμακοεπιδημιολογική έρευνα — μελέτες συσχέτισης συμπεριλαμβανομένης της έρευνας σχετικά με την εγκυμοσύνη και τον θηλασμό

II.2.2) Additional CPV code(s)

73210000

II.2.3) Place of performance

NUTS code:

UKI4

II.2.4) Description of the procurement

Για πλήρη περιγραφή, ανατρέξτε στο τμήμα 3.2) των τεχνικών προδιαγραφών (έγγραφα διαγωνισμού).

II.2.5) Award criteria

Quality criterion: Περιπτωσιολογική μελέτη / Weighting: 30

Quality criterion: Ομάδα έρευνας και καθήκοντα / Weighting: 20

Quality criterion: Διαχείριση σχεδίου και επικοινωνία / Weighting: 20

Price / Weighting:  30

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

Σημειώστε ότι για την παρτίδα 4 προβλέπονται οκτώ συμβάσεις-πλαίσιο κατ' ανώτατο όριο.

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 a sostegno del processo decisionale regolamentare. La ricerca potrà altresì 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 riguarderà 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 può riguardare quattro lotti diversi, con un massimo di cinque contratti quadro per i lotti 1, 2 e 3 e un massimo di otto contratti quadro per il lotto 4.

II.1.6) Information about lots

This contract is divided into lots: Yes

II.1.7) Total value of the procurement

Value excluding VAT: 5 000 000.00  EUR

II.2) Description

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

Quality criterion: Studio di casi / Weighting: 30

Quality criterion: Équipe di ricerca e incarichi / Weighting: 20

Quality criterion: Gestione del progetto e comunicazione / Weighting: 20

Price / Weighting:  30

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 otto 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-epidemiologische 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 genomen 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.1.6) Information about lots

This contract is divided into lots: Yes

II.1.7) Total value of the procurement

Value excluding VAT: 5 000 000.00  EUR

II.2) Description

Lot No: 4

II.2.1) Title

Farmaco-epidemiologisch onderzoek — associatieonderzoeken, 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

Quality criterion: casestudy / Weighting: 30

Quality criterion: onderzoeksteam en taken / Weighting: 20

Quality criterion: projectbeheer en communicatie / Weighting: 20

Price / Weighting:  30

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 de investigação 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 investigação 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 oito contratos-quadro para o lote 4.

II.1.6) Information about lots

This contract is divided into lots: Yes

II.1.7) Total value of the procurement

Value excluding VAT: 5 000 000.00  EUR

II.2) Description

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

Quality criterion: Estudo de caso / Weighting: 30

Quality criterion: Tarefas e equipa de investigação / Weighting: 20

Quality criterion: Gestão do projeto e comunicação / Weighting: 20

Price / Weighting:  30

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 oito 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 regelverk. 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.1.6) Information about lots

This contract is divided into lots: Yes

II.1.7) Total value of the procurement

Value excluding VAT: 5 000 000.00  EUR

II.2) Description

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 avsnitt 3.2 i de tekniska specifikationerna (upphandlingsdokumenten).

II.2.5) Award criteria

Quality criterion: Fallstudie / Weighting: 30

Quality criterion: Forskningsgrupp och uppgifter / Weighting: 20

Quality criterion: Projektledning och kommunikation / Weighting: 20

Price / Weighting:  30

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 účinnosti a bezpečnosti léčivých přípravků

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 zaměřená na účinnost a farmakoepidemiologii v návaznosti na schvalování léčiv s cílem získat údaje a informace na podporu rozhodování v oblasti regulace. Výzkum se může zaměřit také na účinnost přijatých regulačních opatření a na dopad příslušné legislativy. Rozsah témat výzkumu se omezuje na ta s velkým významem pro veřejné zdravotnictví a s evropským dopadem. Rozsah financování zahrnuje národně i centrálně schvalované výrobky, včetně vakcín. Výsledky získané v tomto výzkumu budou následně hodnoceny odpovědným výborem agentury, co se týče potřeby regulačních opatření, a může být následně proveden další výzkum s cílem posoudit efektivitu přijatých regulačních opatření.

Výzkum se může týkat čtyř různých položek. Na položky č. 1, 2 a 3 může být uzavřeno maximálně pět rámcových smluv a na položku č. 4 maximálně 8 rámcových smluv.

II.1.6) Information about lots

This contract is divided into lots: Yes

II.1.7) Total value of the procurement

Value excluding VAT: 5 000 000.00  EUR

II.2) Description

Lot No: 4

II.2.1) Title

Farmakoepidemiologický výzkum – přidružená studie, včetně výzkumu v oblasti těhotenství 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

Quality criterion: Případová studie / Weighting: 30

Quality criterion: Výzkumný tým a úkoly / Weighting: 20

Quality criterion: Řízení projektu a komunikace / Weighting: 20

Price / Weighting:  30

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

Upozorňujeme, že pro položku č. 4 se předpokládá maximálně 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 farmakoepidemioloogilised 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.1.6) Information about lots

This contract is divided into lots: Yes

II.1.7) Total value of the procurement

Value excluding VAT: 5 000 000.00  EUR

II.2) Description

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 kirjelduse punkti 3.2 (hankedokumendid).

II.2.5) Award criteria

Quality criterion: juhtumiuuring / Weighting: 30

Quality criterion: uuringumeeskond ja ülesanded / Weighting: 20

Quality criterion: projektijuhtimine ja teabevahetus / Weighting: 20

Price / Weighting:  30

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 kaheksa 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 előállításához 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 jelentőségű és európai hatású témákra korlátozódnak. A finanszírozás mind a nemzetileg, mind a központilag engedélyezett termékekre kiterjed, a vakcinákat is beleértve. A kutatásból származó eredményeket a későbbiekben értékelni fogja a felelős ügynökség bizottsága a szabályozási intézkedés szükségességét illetően, valamint további kutatás is végezhető a későbbiekben a szabályozási intézkedések hatékonyságának felmérése céljából.

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

II.1.6) Information about lots

This contract is divided into lots: Yes

II.1.7) Total value of the procurement

Value excluding VAT: 5 000 000.00  EUR

II.2) Description

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 műszaki dokumentáció (közbeszerzési dokumentáció) 3.2) szakaszában.

II.2.5) Award criteria

Quality criterion: Esettanulmány / Weighting: 30

Quality criterion: Kutatócsoport és feladatok / Weighting: 20

Quality criterion: Projektirányítás és kommunikáció / Weighting: 20

Price / Weighting:  30

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 keretszerződés megkötését tervezik.

Section II: Object

II.1) Scope of the procurement

II.1.1) Title

Vaistų 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 sprendimų priėmimą. Moksliniais tyrimais taip pat gali būti atkreipiamas dėmesys į reguliavimo priemonių, kurių buvo imtasi, veiksmingumą ir į tinkamų teisės aktų poveikį. Tyrimų temos yra ribotos ir apima tik itin svarbias visuomenės sveikatai ir turinčias įtakos Europos mastu. Finansuojami vaistai, įskaitant vakcinas, kurių rinkodaros leidimas išduotas taikant nacionalinę ir centralizuotą procedūrą. Šio tyrimo metu gauti rezultatai bus įvertinti atsakingo agentūros komiteto atsižvelgiant į reguliavimo priemonių poreikį, o vėliau galimai bus atlikti tolesni tyrimai, skirti patvirtintų reguliavimo priemonių veiksmingumui įvertinti.

Tyrimas gali būti padalytas į keturias skirtingas dalis, skiriant ne daugiau kaip penkias preliminariąsias sutartis 1, 2 ir 3 dalims ir ne daugiau kaip aštuonias preliminariąsias sutartis 4 daliai.

II.1.6) Information about lots

This contract is divided into lots: Yes

II.1.7) Total value of the procurement

Value excluding VAT: 5 000 000.00  EUR

II.2) Description

Lot No: 4

II.2.1) Title

Farmakopepidemiologiniai tyrimai – asociacijų tyrimai, įskaitant nėštumo 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

Išsamus aprašymas pateiktas techninių specifikacijų 3.2 dalyje (pirkimo dokumentai).

II.2.5) Award criteria

Quality criterion: Atvejų tyrimas / Weighting: 30

Quality criterion: Mokslinių tyrimų darbo grupė ir užduotys / Weighting: 20

Quality criterion: Projekto valdymas ir komunikacija / Weighting: 20

Price / Weighting:  30

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 dėmesį, kad 4 daliai numatytos ne daugiau kaip aštuonios preliminariosios sutartys.

Section II: Object

II.1) Scope of the procurement

II.1.1) Title

Zāļu efektivitātes un drošuma pētījumi

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

Pēcreģistrācijas izpēte attiecībā uz iedarbīgumu un farmakoepidemioloģiju nolūkā iegūt datus un informāciju, ko varētu izmantot reglamentējošu lēmumu pieņemšanā. Iespējams, būs jāpēta arī īstenoto reglamentējošo pasākumu iedarbīgums un attiecīgo tiesību aktu ietekme. Pētniecības tematu klāstā ir iekļauti tie temati, kas ir īpaši svarīgi sabiedrības veselībai un kam ir ietekme Eiropas mērogā. Finansējumā ir ietverti gan valstīs, gan centralizēti atļauti produkti, tostarp vakcīnas. Pētījumu rezultātus novērtēs aģentūras atbildīgā komiteja, nosakot vajadzību veikt regulatīvas darbības; var tikt veikti arī papildu pētījumi, lai apzinātu veikto regulatīvo darbību efektivitāti.

Pētījumi var būt saistīti ar 4 dažādām daļām, noslēdzot ne vairāk kā 5 pamatnolīgumus par 1., 2. un 3. daļu un ne vairāk kā 8 pamatnolīgumus par 4. daļu.

II.1.6) Information about lots

This contract is divided into lots: Yes

II.1.7) Total value of the procurement

Value excluding VAT: 5 000 000.00  EUR

II.2) Description

Lot No: 4

II.2.1) Title

Farmakoepidemioloģiskā pētniecība – asociācijas pētījumi, tostarp grūtniecības un zīdīšanas pētījumi

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 lūdzam skatīt tehnisko specifikāciju (iepirkuma dokumentu) 3.2. iedaļā.

II.2.5) Award criteria

Quality criterion: Gadījumu izpēte / Weighting: 30

Quality criterion: Pētniecības grupa un uzdevumi / Weighting: 20

Quality criterion: Projekta vadība un komunikācija / Weighting: 20

Price / Weighting:  30

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

Lūdzam ņemt vērā, ka par 4. daļu plānots noslēgt ne vairāk kā 8 pamatnolīgumus.

Section II: Object

II.1) Scope of the procurement

II.1.1) Title

Studji ta' Effikaċja u Sikurezza dwar il-Mediċini

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-farmakoepidemjoloġija biex jiġu ġġenerati dejta u tagħrif għal appoġġ fit-teħid ta' deċiżjonijiet regolatorji. Ir-riċerka tista' tiffoka wkoll fuq l-effettività ta' miżuri regolatorji meħuda u fuq l-impatt ta' leġiżlazzjoni rilevanti. Il-firxa ta' suġġetti ta' riċerka hija limitata għal dawk b'rilevanza għolja għas-saħħa pubblika u b'impatt Ewropew. L-għan tal-iffinanzjar ikopri prodotti awtorizzati kemm f'livell nazzjonali kif ukoll ċentrali, inkluż vaċċini. Ir-riżultati li jinkisbu minn din ir-riċerka sussegwentement ser jiġu vvalutati mill-kumitat responsabbli tal-aġenzija rigward il-ħtieġa ta' azzjoni regolatorja u wara dan tista' ssir aktar riċerka sabiex titqies l-effettività tal-azzjonijiet regolatorji li jkunu ttieħdu.

Ir-riċerka tista' tikkonċerna erba' lottijiet differenti, b'massimu ta' ħames oqfsa ta' kuntratt għal-lottijiet 1, 2 u 3, u massimu ta' tmien oqfsa ta' kuntratt għal-lott 4.

II.1.6) Information about lots

This contract is divided into lots: Yes

II.1.7) Total value of the procurement

Value excluding VAT: 5 000 000.00  EUR

II.2) Description

Lot No: 4

II.2.1) Title

Riċerka Farmakoepidemjoloġika - Studji ta' Assoċjazzjoni, Inkluż Riċerka dwar Tqala u Treddigħ

II.2.2) Additional CPV code(s)

73210000

II.2.3) Place of performance

NUTS code:

UKI4

II.2.4) Description of the procurement

Għal deskrizzjoni sħiħa jekk jogħġbok ara t-taqsima 3.2 tal-ispeċifikazzjonijiet tekniċi (dokumenti tal-ksib).

II.2.5) Award criteria

Quality criterion: Studju ta' każ / Weighting: 30

Quality criterion: It-Tim tar-Riċerka u x-Xogħlijiet / Weighting: 20

Quality criterion: L-immaniġġjar tal-proġett u l-komunikazzjoni / Weighting: 20

Price / Weighting:  30

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 jogħġbok innota li huwa previst massimu ta' tmien oqfsa ta' kuntratt għal-lott 4.

Section II: Object

II.1) Scope of the procurement

II.1.1) Title

Badanie skuteczności i bezpieczeństwa 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 skuteczności i farmakoepidemiologiczne po wydaniu zatwierdzenia w celu opracowania danych i informacji na potrzeby wsparcia regulacyjnego procesu decyzyjnego. Badanie może również koncentrować się na skuteczności podjętych środków regulacyjnych i wpływie odpowiednich przepisów prawa. Zakres tematyczny jest ograniczony i obejmuje jedynie zagadnienia o dużym znaczeniu dla zdrowia publicznego oraz wywierające wpływ w wymiarze europejskim. Zakres finansowania obejmuje zarówno produkty zatwierdzone na poziomie krajowym, jak i centralnym, między innymi szczepionki. Wyniki niniejszego badania zostaną następnie ocenione przez właściwą komisję agencji pod kątem konieczności podjęcia działań regulacyjnych. Następnie może zostać przeprowadzone kolejne badanie w celu oceny skuteczności podjętych działań regulacyjnych.

Badanie może dotyczyć 4 różnych części, podpisanych może zostać nie więcej niż 5 umów ramowych dla części 1, 2 i 3 oraz nie więcej niż 8 umów ramowych dla części 4.

II.1.6) Information about lots

This contract is divided into lots: Yes

II.1.7) Total value of the procurement

Value excluding VAT: 5 000 000.00  EUR

II.2) Description

Lot No: 4

II.2.1) Title

Badanie farmakoepidemiologiczne — badania asocjacyjne, w tym badania dotyczące ciąży i karmienia piersią

II.2.2) Additional CPV code(s)

73210000

II.2.3) Place of performance

NUTS code:

UKI4

II.2.4) Description of the procurement

Pełen opis dostępny w sekcji 3.2 specyfikacji technicznej (dokumenty zamówienia).

II.2.5) Award criteria

Quality criterion: analiza przykładu / Weighting: 30

Quality criterion: zespół badawczy i zadania / Weighting: 20

Quality criterion: zarządzanie projektem i komunikacja / Weighting: 20

Price / Weighting:  30

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 części 4 przewiduje się nie więcej niż 8 umów ramowych.

Section II: Object

II.1) Scope of the procurement

II.1.1) Title

Štúdie o účinnosti a bezpečnosti 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

Poregistračné farmakoepidemiologické štúdie a štúdie účinnosti s cieľom vygenerovať údaje a informácie na podporu prijímania regulačných rozhodnutí. Výskum môže byť tiež zameraný na účinnosť prijatých regulačných opatrení a na vplyv príslušných právnych predpisov. Rozsah výskumných tém je obmedzený na tie, ktoré sú veľmi významné z hľadiska verejného zdravia a ktoré majú európsky dosah. Rozsah finančných prostriedkov zahŕňa vnútroštátne, ako aj centrálne povolené lieky vrátane vakcín. Výsledky získané na základe tohto výskumu následne posúdi príslušný výbor agentúry, pokiaľ ide o potrebu regulačných opatrení, a následne sa môže vykonať ďalší výskum na hodnotenie účinnosti prijatých regulačných opatrení.

Výskum sa môže týkať 4 rôznych častí s maximálne 5 rámcovými zmluvami pre časti 1, 2 a 3 a s maximálne 8 rámcovými zmluvami pre časť 4.

II.1.6) Information about lots

This contract is divided into lots: Yes

II.1.7) Total value of the procurement

Value excluding VAT: 5 000 000.00  EUR

II.2) Description

Lot No: 4

II.2.1) Title

Farmakoepidemiologický výskum – súvisiace štúdie vrátane výskumu týkajúceho sa tehotenstva a dojčenia

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 (súťažné podklady).

II.2.5) Award criteria

Quality criterion: Prípadová štúdia / Weighting: 30

Quality criterion: Výskumný tím a úlohy / Weighting: 20

Quality criterion: Riadenie projektu a komunikácia / Weighting: 20

Price / Weighting:  30

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

Upozorňujeme, že pre časť 4 sa predpokladá najviac 8 rámcových zmlúv.

Section II: Object

II.1) Scope of the procurement

II.1.1) Title

Raziskave zdravil glede učinkovitosti 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 področju učinkovitosti in farmakoepidemiologije po izdaji dovoljenja za ustvarjanje podatkov in informacij v podporo regulativnemu odločanju. Raziskave so lahko osredotočene tudi na učinkovitost sprejetih regulativnih ukrepov in učinek ustrezne zakonodaje. Obseg raziskovalnih tem je omejen na tiste z visoko pomembnostjo za javno zdravje in z evropskim učinkom. Obseg financiranja zajema nacionalno in centralno odobrena zdravila, vključno s cepivi. Rezultate, pridobljene s temi raziskavami, bo pristojni odbor agencije naknadno ocenil glede potrebe po regulativnem ukrepu, nato pa se lahko izvedejo tudi nadaljnje raziskave za merjenje učinkovitosti sprejetih regulativnih ukrepov.

Raziskava se lahko nanaša na 4 različne sklope, z največ 5 okvirnimi pogodbami za sklope 1, 2 in 3 ter največ 8 okvirnimi pogodbami za sklop 4.

II.1.6) Information about lots

This contract is divided into lots: Yes

II.1.7) Total value of the procurement

Value excluding VAT: 5 000 000.00  EUR

II.2) Description

Lot No: 4

II.2.1) Title

Farmakoepidemiološke raziskave – asociacijske študije, vključno z raziskavami nosečnosti 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 tehničnih specifikacij (razpisna dokumentacija).

II.2.5) Award criteria

Quality criterion: Študija primera / Weighting: 30

Quality criterion: Raziskovalna ekipa in naloge / Weighting: 20

Quality criterion: Vodenje projekta in komuniciranje / Weighting: 20

Price / Weighting:  30

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 največ 8 okvirnih pogodb.

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-údarúcháin 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 cheithre bheart éagsúla, le cúig chreatchonradh ar a uasmhéad do bheart 1, 2 agus 3; agus le hocht gcreatchonradh ar a uasmhéad do bheart 4.

II.1.6) Information about lots

This contract is divided into lots: Yes

II.1.7) Total value of the procurement

Value excluding VAT: 5 000 000.00  EUR

II.2) Description

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

Quality criterion: Cás-staidéar / Weighting: 30

Quality criterion: Foireann taighde agus tascanna / Weighting: 20

Quality criterion: Bainistiú tionscadail agus cumarsáid / Weighting: 20

Price / Weighting:  30

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 ocht gcreatchonradh an t-uasmhéid a bheartaítear do bheart 4.

Section II: Object

II.1) Scope of the procurement

II.1.1) Title

Проучвания за ефикасност и безопасност на лекарствата

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

Проучвания за ефективност и фармакоепидемиология след получаване на разрешение с цел генериране на данни и информация в подкрепа на регулаторното вземане на решения. Проучването може да се концентрира също и върху ефективността на предприетите регулаторни мерки и върху въздействието на съответното законодателство. Обхватът на изследователските теми е ограничен до тези, които се са с голямо значение за общественото здравеопазване и са с европейското въздействие. В обхвата на финансирането са включени продукти, включително ваксини, които са разрешени на национално и централно ниво. Получените резултати от това проучване ще бъдат впоследствие оценени от комисията на компетентната агенция, за да се прецени необходимостта от регулаторни действия, и впоследствие могат да бъдат проведени допълнителни проучвания за измерване на ефективността на предприетите регулаторни действия.

Проучването може да се отнася до четири различни обособени позиции с максимум пет рамкови договора за обособени позиции 1, 2 и 3 и максимум 8 рамкови договора за обособена позиция 4.

II.1.6) Information about lots

This contract is divided into lots: Yes

II.1.7) Total value of the procurement

Value excluding VAT: 5 000 000.00  EUR

II.2) Description

Lot No: 4

II.2.1) Title

Изследване за фармакоепидемиология — проучвания на асоциации, включително изследвания за бременност и кърмене.

II.2.2) Additional CPV code(s)

73210000

II.2.3) Place of performance

NUTS code:

UKI4

II.2.4) Description of the procurement

За пълно описание, моля вижте раздел 3.2) от техническите спецификации (документи за обществена поръчка).

II.2.5) Award criteria

Quality criterion: Целево проучване / Weighting: 30

Quality criterion: Изследователски екип и задачи / Weighting: 20

Quality criterion: Управление на проекта и комуникация / Weighting: 20

Price / Weighting:  30

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

Моля, обърнете внимание, че за обособена позиция 4 се предвиждат максимум 8 рамкови договора.

Section II: Object

II.1) Scope of the procurement

II.1.1) Title

Studii de eficacitate și siguranță 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 eficacității și al farmacoepidemiologiei ulterior autorizării pentru generarea de date și de informații pentru susținerea procesului decizional în materie de reglementare. Cercetarea se poate axa, de asemenea, pe eficacitatea măsurilor de reglementare adoptate și pe impactul legislației relevante. Gama de subiecte în domeniul cercetării este limitată la cele de înaltă relevanță pentru sănătatea publică și cu impact la nivel european. Finanțarea acoperă produse autorizate atât la nivel național, cât și central, incluzând vaccinurile. Rezultatele obținute în urma acestei cercetări vor fi ulterior evaluate de comitetul competent al agenției cu privire la necesitatea unei acțiuni de reglementare și pot fi efectuate ulterior cercetări suplimentare pentru a măsura eficacitatea măsurilor de reglementare luate.

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

II.1.6) Information about lots

This contract is divided into lots: Yes

II.1.7) Total value of the procurement

Value excluding VAT: 5 000 000.00  EUR

II.2) Description

Lot No: 4

II.2.1) Title

Cercetarea farmacoepidemiologică - studii de asociere, inclusiv cercetarea privind sarcina și alăptarea

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 completă, a se vedea secțiunea 3.2 din specificațiile tehnice (dosarul achiziției).

II.2.5) Award criteria

Quality criterion: Studiul de caz / Weighting: 30

Quality criterion: Echipa de cercetare și sarcinile / Weighting: 20

Quality criterion: Gestionarea proiectului și comunicarea / Weighting: 20

Price / Weighting:  30

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

Vă rugăm să țineți cont de faptul că pentru lotul 4 sunt prevăzute maximum opt 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 kojima bi se podržalo regulatorno odlučivanje. Istraživanje se također može usmjeriti na učinkovitost poduzetih regulatornih mjera i na učinak relevantnog zakonodavstva. Raspon tema je ograničen na one od velike važnosti za javno zdravlje i s učinkom u Europi. Opsegom financiranja obuhvaćeni su nacionalni i centralno odobreni proizvodi, uključujući i cjepiva. Rezultate dobivene ovim istraživanjem naknadno će ocijeniti nadležni odbor agencije u pogledu potrebe za regulatornim radnjama te je moguća i naknadna provedba daljnjeg istraživanja za mjerenje učinkovitosti poduzetih regulatornih radnji.

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

II.1.6) Information about lots

This contract is divided into lots: Yes

II.1.7) Total value of the procurement

Value excluding VAT: 5 000 000.00  EUR

II.2) Description

Lot No: 4

II.2.1) Title

Farmakoepidemiološko istraživanje — povezane studije, uključujući istraživanje trudnoće 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 tehničkih specifikacija (dokumentacija o nabavi).

II.2.5) Award criteria

Quality criterion: Studija slučaja / Weighting: 30

Quality criterion: Istraživački tim i zadaci / Weighting: 20

Quality criterion: Vođenje projekta i komunikacija / Weighting: 20

Price / Weighting:  30

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 predviđeno maksimalno 8 okvirnih ugovora za grupu 4.

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

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

The procurement is covered by the Government Procurement Agreement: No

IV.2) Administrative information

IV.2.1) Previous publication concerning this procedure

Notice number in the OJ S:

2017/S 240-497343

Section V: Award of contract

Lot No: 4

Contract No: EMA/2018/27/PE

Title: Farmakoepidemiologisk forskning — associationsundersøgelser, inklusive graviditets- og amningsundersøgelser

A contract/lot is awarded: Yes

V.2 Award of contract

V.2.1) Date of conclusion of the contract

15/02/2019

V.2.2) Information about tenders

Number of tenders received: 8

The contract has been awarded to a group of economic operators: Yes

V.2.3) Name and address of the contractor

University of Ulster

Coleraine

UK

NUTS: UKN

The contractor is an SME: No

V.2.3) Name and address of the contractor

Dipartimento di Scienze Mediche — Università Degli Studi Di Ferrara

Ferrara

IT

NUTS: IT

The contractor is an SME: No

V.2.3) Name and address of the contractor

Consiglio Nazionale Delle Ricerche — Institute of Clinical Physiology

Roma

IT

NUTS: IT

The contractor is an SME: No

V.2.3) Name and address of the contractor

Swansea University

Swansea

UK

NUTS: UKL

The contractor is an SME: No

V.2.3) Name and address of the contractor

University Hospital Center of Toulouse

Toulouse

FR

NUTS: FR

The contractor is an SME: No

V.2.3) Name and address of the contractor

University of Bath

Bath

UK

NUTS: UK

The contractor is an SME: No

V.2.3) Name and address of the contractor

Hospital Lillebaelt, Region Syddanmark

Vejle

DK

NUTS: DK

The contractor is an SME: No

V.2.3) Name and address of the contractor

Stichting ENTIS (European Network Teratology Information Services) Foundation

s’-Hertogenbosch

NL

NUTS: NL

The contractor is an SME: No

V.2.3) Name and address of the contractor

Otto-von-Guericke-Universitaet Magdeburg, Medical faculty

Magdeburg

DE

NUTS: DE

The contractor is an SME: No

V.2.3) Name and address of the contractor

Fundación Para el Fomento de la Investigactión Sanitaria Y Biomédica de la Comunitat Valenciana

Valencia

ES

NUTS: ES

The contractor is an SME: No

V.2.4) Information on value of the contract/lot (excluding VAT)

Initial estimated total value of the contract/lot:

Total value of the contract/lot: : 3 000 000.00  EUR

V.2.5) Information about subcontracting

Section V: Award of contract

Lot No: 4

Contract No: EMA/2018/27/PE

Title: Pharmakoepidemiologische Forschung — Assoziationsstudien, einschließlich Schwangerschaft und Stillforschung

A contract/lot is awarded: Yes

V.2 Award of contract

V.2.1) Date of conclusion of the contract

15/02/2019

V.2.2) Information about tenders

Number of tenders received: 8

The contract has been awarded to a group of economic operators: Yes

V.2.3) Name and address of the contractor

University of Ulster

Coleraine

UK

NUTS: UKN

The contractor is an SME: No

V.2.3) Name and address of the contractor

Dipartimento di Scienze Mediche – Università Degli Studi Di Ferrara

Ferrara

IT

NUTS: IT

The contractor is an SME: No

V.2.3) Name and address of the contractor

Consiglio Nazionale Delle Ricerche – Institute of Clinical Physiology

Roma

IT

NUTS: IT

The contractor is an SME: No

V.2.3) Name and address of the contractor

Swansea University

Swansea

UK

NUTS: UKL

The contractor is an SME: No

V.2.3) Name and address of the contractor

University Hospital Center of Toulouse

Toulouse

FR

NUTS: FR

The contractor is an SME: No

V.2.3) Name and address of the contractor

University of Bath

Bath

UK

NUTS: UK

The contractor is an SME: No

V.2.3) Name and address of the contractor

Hospital Lillebaelt, Region Syddanmark

Vejle

DK

NUTS: DK

The contractor is an SME: No

V.2.3) Name and address of the contractor

Stichting ENTIS (European Network Teratology Information Services) Foundation

s’-Hertogenbosch

NL

NUTS: NL

The contractor is an SME: No

V.2.3) Name and address of the contractor

Otto-von-Guericke-Universitaet Magdeburg, Medical faculty

Magdeburg

DE

NUTS: DE

The contractor is an SME: No

V.2.3) Name and address of the contractor

Fundación Para el Fomento de la Investigactión Sanitaria Y Biomédica de la Comunitat Valenciana

Valencia

ES

NUTS: ES

The contractor is an SME: No

V.2.4) Information on value of the contract/lot (excluding VAT)

Initial estimated total value of the contract/lot:

Total value of the contract/lot: : 3 000 000.00  EUR

V.2.5) Information about subcontracting

Section V: Award of contract

Lot No: 4

Contract No: EMA/2018/27/PE

Title: Pharmacoepidemiology Research - Association Studies, Including Pregnancy and Breastfeeding Research

A contract/lot is awarded: Yes

V.2 Award of contract

V.2.1) Date of conclusion of the contract

15/02/2019

V.2.2) Information about tenders

Number of tenders received: 8

The contract has been awarded to a group of economic operators: Yes

V.2.3) Name and address of the contractor

University of Ulster

Coleraine

UK

NUTS: UKN

The contractor is an SME: No

V.2.3) Name and address of the contractor

Dipartimento di Scienze Mediche – Università Degli Studi Di Ferrara

Ferrara

IT

NUTS: IT

The contractor is an SME: No

V.2.3) Name and address of the contractor

Consiglio Nazionale Delle Ricerche – Institute of Clinical Physiology

Roma

IT

NUTS: IT

The contractor is an SME: No

V.2.3) Name and address of the contractor

Swansea University

Swansea

UK

NUTS: UKL

The contractor is an SME: No

V.2.3) Name and address of the contractor

University Hospital Center of Toulouse

Toulouse

FR

NUTS: FR

The contractor is an SME: No

V.2.3) Name and address of the contractor

University of Bath

Bath

UK

NUTS: UK

The contractor is an SME: No

V.2.3) Name and address of the contractor

Hospital Lillebaelt, Region Syddanmark

Vejle

DK

NUTS: DK

The contractor is an SME: No

V.2.3) Name and address of the contractor

Stichting ENTIS (European Network Teratology Information Services) Foundation

s’-Hertogenbosch

NL

NUTS: NL

The contractor is an SME: No

V.2.3) Name and address of the contractor

Otto-von-Guericke-Universitaet Magdeburg, Medical faculty

Magdeburg

DE

NUTS: DE

The contractor is an SME: No

V.2.3) Name and address of the contractor

Fundación Para el Fomento de la Investigactión Sanitaria Y Biomédica de la Comunitat Valenciana

Valencia

ES

NUTS: ES

The contractor is an SME: No

V.2.4) Information on value of the contract/lot (excluding VAT)

Initial estimated total value of the contract/lot:

Total value of the contract/lot: : 3 000 000.00  EUR

V.2.5) Information about subcontracting

Section V: Award of contract

Lot No: 4

Contract No: EMA/2018/27/PE

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

A contract/lot is awarded: Yes

V.2 Award of contract

V.2.1) Date of conclusion of the contract

15/02/2019

V.2.2) Information about tenders

Number of tenders received: 8

The contract has been awarded to a group of economic operators: Yes

V.2.3) Name and address of the contractor

University of Ulster

Coleraine

UK

NUTS: UKN

The contractor is an SME: No

V.2.3) Name and address of the contractor

Dipartimento di Scienze Mediche – Università Degli Studi Di Ferrara

Ferrara

IT

NUTS: IT

The contractor is an SME: No

V.2.3) Name and address of the contractor

Consiglio Nazionale Delle Ricerche – Institute of Clinical Physiology

Roma

IT

NUTS: IT

The contractor is an SME: No

V.2.3) Name and address of the contractor

Swansea University

Swansea

UK

NUTS: UKL

The contractor is an SME: No

V.2.3) Name and address of the contractor

University Hospital Center of Toulouse

Toulouse

FR

NUTS: FR

The contractor is an SME: No

V.2.3) Name and address of the contractor

University of Bath

Bath

UK

NUTS: UK

The contractor is an SME: No

V.2.3) Name and address of the contractor

Hospital Lillebaelt, Region Syddanmark

Vejle

DK

NUTS: DK

The contractor is an SME: No

V.2.3) Name and address of the contractor

Stichting ENTIS (European Network Teratology Information Services) Foundation

s’-Hertogenbosch

NL

NUTS: NL

The contractor is an SME: No

V.2.3) Name and address of the contractor

Otto-von-Guericke-Universitaet Magdeburg, Medical faculty

Magdeburg

DE

NUTS: DE

The contractor is an SME: No

V.2.3) Name and address of the contractor

Fundación Para el Fomento de la Investigactión Sanitaria Y Biomédica de la Comunitat Valenciana

Valencia

ES

NUTS: ES

The contractor is an SME: No

V.2.4) Information on value of the contract/lot (excluding VAT)

Initial estimated total value of the contract/lot:

Total value of the contract/lot: : 3 000 000.00  EUR

V.2.5) Information about subcontracting

Section V: Award of contract

Lot No: 4

Contract No: EMA/2018/27/PE

Title: Lääke-epidemiologinen tutkimus – assosiaatiotutkimukset sekä raskautta ja imetystä koskeva tutkimus

A contract/lot is awarded: Yes

V.2 Award of contract

V.2.1) Date of conclusion of the contract

15/02/2019

V.2.2) Information about tenders

Number of tenders received: 8

The contract has been awarded to a group of economic operators: Yes

V.2.3) Name and address of the contractor

University of Ulster

Coleraine

UK

NUTS: UKN

The contractor is an SME: No

V.2.3) Name and address of the contractor

Dipartimento di Scienze Mediche – Università Degli Studi Di Ferrara

Ferrara

IT

NUTS: IT

The contractor is an SME: No

V.2.3) Name and address of the contractor

Consiglio Nazionale Delle Ricerche – Institute of Clinical Physiology

Roma

IT

NUTS: IT

The contractor is an SME: No

V.2.3) Name and address of the contractor

Swansea University

Swansea

UK

NUTS: UKL

The contractor is an SME: No

V.2.3) Name and address of the contractor

University Hospital Center of Toulouse

Toulouse

FR

NUTS: FR

The contractor is an SME: No

V.2.3) Name and address of the contractor

University of Bath

Bath

UK

NUTS: UK

The contractor is an SME: No

V.2.3) Name and address of the contractor

Hospital Lillebaelt, Region Syddanmark

Vejle

DK

NUTS: DK

The contractor is an SME: No

V.2.3) Name and address of the contractor

Stichting ENTIS (European Network Teratology Information Services) Foundation

s’-Hertogenbosch

NL

NUTS: NL

The contractor is an SME: No

V.2.3) Name and address of the contractor

Otto-von-Guericke-Universitaet Magdeburg, Medical faculty

Magdeburg

DE

NUTS: DE

The contractor is an SME: No

V.2.3) Name and address of the contractor

Fundación Para el Fomento de la Investigactión Sanitaria Y Biomédica de la Comunitat Valenciana

Valencia

ES

NUTS: ES

The contractor is an SME: No

V.2.4) Information on value of the contract/lot (excluding VAT)

Initial estimated total value of the contract/lot:

Total value of the contract/lot: : 3 000 000.00  EUR

V.2.5) Information about subcontracting

Section V: Award of contract

Lot No: 4

Contract No: EMA/2018/27/PE

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

A contract/lot is awarded: Yes

V.2 Award of contract

V.2.1) Date of conclusion of the contract

15/02/2019

V.2.2) Information about tenders

Number of tenders received: 8

The contract has been awarded to a group of economic operators: Yes

V.2.3) Name and address of the contractor

University of Ulster

Coleraine

UK

NUTS: UKN

The contractor is an SME: No

V.2.3) Name and address of the contractor

Dipartimento di Scienze Mediche – Università Degli Studi Di Ferrara

Ferrara

IT

NUTS: IT

The contractor is an SME: No

V.2.3) Name and address of the contractor

Consiglio Nazionale Delle Ricerche – Institute of Clinical Physiology

Roma

IT

NUTS: IT

The contractor is an SME: No

V.2.3) Name and address of the contractor

Swansea University

Swansea

UK

NUTS: UKL

The contractor is an SME: No

V.2.3) Name and address of the contractor

University Hospital Center of Toulouse

Toulouse

FR

NUTS: FR

The contractor is an SME: No

V.2.3) Name and address of the contractor

University of Bath

Bath

UK

NUTS: UK

The contractor is an SME: No

V.2.3) Name and address of the contractor

Hospital Lillebaelt, Region Syddanmark

Vejle

DK

NUTS: DK

The contractor is an SME: No

V.2.3) Name and address of the contractor

Stichting ENTIS (European Network Teratology Information Services) Foundation

s’-Hertogenbosch

NL

NUTS: NL

The contractor is an SME: No

V.2.3) Name and address of the contractor

Otto-von-Guericke-Universitaet Magdeburg, Medical faculty

Magdeburg

DE

NUTS: DE

The contractor is an SME: No

V.2.3) Name and address of the contractor

Fundación Para el Fomento de la Investigactión Sanitaria Y Biomédica de la Comunitat Valenciana

Valencia

ES

NUTS: ES

The contractor is an SME: No

V.2.4) Information on value of the contract/lot (excluding VAT)

Initial estimated total value of the contract/lot:

Total value of the contract/lot: : 3 000 000.00  EUR

V.2.5) Information about subcontracting

Section V: Award of contract

Lot No: 4

Contract No: EMA/2018/27/PE

Title: Φαρμακοεπιδημιολογική έρευνα — μελέτες συσχέτισης συμπεριλαμβανομένης της έρευνας σχετικά με την εγκυμοσύνη και τον θηλασμό

A contract/lot is awarded: Yes

V.2 Award of contract

V.2.1) Date of conclusion of the contract

15/02/2019

V.2.2) Information about tenders

Number of tenders received: 8

The contract has been awarded to a group of economic operators: Yes

V.2.3) Name and address of the contractor

University of Ulster

Coleraine

UK

NUTS: UKN

The contractor is an SME: No

V.2.3) Name and address of the contractor

Dipartimento di Scienze Mediche – Università Degli Studi Di Ferrara

Ferrara

IT

NUTS: IT

The contractor is an SME: No

V.2.3) Name and address of the contractor

Consiglio Nazionale Delle Ricerche – Institute of Clinical Physiology

Roma

IT

NUTS: IT

The contractor is an SME: No

V.2.3) Name and address of the contractor

Swansea University

Swansea

UK

NUTS: UKL

The contractor is an SME: No

V.2.3) Name and address of the contractor

University Hospital Center of Toulouse

Toulouse

FR

NUTS: FR

The contractor is an SME: No

V.2.3) Name and address of the contractor

University of Bath

Bath

UK

NUTS: UK

The contractor is an SME: No

V.2.3) Name and address of the contractor

Hospital Lillebaelt, Region Syddanmark

Vejle

DK

NUTS: DK

The contractor is an SME: No

V.2.3) Name and address of the contractor

Stichting ENTIS (European Network Teratology Information Services) Foundation

s’-Hertogenbosch

NL

NUTS: NL

The contractor is an SME: No

V.2.3) Name and address of the contractor

Otto-von-Guericke-Universitaet Magdeburg, Medical faculty

Magdeburg

DE

NUTS: DE

The contractor is an SME: No

V.2.3) Name and address of the contractor

Fundación Para el Fomento de la Investigactión Sanitaria Y Biomédica de la Comunitat Valenciana

Valencia

ES

NUTS: ES

The contractor is an SME: No

V.2.4) Information on value of the contract/lot (excluding VAT)

Initial estimated total value of the contract/lot:

Total value of the contract/lot: : 3 000 000.00  EUR

V.2.5) Information about subcontracting

Section V: Award of contract

Lot No: 4

Contract No: EMA/2018/27/PE

Title: Ricerca farmacoepidemiologia — Studi di associazione, compresa la ricerca sulla gravidanza e l'allattamento al seno

A contract/lot is awarded: Yes

V.2 Award of contract

V.2.1) Date of conclusion of the contract

15/02/2019

V.2.2) Information about tenders

Number of tenders received: 8

The contract has been awarded to a group of economic operators: Yes

V.2.3) Name and address of the contractor

University of Ulster

Coleraine

UK

NUTS: UKN

The contractor is an SME: No

V.2.3) Name and address of the contractor

Dipartimento di Scienze Mediche – Università Degli Studi Di Ferrara

Ferrara

IT

NUTS: IT

The contractor is an SME: No

V.2.3) Name and address of the contractor

Consiglio Nazionale Delle Ricerche – Institute of Clinical Physiology

Roma

IT

NUTS: IT

The contractor is an SME: No

V.2.3) Name and address of the contractor

Swansea University

Swansea

UK

NUTS: UKL

The contractor is an SME: No

V.2.3) Name and address of the contractor

University Hospital Center of Toulouse

Toulouse

FR

NUTS: FR

The contractor is an SME: No

V.2.3) Name and address of the contractor

University of Bath

Bath

UK

NUTS: UK

The contractor is an SME: No

V.2.3) Name and address of the contractor

Hospital Lillebaelt, Region Syddanmark

Vejle

DK

NUTS: DK

The contractor is an SME: No

V.2.3) Name and address of the contractor

Stichting ENTIS (European Network Teratology Information Services) Foundation

s’-Hertogenbosch

NL

NUTS: NL

The contractor is an SME: No

V.2.3) Name and address of the contractor

Otto-von-Guericke-Universitaet Magdeburg, Medical faculty

Magdeburg

DE

NUTS: DE

The contractor is an SME: No

V.2.3) Name and address of the contractor

Fundación Para el Fomento de la Investigactión Sanitaria Y Biomédica de la Comunitat Valenciana

Valencia

ES

NUTS: ES

The contractor is an SME: No

V.2.4) Information on value of the contract/lot (excluding VAT)

Initial estimated total value of the contract/lot:

Total value of the contract/lot: : 3 000 000.00  EUR

V.2.5) Information about subcontracting

Section V: Award of contract

Lot No: 4

Contract No: EMA/2018/27/PE

Title: Farmaco-epidemiologisch onderzoek — associatieonderzoeken, met inbegrip van onderzoek inzake zwangerschap en borstvoeding

A contract/lot is awarded: Yes

V.2 Award of contract

V.2.1) Date of conclusion of the contract

15/02/2019

V.2.2) Information about tenders

Number of tenders received: 8

The contract has been awarded to a group of economic operators: Yes

V.2.3) Name and address of the contractor

University of Ulster

Coleraine

UK

NUTS: UKN

The contractor is an SME: No

V.2.3) Name and address of the contractor

Dipartimento di Scienze Mediche – Università Degli Studi Di Ferrara

Ferrara

IT

NUTS: IT

The contractor is an SME: No

V.2.3) Name and address of the contractor

Consiglio Nazionale Delle Ricerche – Institute of Clinical Physiology

Roma

IT

NUTS: IT

The contractor is an SME: No

V.2.3) Name and address of the contractor

Swansea University

Swansea

UK

NUTS: UKL

The contractor is an SME: No

V.2.3) Name and address of the contractor

University Hospital Center of Toulouse

Toulouse

FR

NUTS: FR

The contractor is an SME: No

V.2.3) Name and address of the contractor

University of Bath

Bath

UK

NUTS: UK

The contractor is an SME: No

V.2.3) Name and address of the contractor

Hospital Lillebaelt, Region Syddanmark

Vejle

DK

NUTS: DK

The contractor is an SME: No

V.2.3) Name and address of the contractor

Stichting ENTIS (European Network Teratology Information Services) Foundation

s’-Hertogenbosch

NL

NUTS: NL

The contractor is an SME: No

V.2.3) Name and address of the contractor

Otto-von-Guericke-Universitaet Magdeburg, Medical faculty

Magdeburg

DE

NUTS: DE

The contractor is an SME: No

V.2.3) Name and address of the contractor

Fundación Para el Fomento de la Investigactión Sanitaria Y Biomédica de la Comunitat Valenciana

Valencia

ES

NUTS: ES

The contractor is an SME: No

V.2.4) Information on value of the contract/lot (excluding VAT)

Initial estimated total value of the contract/lot:

Total value of the contract/lot: : 3 000 000.00  EUR

V.2.5) Information about subcontracting

Section V: Award of contract

Lot No: 4

Contract No: EMA/2018/27/PE

Title: Investigação em farmacoepidemiologia — Estudos de associação, incluindo investigação sobre gravidez e amamentação

A contract/lot is awarded: Yes

V.2 Award of contract

V.2.1) Date of conclusion of the contract

15/02/2019

V.2.2) Information about tenders

Number of tenders received: 8

The contract has been awarded to a group of economic operators: Yes

V.2.3) Name and address of the contractor

University of Ulster

Coleraine

UK

NUTS: UKN

The contractor is an SME: No

V.2.3) Name and address of the contractor

Dipartimento di Scienze Mediche – Università Degli Studi Di Ferrara

Ferrara

IT

NUTS: IT

The contractor is an SME: No

V.2.3) Name and address of the contractor

Consiglio Nazionale Delle Ricerche – Institute of Clinical Physiology

Roma

IT

NUTS: IT

The contractor is an SME: No

V.2.3) Name and address of the contractor

Swansea University

Swansea

UK

NUTS: UKL

The contractor is an SME: No

V.2.3) Name and address of the contractor

University Hospital Center of Toulouse

Toulouse

FR

NUTS: FR

The contractor is an SME: No

V.2.3) Name and address of the contractor

University of Bath

Bath

UK

NUTS: UK

The contractor is an SME: No

V.2.3) Name and address of the contractor

Hospital Lillebaelt, Region Syddanmark

Vejle

DK

NUTS: DK

The contractor is an SME: No

V.2.3) Name and address of the contractor

Stichting ENTIS (European Network Teratology Information Services) Foundation

s’-Hertogenbosch

NL

NUTS: NL

The contractor is an SME: No

V.2.3) Name and address of the contractor

Otto-von-Guericke-Universitaet Magdeburg, Medical faculty

Magdeburg

DE

NUTS: DE

The contractor is an SME: No

V.2.3) Name and address of the contractor

Fundación Para el Fomento de la Investigactión Sanitaria Y Biomédica de la Comunitat Valenciana

Valencia

ES

NUTS: ES

The contractor is an SME: No

V.2.4) Information on value of the contract/lot (excluding VAT)

Initial estimated total value of the contract/lot:

Total value of the contract/lot: : 3 000 000.00  EUR

V.2.5) Information about subcontracting

Section V: Award of contract

Lot No: 4

Contract No: EMA/2018/27/PE

Title: Farmakoepidemiologiforskning – associeringsstudier, inklusive forskning kring graviditet och amning

A contract/lot is awarded: Yes

V.2 Award of contract

V.2.1) Date of conclusion of the contract

15/02/2019

V.2.2) Information about tenders

Number of tenders received: 8

The contract has been awarded to a group of economic operators: Yes

V.2.3) Name and address of the contractor

University of Ulster

Coleraine

UK

NUTS: UKN

The contractor is an SME: No

V.2.3) Name and address of the contractor

Dipartimento di Scienze Mediche – Università Degli Studi Di Ferrara

Ferrara

IT

NUTS: IT

The contractor is an SME: No

V.2.3) Name and address of the contractor

Consiglio Nazionale Delle Ricerche – Institute of Clinical Physiology

Roma

IT

NUTS: IT

The contractor is an SME: No

V.2.3) Name and address of the contractor

Swansea University

Swansea

UK

NUTS: UKL

The contractor is an SME: No

V.2.3) Name and address of the contractor

University Hospital Center of Toulouse

Toulouse

FR

NUTS: FR

The contractor is an SME: No

V.2.3) Name and address of the contractor

University of Bath

Bath

UK

NUTS: UK

The contractor is an SME: No

V.2.3) Name and address of the contractor

Hospital Lillebaelt, Region Syddanmark

Vejle

DK

NUTS: DK

The contractor is an SME: No

V.2.3) Name and address of the contractor

Stichting ENTIS (European Network Teratology Information Services) Foundation

s’-Hertogenbosch

NL

NUTS: NL

The contractor is an SME: No

V.2.3) Name and address of the contractor

Otto-von-Guericke-Universitaet Magdeburg, Medical faculty

Magdeburg

DE

NUTS: DE

The contractor is an SME: No

V.2.3) Name and address of the contractor

Fundación Para el Fomento de la Investigactión Sanitaria Y Biomédica de la Comunitat Valenciana

Valencia

ES

NUTS: ES

The contractor is an SME: No

V.2.4) Information on value of the contract/lot (excluding VAT)

Initial estimated total value of the contract/lot:

Total value of the contract/lot: : 3 000 000.00  EUR

V.2.5) Information about subcontracting

Section V: Award of contract

Lot No: 4

Contract No: EMA/2018/27/PE

Title: Farmakoepidemiologický výzkum – přidružená studie, včetně výzkumu v oblasti těhotenství a kojení.

A contract/lot is awarded: Yes

V.2 Award of contract

V.2.1) Date of conclusion of the contract

15/02/2019

V.2.2) Information about tenders

Number of tenders received: 8

The contract has been awarded to a group of economic operators: Yes

V.2.3) Name and address of the contractor

University of Ulster

Coleraine

UK

NUTS: UKN

The contractor is an SME: No

V.2.3) Name and address of the contractor

Dipartimento di Scienze Mediche – Università Degli Studi Di Ferrara

Ferrara

IT

NUTS: IT

The contractor is an SME: No

V.2.3) Name and address of the contractor

Consiglio Nazionale Delle Ricerche – Institute of Clinical Physiology

Roma

IT

NUTS: IT

The contractor is an SME: No

V.2.3) Name and address of the contractor

Swansea University

Swansea

UK

NUTS: UKL

The contractor is an SME: No

V.2.3) Name and address of the contractor

University Hospital Center of Toulouse

Toulouse

FR

NUTS: FR

The contractor is an SME: No

V.2.3) Name and address of the contractor

University of Bath

Bath

UK

NUTS: UK

The contractor is an SME: No

V.2.3) Name and address of the contractor

Hospital Lillebaelt, Region Syddanmark

Vejle

DK

NUTS: DK

The contractor is an SME: No

V.2.3) Name and address of the contractor

Stichting ENTIS (European Network Teratology Information Services) Foundation

s’-Hertogenbosch

NL

NUTS: NL

The contractor is an SME: No

V.2.3) Name and address of the contractor

Otto-von-Guericke-Universitaet Magdeburg, Medical faculty

Magdeburg

DE

NUTS: DE

The contractor is an SME: No

V.2.3) Name and address of the contractor

Fundación Para el Fomento de la Investigactión Sanitaria Y Biomédica de la Comunitat Valenciana

Valencia

ES

NUTS: ES

The contractor is an SME: No

V.2.4) Information on value of the contract/lot (excluding VAT)

Initial estimated total value of the contract/lot:

Total value of the contract/lot: : 3 000 000.00  EUR

V.2.5) Information about subcontracting

Section V: Award of contract

Lot No: 4

Contract No: EMA/2018/27/PE

Title: Farmakoepidemioloogilised uuringud – assotsiatsiooniuuringud, sh rasedust ja rinnaga toitmist käsitlevad uuringud

A contract/lot is awarded: Yes

V.2 Award of contract

V.2.1) Date of conclusion of the contract

15/02/2019

V.2.2) Information about tenders

Number of tenders received: 8

The contract has been awarded to a group of economic operators: Yes

V.2.3) Name and address of the contractor

University of Ulster

Coleraine

UK

NUTS: UKN

The contractor is an SME: No

V.2.3) Name and address of the contractor

Dipartimento di Scienze Mediche – Università Degli Studi Di Ferrara

Ferrara

IT

NUTS: IT

The contractor is an SME: No

V.2.3) Name and address of the contractor

Consiglio Nazionale Delle Ricerche – Institute of Clinical Physiology

Roma

IT

NUTS: IT

The contractor is an SME: No

V.2.3) Name and address of the contractor

Swansea University

Swansea

UK

NUTS: UKL

The contractor is an SME: No

V.2.3) Name and address of the contractor

University Hospital Center of Toulouse

Toulouse

FR

NUTS: FR

The contractor is an SME: No

V.2.3) Name and address of the contractor

University of Bath

Bath

UK

NUTS: UK

The contractor is an SME: No

V.2.3) Name and address of the contractor

Hospital Lillebaelt, Region Syddanmark

Vejle

DK

NUTS: DK

The contractor is an SME: No

V.2.3) Name and address of the contractor

Stichting ENTIS (European Network Teratology Information Services) Foundation

s’-Hertogenbosch

NL

NUTS: NL

The contractor is an SME: No

V.2.3) Name and address of the contractor

Otto-von-Guericke-Universitaet Magdeburg, Medical faculty

Magdeburg

DE

NUTS: DE

The contractor is an SME: No

V.2.3) Name and address of the contractor

Fundación Para el Fomento de la Investigactión Sanitaria Y Biomédica de la Comunitat Valenciana

Valencia

ES

NUTS: ES

The contractor is an SME: No

V.2.4) Information on value of the contract/lot (excluding VAT)

Initial estimated total value of the contract/lot:

Total value of the contract/lot: : 3 000 000.00  EUR

V.2.5) Information about subcontracting

Section V: Award of contract

Lot No: 4

Contract No: EMA/2018/27/PE

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

A contract/lot is awarded: Yes

V.2 Award of contract

V.2.1) Date of conclusion of the contract

15/02/2019

V.2.2) Information about tenders

Number of tenders received: 8

The contract has been awarded to a group of economic operators: Yes

V.2.3) Name and address of the contractor

University of Ulster

Coleraine

UK

NUTS: UKN

The contractor is an SME: No

V.2.3) Name and address of the contractor

Dipartimento di Scienze Mediche – Università Degli Studi Di Ferrara

Ferrara

IT

NUTS: IT

The contractor is an SME: No

V.2.3) Name and address of the contractor

Consiglio Nazionale Delle Ricerche – Institute of Clinical Physiology

Roma

IT

NUTS: IT

The contractor is an SME: No

V.2.3) Name and address of the contractor

Swansea University

Swansea

UK

NUTS: UKL

The contractor is an SME: No

V.2.3) Name and address of the contractor

University Hospital Center of Toulouse

Toulouse

FR

NUTS: FR

The contractor is an SME: No

V.2.3) Name and address of the contractor

University of Bath

Bath

UK

NUTS: UK

The contractor is an SME: No

V.2.3) Name and address of the contractor

Hospital Lillebaelt, Region Syddanmark

Vejle

DK

NUTS: DK

The contractor is an SME: No

V.2.3) Name and address of the contractor

Stichting ENTIS (European Network Teratology Information Services) Foundation

s’-Hertogenbosch

NL

NUTS: NL

The contractor is an SME: No

V.2.3) Name and address of the contractor

Otto-von-Guericke-Universitaet Magdeburg, Medical faculty

Magdeburg

DE

NUTS: DE

The contractor is an SME: No

V.2.3) Name and address of the contractor

Fundación Para el Fomento de la Investigactión Sanitaria Y Biomédica de la Comunitat Valenciana

Valencia

ES

NUTS: ES

The contractor is an SME: No

V.2.4) Information on value of the contract/lot (excluding VAT)

Initial estimated total value of the contract/lot:

Total value of the contract/lot: : 3 000 000.00  EUR

V.2.5) Information about subcontracting

Section V: Award of contract

Lot No: 4

Contract No: EMA/2018/27/PE

Title: Farmakopepidemiologiniai tyrimai – asociacijų tyrimai, įskaitant nėštumo ir žindymo tyrimus

A contract/lot is awarded: Yes

V.2 Award of contract

V.2.1) Date of conclusion of the contract

15/02/2019

V.2.2) Information about tenders

Number of tenders received: 8

The contract has been awarded to a group of economic operators: Yes

V.2.3) Name and address of the contractor

University of Ulster

Coleraine

UK

NUTS: UKN

The contractor is an SME: No

V.2.3) Name and address of the contractor

Dipartimento di Scienze Mediche – Università Degli Studi Di Ferrara

Ferrara

IT

NUTS: IT

The contractor is an SME: No

V.2.3) Name and address of the contractor

Consiglio Nazionale Delle Ricerche – Institute of Clinical Physiology

Roma

IT

NUTS: IT

The contractor is an SME: No

V.2.3) Name and address of the contractor

Swansea University

Swansea

UK

NUTS: UKL

The contractor is an SME: No

V.2.3) Name and address of the contractor

University Hospital Center of Toulouse

Toulouse

FR

NUTS: FR

The contractor is an SME: No

V.2.3) Name and address of the contractor

University of Bath

Bath

UK

NUTS: UK

The contractor is an SME: No

V.2.3) Name and address of the contractor

Hospital Lillebaelt, Region Syddanmark

Vejle

DK

NUTS: DK

The contractor is an SME: No

V.2.3) Name and address of the contractor

Stichting ENTIS (European Network Teratology Information Services) Foundation

s’-Hertogenbosch

NL

NUTS: NL

The contractor is an SME: No

V.2.3) Name and address of the contractor

Otto-von-Guericke-Universitaet Magdeburg, Medical faculty

Magdeburg

DE

NUTS: DE

The contractor is an SME: No

V.2.3) Name and address of the contractor

Fundación Para el Fomento de la Investigactión Sanitaria Y Biomédica de la Comunitat Valenciana

Valencia

ES

NUTS: ES

The contractor is an SME: No

V.2.4) Information on value of the contract/lot (excluding VAT)

Initial estimated total value of the contract/lot:

Total value of the contract/lot: : 3 000 000.00  EUR

V.2.5) Information about subcontracting

Section V: Award of contract

Lot No: 4

Contract No: EMA/2018/27/PE

Title: Farmakoepidemioloģiskā pētniecība – asociācijas pētījumi, tostarp grūtniecības un zīdīšanas pētījumi

A contract/lot is awarded: Yes

V.2 Award of contract

V.2.1) Date of conclusion of the contract

15/02/2019

V.2.2) Information about tenders

Number of tenders received: 8

The contract has been awarded to a group of economic operators: Yes

V.2.3) Name and address of the contractor

University of Ulster

Coleraine

UK

NUTS: UKN

The contractor is an SME: No

V.2.3) Name and address of the contractor

Dipartimento di Scienze Mediche – Università Degli Studi Di Ferrara

Ferrara

IT

NUTS: IT

The contractor is an SME: No

V.2.3) Name and address of the contractor

Consiglio Nazionale Delle Ricerche – Institute of Clinical Physiology

Roma

IT

NUTS: IT

The contractor is an SME: No

V.2.3) Name and address of the contractor

Swansea University

Swansea

UK

NUTS: UKL

The contractor is an SME: No

V.2.3) Name and address of the contractor

University Hospital Center of Toulouse

Toulouse

FR

NUTS: FR

The contractor is an SME: No

V.2.3) Name and address of the contractor

University of Bath

Bath

UK

NUTS: UK

The contractor is an SME: No

V.2.3) Name and address of the contractor

Hospital Lillebaelt, Region Syddanmark

Vejle

DK

NUTS: DK

The contractor is an SME: No

V.2.3) Name and address of the contractor

Stichting ENTIS (European Network Teratology Information Services) Foundation

s’-Hertogenbosch

NL

NUTS: NL

The contractor is an SME: No

V.2.3) Name and address of the contractor

Otto-von-Guericke-Universitaet Magdeburg, Medical faculty

Magdeburg

DE

NUTS: DE

The contractor is an SME: No

V.2.3) Name and address of the contractor

Fundación Para el Fomento de la Investigactión Sanitaria Y Biomédica de la Comunitat Valenciana

Valencia

ES

NUTS: ES

The contractor is an SME: No

V.2.4) Information on value of the contract/lot (excluding VAT)

Initial estimated total value of the contract/lot:

Total value of the contract/lot: : 3 000 000.00  EUR

V.2.5) Information about subcontracting

Section V: Award of contract

Lot No: 4

Contract No: EMA/2018/27/PE

Title: Riċerka Farmakoepidemjoloġika - Studji ta' Assoċjazzjoni, Inkluż Riċerka dwar Tqala u Treddigħ

A contract/lot is awarded: Yes

V.2 Award of contract

V.2.1) Date of conclusion of the contract

15/02/2019

V.2.2) Information about tenders

Number of tenders received: 8

The contract has been awarded to a group of economic operators: Yes

V.2.3) Name and address of the contractor

University of Ulster

Coleraine

UK

NUTS: UKN

The contractor is an SME: No

V.2.3) Name and address of the contractor

Dipartimento di Scienze Mediche – Università Degli Studi Di Ferrara

Ferrara

IT

NUTS: IT

The contractor is an SME: No

V.2.3) Name and address of the contractor

Consiglio Nazionale Delle Ricerche – Institute of Clinical Physiology

Roma

IT

NUTS: IT

The contractor is an SME: No

V.2.3) Name and address of the contractor

Swansea University

Swansea

UK

NUTS: UKL

The contractor is an SME: No

V.2.3) Name and address of the contractor

University Hospital Center of Toulouse

Toulouse

FR

NUTS: FR

The contractor is an SME: No

V.2.3) Name and address of the contractor

University of Bath

Bath

UK

NUTS: UK

The contractor is an SME: No

V.2.3) Name and address of the contractor

Hospital Lillebaelt, Region Syddanmark

Vejle

DK

NUTS: DK

The contractor is an SME: No

V.2.3) Name and address of the contractor

Stichting ENTIS (European Network Teratology Information Services) Foundation

s’-Hertogenbosch

NL

NUTS: NL

The contractor is an SME: No

V.2.3) Name and address of the contractor

Otto-von-Guericke-Universitaet Magdeburg, Medical faculty

Magdeburg

DE

NUTS: DE

The contractor is an SME: No

V.2.3) Name and address of the contractor

Fundación Para el Fomento de la Investigactión Sanitaria Y Biomédica de la Comunitat Valenciana

Valencia

ES

NUTS: ES

The contractor is an SME: No

V.2.4) Information on value of the contract/lot (excluding VAT)

Initial estimated total value of the contract/lot:

Total value of the contract/lot: : 3 000 000.00  EUR

V.2.5) Information about subcontracting

Section V: Award of contract

Lot No: 4

Contract No: EMA/2018/27/PE

Title: Badanie farmakoepidemiologiczne — badania asocjacyjne, w tym badania dotyczące ciąży i karmienia piersią

A contract/lot is awarded: Yes

V.2 Award of contract

V.2.1) Date of conclusion of the contract

15/02/2019

V.2.2) Information about tenders

Number of tenders received: 8

The contract has been awarded to a group of economic operators: Yes

V.2.3) Name and address of the contractor

University of Ulster

Coleraine

UK

NUTS: UKN

The contractor is an SME: No

V.2.3) Name and address of the contractor

Dipartimento di Scienze Mediche – Università Degli Studi Di Ferrara

Ferrara

IT

NUTS: IT

The contractor is an SME: No

V.2.3) Name and address of the contractor

Consiglio Nazionale Delle Ricerche – Institute of Clinical Physiology

Roma

IT

NUTS: IT

The contractor is an SME: No

V.2.3) Name and address of the contractor

Swansea University

Swansea

UK

NUTS: UKL

The contractor is an SME: No

V.2.3) Name and address of the contractor

University Hospital Center of Toulouse

Toulouse

FR

NUTS: FR

The contractor is an SME: No

V.2.3) Name and address of the contractor

University of Bath

Bath

UK

NUTS: UK

The contractor is an SME: No

V.2.3) Name and address of the contractor

Hospital Lillebaelt, Region Syddanmark

Vejle

DK

NUTS: DK

The contractor is an SME: No

V.2.3) Name and address of the contractor

Stichting ENTIS (European Network Teratology Information Services) Foundation

s’-Hertogenbosch

NL

NUTS: NL

The contractor is an SME: No

V.2.3) Name and address of the contractor

Otto-von-Guericke-Universitaet Magdeburg, Medical faculty

Magdeburg

DE

NUTS: DE

The contractor is an SME: No

V.2.3) Name and address of the contractor

Fundación Para el Fomento de la Investigactión Sanitaria Y Biomédica de la Comunitat Valenciana

Valencia

ES

NUTS: ES

The contractor is an SME: No

V.2.4) Information on value of the contract/lot (excluding VAT)

Initial estimated total value of the contract/lot:

Total value of the contract/lot: : 3 000 000.00  EUR

V.2.5) Information about subcontracting

Section V: Award of contract

Lot No: 4

Contract No: EMA/2018/27/PE

Title: Farmakoepidemiologický výskum – súvisiace štúdie vrátane výskumu týkajúceho sa tehotenstva a dojčenia

A contract/lot is awarded: Yes

V.2 Award of contract

V.2.1) Date of conclusion of the contract

15/02/2019

V.2.2) Information about tenders

Number of tenders received: 8

The contract has been awarded to a group of economic operators: Yes

V.2.3) Name and address of the contractor

University of Ulster

Coleraine

UK

NUTS: UKN

The contractor is an SME: No

V.2.3) Name and address of the contractor

Dipartimento di Scienze Mediche – Università Degli Studi Di Ferrara

Ferrara

IT

NUTS: IT

The contractor is an SME: No

V.2.3) Name and address of the contractor

Consiglio Nazionale Delle Ricerche – Institute of Clinical Physiology

Roma

IT

NUTS: IT

The contractor is an SME: No

V.2.3) Name and address of the contractor

Swansea University

Swansea

UK

NUTS: UKL

The contractor is an SME: No

V.2.3) Name and address of the contractor

University Hospital Center of Toulouse

Toulouse

FR

NUTS: FR

The contractor is an SME: No

V.2.3) Name and address of the contractor

University of Bath

Bath

UK

NUTS: UK

The contractor is an SME: No

V.2.3) Name and address of the contractor

Hospital Lillebaelt, Region Syddanmark

Vejle

DK

NUTS: DK

The contractor is an SME: No

V.2.3) Name and address of the contractor

Stichting ENTIS (European Network Teratology Information Services) Foundation

s’-Hertogenbosch

NL

NUTS: NL

The contractor is an SME: No

V.2.3) Name and address of the contractor

Otto-von-Guericke-Universitaet Magdeburg, Medical faculty

Magdeburg

DE

NUTS: DE

The contractor is an SME: No

V.2.3) Name and address of the contractor

Fundación Para el Fomento de la Investigactión Sanitaria Y Biomédica de la Comunitat Valenciana

Valencia

ES

NUTS: ES

The contractor is an SME: No

V.2.4) Information on value of the contract/lot (excluding VAT)

Initial estimated total value of the contract/lot:

Total value of the contract/lot: : 3 000 000.00  EUR

V.2.5) Information about subcontracting

Section V: Award of contract

Lot No: 4

Contract No: EMA/2018/27/PE

Title: Farmakoepidemiološke raziskave – asociacijske študije, vključno z raziskavami nosečnosti in dojenja

A contract/lot is awarded: Yes

V.2 Award of contract

V.2.1) Date of conclusion of the contract

15/02/2019

V.2.2) Information about tenders

Number of tenders received: 8

The contract has been awarded to a group of economic operators: Yes

V.2.3) Name and address of the contractor

University of Ulster

Coleraine

UK

NUTS: UKN

The contractor is an SME: No

V.2.3) Name and address of the contractor

Dipartimento di Scienze Mediche – Università Degli Studi Di Ferrara

Ferrara

IT

NUTS: IT

The contractor is an SME: No

V.2.3) Name and address of the contractor

Consiglio Nazionale Delle Ricerche – Institute of Clinical Physiology

Roma

IT

NUTS: IT

The contractor is an SME: No

V.2.3) Name and address of the contractor

Swansea University

Swansea

UK

NUTS: UKL

The contractor is an SME: No

V.2.3) Name and address of the contractor

University Hospital Center of Toulouse

Toulouse

FR

NUTS: FR

The contractor is an SME: No

V.2.3) Name and address of the contractor

University of Bath

Bath

UK

NUTS: UK

The contractor is an SME: No

V.2.3) Name and address of the contractor

Hospital Lillebaelt, Region Syddanmark

Vejle

DK

NUTS: DK

The contractor is an SME: No

V.2.3) Name and address of the contractor

Stichting ENTIS (European Network Teratology Information Services) Foundation

s’-Hertogenbosch

NL

NUTS: NL

The contractor is an SME: No

V.2.3) Name and address of the contractor

Otto-von-Guericke-Universitaet Magdeburg, Medical faculty

Magdeburg

DE

NUTS: DE

The contractor is an SME: No

V.2.3) Name and address of the contractor

Fundación Para el Fomento de la Investigactión Sanitaria Y Biomédica de la Comunitat Valenciana

Valencia

ES

NUTS: ES

The contractor is an SME: No

V.2.4) Information on value of the contract/lot (excluding VAT)

Initial estimated total value of the contract/lot:

Total value of the contract/lot: : 3 000 000.00  EUR

V.2.5) Information about subcontracting

Section V: Award of contract

Lot No: 4

Contract No: EMA/2018/27/PE

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

A contract/lot is awarded: Yes

V.2 Award of contract

V.2.1) Date of conclusion of the contract

15/02/2019

V.2.2) Information about tenders

Number of tenders received: 8

The contract has been awarded to a group of economic operators: Yes

V.2.3) Name and address of the contractor

Ollscoil Uladh

Coleraine

UK

NUTS: UKN

The contractor is an SME: No

V.2.3) Name and address of the contractor

Dipartimento di Scienze Mediche – Università Degli Studi Di Ferrara

Ferrara

IT

NUTS: IT

The contractor is an SME: No

V.2.3) Name and address of the contractor

Consiglio Nazionale Delle Ricerche – Institute of Clinical Physiology

Roma

IT

NUTS: IT

The contractor is an SME: No

V.2.3) Name and address of the contractor

Swansea University

Swansea

UK

NUTS: UKL

The contractor is an SME: No

V.2.3) Name and address of the contractor

University Hospital Center of Toulouse

Toulouse

FR

NUTS: FR

The contractor is an SME: No

V.2.3) Name and address of the contractor

University of Bath

Bath

UK

NUTS: UK

The contractor is an SME: No

V.2.3) Name and address of the contractor

Hospital Lillebaelt, Region Syddanmark

Vejle

DK

NUTS: DK

The contractor is an SME: No

V.2.3) Name and address of the contractor

Stichting ENTIS (European Network Teratology Information Services) Foundation

s’-Hertogenbosch

NL

NUTS: NL

The contractor is an SME: No

V.2.3) Name and address of the contractor

Otto-von-Guericke-Universitaet Magdeburg, Medical faculty

Magdeburg

DE

NUTS: DE

The contractor is an SME: No

V.2.3) Name and address of the contractor

Fundación Para el Fomento de la Investigactión Sanitaria Y Biomédica de la Comunitat Valenciana

Valencia

ES

NUTS: ES

The contractor is an SME: No

V.2.4) Information on value of the contract/lot (excluding VAT)

Initial estimated total value of the contract/lot:

Total value of the contract/lot: : 3 000 000.00  EUR

V.2.5) Information about subcontracting

Section V: Award of contract

Lot No: 4

Contract No: EMA/2018/27/PE

Title: Изследване за фармакоепидемиология — проучвания на асоциации, включително изследвания за бременност и кърмене.

A contract/lot is awarded: Yes

V.2 Award of contract

V.2.1) Date of conclusion of the contract

15/02/2019

V.2.2) Information about tenders

Number of tenders received: 8

The contract has been awarded to a group of economic operators: Yes

V.2.3) Name and address of the contractor

University of Ulster

Coleraine

UK

NUTS: UKN

The contractor is an SME: No

V.2.3) Name and address of the contractor

Dipartimento di Scienze Mediche – Università Degli Studi Di Ferrara

Ferrara

IT

NUTS: IT

The contractor is an SME: No

V.2.3) Name and address of the contractor

Consiglio Nazionale Delle Ricerche – Institute of Clinical Physiology

Roma

IT

NUTS: IT

The contractor is an SME: No

V.2.3) Name and address of the contractor

Swansea University

Swansea

UK

NUTS: UKL

The contractor is an SME: No

V.2.3) Name and address of the contractor

University Hospital Center of Toulouse

Toulouse

FR

NUTS: FR

The contractor is an SME: No

V.2.3) Name and address of the contractor

University of Bath

Bath

UK

NUTS: UK

The contractor is an SME: No

V.2.3) Name and address of the contractor

Hospital Lillebaelt, Region Syddanmark

Vejle

DK

NUTS: DK

The contractor is an SME: No

V.2.3) Name and address of the contractor

Stichting ENTIS (European Network Teratology Information Services) Foundation

s’-Hertogenbosch

NL

NUTS: NL

The contractor is an SME: No

V.2.3) Name and address of the contractor

Otto-von-Guericke-Universitaet Magdeburg, Medical faculty

Magdeburg

DE

NUTS: DE

The contractor is an SME: No

V.2.3) Name and address of the contractor

Fundación Para el Fomento de la Investigactión Sanitaria Y Biomédica de la Comunitat Valenciana

Valencia

ES

NUTS: ES

The contractor is an SME: No

V.2.4) Information on value of the contract/lot (excluding VAT)

Initial estimated total value of the contract/lot:

Total value of the contract/lot: : 3 000 000.00  EUR

V.2.5) Information about subcontracting

Section V: Award of contract

Lot No: 4

Contract No: EMA/2018/27/PE

Title: Cercetarea farmacoepidemiologică - studii de asociere, inclusiv cercetarea privind sarcina și alăptarea

A contract/lot is awarded: Yes

V.2 Award of contract

V.2.1) Date of conclusion of the contract

15/02/2019

V.2.2) Information about tenders

Number of tenders received: 8

The contract has been awarded to a group of economic operators: Yes

V.2.3) Name and address of the contractor

University of Ulster

Coleraine

UK

NUTS: UKN

The contractor is an SME: No

V.2.3) Name and address of the contractor

Dipartimento di Scienze Mediche – Università Degli Studi Di Ferrara

Ferrara

IT

NUTS: IT

The contractor is an SME: No

V.2.3) Name and address of the contractor

Consiglio Nazionale Delle Ricerche – Institute of Clinical Physiology

Roma

IT

NUTS: IT

The contractor is an SME: No

V.2.3) Name and address of the contractor

Swansea University

Swansea

UK

NUTS: UKL

The contractor is an SME: No

V.2.3) Name and address of the contractor

University Hospital Center of Toulouse

Toulouse

FR

NUTS: FR

The contractor is an SME: No

V.2.3) Name and address of the contractor

University of Bath

Bath

UK

NUTS: UK

The contractor is an SME: No

V.2.3) Name and address of the contractor

Hospital Lillebaelt, Region Syddanmark

Vejle

DK

NUTS: DK

The contractor is an SME: No

V.2.3) Name and address of the contractor

Stichting ENTIS (European Network Teratology Information Services) Foundation

s’-Hertogenbosch

NL

NUTS: NL

The contractor is an SME: No

V.2.3) Name and address of the contractor

Otto-von-Guericke-Universitaet Magdeburg, Medical faculty

Magdeburg

DE

NUTS: DE

The contractor is an SME: No

V.2.3) Name and address of the contractor

Fundación Para el Fomento de la Investigactión Sanitaria Y Biomédica de la Comunitat Valenciana

Valencia

ES

NUTS: ES

The contractor is an SME: No

V.2.4) Information on value of the contract/lot (excluding VAT)

Initial estimated total value of the contract/lot:

Total value of the contract/lot: : 3 000 000.00  EUR

V.2.5) Information about subcontracting

Section V: Award of contract

Lot No: 4

Contract No: EMA/2018/27/PE

Title: Farmakoepidemiološko istraživanje — povezane studije, uključujući istraživanje trudnoće i dojenja

A contract/lot is awarded: Yes

V.2 Award of contract

V.2.1) Date of conclusion of the contract

15/02/2019

V.2.2) Information about tenders

Number of tenders received: 8

The contract has been awarded to a group of economic operators: Yes

V.2.3) Name and address of the contractor

University of Ulster

Coleraine

UK

NUTS: UKN

The contractor is an SME: No

V.2.3) Name and address of the contractor

Dipartimento di Scienze Mediche – Università Degli Studi Di Ferrara

Ferrara

IT

NUTS: IT

The contractor is an SME: No

V.2.3) Name and address of the contractor

Consiglio Nazionale Delle Ricerche – Institute of Clinical Physiology

Roma

IT

NUTS: IT

The contractor is an SME: No

V.2.3) Name and address of the contractor

Swansea University

Swansea

UK

NUTS: UKL

The contractor is an SME: No

V.2.3) Name and address of the contractor

University Hospital Center of Toulouse

Toulouse

FR

NUTS: FR

The contractor is an SME: No

V.2.3) Name and address of the contractor

University of Bath

Bath

UK

NUTS: UK

The contractor is an SME: No

V.2.3) Name and address of the contractor

Hospital Lillebaelt, Region Syddanmark

Vejle

DK

NUTS: DK

The contractor is an SME: No

V.2.3) Name and address of the contractor

Stichting ENTIS (European Network Teratology Information Services) Foundation

s’-Hertogenbosch

NL

NUTS: NL

The contractor is an SME: No

V.2.3) Name and address of the contractor

Otto-von-Guericke-Universitaet Magdeburg, Medical faculty

Magdeburg

DE

NUTS: DE

The contractor is an SME: No

V.2.3) Name and address of the contractor

Fundación Para el Fomento de la Investigactión Sanitaria Y Biomédica de la Comunitat Valenciana

Valencia

ES

NUTS: ES

The contractor is an SME: No

V.2.4) Information on value of the contract/lot (excluding VAT)

Initial estimated total value of the contract/lot:

Total value of the contract/lot: : 3 000 000.00  EUR

V.2.5) Information about subcontracting

Section VI: Complementary information

VI.4) Procedures for review

VI.4.1) Review body

Retten

Rue du Fort Niedergrünewald

Luxembourg

L-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 fristen for indgivelse af en klage afbrydes, eller at der påbegyndes en ny periode for indgivelse af klage.

Indtil 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).

Tarjoajat voivat toimittaa mahdolliset sopimuksentekomenettelyä koskevat huomautukset kohdassa I.1 ilmoitetulle hankintaviranomaiselle.

Epäiltäessä hallinnollista epäkohtaa asiasta voidaan tehdä kantelu Euroopan oikeusasiamiehelle 2 vuoden kuluessa siitä päivämäärästä, jona kantelun perusteena olevat seikat havaittiin (katso http://www.ombudsman.europa.eu). Kantelu ei vaikuta muutoksenhaun määräaikaan, eikä sen vuoksi muutoksenhaulle 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 réclamation 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 réclamation (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 pour le dépôt d’un 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.

Οι υποψήφιοι μπορούν να υποβάλουν τυχόν παρατηρήσεις σχετικά με τη διαδικασία ανάθεσης στην αναθέτουσα αρχή που αναφέρεται στο σημείο I.1).

Εάν πιστεύετε πως υπήρξε ζήτημα κακής διοίκησης, μπορείτε να υποβάλετε καταγγελία στον Ευρωπαίο Διαμεσολαβητή εντός 2 ετών από την ημερομηνία κατά την οποία λάβατε γνώση των γεγονότων στα οποία βασίζεται η καταγγελία (βλέπε http://www.ombudsman.europa.eu). Η εν λόγω καταγγελία δεν έχει ως αποτέλεσμα ούτε την αναστολή της προθεσμίας για την υποβολή προσφυγών ούτε την έναρξη νέας περιόδου για την υποβολή προσφυγών.

Εντός 2 μηνών από την κοινοποίηση της απόφασης ανάθεσης μπορείτε να υποβάλετε προσφυγή στον φορέα που αναφέρεται στο σημείο 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 ricorso al Mediatore europeo entro 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 ricorso non produrrà né l'effetto di sospendere il periodo di tempo per la presentazione di ricorsi né di aprirne uno nuovo.

La presentazione del ricorso all'organismo di cui al punto VI.4.1) potrà essere eseguita entro 2 mesi dalla notifica della decisione di aggiudicazione.

eventuele opmerkingen in verband met de gunningsprocedure mogen naar de aanbestedende dienst vermeld in I.1) worden verstuurd.

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 instantie 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 anföras 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 överklagande skjuts upp eller till att en ny period för begäran om att anföra ett överklagande inleds.

Du får anföra ett överklagande till det organ som nämns i punkt VI.4.1) inom 2 månader efter meddelandet om tilldelningsbeslutet.

Případné připomínky týkající se zadávacího řízení lze předložit veřejnému zadavateli uvedenému v bodě I.1).

Pokud si myslíte, že došlo k nesprávnému administrativnímu postupu, můžete podat stížnost evropskému veřejnému ochránci práv ve lhůtě 2 let od data, kdy jste se dozvěděli o skutečnostech, na nichž se stížnost zakládá (viz http://www.ombudsman.europa.eu). Taková stížnost nebude mít za následek ani pozastavení lhůty, ani započetí nové lhůty pro podání odvolání.

Ve lhůtě 2 měsíců od oznámení rozhodnutí o zadání zakázky můžete podat odvolání k instituci uvedené v bodě VI.4.1).

Lepingu sõlmimise menetluse kohta võib esitada tähelepanekuid punktis I.1) nimetatud avaliku sektori hankijale.

Juhul kui kogete haldusomavoli, 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 kaebusi esitada 2 kuu jooksul lepingu sõlmimise otsusest teavitamisest.

Az odaítélési eljárással kapcsolatos észrevételeit az I.1) pontban feltüntetett ajánlatkérőnek jelezheti.

Amennyiben az ajánlattevő úgy véli, hogy hivatali visszásságra került sor, panaszt tehet az európai ombudsmannál attól a naptól számított 2 éven belül, hogy a panaszra okot adó tényről tudomást szerzett (lásd a http://www.ombudsman.europa.eu oldalon). A benyújtott panasz nem eredményezi sem a fellebbezési időszak meghosszabbítását, sem új időszak megnyitását.

Az odaítélési határozatra vonatkozó értesítést követő 2 hónapon belül jogorvoslati kérelmet nyújthat be a VI.4.1) pontban feltüntetett szervnek.

Galite pateikti bet kokias pastabas dėl sutarties skyrimo procedūros I.1) dalyje nurodytai perkančiajai organizacijai.

Jeigu manote, kad buvo blogai administruojama, galite pateikti skundą Europos ombudsmenui per 2 metus nuo dienos, kai tapo žinomi faktai, kuriais grindžiamas skundas (žr. http://www.ombudsman.europa.eu). Dėl tokio skundo nebus sustabdytas apeliacijų teikimo laikotarpis ar pradėtas naujas apeliacijų teikimo laikotarpis.

Per 2 mėnesius nuo sprendimo paskirti sutartį galima pateikti apeliaciją VI.4.1) dalyje nurodytai institucijai.

piezīmes par piešķiršanas procedūru var iesniegt I.1) iedaļā minētajai līgumslēdzējai iestādei.

Ja uzskatāt, ka pieļauta administratīva kļūme, varat iesniegt sūdzību Eiropas Ombudam 2 gadu laikā no dienas, kad esat uzzinājis par faktiem, uz kuriem balstīta sūdzība (sk. http://www.ombudsman.europa.eu). Šādas sūdzības iesniegšana nevar ne atlikt pārsūdzību iesniegšanas termiņu, ne arī noteikt jaunu periodu pārsūdzību iesniegšanai.

Pārsūdzību var iesniegt VI.4.1) iedaļā minētajai struktūrai 2 mēnešu laikā no paziņojuma par līguma piešķiršanu paziņošanas.

Inti tista' tressaq kwalunkwe osservazzjoni dwar il-proċedura tal-għoti lill-awtorità li qiegħda toħroġ il-kuntratt indikata taħt l-intestatura I.1).

Jekk temmen li kien hemm amministrazzjoni ħażina, tista' tressaq ilment lill-Ombudsman Ewropew fi żmien sentejn (2) mid-data li fiha sirt taf dwar il-fatti li fuqhom huwa bbażat l-ilment (ara http://www.ombudsman.europa.eu). Ilment bħal dan mhux se jwassal biex jew ikun sospiż il-limitu taż-żmien għat-tressiq ta' appell jew biex jinfetaħ perijodu ġdid għat-tressiq ta' appell.

Fi żmien xahrejn (2) mill-avviż dwar id-deċiżjoni tal-għoti, inti tista' tressaq appell quddiem l-entità msemmija fil-punt VI.4.1).

uwagi dotyczące procedury udzielania zamówienia można przesyłać do instytucji zamawiającej wskazanej w pkt I.1).

W przypadku stwierdzenia niewłaściwego administrowania istnieje możliwość złożenia skargi do Europejskiego Rzecznika Praw Obywatelskich w ciągu 2 lat od powzięcia wiadomości o faktach będących podstawą skargi (zob. http://www.ombudsman.europa.eu). Taka skarga nie skutkuje zawieszeniem ani rozpoczęciem na nowo biegu terminu składania odwołań.

Odwołanie do organu, o którym mowa w pkt VI.4.1), można złożyć w ciągu 2 miesięcy od zawiadomienia o decyzji o udzieleniu zamówienia.

Prípadné pripomienky týkajúce sa výberového konania môžete predložiť verejnému obstarávateľovi uvedenému v bode I.1).

Ak ste presvedčený, že došlo k nesprávnemu úradnému postupu, môžete podať sťažnosť európskemu ombudsmanovi do 2 rokov od dátumu, keď ste sa dozvedeli o skutočnosti, na ktorej sa táto sťažnosť zakladá (pozri http://www.ombudsman.europa.eu). Takáto sťažnosť nebude mať za následok prerušenie, ani začatie novej lehoty na predloženie odvolania.

Odvolanie môžete podať orgánu uvedenému v bode VI.4.1) do 2 mesiacov od oznámenia o pridelení zákazky.

Pripombe v zvezi s postopkom oddaje naročila lahko pošljete naročniku na naslov iz oddelka I.1).

Če menite, da je prišlo do nepravilnosti, lahko vložite pritožbo pri Evropskem varuhu človekovih pravic v 2 letih od datuma, ko ste bili obveščeni o dejstvih, ki predstavljajo podlago za pritožbo (glejte http://www.ombudsman.europa.eu). Takšna pritožba ne prekine roka za vložitev pritožb niti ne začne novega obdobja za vložitev pritožb.

Pritožbo lahko vložite v 2 mesecih od obvestila o sklepu o oddaji naročila 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).

Можете да подадете всякакви коментари относно процедурата по възлагане до възлагащия орган, посочен в точка I.1).

Ако считате, че е имало лошо управление, Вие можете да подадете жалба до Европейския омбудсман в рамките на 2 години от датата, на която сте узнали за фактите, на които се основава жалбата (вж. http://www.ombudsman.europa.eu). Такава жалба няма нито да спре срока по внасяне на жалби, нито ще доведе до откриване на нов срок за подаване на жалби.

В рамките на 2 месеца от уведомяването за решението за възлагане, Вие можете да подадете жалба до органа, посочен в точка VI.4.1).

Eventualele observații privind procedura de atribuire se pot depune la autoritatea contractantă indicată la punctul I.1).

În cazul unei presupuse administrări necorespunzătoare, se poate depune o plângere la Ombudsmanul European în termen de 2 ani de la data la care s-a luat cunoștință de faptele pe care se bazează plângerea (a se vedea http://www.ombudsman.europa.eu). O astfel de plângere nu are drept efect suspendarea termenului-limită sau deschiderea unui nou termen pentru introducerea căilor de atac.

În termen de 2 luni de la notificarea deciziei de atribuire se poate introduce o cale de atac la organismul menționat la punctul VI.4.1).

Primjedbe u vezi s postupkom sklapanja ugovora možete dostaviti javnom naručitelju iz točke 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 (vidjeti http://www.ombudsman.europa.eu). Takvom se pritužbom ne obustavlja rok za ulaganje žalbe niti se otvara novo razdoblje za podnošenje žalbe.

Žalbu možete uložiti tijelu iz točke VI.4.1). u roku od 2 mjeseca od obavijesti o sklapanju ugovora.

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

25/02/2019

Coding

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73000000 Research and development services and related consultancy services Research and Development
73210000 Research consultancy services Research and development consultancy services

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100 UK - All

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