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)

Summary

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

Abstract

Målet med dette udbud er at træffe kontraktlige foranstaltninger, hvorigennem EMA skal sættes i stand til at specificere og erhverve ydelser fra ressourcer, som ikke er direkte antaget af EMA. Disse ressourcer skal bidrage med ekspertise direkte til aktiviteter forbundet med dataforvaltning (manuel omkodning, dobbelt sporing og kvalitetskontrol af både XEVMPD- og ICSR-data) til EudraVigilance, agenturets farmakologiske overvågningssystem.

Resultatet af arbejdet skal gemmes elektronisk i de systemer, som agenturet hoster. Sporingsinformation i forbindelse med opgaverne skal vedligeholdes af kontrahenten og gøres elektronisk tilgængeligt for EMA. Arbejdsresultaterne skal fremlægges ugentligt for EMA, et arbejdsområde ad gangen. Arbejdet skal udføres i kontrahentens lokaler, omend kontrahentens medarbejdere kan blive indkaldt til møder i EMA's lokaler på 30 Churchill Place, Canary Wharf, London E14 5EU, Det Forenede Kongerige.

Full notice text

Contract award notice

Results of the procurement procedure

Section I: Contracting entity

I.1) Name and addresses

Det Europæiske Lægemiddelagentur (EMA)

30 Churchill Place, Canary Wharf

London

E14 5EU

E-mail: ContractsandProcurement@ema.europa.eu

NUTS: UKI42

Internet address(es)

Main address: http://www.ema.europa.eu

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, Canary Wharf

London

E14 5EU

E-mail: ContractsandProcurement@ema.europa.eu

NUTS: UKI42

Internet address(es)

Main address: http://www.ema.europa.eu

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, Canary Wharf

London

E14 5EU

E-mail: ContractsandProcurement@ema.europa.eu

NUTS: UKI42

Internet address(es)

Main address: http://www.ema.europa.eu

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, Canary Wharf

London

E14 5EU

E-mail: ContractsandProcurement@ema.europa.eu

NUTS: UKI42

Internet address(es)

Main address: http://www.ema.europa.eu

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, Canary Wharf

London

E14 5EU

E-mail: ContractsandProcurement@ema.europa.eu

NUTS: UKI42

Internet address(es)

Main address: http://www.ema.europa.eu

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 (EMA)

30 Churchill Place, Canary Wharf

London

E14 5EU

E-mail: ContractsandProcurement@ema.europa.eu

NUTS: UKI42

Internet address(es)

Main address: http://www.ema.europa.eu

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, Canary Wharf

London

E14 5EU

E-mail: ContractsandProcurement@ema.europa.eu

NUTS: UKI42

Internet address(es)

Main address: http://www.ema.europa.eu

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, Canary Wharf

London

E14 5EU

E-mail: ContractsandProcurement@ema.europa.eu

NUTS: UKI42

Internet address(es)

Main address: http://www.ema.europa.eu

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

I.1) Name and addresses

Europees Geneesmiddelenbureau

30 Churchill Place, Canary Wharf

London

E14 5EU

E-mail: ContractsandProcurement@ema.europa.eu

NUTS: UKI42

Internet address(es)

Main address: http://www.ema.europa.eu

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, Canary Wharf

London

E14 5EU

E-mail: ContractsandProcurement@ema.europa.eu

NUTS: UKI42

Internet address(es)

Main address: http://www.ema.europa.eu

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, Canary Wharf

London

E14 5EU

E-mail: ContractsandProcurement@ema.europa.eu

NUTS: UKI42

Internet address(es)

Main address: http://www.ema.europa.eu

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, Canary Wharf

London

E14 5EU

E-mail: ContractsandProcurement@ema.europa.eu

NUTS: UKI42

Internet address(es)

Main address: http://www.ema.europa.eu

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, Canary Wharf

London

E14 5EU

E-mail: ContractsandProcurement@ema.europa.eu

NUTS: UKI42

Internet address(es)

Main address: http://www.ema.europa.eu

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, Canary Wharf

London

E14 5EU

E-mail: ContractsandProcurement@ema.europa.eu

NUTS: UKI42

Internet address(es)

Main address: http://www.ema.europa.eu

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, Canary Wharf

London

E14 5EU

E-mail: ContractsandProcurement@ema.europa.eu

NUTS: UKI42

Internet address(es)

Main address: http://www.ema.europa.eu

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, Canary Wharf

London

E14 5EU

E-mail: ContractsandProcurement@ema.europa.eu

NUTS: UKI42

Internet address(es)

Main address: http://www.ema.europa.eu

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, Canary Wharf

London

E14 5EU

E-mail: ContractsandProcurement@ema.europa.eu

NUTS: UKI42

Internet address(es)

Main address: http://www.ema.europa.eu

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, Canary Wharf

London

E14 5EU

E-mail: ContractsandProcurement@ema.europa.eu

NUTS: UKI42

Internet address(es)

Main address: http://www.ema.europa.eu

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, Canary Wharf

London

E14 5EU

E-mail: ContractsandProcurement@ema.europa.eu

NUTS: UKI42

Internet address(es)

Main address: http://www.ema.europa.eu

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, Canary Wharf

London

E14 5EU

E-mail: ContractsandProcurement@ema.europa.eu

NUTS: UKI42

Internet address(es)

Main address: http://www.ema.europa.eu

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, Canary Wharf

London

E14 5EU

E-mail: ContractsandProcurement@ema.europa.eu

NUTS: UKI42

Internet address(es)

Main address: http://www.ema.europa.eu

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, Canary Wharf

London

E14 5EU

E-mail: ContractsandProcurement@ema.europa.eu

NUTS: UKI42

Internet address(es)

Main address: http://www.ema.europa.eu

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, Canary Wharf

London

E14 5EU

E-mail: ContractsandProcurement@ema.europa.eu

NUTS: UKI42

Internet address(es)

Main address: http://www.ema.europa.eu

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, Canary Wharf

London

E14 5EU

E-mail: ContractsandProcurement@ema.europa.eu

NUTS: UKI42

Internet address(es)

Main address: http://www.ema.europa.eu

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

I.5) Main activity

General public services

Section II: Object

II.1) Scope of the procurement

II.1.1) Title

Dataforvaltning af EudraVigilance — forhøjelse af loftet

Reference number: EMA/2014/30/BD

II.1.2) Main CPV code

73000000

II.1.3) Type of contract

Services

II.1.4) Short description

II.1.6) Information about lots

This contract is divided into lots: No

II.1.7) Total value of the procurement

Value excluding VAT: 8 626 618.50 EUR

II.2) Description

II.2.3) Place of performance

NUTS code:

UKI4

II.2.4) Description of the procurement

II.2.5) Award criteria

Price

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

Section II: Object

II.1) Scope of the procurement

II.1.1) Title

EudraVigilance-Datenverwaltung — Erhöhung der Obergrenze

Reference number: EMA/2014/30/BD

II.1.2) Main CPV code

73000000

II.1.3) Type of contract

Services

II.1.4) Short description

Ziel dieser Ausschreibung ist der Abschluss vertraglicher Vereinbarungen, welche die EMA in die Lage versetzen, Dienstleistungen festzulegen und zu erwerben, die von nicht direkt bei der EMA beschäftigten Ressourcen erbracht werden. Die Ressourcen sollen sich mit ihrem Fachwissen direkt an den Datenverwaltungstätigkeiten (manuelle Erfassung, Erkennung von Doppeleinträgen und Qualitätskontrolle betreffend sowohl XEVMPD- als auch ICSR-Daten) für EudraVigilance, dem Pharmakovigilanz-System der Agentur, beteiligen.

Die Ergebnisse der Arbeiten sollen in den Systemen, die bei der Agentur untergebracht sind, elektronisch gespeichert werden. Begleitinformationen in Bezug auf die Aufgaben sind vom Auftragnehmer zu pflegen und der EMA elektronisch verfügbar zu machen. Die Ergebnisse der Arbeiten sind der EMA wöchentlich je Arbeitsabschnitt vorzulegen. Die Arbeiten sind in den Räumlichkeiten des Auftragnehmers zu erbringen, wenngleich das Personal des Auftragnehmers an Sitzungen in den Räumlichkeiten der EMA, 30 Churchill Place, Canary Wharf, London, E14 5EU, Vereinigte Königreich, teilnehmen soll.

II.1.6) Information about lots

This contract is divided into lots: No

II.1.7) Total value of the procurement

Value excluding VAT: 8 626 618.50 EUR

II.2) Description

II.2.3) Place of performance

NUTS code:

UKI4

II.2.4) Description of the procurement

II.2.5) Award criteria

Price

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

Section II: Object

II.1) Scope of the procurement

II.1.1) Title

EudraVigilance data management — increase in ceiling

Reference number: EMA/2014/30/BD

II.1.2) Main CPV code

73000000

II.1.3) Type of contract

Services

II.1.4) Short description

This tender aims to put into place contractual arrangements that will enable the EMA to specify and acquire services provided by resources not employed directly by the EMA. These resources will contribute expertise directly to the data management activities (manual recoding, duplicate detection and quality control for both XEVMPD and ICSR data) for EudraVigilance, the Agency's pharmacovigilance system.

The results of the work are to be stored electronically on the systems hosted at the Agency. Tracking information in relation to the tasks is to be maintained by the contractor and made available to the EMA electronically. The results of the work are to be presented to EMA weekly, work stream by work stream. The work is to be performed at the contractor's premises; although the contractor's staff will be expected to attend meetings at EMA's premises at 30 Churchill Place, Canary Wharf, London, E14 5EU, United Kingdom.

II.1.6) Information about lots

This contract is divided into lots: No

II.1.7) Total value of the procurement

Value excluding VAT: 8 626 618.50 EUR

II.2) Description

II.2.3) Place of performance

NUTS code:

UKI4

II.2.4) Description of the procurement

II.2.5) Award criteria

Price

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

Section II: Object

II.1) Scope of the procurement

II.1.1) Title

Gestión de los datos de EudraVigilance — aumento del límite máximo

Reference number: EMA/2014/30/BD

II.1.2) Main CPV code

73000000

II.1.3) Type of contract

Services

II.1.4) Short description

El presente concurso tiene por objeto establecer acuerdos contractuales que permitan a la EMA especificar y adquirir servicios proporcionados mediante diferentes recursos que la EMA no emplea directamente. Tales recursos aportarán conocimientos para llevar a cabo las actividades de gestión de datos [recodificación del manual, detección de datos duplicados y control de calidad tanto para datos del Diccionario extendido de productos médicos (XEVMPD) como de los informes de seguridad de caso individual (ICSR)] de EudraVigilance, el sistema de farmacovigilancia de la Agencia.

Los resultados del trabajo se almacenarán electrónicamente en los sistemas alojados en la Agencia. El contratista deberá mantener la información de seguimiento relativa a las tareas y ponerla a disposición de la EMA por vía electrónica. Los resultados del trabajo se presentarán a la EMA una vez a la semana, en función de cada línea de trabajo. El trabajo se llevará a cabo en las instalaciones del contratista, aunque se espera que su personal asista a las reuniones en las instalaciones de la EMA en la siguiente dirección: 30 Churchill Place, Canary Wharf, London, E14 5EU, Reino Unido.

II.1.6) Information about lots

This contract is divided into lots: No

II.1.7) Total value of the procurement

Value excluding VAT: 8 626 618.50 EUR

II.2) Description

II.2.3) Place of performance

NUTS code:

UKI4

II.2.4) Description of the procurement

II.2.5) Award criteria

Price

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

Section II: Object

II.1) Scope of the procurement

II.1.1) Title

EudraVigilance-järjestelmän tietojen hallinta – rahoituskaton korottaminen

Reference number: EMA/2014/30/BD

II.1.2) Main CPV code

73000000

II.1.3) Type of contract

Services

II.1.4) Short description

Tämän tarjouspyynnön tavoitteena on sellaisten sopimusjärjestelyjen tekeminen, joiden avulla Euroopan lääkevirasto voi määrittää ja hankkia palveluja tahoilta, jotka eivät ole suoraan lääkeviraston palveluksessa. Nämä tahot toimittavat asiantuntemusta suoraan EudraVigilance-järjestelmän (viraston lääketurvajärjestelmä) tietojen hallintatoimia varten (manuaalisesti tehtävä tallennus, toisintojen havaitseminen ja laadunvalvonta sellaisia tietoja varten, jotka koskevat sekä EudraVigilance-järjestelmän laajennettua lääkevalmistehakemistoa (XEVMPD) että yksittäistapausta koskevaa turvallisuusraporttia (ICSR)).

Työn tulokset tallennetaan sähköisesti viraston ylläpitämiin järjestelmiin. Sopimusosapuolen on ylläpidettävä tehtäviin liittyviä seurantatietoja ja toimitettava ne Euroopan lääkevirastolle sähköisessä muodossa. Työn tulokset on esitettävä Euroopan lääkevirastolle viikoittain kunkin toimintalinjan osalta. Työt suoritetaan sopimusosapuolen toimitiloissa, mutta sopimusosapuolen työntekijöiden odotetaan osallistuvan kokouksiin Euroopan lääkeviraston toimitiloissa seuraavassa osoitteessa: 30 Churchill Place, Canary Wharf, London, E14 5EU, Yhdistynyt kuningaskunta.

II.1.6) Information about lots

This contract is divided into lots: No

II.1.7) Total value of the procurement

Value excluding VAT: 8 626 618.50 EUR

II.2) Description

II.2.3) Place of performance

NUTS code:

UKI4

II.2.4) Description of the procurement

II.2.5) Award criteria

Price

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

Section II: Object

II.1) Scope of the procurement

II.1.1) Title

Gestion des données du système EudraVigilance — augmentation du plafond

Reference number: EMA/2014/30/BD

II.1.2) Main CPV code

73000000

II.1.3) Type of contract

Services

II.1.4) Short description

Le présent marché vise à mettre en place des accords contractuels qui permettront à l'EMA de préciser et d'acquérir des services fournis par des ressources humaines qui ne sont pas directement employées par l'Agence. Ces ressources contribueront directement de par leur expertise aux activités de gestion des données (recodification manuelle, détection des doublons et contrôle de la qualité des données XEVMPD et ICSR) d’EudraVigilance, le système de pharmacovigilance de l'Agence.

Les résultats de ce travail seront enregistrés de manière électronique dans les systèmes hébergés à l'Agence. Les informations de suivi relatives aux tâches effectuées seront tenues à jour par le contractant et mises à la disposition de l'EMA par voie électronique. Les résultats du travail doivent être présentés à EMA chaque semaine, axe de travail par axe de travail. Le travail sera exécuté dans les locaux du contractant, mais le personnel de celui-ci sera tenu d'assister à des réunions dans les locaux de l'EMA, à l'adresse suivante : 30 Churchill Place, Canary Wharf, London, E14 5EU, Royaume-Uni.

II.1.6) Information about lots

This contract is divided into lots: No

II.1.7) Total value of the procurement

Value excluding VAT: 8 626 618.50 EUR

II.2) Description

II.2.3) Place of performance

NUTS code:

UKI4

II.2.4) Description of the procurement

II.2.5) Award criteria

Price

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

Section II: Object

II.1) Scope of the procurement

II.1.1) Title

Διαχείριση δεδομένων EudraVigilance — Αύξηση του ανώτατου ορίου

Reference number: EMA/2014/30/BD

II.1.2) Main CPV code

73000000

II.1.3) Type of contract

Services

II.1.4) Short description

Ο παρών διαγωνισμός αποσκοπεί στην εφαρμογή συμβατικών ρυθμίσεων, οι οποίες θα επιτρέψουν στον EMA να καθορίσει και να λάβει υπηρεσίες που παρέχονται από πόρους οι οποίοι δεν απασχολούνται άμεσα από τον EMA. Οι εν λόγω πόροι θα συμβάλουν άμεσα μέσω της εμπειρογνωμοσύνης στις δραστηριότητες διαχείρισης δεδομένων (χειροκίνητη επανακωδικοποίηση, εντοπισμός αντιγράφων και έλεγχος ποιότητας για δεδομένα XEVMPD και ICSR) για το EudraVigilance, το σύστημα φαρμακοεπαγρύπνησης του Οργανισμού.

Τα αποτελέσματα των εργασιών θα αποθηκευτούν ηλεκτρονικά στα συστήματα που φιλοξενεί ο Οργανισμός. Οι πληροφορίες παρακολούθησης σε σχέση με τις εργασίες πρέπει να τηρούνται από τον ανάδοχο και να τίθενται στη διάθεση του EMA ηλεκτρονικά. Τα αποτελέσματα των εργασιών θα παρουσιάζονται στον EMA σε εβδομαδιαία βάση, ανά άξονα εργασιών. Η εκτέλεση των εργασιών θα πραγματοποιηθεί στα γραφεία του αναδόχου, ωστόσο, το προσωπικό του αναδόχου αναμένεται να παρευρίσκεται σε συνεδριάσεις στις εγκαταστάσεις του EMA στη διεύθυνση 30 Churchill Place, Canary Wharf, London E14 5EU, Ηνωμένο Βασίλειο.

II.1.6) Information about lots

This contract is divided into lots: No

II.1.7) Total value of the procurement

Value excluding VAT: 8 626 618.50 EUR

II.2) Description

II.2.3) Place of performance

NUTS code:

UKI4

II.2.4) Description of the procurement

II.2.5) Award criteria

Price

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

Section II: Object

II.1) Scope of the procurement

II.1.1) Title

Gestione dei dati di EudraVigilance — aumento del tetto

Reference number: EMA/2014/30/BD

II.1.2) Main CPV code

73000000

II.1.3) Type of contract

Services

II.1.4) Short description

Il presente bando mira a mettere in atto degli accordi contrattuali che permetteranno all'Agenzia di individuare e acquisire servizi prestati da risorse non impiegate direttamente dall'EMA. Tali risorse contribuiranno con competenze direttamente alle attività di gestione dei dati (ricodifica manuale, individuazione di duplicati e controllo della qualità sia per i dati XEVMPD che ICSR) per Eudravigilance, il sistema di farmacovigilanza dell'Agenzia.

I risultati dei lavori dovranno essere memorizzati elettronicamente sui sistemi ospitati dall'Agenzia. La tracciabilità delle informazioni in relazione ai compiti dovrà essere mantenuta dal contraente e resa disponibile elettronicamente all'EMA. I risultati dei lavori dovranno essere presentati all'EMA settimanalmente, asse di intervento per asse di intervento. Il lavoro dovrà essere eseguito presso i locali del contraente, sebbene il personale del contraente sarà tenuto a partecipare a riunioni presso i locali dell'EMA all'indirizzo 30 Churchill Place, Canary Wharf, London E14 5EU, Regno Unito.

II.1.6) Information about lots

This contract is divided into lots: No

II.1.7) Total value of the procurement

Value excluding VAT: 8 626 618.50 EUR

II.2) Description

II.2.3) Place of performance

NUTS code:

UKI4

II.2.4) Description of the procurement

II.2.5) Award criteria

Price

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

Section II: Object

II.1) Scope of the procurement

II.1.1) Title

EudraVigilance-gegevensbeheer — verhoging van het plafond

Reference number: EMA/2014/30/BD

II.1.2) Main CPV code

73000000

II.1.3) Type of contract

Services

II.1.4) Short description

Doelstelling van deze aanbesteding is het sluiten van overeenkomsten op basis waarvan het EMA bij derden diensten kan specificeren en verwerven. Deze derden moeten rechtstreeks deskundigheid verlenen met betrekking tot de gegevensbeheeractiviteiten (manuele recodering, opsporen van duplicaten en kwaliteitscontrole voor zowel XEVMPD- als ICSR-gegevens) van EudraVigilance, het geneesmiddelenbewakingssysteem van het Bureau.

De resultaten van het werk moeten elektronisch worden opgeslagen in de systemen die in het Bureau worden gehost. Opsporingsinformatie in verband met de taken moet door de contractant worden bewaard en elektronisch aan het EMA worden bezorgd. De resultaten van het werk moeten wekelijks per werkstroom aan het EMA worden voorgesteld. Het werk moet in de kantoren van de contractant worden uitgevoerd. Het personeel van de contractant moet echter vergaderingen bijwonen in de kantoren van het EMA op het volgende adres: 30 Churchill Place, Canary Wharf, London E14 5EU, Verenigd Koninkrijk.

II.1.6) Information about lots

This contract is divided into lots: No

II.1.7) Total value of the procurement

Value excluding VAT: 8 626 618.50 EUR

II.2) Description

II.2.3) Place of performance

NUTS code:

UKI4

II.2.4) Description of the procurement

II.2.5) Award criteria

Price

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

Section II: Object

II.1) Scope of the procurement

II.1.1) Title

Gestão de dados do EudraVigilance — aumento do teto

Reference number: EMA/2014/30/BD

II.1.2) Main CPV code

73000000

II.1.3) Type of contract

Services

II.1.4) Short description

O presente concurso visa a colocação em prática de disposições contratuais que permitam à EMA especificar e adquirir serviços disponibilizados por recursos indiretamente ligados à EMA. Estes recursos contribuirão com especialização diretamente para as atividades de gestão de dados (registo manual, deteção de duplicados e controlo da qualidade de dados XEVMPD e ICSR) do EudraVigilance, o sistema de vigilância farmacológica da Agência.

Os resultados do trabalho deverão ser armazenados eletronicamente nos sistemas alojados na Agência. O contratante deverá manter informação de localização relativamente às tarefas, devendo esta estar disponível para a EMA eletronicamente. Os resultados do trabalho deverão ser apresentados semanalmente à EMA, cada tipo de trabalho individualmente. O trabalho deverá ser realizado nas instalações do contratante; contudo, os funcionários do contratante deverão participar em reuniões nas instalações da EMA em 30 Churchill Place, Canary Wharf, London, E14 5EU, Reino Unido.

II.1.6) Information about lots

This contract is divided into lots: No

II.1.7) Total value of the procurement

Value excluding VAT: 8 626 618.50 EUR

II.2) Description

II.2.3) Place of performance

NUTS code:

UKI4

II.2.4) Description of the procurement

II.2.5) Award criteria

Price

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

Section II: Object

II.1) Scope of the procurement

II.1.1) Title

Datahantering för EudraVigilance – höjning av budgettaket

Reference number: EMA/2014/30/BD

II.1.2) Main CPV code

73000000

II.1.3) Type of contract

Services

II.1.4) Short description

Denna anbudsinfordran syftar till att upprätta kontraktsmässiga överenskommelser, som ska göra det möjligt för EMA att ange och anskaffa tjänster, som tillhandahålls av personalresurser, som inte är direktanställda av EMA. Dessa personalresurser kommer att bidra med expertis direkt till datahanteringsverksamheten (manuell omkodning, detektering av duplikat och kvalitetskontroll för både XEVMPD- och ICSR-data) för EudraVigilance, myndighetens system för säkerhetsövervakning av läkemedel.

Arbetets resultat ska lagras elektroniskt i systemen, som myndigheten hyser. Spårningsinformation när det gäller uppgifterna ska bevaras av uppdragstagaren och göras tillgänglig för EMA på elektronisk väg. Arbetets resultat ska presenteras för EMA varje vecka, område för område. Arbetet ska utföras i uppdragstagarens lokaler, men uppdragstagarens personal kommer att förväntas närvara vid möten i EMA:s lokaler på 30 Churchill Place, Canary Wharf, London, E14 5EU, Förenade Kungariket.

II.1.6) Information about lots

This contract is divided into lots: No

II.1.7) Total value of the procurement

Value excluding VAT: 8 626 618.50 EUR

II.2) Description

II.2.3) Place of performance

NUTS code:

UKI4

II.2.4) Description of the procurement

II.2.5) Award criteria

Price

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

Section II: Object

II.1) Scope of the procurement

II.1.1) Title

Správa dat EudraVigilance – zvýšení finančního stropu

Reference number: EMA/2014/30/BD

II.1.2) Main CPV code

73000000

II.1.3) Type of contract

Services

II.1.4) Short description

Cílem této zakázky je stanovit smluvní podmínky, které umožní agentuře EMA specifikovat a čerpat služby zajišťované prostřednictvím zdrojů, které nepatří přímo agentuře EMA. Tyto zdroje se budou svou odborností podílet přímo na činnostech správy dat (manuální překódování, vyhledávání duplikátů a kontrola kvality pro data XEVMPD i ICSR) pro EudraVigilance, systém agentury pro farmakovigilanci.

Výsledky práce budou uloženy elektronicky v systémech hostovaných u agentury. Sledování informací ve vztahu k úkolům bude prováděno veřejným zadavatelem a agentuře EMA zpřístupněno elektronicky. Výsledky práce musí být agentuře EMA předkládány v týdenním intervalu po jednotlivých pracovních tocích. Práce musí být provedena v prostorách zadavatele; ačkoliv od personálu poskytovatele služeb se očekává, že se zúčastní jednání v prostorách EMA na adrese 30 Churchill Place, Canary Wharf, Londýn, E14 5EU, Spojené království.

II.1.6) Information about lots

This contract is divided into lots: No

II.1.7) Total value of the procurement

Value excluding VAT: 8 626 618.50 EUR

II.2) Description

II.2.3) Place of performance

NUTS code:

UKI4

II.2.4) Description of the procurement

II.2.5) Award criteria

Price

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

Section II: Object

II.1) Scope of the procurement

II.1.1) Title

EudraVigilance'i andmete haldus – maksimaalse maksumuse suurendamine

Reference number: EMA/2014/30/BD

II.1.2) Main CPV code

73000000

II.1.3) Type of contract

Services

II.1.4) Short description

Käesoleva pakkumise eesmärk on lepingute sõlmimine, mis võimaldaksid EMA-l täpsustada ja hankida teenuseid, mille osutajad ei tööta vahetult EMA koosseisus. Nimetatud teenuseosutajad aitavad oma eksperditeadmistega vahetult kaasa EMA ravimiohutuse järelevalve süsteemi ehk EudraVigilance'i andmete haldamise ülesannete täitmisele (nii XEVMPD kui ka ICSRi andmete käsitsi taaskodeerimine, korduste avastamine ja kvaliteedi kontroll).

Töö tulemused tuleb salvestada elektroonilisel kujul EMAs majutatavates süsteemides. Ülesannetega seotud seireandmete talletamine on töövõtja kohustus ning töövõtja peab need andmed EMA-le elektrooniliselt kättesaadavaks tegema. Töö tulemused tuleb edastada EMA-le igal nädalal töövoogude kaupa. Töövõtja peab tööd tegema oma ruumides, kuid töövõtja töötajatelt eeldatakse osalemist EMA ruumides (aadressil 30 Churchill Place, Canary Wharf, London, E14 5EU, Ühendkuningriik) toimuvatel kohtumistel.

II.1.6) Information about lots

This contract is divided into lots: No

II.1.7) Total value of the procurement

Value excluding VAT: 8 626 618.50 EUR

II.2) Description

II.2.3) Place of performance

NUTS code:

UKI4

II.2.4) Description of the procurement

II.2.5) Award criteria

Price

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

Section II: Object

II.1) Scope of the procurement

II.1.1) Title

EudraVigilance adatkezelés – a maximális szerződéses érték emelése

Reference number: EMA/2014/30/BD

II.1.2) Main CPV code

73000000

II.1.3) Type of contract

Services

II.1.4) Short description

A pályázat célja olyan szerződéses viszonyok létrehozása, amelyek alapján az EMA az általa közvetlenül alkalmazottakon kívüli erőforrásokból származó szolgáltatásokat határozhat meg és vehet igénybe. Ezen erőforrások közvetlen szakértői tevékenységgel támogatják az ügynökség EudraVigilance gyógyszerfelügyeleti rendszerével kapcsolatos adatkezelési feladatokat (manuális adatrögzítés, az XEVMPD és ICSR adatokban lévő ismétlődések észlelése és ezen adatok minőség-ellenőrzése).

A munka eredményeit elektronikusan kell tárolni az ügynökségnél futó rendszerekben. A feladatokkal kapcsolatos információk nyomon követését a nyertes ajánlattevő végzi, és azokat elektronikusan elérhetővé teszi az EMA számára. A munka eredményeit munkafolyamatonként, hetente kell az EMA számára bemutatni. A munkát a nyertes ajánlattevő által biztosított helyszínen kell elvégezni; ugyanakkor a nyertes ajánlattevő alkalmazottainak részt kell venniük az EMA helyiségeiben tartott megbeszéléseken a következő címen: 30 Churchill Place, Canary Wharf, London E14 5EU, Egyesült Királyság.

II.1.6) Information about lots

This contract is divided into lots: No

II.1.7) Total value of the procurement

Value excluding VAT: 8 626 618.50 EUR

II.2) Description

II.2.3) Place of performance

NUTS code:

UKI4

II.2.4) Description of the procurement

II.2.5) Award criteria

Price

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

Section II: Object

II.1) Scope of the procurement

II.1.1) Title

„EudraVigilance“ duomenų valdymas – viršutinės ribos padidinimas

Reference number: EMA/2014/30/BD

II.1.2) Main CPV code

73000000

II.1.3) Type of contract

Services

II.1.4) Short description

Šio konkurso tikslas – sutvarkyti sutartinius įsipareigojimus, kurie leistų EMA specifikuoti ir gauti paslaugas, kurias teikia ištekliai, netiesiogiai dirbantys EMA. Šie ištekliai suteiks kompetencijos tiesiogiai duomenų valdymo veiklai (įrašymas rankiniu būdu, dublikatų suradimas ir kokybės kontrolė tiek XEVMPD, tiek ICSR duomenims), vykdomai „EudraVigilance“, agentūros farmakologinio budrumo sistemos.

Darbo rezultatai bus saugomi elektroniniu formatu sistemose, kurias prižiūri agentūra. Su užduotimis susijusią sekimo informaciją prižiūrės rangovas ir EMA suteiks elektroninę prieigą. Darbo rezultatus reikia pristatyti EMA kas savaitę, kiekvieną kartą pateikiant veiklos darbotvarkę. Darbas bus atliekamas rangovo patalpose, nors bus tikimasi, kad rangovo personalas dalyvaus EMA patalpose vyksiančiuose susitikimuose adresu 30 Churchill Place, Canary Wharf, London E14 5EU, Jungtinė Karalystė.

II.1.6) Information about lots

This contract is divided into lots: No

II.1.7) Total value of the procurement

Value excluding VAT: 8 626 618.50 EUR

II.2) Description

II.2.3) Place of performance

NUTS code:

UKI4

II.2.4) Description of the procurement

II.2.5) Award criteria

Price

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

Section II: Object

II.1) Scope of the procurement

II.1.1) Title

EudraVigilance datu pārvaldība – maksimālās vērtības palielināšana

Reference number: EMA/2014/30/BD

II.1.2) Main CPV code

73000000

II.1.3) Type of contract

Services

II.1.4) Short description

Šā konkursa mērķis ir izveidot tādas līgumiskas vienošanās, kas dos iespēju EMA noteikt un iegūt pakalpojumus, kurus sniedz EMA netieši nodarbinātie resursi. Šie resursi tiešā veidā nodrošinās ekspertīzi saistībā ar EudraVigilance – aģentūras farmakovigilances sistēmas – datu pārvaldības pasākumiem (manuāla ierakstīšana, dublējumu noteikšana un kvalitātes kontrole gan XEVMPD, gan ICSR datiem).

Darba rezultāti jāglabā elektroniski aģentūrā mitinātajās sistēmās. Darbuzņēmējam jāsaglabā ar uzdevumiem saistītā izsekošanas informācija un jānodrošina, ka tā ir elektroniski pieejama EMA. Darba rezultāti jāiesniedz EMA katru nedēļu pa attiecīgajām darba plūsmām. Darbs jāveic darbuzņēmēja telpās; tomēr darbuzņēmēja darbiniekiem būs jāapmeklē sanāksmes EMA telpās – 30 Churchill Place, Canary Wharf, London, E14 5EU, Apvienotā Karaliste.

II.1.6) Information about lots

This contract is divided into lots: No

II.1.7) Total value of the procurement

Value excluding VAT: 8 626 618.50 EUR

II.2) Description

II.2.3) Place of performance

NUTS code:

UKI4

II.2.4) Description of the procurement

II.2.5) Award criteria

Price

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

Section II: Object

II.1) Scope of the procurement

II.1.1) Title

L-immaniġġjar tad-dejta EudraVigilance — żieda fil-limitu massimu

Reference number: EMA/2014/30/BD

II.1.2) Main CPV code

73000000

II.1.3) Type of contract

Services

II.1.4) Short description

Din l-offerta għandha l-għan li ddaħħal fis-seħħ arranġamenti kuntrattwali li se jippermettu lill-EMA tispeċifika u takkwista s-servizzi pprovduti minn riżorsi mhux użati direttament mill-EMA. Dawn ir-riżorsi se jikkontribwixxu għal għarfien dirett għall-attivitajiet tal-immaniġġjar tad-dejta (l-irrekordjar manwali, l-idditektjar ta' duplikazzjoni u l-kontroll tal-kwalità kemm għal dejta XEVMPD u ICSR) għall-EudraVigilance, is-sistema ta' farmakoviġilanza tal-Aġenzija.

Ir-riżultati tax-xogħol għandhom ikunu maħżuna elettronikament fuq is-sistemi miżmuma fl-Aġenzija. L-informazzjoni tal-intraċċar b'rabta max-xogħlijiet għandha tinżamm mill-kuntrattur u titqiegħed għad-disponibbiltà tal-EMA elettronikament. Ir-riżultati tax-xogħol għandhom ikunu ppreżentati lill-EMA kull ġimgħa, fluss tax-xogħol wara fluss tax-xogħol. Ix-xogħol għandu jitwettaq fil-bini tal-kuntrattur; għalkemm il-persunal tal-kuntrattur se jkun mistenni jattendi għal-laqgħat fil-bini tal-EMA li jinsab fl-indirizz: 30 Churchill Place, Canary Wharf, London, E14 5EU, ir-Renju Unit.

II.1.6) Information about lots

This contract is divided into lots: No

II.1.7) Total value of the procurement

Value excluding VAT: 8 626 618.50 EUR

II.2) Description

II.2.3) Place of performance

NUTS code:

UKI4

II.2.4) Description of the procurement

II.2.5) Award criteria

Price

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

Section II: Object

II.1) Scope of the procurement

II.1.1) Title

Zarządzanie danymi systemu EudraVigilance — zwiększenie budżetu

Reference number: EMA/2014/30/BD

II.1.2) Main CPV code

73000000

II.1.3) Type of contract

Services

II.1.4) Short description

W wyniku tego zamówienia EMA planuje zawrzeć umowy, które umożliwią jej określenie oraz nabycie usług od podmiotów niezatrudnionych bezpośrednio przez EMA. Podmioty te zapewnią specjalistyczną wiedzę bezpośrednio na potrzeby zarządzania danymi (przekodowywanie, wykrywanie danych powtarzających się i kontrola jakości w zakresie danych XEVMPD i ICSR) w systemie EudraVigilance, czyli systemie nadzoru nad bezpieczeństwem farmakoterapii prowadzonym przez Agencję.

Wyniki prac będą przechowywane w wersji elektronicznej, w systemach prowadzonych przez Agencję. Wykonawca będzie monitorował informacje wymagane do realizacji zadań oraz będzie je udostępniał EMA w formie elektronicznej. Wyniki prac będą prezentowane EMA co tydzień, według poszczególnych etapów pracy. Prace będą wykonywane w siedzibie wykonawcy, chociaż oczekuje się, że pracownicy wykonawcy będą uczestniczyli w spotkaniach odbywających się w siedzibie EMA pod adresem: Prace będą wykonywane w siedzibie wykonawcy, jednak pracownicy wykonawcy powinni uczestniczyć w spotkaniach w siedzibie EMA pod adresem 30 Churchill Place, Canary Wharf, London, E14 5EU, Zjednoczone Królestwo.

II.1.6) Information about lots

This contract is divided into lots: No

II.1.7) Total value of the procurement

Value excluding VAT: 8 626 618.50 EUR

II.2) Description

II.2.3) Place of performance

NUTS code:

UKI4

II.2.4) Description of the procurement

II.2.5) Award criteria

Price

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

Section II: Object

II.1) Scope of the procurement

II.1.1) Title

Správa údajov Eudravigilance – zvýšenie stropu

Reference number: EMA/2014/30/BD

II.1.2) Main CPV code

73000000

II.1.3) Type of contract

Services

II.1.4) Short description

Cieľom tohto obstarávania je uplatniť zmluvné podmienky, ktoré umožnia agentúre EMA určiť a obstarať služby poskytnuté zdrojmi priamo nepoužívanými agentúrou EMA. Tieto zdroje budú priamo prispievať svojimi odbornými znalosťami k činnostiam správy údajov (prekódovanie príručky, detekcia duplikátov a kontrola kvality pre údaje XEVMPD a ICSR) pre Eudravigilance, ktorý je systémom agentúry pre dohľad nad liekmi.

Výsledky práce budú uložené elektronicky do systémov spravovaných v agentúre. Informácie získané prostredníctvom sledovania úloh budú spravované poskytovateľom služieb a sprístupnené elektronicky pre EMA. Výsledky práce budú prezentované EMA týždenne, úsek po úseku. Práca bude uskutočnená v priestoroch poskytovateľa, napriek tomu, že od jeho zamestnancov sa bude požadovať účasť na zasadnutiach v priestoroch EMA na adrese 30 Churchill Place, Canary Wharf, London, E14 5EU, Spojené kráľovstvo.

II.1.6) Information about lots

This contract is divided into lots: No

II.1.7) Total value of the procurement

Value excluding VAT: 8 626 618.50 EUR

II.2) Description

II.2.3) Place of performance

NUTS code:

UKI4

II.2.4) Description of the procurement

II.2.5) Award criteria

Price

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

Section II: Object

II.1) Scope of the procurement

II.1.1) Title

Upravljanje podatkov EudraVigilance – povišanje zgornje meje

Reference number: EMA/2014/30/BD

II.1.2) Main CPV code

73000000

II.1.3) Type of contract

Services

II.1.4) Short description

Namen razpisa je vzpostavitev pogodbenih ureditev, ki bodo EMA omogočile določitev in pridobitev storitev, ki jih zagotavljajo kadri, ki niso zaposleni neposredno pri EMA. Ti kadri bodo prispevali strokovno znanje neposredno za dejavnosti upravljanja podatkov (ročno beleženje, zaznavanje dvojnih vnosov in nadzor kakovosti za podatke XEVMPD in ICSR) za EudraVigilance, sistem farmakovigilance Agencije.

Rezultati dela bodo hranjeni elektronsko v sistemih, ki jih gosti Agencija. Izvajalec mora poskrbeti za sledenje informacij v zvezi z nalogami ter poskrbeti za njihovo elektronsko dostopnost za EMA. Rezultate dela je treba tedensko posredovati EMA, po delovnih tokovih. Delo se bo izvajalo v prostorih izvajalca, vendar bo moralo osebje izvajalca sodelovati na sestankih v prostorih EMA na naslovu Churchill Place 30, Canary Wharf, London, E14 5EU, Združeno kraljestvo.

II.1.6) Information about lots

This contract is divided into lots: No

II.1.7) Total value of the procurement

Value excluding VAT: 8 626 618.50 EUR

II.2) Description

II.2.3) Place of performance

NUTS code:

UKI4

II.2.4) Description of the procurement

II.2.5) Award criteria

Price

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

Section II: Object

II.1) Scope of the procurement

II.1.1) Title

Bainistíocht sonraí EudraVigilance — méadú san uasteorainn

Reference number: EMA/2014/30/BD

II.1.2) Main CPV code

73000000

II.1.3) Type of contract

Services

II.1.4) Short description

Tá sé mar aidhm ag an tairiscint socruithe conarthacha a chur i bhfeidhm lena gcuirfear ar chumas EMA seirbhísí a shonrú agus a fháil arna soláthar ag acmhainní gan bheith faoi fhostaíocht dhíreach leis an EMA. Soláthrófar leis na hacmhainní sin saineolas go díreach do na gníomhaíochtaí bainistíochta sonraí (athchódú láimhe, brath dúblach agus rialú cáilíochta do shonraí XEVMPD agus ICSR araon) le haghaidh EudraVigilance, córas faireachais cógas na Gníomhaireachta.

Stórálfar torthaí na hoibre go leictreonach ar na córais arna n-óstáil ag an nGníomhaireacht. Cothabhálfaidh an conraitheoir faisnéis rianaithe maidir leis na tascanna agus cuirfear ar fáil go leictreonach don EMA í. Cuirfear torthaí na hoibre faoi bhráid EMA ar bhonn seachtainiúil, sruth oibre i ndiaidh a chéile. Feidhmeofar an saothar ag áitreabh an chonraitheora; cé go mbeifear ag súil go mbeidh foireann an chonraitheora i láthair ag cruinnithe ag áitreabh EMA ag 30 Churchill Place, Canary Wharf, London E14 5EU, an Ríocht Aontaithe.

II.1.6) Information about lots

This contract is divided into lots: No

II.1.7) Total value of the procurement

Value excluding VAT: 8 626 618.50 EUR

II.2) Description

II.2.3) Place of performance

NUTS code:

UKI4

II.2.4) Description of the procurement

II.2.5) Award criteria

Price

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

Section II: Object

II.1) Scope of the procurement

II.1.1) Title

Управление на данни на EudraVigilance — увеличение на тавана

Reference number: EMA/2014/30/BD

II.1.2) Main CPV code

73000000

II.1.3) Type of contract

Services

II.1.4) Short description

Този търг има за цел да осъществи договорни споразумения, които ще позволят на EMA да определи и набави услуги, предоставени от ресурси, които не са пряко наети от EMA. Тези ресурси ще предоставят експертни познания директно до дейностите по управление на данни (ръчно записване, засичане на копия и контрол на качеството за XEVMPD и ICSR данни) за EudraVigilance, системата за лекарствена безопасност на агенцията.

Резултатите от работата трябва да се съхранят в електронен вид в системите, хоствани в агенцията. Проследяването на информация по отношение на задачите трябва да се извършва от изпълнителя и да се представя на EMA по електронен път. Резултатите от работата трябва да се представят на EMA ежеседмично, работен цикъл по работен цикъл. Работата трябва да се извърши в помещения на изпълнителя; въпреки че от служителите на изпълнителя ще се очаква да присъстват на срещи в помещенията на EMA на 30 Churchill Place, Canary Wharf, London, E14 5EU, Обединено Кралство.

II.1.6) Information about lots

This contract is divided into lots: No

II.1.7) Total value of the procurement

Value excluding VAT: 8 626 618.50 EUR

II.2) Description

II.2.3) Place of performance

NUTS code:

UKI4

II.2.4) Description of the procurement

II.2.5) Award criteria

Price

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

Section II: Object

II.1) Scope of the procurement

II.1.1) Title

Gestionarea datelor EudraVigilance – creșterea plafonului

Reference number: EMA/2014/30/BD

II.1.2) Main CPV code

73000000

II.1.3) Type of contract

Services

II.1.4) Short description

Această licitație vizează stabilirea de acorduri contractuale care vor permite EMA să specifice și să obțină servicii prestate de resurse care nu sunt angajate direct de EMA. Aceste resurse vor contribui cu competențe direct în cadrul activităților de gestionare a datelor (recodificare manuală, detectarea duplicatelor și controlul calității atât pentru datele XEVMPD, cât și pentru datele ICSR) pentru EudraVigilance, sistemul de farmacovigilență al agenției.

Rezultatele activităților vor fi stocate electronic în sistemele găzduite de agenție. Informațiile de monitorizare legate de sarcini vor fi păstrate de contractant și vor fi puse la dispoziția EMA pe cale electronică. Rezultatele activităților vor fi prezentate EMA săptămânal, flux de lucru cu flux de lucru. Activitățile trebuie executate la sediul contractantului, deși personalul contractantului va trebui să participe la reuniuni organizate la sediul EMA de la adresa 30 Churchill Place, Canary Wharf, London, E14 5EU, Regatul Unit.

II.1.6) Information about lots

This contract is divided into lots: No

II.1.7) Total value of the procurement

Value excluding VAT: 8 626 618.50 EUR

II.2) Description

II.2.3) Place of performance

NUTS code:

UKI4

II.2.4) Description of the procurement

II.2.5) Award criteria

Price

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

Section II: Object

II.1) Scope of the procurement

II.1.1) Title

Upravljanje podacima u okviru sustava EudraVigilance — podizanje gornje granice

Reference number: EMA/2014/30/BD

II.1.2) Main CPV code

73000000

II.1.3) Type of contract

Services

II.1.4) Short description

Ovaj poziv na nadmetanje ima za cilj sklapanje ugovornih sporazuma koji će omogućiti EMA-i određivanje i stjecanje usluga koje pružaju izvori koje nije izravno zaposlila EMA. Ti će izvori svojom stručnošću izravno doprinijeti aktivnostima upravljanja podataka (ručno ponovno kodiranje, otkrivanje kopija i kontrola kvalitete za podatke XEVMPD i ICSR) za EudraVigilance, sustav farmakovigilancije Agencije.

Rezultati rada pohranjivat će se elektronički u sustave kojima upravlja Agencija. Podatke praćenja povezane sa zadacima treba održavati izvoditelj i staviti na raspolaganje EMA-i elektroničkim putem. Rezultati rada trebaju se predstaviti EMA-i tjedno, po radnim tokovima. Radovi će se izvoditi u prostorijama izvoditelja; iako se od izvoditeljevog osoblja očekuje da nazoči sastancima u prostorijama EMA-e na lokaciji 30 Churchill Place, Canary Wharf, London, E14 5EU, Ujedinjena kraljevina.

II.1.6) Information about lots

This contract is divided into lots: No

II.1.7) Total value of the procurement

Value excluding VAT: 8 626 618.50 EUR

II.2) Description

II.2.3) Place of performance

NUTS code:

UKI4

II.2.4) Description of the procurement

II.2.5) Award criteria

Price

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

Section IV: Procedure

IV.1) Description

IV.1.1) Type of procedure

Award of a contract without prior publication of a call for competition

Justification for selected award procedure:

New works/services, constituting a repetition of existing works/services and ordered in accordance with the strict conditions stated in the Directive

Explanation

Udbud efter forhandling uden forudgående offentliggørelse af en udbudsbekendtgørelse i henhold til artikel 134, stk. 1, litra e), i gennemførelsesbestemmelserne med henblik på at øge rammekontraktens loft fra 5 751 079 EUR til 8 626 618,50 EUR som meddelt i det oprindelige udbud.

Award of a contract without prior publication of a call for competition

Justification for selected award procedure:

New works/services, constituting a repetition of existing works/services and ordered in accordance with the strict conditions stated in the Directive

Explanation

Verhandlungsverfahren ohne vorherige Veröffentlichung einer Auftragsbekanntmachung gemäß Artikel 134 Absatz 1 Buchstabe e der Anwendungsbestimmungen zur Anhebung der Obergrenze eines Rahmenvertrags von 5 751 079 EUR auf 8 626 618,50 EUR, wie in der ursprünglichen Ausschreibung angekündigt.

Award of a contract without prior publication of a call for competition

Justification for selected award procedure:

New works/services, constituting a repetition of existing works/services and ordered in accordance with the strict conditions stated in the Directive

Explanation

Negotiated procedure without prior publication of a contract notice Article 134(1)(e) RAP to increase the ceiling of a framework contract from 5 751 079 EUR to 8 626 618.50 EUR, as announced in the original invitation to tender.

Award of a contract without prior publication of a call for competition

Justification for selected award procedure:

New works/services, constituting a repetition of existing works/services and ordered in accordance with the strict conditions stated in the Directive

Explanation

Procedimiento negociado sin publicación previa de un anuncio de licitación, atendiendo al artículo 134, apartado 1, letra e), de las normas de desarrollo, para aumentar el límite máximo del contrato marco de 5 751 079 EUR a 8 626 618,50 EUR, tal como se anunció en la invitación a licitar original.

Award of a contract without prior publication of a call for competition

Justification for selected award procedure:

New works/services, constituting a repetition of existing works/services and ordered in accordance with the strict conditions stated in the Directive

Explanation

kyseessä on neuvottelumenettely ilman hankintailmoituksen julkaisemista etukäteen soveltamissääntöjen 134 artiklan 1 kohdan e alakohdan mukaisesti puitesopimuksen enimmäisarvon lisäämiseksi 5 751 079 EUR 8 626 618,50 EUR.

Award of a contract without prior publication of a call for competition

Justification for selected award procedure:

New works/services, constituting a repetition of existing works/services and ordered in accordance with the strict conditions stated in the Directive

Explanation

Procédure négociée sans publication préalable d'un avis de marché conformément à l'article 134, paragraphe 1, point e) des règles d'application, pour relever le plafond d'un contrat-cadre de 5 751 079 EUR à 8 626 618,50 EUR, comme annoncé dans l'appel d'offres initial.

Award of a contract without prior publication of a call for competition

Justification for selected award procedure:

New works/services, constituting a repetition of existing works/services and ordered in accordance with the strict conditions stated in the Directive

Explanation

Διαδικασία με διαπραγμάτευση χωρίς προηγούμενη δημοσίευση προκήρυξης σύμβασης, Άρθρο 134 παράγραφος 1 στοιχείο ε) των κανόνων εφαρμογής, για την αύξηση του ανώτατου ορίου της σύμβασης-πλαίσιο από 5 751 079 EUR σε 8 626 618,50 EUR, όπως ανακοινώθηκε στην αρχική πρόσκληση υποβολής προσφορών.

Award of a contract without prior publication of a call for competition

Justification for selected award procedure:

New works/services, constituting a repetition of existing works/services and ordered in accordance with the strict conditions stated in the Directive

Explanation

Procedura negoziata senza previa pubblicazione di un bando di gara ai sensi dell'articolo 134, paragrafo 1, lettera e), per aumentare il massimale del contratto quadro da 5 751 079 EUR a 8 626 618,50 EUR, come annunciato nel bando di gara originario.

Award of a contract without prior publication of a call for competition

Justification for selected award procedure:

New works/services, constituting a repetition of existing works/services and ordered in accordance with the strict conditions stated in the Directive

Explanation

onderhandelingsprocedure zonder voorafgaande publicatie van een aankondiging van opdracht overeenkomstig artikel 134, lid 1, onder e), van de uitvoeringsvoorschriften tot verhoging van het plafond van de raamovereenkomst van 5 751 079 EUR naar 8 626 618,50 EUR, zoals vermeld in de oorspronkelijke uitnodiging tot inschrijving.

Award of a contract without prior publication of a call for competition

Justification for selected award procedure:

New works/services, constituting a repetition of existing works/services and ordered in accordance with the strict conditions stated in the Directive

Explanation

Procedimento por negociação sem publicação prévia de um anúncio de concurso nos termos do artigo 134.º, n.º 1, alínea e), das normas de execução, para aumentar o teto de um contrato-quadro de 5 751 079 EUR para 8 626 618,50 EUR, consoante anunciado no anúncio de concurso original.

Award of a contract without prior publication of a call for competition

Justification for selected award procedure:

New works/services, constituting a repetition of existing works/services and ordered in accordance with the strict conditions stated in the Directive

Explanation

Förhandlat förfarande utan föregående publicering av ett meddelande om upphandling – artikel 134.1 e i tillämpningsföreskrifterna om höjning av taket för ett ramavtal från 5 751 079 EUR till 8 626 618,50 EUR, enligt vad som anges i den ursprungliga anbudsinfordran.

Award of a contract without prior publication of a call for competition

Justification for selected award procedure:

New works/services, constituting a repetition of existing works/services and ordered in accordance with the strict conditions stated in the Directive

Explanation

Jednací řízení bez předchozího zveřejnění oznámení o zakázce podle čl. 134 odst. 1 písm. e) prováděcích pravidel, kterým se zvyšuje finanční strop rámcové smlouvy z 5 751 079 EUR na 8 626 618,50 EUR, jak bylo uvedeno v původní výzvě k podání nabídky.

Award of a contract without prior publication of a call for competition

Justification for selected award procedure:

New works/services, constituting a repetition of existing works/services and ordered in accordance with the strict conditions stated in the Directive

Explanation

Kohaldamise eeskirjade artikli 134 lõike 1 punkti e alusel läbirääkimistega menetlus hanketeate eelneva avaldamiseta, et suurendada raamlepingu maksimaalset maksumust summalt 5 751 079 EUR summale 8 626 618,50 EUR, nagu algses pakkumuskutses välja kuulutatud.

Award of a contract without prior publication of a call for competition

Justification for selected award procedure:

New works/services, constituting a repetition of existing works/services and ordered in accordance with the strict conditions stated in the Directive

Explanation

A költségvetési rendelet 134. cikke (1) bekezdésének e) pontja szerinti ajánlati felhívás előzetes közzététele nélküli tárgyalásos eljárás, az eredeti ajánlati felhívásban feltüntetettek szerint a keretszerződés felső összeghatárának 5 751 079 EUR-ról 8 626 618,50 EUR-ra történő emelése céljából.

Award of a contract without prior publication of a call for competition

Justification for selected award procedure:

New works/services, constituting a repetition of existing works/services and ordered in accordance with the strict conditions stated in the Directive

Explanation

Derybų procedūra be išankstinio skelbimo apie sutartį (pagal Taikymo taisyklių 134 straipsnio 1 dalies e punktą) siekiant padidinti preliminariosios sutarties viršutinę ribą nuo 5 751 079 EUR iki 8 626 618,50 EUR, kaip pranešta pradiniame kvietime dalyvauti konkurse.

Award of a contract without prior publication of a call for competition

Justification for selected award procedure:

New works/services, constituting a repetition of existing works/services and ordered in accordance with the strict conditions stated in the Directive

Explanation

sarunu procedūra bez iepriekšējas paziņojuma par līgumu publicēšanas (saskaņā ar Piemērošanas noteikumu (Rules of application – RAP) 134. panta 1. punkta e) apakšpunktu) par pamatnolīguma maksimālās vērtības palielināšanu no 5 751 079 EUR līdz 8 626 618,50 EUR, kā paziņots sākotnējā uzaicinājumā uz konkursu.

Award of a contract without prior publication of a call for competition

Justification for selected award procedure:

New works/services, constituting a repetition of existing works/services and ordered in accordance with the strict conditions stated in the Directive

Explanation

Proċedura nnegozjata mingħajr il-pubblikazzjoni minn qabel ta' avviż ta' kuntratt Artiklu 134(1)(e) tar-RAP li jżid il-limitu massimu tal-qafas ta' kuntratt minn 5 751 079 EUR għal 8 626 618,50 EUR, kif imħabbar fis-sejħa għall-offerti oriġinali.

Award of a contract without prior publication of a call for competition

Justification for selected award procedure:

New works/services, constituting a repetition of existing works/services and ordered in accordance with the strict conditions stated in the Directive

Explanation

Procedura negocjacyjna bez uprzedniej publikacji ogłoszenia o zamówieniu zgodnie z art. 134 ust. 1 lit. e) zasad stosowania, zwiększająca budżet umowy ramowej z 5 751 079 EUR do 8 626 618,50 EUR, jak ogłoszono w zaproszeniu do składania wniosków.

Award of a contract without prior publication of a call for competition

Justification for selected award procedure:

New works/services, constituting a repetition of existing works/services and ordered in accordance with the strict conditions stated in the Directive

Explanation

Rokovacie konanie bez predchádzajúceho zverejnenia oznámenia o vyhlásení verejného obstarávania podľa článku 134 ods. 1 písm. e) pravidiel uplatňovania, ktorým sa zvyšuje horná hranica rámcovej zmluvy z 5 751 079 EUR na 8 626 618,50 EUR, ako bolo oznámené v pôvodnej výzve na predkladanie ponúk.

Award of a contract without prior publication of a call for competition

Justification for selected award procedure:

New works/services, constituting a repetition of existing works/services and ordered in accordance with the strict conditions stated in the Directive

Explanation

Postopek s pogajanji brez predhodne objave obvestila o naročilu v skladu s členom 134(1)(e) pravil uporabe za povišanje zgornje meje okvirne pogodbe s 5 751 079 EUR na 8 626 618,50 EUR, kot je bilo napovedano v prvotnem povabilu k oddaji ponudb.

Award of a contract without prior publication of a call for competition

Justification for selected award procedure:

New works/services, constituting a repetition of existing works/services and ordered in accordance with the strict conditions stated in the Directive

Explanation

Nós imeachta idirbheartaithe gan fógra conartha a fhoilsiú roimh ré de réir Airteagal 134(1)(e) RAP d'fhonn uasteorainn an chreatchonartha a mhéadú ó 5 751 079 EUR go 8 626 618,50 EUR, faoi mar a fógraíodh sa chuireadh bunaidh chun tairisceana.

Award of a contract without prior publication of a call for competition

Justification for selected award procedure:

New works/services, constituting a repetition of existing works/services and ordered in accordance with the strict conditions stated in the Directive

Explanation

Процедура на договаряне без предварително публикуване на обявление за поръчка, член 134, параграф 1, буква д) от правилата за прилагане, за увеличение на тавана на рамковия договор от 5 751 079 EUR на 8 626 618,50 EUR.

Award of a contract without prior publication of a call for competition

Justification for selected award procedure:

New works/services, constituting a repetition of existing works/services and ordered in accordance with the strict conditions stated in the Directive

Explanation

Procedură negociată fără publicarea prealabilă a unui anunț de participare, conform articolului 134 alineatul (1) litera (e) din normele de aplicare, pentru majorarea plafonului contractului-cadru de la 5 751 079 EUR la 8 626 618,50 EUR, după cum s-a anunțat în invitația la licitație inițială.

Award of a contract without prior publication of a call for competition

Justification for selected award procedure:

New works/services, constituting a repetition of existing works/services and ordered in accordance with the strict conditions stated in the Directive

Explanation

Pregovarački postupak bez prethodne objave obavijesti o nadmetanju u skladu s člankom 134. stavkom 1. točkom (e) pravila za primjenu u svrhu podizanja gornje granice okvirnog ugovora s 5 751 079 EUR na 8 626 618,50 EUR, kako je objavljeno u izvornom pozivu na nadmetanje.

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:

2015/S 166-302355

Section V: Award of contract

Contract No: EMA/2014/30/BD

Title: Dataforvaltning af EudraVigilance — forhøjelse af loftet

A contract/lot is awarded: Yes

V.2 Award of contract

V.2.1) Date of conclusion of the contract

28/06/2018

V.2.2) Information about tenders

Number of tenders received: 1

The contract has been awarded to a group of economic operators: No

V.2.3) Name and address of the contractor

Kinapse Ltd

London

SW19 4EU

NUTS: UKI6

The contractor is an SME: No

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

Total value of the contract/lot: : 8 626 618.50 EUR

V.2.5) Information about subcontracting

Section V: Award of contract

Contract No: EMA/2014/30/BD

Title: EudraVigilance-Datenverwaltung — Erhöhung der Obergrenze

A contract/lot is awarded: Yes

V.2 Award of contract

V.2.1) Date of conclusion of the contract

28/06/2018

V.2.2) Information about tenders

Number of tenders received: 1

The contract has been awarded to a group of economic operators: No

V.2.3) Name and address of the contractor

Kinapse Ltd

London

SW19 4EU

NUTS: UKI6

The contractor is an SME: No

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

Total value of the contract/lot: : 8 626 618.50 EUR

V.2.5) Information about subcontracting

Section V: Award of contract

Contract No: EMA/2014/30/BD

Title: EudraVigilance Data Management — increase in ceiling

A contract/lot is awarded: Yes

V.2 Award of contract

V.2.1) Date of conclusion of the contract

28/06/2018

V.2.2) Information about tenders

Number of tenders received: 1

The contract has been awarded to a group of economic operators: No

V.2.3) Name and address of the contractor

Kinapse Ltd

London

SW19 4EU

NUTS: UKI6

The contractor is an SME: No

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

Total value of the contract/lot: : 8 626 618.50 EUR

V.2.5) Information about subcontracting

Section V: Award of contract

Contract No: EMA/2014/30/BD

Title: Gestión de los datos de EudraVigilance — aumento del límite máximo

A contract/lot is awarded: Yes

V.2 Award of contract

V.2.1) Date of conclusion of the contract

28/06/2018

V.2.2) Information about tenders

Number of tenders received: 1

The contract has been awarded to a group of economic operators: No

V.2.3) Name and address of the contractor

Kinapse Ltd

London

SW19 4EU

NUTS: UKI6

The contractor is an SME: No

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

Total value of the contract/lot: : 8 626 618.50 EUR

V.2.5) Information about subcontracting

Section V: Award of contract

Contract No: EMA/2014/30/BD

Title: EudraVigilance-järjestelmän tietojen hallinta – rahoituskaton korottaminen

A contract/lot is awarded: Yes

V.2 Award of contract

V.2.1) Date of conclusion of the contract

28/06/2018

V.2.2) Information about tenders

Number of tenders received: 1

The contract has been awarded to a group of economic operators: No

V.2.3) Name and address of the contractor

Kinapse Ltd

London

SW19 4EU

NUTS: UKI6

The contractor is an SME: No

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

Total value of the contract/lot: : 8 626 618.50 EUR

V.2.5) Information about subcontracting

Section V: Award of contract

Contract No: EMA/2014/30/BD

Title: Gestion des données du système EudraVigilance — augmentation du plafond

A contract/lot is awarded: Yes

V.2 Award of contract

V.2.1) Date of conclusion of the contract

28/06/2018

V.2.2) Information about tenders

Number of tenders received: 1

The contract has been awarded to a group of economic operators: No

V.2.3) Name and address of the contractor

Kinapse Ltd

London

SW19 4EU

NUTS: UKI6

The contractor is an SME: No

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

Total value of the contract/lot: : 8 626 618.50 EUR

V.2.5) Information about subcontracting

Section V: Award of contract

Contract No: EMA/2014/30/BD

Title: Διαχείριση δεδομένων EudraVigilance — Αύξηση του ανώτατου ορίου

A contract/lot is awarded: Yes

V.2 Award of contract

V.2.1) Date of conclusion of the contract

28/06/2018

V.2.2) Information about tenders

Number of tenders received: 1

The contract has been awarded to a group of economic operators: No

V.2.3) Name and address of the contractor

Kinapse Ltd

London

SW19 4EU

NUTS: UKI6

The contractor is an SME: No

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

Total value of the contract/lot: : 8 626 618.50 EUR

V.2.5) Information about subcontracting

Section V: Award of contract

Contract No: EMA/2014/30/BD

Title: Gestione dei dati di EudraVigilance — aumento del tetto

A contract/lot is awarded: Yes

V.2 Award of contract

V.2.1) Date of conclusion of the contract

28/06/2018

V.2.2) Information about tenders

Number of tenders received: 1

The contract has been awarded to a group of economic operators: No

V.2.3) Name and address of the contractor

Kinapse Ltd

London

SW19 4EU

NUTS: UKI6

The contractor is an SME: No

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

Total value of the contract/lot: : 8 626 618.50 EUR

V.2.5) Information about subcontracting

Section V: Award of contract

Contract No: EMA/2014/30/BD

Title: EudraVigilance-gegevensbeheer — verhoging van het plafond

A contract/lot is awarded: Yes

V.2 Award of contract

V.2.1) Date of conclusion of the contract

28/06/2018

V.2.2) Information about tenders

Number of tenders received: 1

The contract has been awarded to a group of economic operators: No

V.2.3) Name and address of the contractor

Kinapse Ltd

London

SW19 4EU

NUTS: UKI6

The contractor is an SME: No

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

Total value of the contract/lot: : 8 626 618.50 EUR

V.2.5) Information about subcontracting

Section V: Award of contract

Contract No: EMA/2014/30/BD

Title: Gestão de dados do EudraVigilance — aumento do teto

A contract/lot is awarded: Yes

V.2 Award of contract

V.2.1) Date of conclusion of the contract

28/06/2018

V.2.2) Information about tenders

Number of tenders received: 1

The contract has been awarded to a group of economic operators: No

V.2.3) Name and address of the contractor

Kinapse Ltd

London

SW19 4EU

NUTS: UKI6

The contractor is an SME: No

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

Total value of the contract/lot: : 8 626 618.50 EUR

V.2.5) Information about subcontracting

Section V: Award of contract

Contract No: EMA/2014/30/BD

Title: Datahantering för EudraVigilance – höjning av budgettaket

A contract/lot is awarded: Yes

V.2 Award of contract

V.2.1) Date of conclusion of the contract

28/06/2018

V.2.2) Information about tenders

Number of tenders received: 1

The contract has been awarded to a group of economic operators: No

V.2.3) Name and address of the contractor

Kinapse Ltd

London

SW19 4EU

NUTS: UKI6

The contractor is an SME: No

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

Total value of the contract/lot: : 8 626 618.50 EUR

V.2.5) Information about subcontracting

Section V: Award of contract

Contract No: EMA/2014/30/BD

Title: Správa dat EudraVigilance – zvýšení finančního stropu

A contract/lot is awarded: Yes

V.2 Award of contract

V.2.1) Date of conclusion of the contract

28/06/2018

V.2.2) Information about tenders

Number of tenders received: 1

The contract has been awarded to a group of economic operators: No

V.2.3) Name and address of the contractor

Kinapse Ltd

London

SW19 4EU

NUTS: UKI6

The contractor is an SME: No

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

Total value of the contract/lot: : 8 626 618.50 EUR

V.2.5) Information about subcontracting

Section V: Award of contract

Contract No: EMA/2014/30/BD

Title: EudraVigilance'i andmete haldus – maksimaalse maksumuse suurendamine

A contract/lot is awarded: Yes

V.2 Award of contract

V.2.1) Date of conclusion of the contract

28/06/2018

V.2.2) Information about tenders

Number of tenders received: 1

The contract has been awarded to a group of economic operators: No

V.2.3) Name and address of the contractor

Kinapse Ltd

London

SW19 4EU

NUTS: UKI6

The contractor is an SME: No

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

Total value of the contract/lot: : 8 626 618.50 EUR

V.2.5) Information about subcontracting

Section V: Award of contract

Contract No: EMA/2014/30/BD

Title: EudraVigilance adatkezelés – felső határ emelése

A contract/lot is awarded: Yes

V.2 Award of contract

V.2.1) Date of conclusion of the contract

28/06/2018

V.2.2) Information about tenders

Number of tenders received: 1

The contract has been awarded to a group of economic operators: No

V.2.3) Name and address of the contractor

Kinapse Ltd

London

SW19 4EU

NUTS: UKI6

The contractor is an SME: No

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

Total value of the contract/lot: : 8 626 618.50 EUR

V.2.5) Information about subcontracting

Section V: Award of contract

Contract No: EMA/2014/30/BD

Title: „EudraVigilance“ duomenų valdymas – viršutinės ribos padidinimas

A contract/lot is awarded: Yes

V.2 Award of contract

V.2.1) Date of conclusion of the contract

28/06/2018

V.2.2) Information about tenders

Number of tenders received: 1

The contract has been awarded to a group of economic operators: No

V.2.3) Name and address of the contractor

Kinapse Ltd

London

SW19 4EU

NUTS: UKI6

The contractor is an SME: No

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

Total value of the contract/lot: : 8 626 618.50 EUR

V.2.5) Information about subcontracting

Section V: Award of contract

Contract No: EMA/2014/30/BD

Title: EudraVigilance datu pārvaldība – maksimālās vērtības palielināšana

A contract/lot is awarded: Yes

V.2 Award of contract

V.2.1) Date of conclusion of the contract

28/06/2018

V.2.2) Information about tenders

Number of tenders received: 1

The contract has been awarded to a group of economic operators: No

V.2.3) Name and address of the contractor

Kinapse Ltd

London

SW19 4EU

NUTS: UKI6

The contractor is an SME: No

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

Total value of the contract/lot: : 8 626 618.50 EUR

V.2.5) Information about subcontracting

Section V: Award of contract

Contract No: EMA/2014/30/BD

Title: L-immaniġġjar tad-dejta EudraVigilance — żieda fil-limitu massimu

A contract/lot is awarded: Yes

V.2 Award of contract

V.2.1) Date of conclusion of the contract

28/06/2018

V.2.2) Information about tenders

Number of tenders received: 1

The contract has been awarded to a group of economic operators: No

V.2.3) Name and address of the contractor

Kinapse Ltd

London

SW19 4EU

NUTS: UKI6

The contractor is an SME: No

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

Total value of the contract/lot: : 8 626 618.50 EUR

V.2.5) Information about subcontracting

Section V: Award of contract

Contract No: EMA/2014/30/BD

Title: Zarządzanie danymi systemu EudraVigilance — zwiększenie budżetu

A contract/lot is awarded: Yes

V.2 Award of contract

V.2.1) Date of conclusion of the contract

28/06/2018

V.2.2) Information about tenders

Number of tenders received: 1

The contract has been awarded to a group of economic operators: No

V.2.3) Name and address of the contractor

Kinapse Ltd

London

SW19 4EU

NUTS: UKI6

The contractor is an SME: No

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

Total value of the contract/lot: : 8 626 618.50 EUR

V.2.5) Information about subcontracting

Section V: Award of contract

Contract No: EMA/2014/30/BD

Title: Správa údajov Eudravigilance – zvýšenie stropu

A contract/lot is awarded: Yes

V.2 Award of contract

V.2.1) Date of conclusion of the contract

28/06/2018

V.2.2) Information about tenders

Number of tenders received: 1

The contract has been awarded to a group of economic operators: No

V.2.3) Name and address of the contractor

Kinapse Ltd

London

SW19 4EU

NUTS: UKI6

The contractor is an SME: No

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

Total value of the contract/lot: : 8 626 618.50 EUR

V.2.5) Information about subcontracting

Section V: Award of contract

Contract No: EMA/2014/30/BD

Title: Upravljanje podatkov EudraVigilance – povišanje zgornje meje

A contract/lot is awarded: Yes

V.2 Award of contract

V.2.1) Date of conclusion of the contract

28/06/2018

V.2.2) Information about tenders

Number of tenders received: 1

The contract has been awarded to a group of economic operators: No

V.2.3) Name and address of the contractor

Kinapse Ltd

London

SW19 4EU

NUTS: UKI6

The contractor is an SME: No

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

Total value of the contract/lot: : 8 626 618.50 EUR

V.2.5) Information about subcontracting

Section V: Award of contract

Contract No: EMA/2014/30/BD

Title: Bainistíocht sonraí EudraVigilance — méadú san uasteorainn

A contract/lot is awarded: Yes

V.2 Award of contract

V.2.1) Date of conclusion of the contract

28/06/2018

V.2.2) Information about tenders

Number of tenders received: 1

The contract has been awarded to a group of economic operators: No

V.2.3) Name and address of the contractor

Kinapse Ltd

London

SW19 4EU

NUTS: UKI6

The contractor is an SME: No

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

Total value of the contract/lot: : 8 626 618.50 EUR

V.2.5) Information about subcontracting

Section V: Award of contract

Contract No: EMA/2014/30/BD

Title: Управление на данни на EudraVigilance — увеличение на тавана

A contract/lot is awarded: Yes

V.2 Award of contract

V.2.1) Date of conclusion of the contract

28/06/2018

V.2.2) Information about tenders

Number of tenders received: 1

The contract has been awarded to a group of economic operators: No

V.2.3) Name and address of the contractor

Kinapse Ltd

London

SW19 4EU

NUTS: UKI6

The contractor is an SME: No

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

Total value of the contract/lot: : 8 626 618.50 EUR

V.2.5) Information about subcontracting

Section V: Award of contract

Contract No: EMA/2014/30/BD

Title: Gestionarea datelor EudraVigilance – creșterea plafonului

A contract/lot is awarded: Yes

V.2 Award of contract

V.2.1) Date of conclusion of the contract

28/06/2018

V.2.2) Information about tenders

Number of tenders received: 1

The contract has been awarded to a group of economic operators: No

V.2.3) Name and address of the contractor

Kinapse Ltd

London

SW19 4EU

NUTS: UKI6

The contractor is an SME: No

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

Total value of the contract/lot: : 8 626 618.50 EUR

V.2.5) Information about subcontracting

Section V: Award of contract

Contract No: EMA/2014/30/BD

Title: Upravljanje podacima u okviru sustava EudraVigilance — podizanje gornje granice

A contract/lot is awarded: Yes

V.2 Award of contract

V.2.1) Date of conclusion of the contract

28/06/2018

V.2.2) Information about tenders

Number of tenders received: 1

The contract has been awarded to a group of economic operators: No

V.2.3) Name and address of the contractor

Kinapse Ltd

London

SW19 4EU

NUTS: UKI6

The contractor is an SME: No

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

Total value of the contract/lot: : 8 626 618.50 EUR

V.2.5) Information about subcontracting

Section VI: Complementary information

VI.3) Additional information

Det Europæiske Lægemiddelagentur anbefaler, at denne kontrakts endelige værdi hæves til 8 626 618,50 EUR i forbindelse med et udbud efter forhandling.

Die Agentur gibt bekannt, dass der maximale Auftragswert für diesen Rahmenvertrag durch ein Verhandlungsverfahren auf 8 626 618,50 EUR angehoben werden soll.

The Agency advises that the total final value of this contract is to be increased by negotiated procedure to 8 626 618.50 EUR.

La Agencia informa que el valor total final del presente contrato será aumentado mediante un procedimiento negociado a la cantidad de 8 626 618,50 EUR.

Virasto tiedottaa, että tämän sopimuksen lopullista kokonaisarvoa korotetaan neuvottelumenettelyllä 8 626 618,50 EUR.

L'Agence informe que la valeur totale finale du présent marché sera relevée à 8 626 618,50 EUR par le biais d'une procédure négociée.

Ο Οργανισμός ενημερώνει ότι η συνολική τελική αξία της εν λόγω σύμβασης πρόκειται να αυξηθεί με διαδικασία με διαπραγμάτευση σε 8 626 618,50 EUR.

L'Agenzia raccomanda di aumentare il valore totale finale del presente appalto a 8 626 618,50 EUR tramite procedura negoziata.

Het Bureau raadt aan om het totale eindbedrag voor deze overeenkomst via een onderhandelingsprocedure te verhogen tot 8 626 618,50 EUR.

A agência aconselha que o valor total definitivo deste contrato seja aumentado através de um processo por negociação para 8 626 618,50 EUR.

Myndigheten upplyser om att det slutliga totalvärdet för detta kontrakt genom ett förhandlat förfarande ska höjas till 8 626 618,50 EUR.

Agentura doporučuje zvýšit celkovou konečnou hodnotu v případě této zakázky jednacím řízením na 8 626 618,50 EUR.

Amet annab teada, et käesoleva lepingu lõplikku kogumaksumust suurendatakse läbirääkimistega menetluse käigus summani 8 626 618,50 EUR.

Az ügynökség azt javasolja, hogy a jelen szerződés teljes végleges értékét tárgyalásos eljárás keretében emeljék 8 626 618,50 EUR-ra.

Agentūra informuoja, kad pagal derybų procedūrą šios sutarties bendra galutinė vertė bus padidinta iki 8 626 618,50 EUR.

Aģentūra paziņo, ka sarunu procedūras rezultātā šā līguma kopējā galīgā vērtība tiek palielināta līdz 8 626 618,50 EUR.

L-Aġenzija tgħarraf li l-valur finali totali ta' dan il-kuntratt għandu jiżdied bi proċedura nnegozjata għal 8 626 618,50 EUR.

Agencja informuje o zamiarze zwiększenia całkowitej wartości końcowej tego zamówienia do 8 626 618,50 EUR w trybie procedury negocjacyjnej.

Agentúra odporúča, aby celková konečná hodnota tohto obstarávania bola v rámci rokovacieho konania zvýšená na 8 626 618,50 EUR.

Agencija sporoča, da se skupna končna vrednost tega naročila poveča s postopkom s pogajanji na 8 626 618,50 EUR.

Tugann an Ghníomhaireacht le fios go bhfuiltear chun luach deiridh iomlán an chonartha seo a mhéadú trí nós imeachta idirbheartaithe go 8 626 618,50 EUR.

Агенцията препоръчва съвкупната крайна стойност за тази поръчка да бъда повишена чрез процедура на договаряне до 8 626 618,50 EUR.

Agenția informează că valoarea totală finală a acestui contract urmează să fie majorată, prin intermediul unei proceduri negociate, până la valoarea de 8 626 618,50 EUR.

Agencija obavještava da će se pregovaračkim postupkom ukupna vrijednost predmetnog ugovora povećati na 8 626 618,50 EUR.

VI.4) Procedures for review

VI.4.1) Review body

Retten

Rue du Fort Niedergrünewald

Luxembourg

L-2925

Telephone: +352 4303-1

E-mail: GeneralCourt.Registry@curia.europa.eu

Fax: +352 4303-2100

Internet address(es)

URL: http://curia.europa.eu

VI.4.4) Service from which information about the review procedure may be obtained

Det Europæiske Lægemiddelagentur (EMA)

30 Churchill Place

London

E14 5EU

Telephone: +44 2036606000

E-mail: info@ema.europa.eu

Internet address(es)

URL: http://www.ema.europa.eu

VI.5) Date of dispatch of this notice

09/07/2018

Coding

Commodity categories

ID	Title	Parent category
73000000	Research and development services and related consultancy services	Research and Development

Delivery locations

ID	Description
100	UK - All

Alert region restrictions

The buyer has restricted the alert for this notice to suppliers based in the following regions.

ID	Description
There are no alert restrictions for this notice.

About the buyer

Main contact:: ContractsandProcurement@ema.europa.eu
Admin contact:: N/a
Technical contact:: N/a
Other contact:: N/a

Further information

Date	Details
No further information has been uploaded.

Dataforvaltning af EudraVigilance — forhøjelse af loftet

Contents

Summary

Abstract

Full notice text

Contract award notice

Section I: Contracting entity

I.1) Name and addresses

I.1) Name and addresses

I.1) Name and addresses

I.1) Name and addresses

I.1) Name and addresses

I.1) Name and addresses

I.1) Name and addresses

I.1) Name and addresses

I.1) Name and addresses

I.1) Name and addresses

I.1) Name and addresses

I.1) Name and addresses

I.1) Name and addresses

I.1) Name and addresses

I.1) Name and addresses

I.1) Name and addresses

I.1) Name and addresses

I.1) Name and addresses

I.1) Name and addresses

I.1) Name and addresses

I.1) Name and addresses

I.1) Name and addresses

I.1) Name and addresses

I.1) Name and addresses

I.4) Type of the contracting authority

I.5) Main activity

Section II: Object

II.1) Scope of the procurement

II.1.1) Title

II.1.2) Main CPV code

II.1.3) Type of contract

II.1.4) Short description

II.1.6) Information about lots

II.1.7) Total value of the procurement

II.2) Description

II.2.3) Place of performance

II.2.4) Description of the procurement

II.2.5) Award criteria

II.2.11) Information about options

II.2.13) Information about European Union funds

Section II: Object

II.1) Scope of the procurement

II.1.1) Title

II.1.2) Main CPV code

II.1.3) Type of contract

II.1.4) Short description

II.1.6) Information about lots

II.1.7) Total value of the procurement

II.2) Description

II.2.3) Place of performance

II.2.4) Description of the procurement

II.2.5) Award criteria

II.2.11) Information about options

II.2.13) Information about European Union funds

Section II: Object

II.1) Scope of the procurement

II.1.1) Title

II.1.2) Main CPV code

II.1.3) Type of contract

II.1.4) Short description

II.1.6) Information about lots

II.1.7) Total value of the procurement

II.2) Description

II.2.3) Place of performance

II.2.4) Description of the procurement

II.2.5) Award criteria

II.2.11) Information about options

II.2.13) Information about European Union funds

Section II: Object

II.1) Scope of the procurement

II.1.1) Title

II.1.2) Main CPV code

II.1.3) Type of contract