Quality, Efficacy and Safety Studies on Medicines

Durchführung von Qualitäts-, Wirksamkeits- und Unbedenklichkeitsuntersuchungen von Arzneimitteln vor und nach der Zulassung, um Daten und Informationen zur Unterstützung der Entscheidungsfindung im Bereich der Human- und Tierarzneimittelzulassung zu generieren. Lääkkeiden myyntiluvan myöntämistä edeltävää ja jälkeistä laatua, tehokkuutta ja turvallisuutta koskevan tutkimuksen suorittaminen tietojen tuottamiseksi sääntelyä koskevan päätöksenteon tukemiseksi ihmisille ja …

CPV: 73000000 Servicios de investigación y desarrollo y servicios de consultoría conexos, 73210000 Servicios de consultoría en investigación
Lugar de ejecución:
Quality, Efficacy and Safety Studies on Medicines
Organismo adjudicador:
European Medicines Agency (EMA)
Número de premio:
EMA/2020/46/TDA

1. Buyer

1.1 Buyer

Official name : European Medicines Agency (EMA)
Legal type of the buyer : EU institution, body or agency
Activity of the contracting authority : General public services

2. Procedure

2.1 Procedure

Title : Quality, Efficacy and Safety Studies on Medicines
Description : Performance of pre- and post-authorisation quality, efficacy and safety research on medicines to generate data and information to support regulatory decision-making in the human and veterinary medicines regulatory domain.
Procedure identifier : ba680861-e4b7-4a05-b442-1eb00b01be90
Previous notice : 00122187-2021
Internal identifier : EMA/2020/46/TDA
Type of procedure : Open
Justification for the accelerated procedure :
Main features of the procedure :

2.1.1 Purpose

Main nature of the contract : Services
Main classification ( cpv ): 73000000 Research and development services and related consultancy services

2.1.2 Place of performance

Country subdivision (NUTS) : Groot-Amsterdam ( NL32B )
Country : Netherlands
Additional information : Contractor's premises

2.1.4 General information

Legal basis :
Regulation (EU, Euratom) 2018/1046

5. Lot

5.1 Lot technical ID : LOT-0001

Title : Pre-clinical Research
Description : Quality, efficacy and safety studies on medicines, lot 1: pre-clinical research.

5.1.1 Purpose

Main nature of the contract : Services
Main classification ( cpv ): 73000000 Research and development services and related consultancy services
Additional classification ( cpv ): 73210000 Research consultancy services

5.1.2 Place of performance

Postal address : Contractor's premises
Town : Amsterdam
Postcode : 1083HS
Country subdivision (NUTS) : Kop van Noord-Holland ( NL321 )
Country : Netherlands
Additional information :

5.1.3 Estimated duration

Start date : 06/10/2021
Duration end date : 05/10/2025

5.1.5 Value

Estimated value excluding VAT : 4 500 000 Euro

5.1.6 General information

Procurement Project not financed with EU Funds.
The procurement is covered by the Government Procurement Agreement (GPA) : no

5.1.10 Award criteria

Criterion :
Type : Quality
Name :
Description : Case study
Category of award threshold criterion : Weight (percentage, exact)
Award criterion number : 35
Criterion :
Type : Quality
Name :
Description : Research team and tasks
Category of award threshold criterion : Weight (percentage, exact)
Award criterion number : 25
Criterion :
Type : Quality
Name :
Description : Project management and communication
Category of award threshold criterion : Weight (percentage, exact)
Award criterion number : 10
Criterion :
Type : Price
Name :
Description : Best price quality ratio
Category of award threshold criterion : Weight (percentage, exact)
Award criterion number : 30
Description of the method to be used if weighting cannot be expressed by criteria :
Justification for not indicating the weighting of the award criteria :

5.1.15 Techniques

Framework agreement :
Framework agreement, without reopening of competition
Information about the dynamic purchasing system :
No dynamic purchase system

5.1.16 Further information, mediation and review

Review organisation : General Court of the European Union -
Information about review deadlines : 2 months
Organisation providing more information on the review procedures : European Medicines Agency (EMA) -

5.1 Lot technical ID : LOT-0002

Title : Veterinary Studies
Description : Quality, efficacy and safety studies on medicines, lot 2: veterinary studies.

5.1.1 Purpose

Main nature of the contract : Services
Main classification ( cpv ): 73000000 Research and development services and related consultancy services
Additional classification ( cpv ): 73210000 Research consultancy services

5.1.2 Place of performance

Postal address : Contractor's premises
Town : Amsterdam
Postcode : 1083 HS
Country subdivision (NUTS) : Groot-Amsterdam ( NL32B )
Country : Netherlands
Additional information :

5.1.3 Estimated duration

Start date : 05/11/2021
Other duration : Unlimited

5.1.5 Value

Estimated value excluding VAT : 3 000 000 Euro

5.1.6 General information

Procurement Project not financed with EU Funds.
The procurement is covered by the Government Procurement Agreement (GPA) : no

5.1.10 Award criteria

Criterion :
Type : Quality
Name :
Description : Case study
Category of award threshold criterion : Weight (percentage, exact)
Award criterion number : 35
Criterion :
Type : Quality
Name :
Description : Research team and tasks
Category of award threshold criterion : Weight (percentage, exact)
Award criterion number : 25
Criterion :
Type : Quality
Name :
Description : Project management and communication
Category of award threshold criterion : Weight (percentage, exact)
Award criterion number : 10
Criterion :
Type : Price
Name :
Description : Price
Category of award threshold criterion : Weight (percentage, exact)
Award criterion number : 30
Description of the method to be used if weighting cannot be expressed by criteria :
Justification for not indicating the weighting of the award criteria :

5.1.15 Techniques

Framework agreement :
Framework agreement, without reopening of competition
Information about the dynamic purchasing system :
No dynamic purchase system

5.1.16 Further information, mediation and review

Review organisation : General Court of the European Union -
Information about review deadlines : 2 months

5.1 Lot technical ID : LOT-0003

Title : Statistical Research
Description : Quality, efficacy and safety studies on medicines, lot 3: statistical research.

5.1.1 Purpose

Main nature of the contract : Services
Main classification ( cpv ): 73000000 Research and development services and related consultancy services
Additional classification ( cpv ): 73210000 Research consultancy services

5.1.2 Place of performance

Postal address : Contractor's premises
Town : Amsterdam
Postcode : 1083 HS
Country subdivision (NUTS) : Kop van Noord-Holland ( NL321 )
Country : Netherlands
Additional information :

5.1.3 Estimated duration

Start date : 22/10/2021
Other duration : Unlimited

5.1.5 Value

Estimated value excluding VAT : 3 000 000 Euro

5.1.6 General information

Procurement Project not financed with EU Funds.
The procurement is covered by the Government Procurement Agreement (GPA) : no

5.1.10 Award criteria

Criterion :
Type : Quality
Name :
Description : Case study
Category of award threshold criterion : Weight (percentage, exact)
Award criterion number : 35
Criterion :
Type : Quality
Name :
Description : Research team and tasks
Category of award threshold criterion : Weight (percentage, exact)
Award criterion number : 25
Criterion :
Type : Quality
Name :
Description : Project management and communication
Category of award threshold criterion : Weight (percentage, exact)
Award criterion number : 10
Criterion :
Type : Price
Name :
Description : Price
Category of award threshold criterion : Weight (percentage, exact)
Award criterion number : 30
Description of the method to be used if weighting cannot be expressed by criteria :
Justification for not indicating the weighting of the award criteria :

5.1.15 Techniques

Framework agreement :
Framework agreement, without reopening of competition
Information about the dynamic purchasing system :
No dynamic purchase system

5.1.16 Further information, mediation and review

Review organisation : General Court of the European Union -
Information about review deadlines : 2 months

5.1 Lot technical ID : LOT-0004

Title : Qualitative Research
Description : Quality, efficacy and safety studies on medicines, lot 4: qualitative research.

5.1.1 Purpose

Main nature of the contract : Services
Main classification ( cpv ): 73000000 Research and development services and related consultancy services
Additional classification ( cpv ): 73210000 Research consultancy services

5.1.2 Place of performance

Postal address : Contractor's premisses
Town : Amsterdam
Postcode : 1083HS
Country subdivision (NUTS) : Kop van Noord-Holland ( NL321 )
Country : Netherlands
Additional information :

5.1.3 Estimated duration

Start date : 15/10/2021
Other duration : Unlimited

5.1.5 Value

Estimated value excluding VAT : 2 000 000 Euro

5.1.6 General information

Procurement Project not financed with EU Funds.
The procurement is covered by the Government Procurement Agreement (GPA) : no

5.1.10 Award criteria

Criterion :
Type : Quality
Name :
Description : Case study
Category of award threshold criterion : Weight (percentage, exact)
Award criterion number : 35
Criterion :
Type : Quality
Name :
Description : Research team and tasks
Category of award threshold criterion : Weight (percentage, exact)
Award criterion number : 25
Criterion :
Type : Quality
Name :
Description : Project management and communication
Category of award threshold criterion : Weight (percentage, exact)
Award criterion number : 10
Criterion :
Type : Price
Name :
Description : Price
Category of award threshold criterion : Weight (percentage, exact)
Award criterion number : 30
Description of the method to be used if weighting cannot be expressed by criteria :
Justification for not indicating the weighting of the award criteria :

5.1.15 Techniques

Framework agreement :
Framework agreement, without reopening of competition
Information about the dynamic purchasing system :
No dynamic purchase system

5.1.16 Further information, mediation and review

Review organisation : General Court of the European Union -
Information about review deadlines : 2 months

5.1 Lot technical ID : LOT-0005

Title : Pharmacoepidemiological Research
Description : Quality, efficacy and safety studies on medicines, lot 5: pharmacoepidemiological research.

5.1.1 Purpose

Main nature of the contract : Services
Main classification ( cpv ): 73000000 Research and development services and related consultancy services
Additional classification ( cpv ): 73210000 Research consultancy services

5.1.2 Place of performance

Postal address : Contractor's premisses
Town : Amsterdam
Postcode : 1083 HS
Country subdivision (NUTS) : Kop van Noord-Holland ( NL321 )
Country : Netherlands
Additional information :

5.1.3 Estimated duration

Start date : 15/10/2021
Other duration : Unlimited

5.1.5 Value

Estimated value excluding VAT : 22 800 000 Euro

5.1.6 General information

Procurement Project not financed with EU Funds.
The procurement is covered by the Government Procurement Agreement (GPA) : no

5.1.10 Award criteria

Criterion :
Type : Quality
Name :
Description : Case study
Category of award threshold criterion : Weight (percentage, exact)
Award criterion number : 35
Criterion :
Type : Quality
Name :
Description : Research team and tasks
Category of award threshold criterion : Weight (percentage, exact)
Award criterion number : 25
Criterion :
Type : Quality
Name :
Description : Project management and communication
Category of award threshold criterion : Weight (percentage, exact)
Award criterion number : 10
Criterion :
Type : Price
Name :
Description : Price
Category of award threshold criterion : Weight (percentage, exact)
Award criterion number : 30
Description of the method to be used if weighting cannot be expressed by criteria :
Justification for not indicating the weighting of the award criteria :

5.1.15 Techniques

Framework agreement :
Framework agreement, without reopening of competition
Information about the dynamic purchasing system :
No dynamic purchase system

5.1.16 Further information, mediation and review

Review organisation : General Court of the European Union -
Information about review deadlines : 2 months

5.1 Lot technical ID : LOT-0006

Title : Quality of Medicines
Description : Quality, efficacy and safety studies on medicines, lot 6: quality of medicines.

5.1.1 Purpose

Main nature of the contract : Services
Main classification ( cpv ): 73000000 Research and development services and related consultancy services
Additional classification ( cpv ): 73210000 Research consultancy services

5.1.2 Place of performance

Postal address : Contractor's premises 1083 HS
Town : Amsterdam
Postcode : 1083 HS
Country subdivision (NUTS) : Kop van Noord-Holland ( NL321 )
Country : Netherlands
Additional information :

5.1.6 General information

Procurement Project not financed with EU Funds.
The procurement is covered by the Government Procurement Agreement (GPA) : no

5.1.10 Award criteria

Criterion :
Type : Quality
Name :
Description : Case study
Category of award threshold criterion : Weight (percentage, exact)
Award criterion number : 35
Criterion :
Type : Quality
Name :
Description : Research team and tasks
Category of award threshold criterion : Weight (percentage, exact)
Award criterion number : 25
Criterion :
Type : Quality
Name :
Description : Project management and communication
Category of award threshold criterion : Weight (percentage, exact)
Award criterion number : 10
Criterion :
Type : Price
Name :
Description : Price
Category of award threshold criterion : Weight (percentage, exact)
Award criterion number : 30
Description of the method to be used if weighting cannot be expressed by criteria :
Justification for not indicating the weighting of the award criteria :

5.1.15 Techniques

Framework agreement :
Framework agreement, without reopening of competition
Information about the dynamic purchasing system :
No dynamic purchase system

5.1.16 Further information, mediation and review

Review organisation : General Court of the European Union -
Information about review deadlines : 2 months

6. Results

Value of all contracts awarded in this notice : 35 300 000 Euro
Approximate value of the framework agreements : 35 300 000 Euro

6.1 Result lot ldentifier : LOT-0001

At least one winner was chosen.
Framework agreement :
Re-estimated value of the framework agreement : 4 500 000 Euro

6.1.2 Information about winners

Winner :
Official name : Associação para o Desenvolvimento do Centro Académico de Investigação e Formação Biomédica do Algarve, AD-ABC (Algarve Biomedical Center)
Tender :
Tender identifier : Associação para o Desenvolvimento do Centro Académico de Investigação e Formação Biomédica do Algarve, AD-ABC (Algarve Biomedical Center)
Identifier of lot or group of lots : LOT-0001
Value of the tender : 3 000 000 Euro
The tender was ranked : no
The tender is a variant : no
Subcontracting : Not yet known
Contract information :
Identifier of the contract : EMA/2020/46/TDA/L1.01
Title : Pre-clinical Research
Date of the conclusion of the contract : 06/10/2021
The contract is awarded within a framework agreement : yes
Notice that created the framework agreement : 575628-2021
Winner :
Official name : Fraunhofer-Gesellschaft zur Förderung der angewandten Forschung e.V.
Tender :
Tender identifier : Fraunhofer-Gesellschaft zur Förderung der angewandten Forschung e.V.
Identifier of lot or group of lots : LOT-0001
Value of the tender : 3 000 000 Euro
Subcontracting : Yes
Subcontracting value is known : no
Subcontracting percentage is known : no
Contract information :
Identifier of the contract : EMA/2020/46/TDA/L1.02
Title : Pre-clinical Research
Date of the conclusion of the contract : 06/10/2021
The contract is awarded within a framework agreement : yes
Notice that created the framework agreement : 575628-2021

6.1.4 Statistical information

Received tenders or requests to participate :
Type of received submissions : Tenders
Number of tenders or requests to participate received : 3

6.1 Result lot ldentifier : LOT-0002

At least one winner was chosen.
Framework agreement :
Re-estimated value of the framework agreement : 3 000 000 Euro

6.1.2 Information about winners

Winner :
Official name : Gezondheidsdienst voor Dieren BV d/b/a Royal GD BV
Tender :
Tender identifier : Stichting Wageningen Research
Identifier of lot or group of lots : LOT-0002
Value of the tender : 3 000 000 Euro
Subcontracting : Yes
Subcontracting value is known : no
Subcontracting percentage is known : no
Contract information :
Identifier of the contract : EMA/2020/46/TDA/L2.01
Title : Veterinary Studies
Date of the conclusion of the contract : 05/11/2021
The contract is awarded within a framework agreement : yes
Notice that created the framework agreement : 575628-2021
Winner :
Leader of tendering party : Utrecht University Faculty of Veterinary Medicine
Official name : Ecole Nationale Vétérinaire de Toulouse
Tender :
Tender identifier : Gezondheidsdienst voor Dieren BV d/b/a Royal GD BV
Identifier of lot or group of lots : LOT-0002
Value of the tender : 3 000 000 Euro
Subcontracting : Yes
Subcontracting value is known : no
Subcontracting percentage is known : no
Contract information :
Identifier of the contract : EMA/2020/46/TDA/L2.02
Title : Veterinary Studies
Date of the conclusion of the contract : 05/11/2021
The contract is awarded within a framework agreement : yes
Notice that created the framework agreement : 575628-2021
Winner :
Official name : Stichting Wageningen Research
Tender :
Tender identifier : Utrecht University Faculty of Veterinary Medicine
Identifier of lot or group of lots : LOT-0002
Value of the tender : 3 000 000 Euro
Subcontracting : Yes
Subcontracting value is known : no
Subcontracting percentage is known : no
Contract information :
Identifier of the contract : EMA/2020/46/TDA/L2.03
Title : Veterinary Studies
Date of the conclusion of the contract : 05/11/2021
The contract is awarded within a framework agreement : yes
Notice that created the framework agreement : 575628-2021

6.1.4 Statistical information

Received tenders or requests to participate :
Type of received submissions : Tenders
Number of tenders or requests to participate received : 3

6.1 Result lot ldentifier : LOT-0003

At least one winner was chosen.
Framework agreement :
Re-estimated value of the framework agreement : 3 000 000 Euro

6.1.2 Information about winners

Winner :
Official name : Frontier Science Foundation Hellas (FSF-H)
Tender :
Tender identifier : Ecole Nationale Vétérinaire de Toulouse
Identifier of lot or group of lots : LOT-0003
Value of the tender : 3 000 000 Euro
Subcontracting : Yes
Subcontracting value is known : no
Subcontracting percentage is known : no
Contract information :
Identifier of the contract : EMA/2020/46/TDA/L3.01
Title : Statistical Research
Date of the conclusion of the contract : 22/10/2021
The contract is awarded within a framework agreement : yes
Notice that created the framework agreement : 575628-2021
Winner :
Leader of tendering party : Medizinische Universität Wien
Official name : Universitätsmedizin Göttingen – Georg-August-Universität Göttingen Uppsala Universitet Österreichische Agentur für Gesundheit und Ernährungssicherheit GmbH
Tender :
Tender identifier : Lægemiddelstyrelsen (Danish Medicines Agency)
Identifier of lot or group of lots : LOT-0003
Value of the tender : 3 000 000 Euro
Subcontracting : Yes
Subcontracting value is known : no
Subcontracting percentage is known : no
Contract information :
Identifier of the contract : EMA/2020/46/TDA/L3.02
Title : Statistical Research
Date of the conclusion of the contract : 22/10/2021
The contract is awarded within a framework agreement : yes
Notice that created the framework agreement : 575628-2021
Winner :
Leader of tendering party : Stichting Radboud universitair medisch centrum
Official name : Medizinische Hochschule Hannover Universitat Autònoma de Barcelona
Tender :
Tender identifier : Medizinische Universität Wien
Identifier of lot or group of lots : LOT-0003
Value of the tender : 3 000 000 Euro
Subcontracting : Yes
Subcontracting value is known : no
Subcontracting percentage is known : no
Contract information :
Identifier of the contract : EMA/2020/46/TDA/L3.03
Title : Statistical Research
Date of the conclusion of the contract : 22/10/2021
The contract is awarded within a framework agreement : yes
Notice that created the framework agreement : 575628-2021
Winner :
Official name : IQVIA Solutions BV
Tender :
Tender identifier : Universitätsmedizin Göttingen – Georg-August-Universität Göttingen
Identifier of lot or group of lots : LOT-0003
Value of the tender : 3 000 000 Euro
Subcontracting : Yes
Subcontracting value is known : no
Subcontracting percentage is known : no
Contract information :
Identifier of the contract : EMA/2020/46/TDA/L3.04
Title : Statistical Research
Date of the conclusion of the contract : 22/10/2021
The contract is awarded within a framework agreement : yes
Notice that created the framework agreement : 575628-2021
Winner :
Leader of tendering party : Certara France SARL
Official name : Quinten SAS
Tender :
Tender identifier : Uppsala Universitet
Identifier of lot or group of lots : LOT-0003
Value of the tender : 3 000 000 Euro
Subcontracting : Yes
Subcontracting value is known : no
Subcontracting percentage is known : no
Contract information :
Identifier of the contract : EMA/2020/46/TDA/L3.05
Title : Statistical Research
Date of the conclusion of the contract : 22/10/2021
The contract is awarded within a framework agreement : yes
Notice that created the framework agreement : 575628-2021
Winner :
Leader of tendering party : Karolinska Institutet
Official name : Università degli Studi di Milano – Bicocca
Tender :
Tender identifier : Österreichische Agentur für Gesundheit und Ernährungssicherheit GmbH
Identifier of lot or group of lots : LOT-0003
Value of the tender : 3 000 000 Euro
Subcontracting : Yes
Subcontracting value is known : no
Subcontracting percentage is known : no
Contract information :
Identifier of the contract : EMA/2020/46/TDA/L3.06
Title : Statistical Research
Date of the conclusion of the contract : 22/10/2021
The contract is awarded within a framework agreement : yes
Notice that created the framework agreement : 575628-2021
Winner :
Official name : Lægemiddelstyrelsen (Danish Medicines Agency)
Tender :
Tender identifier : Frontier Science Foundation Hellas (FSF-H)
Identifier of lot or group of lots : LOT-0003
Value of the tender : 3 000 000 Euro
Subcontracting : Yes
Subcontracting value is known : no
Subcontracting percentage is known : no
Contract information :
Identifier of the contract : EMA/2020/46/TDA/L3.07
Title : Statistical Research
Date of the conclusion of the contract : 22/10/2021
The contract is awarded within a framework agreement : yes
Notice that created the framework agreement : 575628-2021
Winner :
Official name : European Organisation for Research and Treatment of Cancer
Tender :
Tender identifier : Stichting Radboud universitair medisch centrum
Identifier of lot or group of lots : LOT-0003
Value of the tender : 3 000 000 Euro
Subcontracting : Yes
Subcontracting value is known : no
Subcontracting percentage is known : no
Contract information :
Identifier of the contract : EMA/2020/46/TDA/L3.08
Title : Statistical Research
Date of the conclusion of the contract : 22/10/2021
The contract is awarded within a framework agreement : yes
Notice that created the framework agreement : 575628-2021

6.1.4 Statistical information

Received tenders or requests to participate :
Type of received submissions : Tenders
Number of tenders or requests to participate received : 10

6.1 Result lot ldentifier : LOT-0004

At least one winner was chosen.
Framework agreement :
Re-estimated value of the framework agreement : 2 000 000 Euro

6.1.2 Information about winners

Winner :
Official name : Stichting Nederlands Instituut vor Onderzoek van de Gezondheidszorg (Nivel)
Tender :
Tender identifier : Medizinische Hochschule Hannover
Identifier of lot or group of lots : LOT-0004
Value of the tender : 2 000 000 Euro
Subcontracting : Yes
Subcontracting value is known : no
Subcontracting percentage is known : no
Contract information :
Identifier of the contract : EMA/2020/46/TDA/L4.01
Title : Qualitative Research
Date of the conclusion of the contract : 15/10/2021
The contract is awarded within a framework agreement : yes
Notice that created the framework agreement : 575628-2021
Winner :
Leader of tendering party : Universiteit Utrecht
Official name : Rijksinstituut voor Volksgezondheid en Milieu University Medical Center Utrecht University Medical Center Utrecht
Tender :
Tender identifier : Universitat Autònoma de Barcelona
Identifier of lot or group of lots : LOT-0004
Value of the tender : 2 000 000 Euro
Subcontracting : Yes
Subcontracting value is known : no
Subcontracting percentage is known : no
Contract information :
Identifier of the contract : EMA/2020/46/TDA/L4.02
Title : Qualitative Research
Date of the conclusion of the contract : 15/10/2021
The contract is awarded within a framework agreement : yes
Notice that created the framework agreement : 575628-2021
Winner :
Official name : Pharmerit Coöperatief U.A.
Tender :
Tender identifier : Karolinska Institutet
Identifier of lot or group of lots : LOT-0004
Value of the tender : 2 000 000 Euro
Subcontracting : Yes
Subcontracting value is known : no
Subcontracting percentage is known : no
Contract information :
Identifier of the contract : EMA/2020/46/TDA/L4.03
Title : Qualitative Research
Date of the conclusion of the contract : 15/10/2021
The contract is awarded within a framework agreement : yes
Notice that created the framework agreement : 575628-2021
Winner :
Official name : IQVIA Solutions BV
Tender :
Tender identifier : Università degli Studi di Milano – Bicocca
Identifier of lot or group of lots : LOT-0004
Value of the tender : 2 000 000 Euro
Subcontracting : Yes
Subcontracting value is known : no
Subcontracting percentage is known : no
Contract information :
Identifier of the contract : EMA/2020/46/TDA/L4.04
Title : Qualitative Research
Date of the conclusion of the contract : 15/10/2021
The contract is awarded within a framework agreement : yes
Notice that created the framework agreement : 575628-2021

6.1.4 Statistical information

Received tenders or requests to participate :
Type of received submissions : Tenders
Number of tenders or requests to participate received : 5

6.1 Result lot ldentifier : LOT-0005

At least one winner was chosen.
Framework agreement :
Re-estimated value of the framework agreement : 22 800 000 Euro

6.1.2 Information about winners

Winner :
Official name : Aetion Germany GmbH
Tender :
Tender identifier : European Organisation for Research and Treatment of Cancer
Identifier of lot or group of lots : LOT-0005
Value of the tender : 19 000 000 Euro
Subcontracting : Yes
Subcontracting value is known : no
Subcontracting percentage is known : no
Contract information :
Identifier of the contract : EMA/2020/46/TDA/L5.01
Title : Pharmacoepidemiological Research
Date of the conclusion of the contract : 15/10/2021
The contract is awarded within a framework agreement : yes
Notice that created the framework agreement : 575628-2021
Winner :
Official name : Erasmus University Medical Center Rotterdam
Tender :
Tender identifier : IQVIA Solutions BV
Identifier of lot or group of lots : LOT-0005
Value of the tender : 19 000 000 Euro
Subcontracting : Yes
Subcontracting value is known : no
Subcontracting percentage is known : no
Contract information :
Identifier of the contract : EMA/2020/46/TDA/L5.02
Title : Pharmacoepidemiological Research
Date of the conclusion of the contract : 15/10/2021
The contract is awarded within a framework agreement : yes
Notice that created the framework agreement : 575628-2021
Winner :
Leader of tendering party : Syreon Kutató Intézet Kft.
Official name : Medical University of Lodz Comenius University in Bratislava RxTarget Kft. National and Kapodistrian University of Athens Syreon Research Romania
Tender :
Tender identifier : Quinten SAS
Identifier of lot or group of lots : LOT-0005
Value of the tender : 19 000 000 Euro
Subcontracting : Yes
Subcontracting value is known : no
Subcontracting percentage is known : no
Contract information :
Identifier of the contract : EMA/2020/46/TDA/L5.03
Title : Pharmacoepidemiological Research
Date of the conclusion of the contract : 15/10/2021
The contract is awarded within a framework agreement : yes
Notice that created the framework agreement : 575628-2021
Winner :
Official name : Lægemiddelstyrelsen (Danish Medicines Agency)
Tender :
Tender identifier : Certara France SARL
Identifier of lot or group of lots : LOT-0005
Value of the tender : 19 000 000 Euro
Subcontracting : Yes
Subcontracting value is known : no
Subcontracting percentage is known : no
Contract information :
Identifier of the contract : EMA/2020/46/TDA/L5.04
Title : Pharmacoepidemiological Research
Date of the conclusion of the contract : 15/10/2021
The contract is awarded within a framework agreement : yes
Notice that created the framework agreement : 575628-2021
Winner :
Official name : IQVIA Solutions BV
Tender :
Tender identifier : Universiteit Utrecht
Identifier of lot or group of lots : LOT-0005
Value of the tender : 19 000 000 Euro
Subcontracting : Yes
Subcontracting value is known : no
Subcontracting percentage is known : no
Contract information :
Identifier of the contract : EMA/2020/46/TDA/L5.05
Title : Pharmacoepidemiological Research
Date of the conclusion of the contract : 15/10/2021
The contract is awarded within a framework agreement : yes
Notice that created the framework agreement : 575628-2021
Winner :
Leader of tendering party : Universiteit Utrecht
Official name : Agencia Española de Medicamentos y Productos Sanitarios Fundació Hospital Universitari Vall Hebron – Institut de Recerca Fundación para el Fomento de la Investigación Sanitaria y Biomédica de la Comunitat Valenciana Vaccine Monitoring Collaboration for Europe University of Verona – Department of Diagnostics and Public Health University Medical Center Utrecht University Medical Center Utrecht
Tender :
Tender identifier : Rijksinstituut voor Volksgezondheid en Milieu
Identifier of lot or group of lots : LOT-0005
Value of the tender : 19 000 000 Euro
Subcontracting : Yes
Subcontracting value is known : no
Subcontracting percentage is known : no
Contract information :
Identifier of the contract : EMA/2020/46/TDA/L5.06
Title : Pharmacoepidemiological Research
Date of the conclusion of the contract : 15/10/2021
The contract is awarded within a framework agreement : yes
Notice that created the framework agreement : 575628-2021
Winner :
Leader of tendering party : Certara France SARL
Official name : Quinten Health
Tender :
Tender identifier : University Medical Center Utrecht
Identifier of lot or group of lots : LOT-0005
Value of the tender : 19 000 000 Euro
Subcontracting : Yes
Subcontracting value is known : no
Subcontracting percentage is known : no
Contract information :
Identifier of the contract : EMA/2020/46/TDA/L5.07
Title : Pharmacoepidemiological Research
Date of the conclusion of the contract : 15/10/2021
The contract is awarded within a framework agreement : yes
Notice that created the framework agreement : 575628-2021
Winner :
Official name : Pharmerit Coöperatief U.A.
Tender :
Tender identifier : Stichting Nederlands Instituut vor Onderzoek van de Gezondheidszorg (Nivel)
Identifier of lot or group of lots : LOT-0005
Value of the tender : 19 000 000 Euro
Subcontracting : Yes
Subcontracting value is known : no
Subcontracting percentage is known : no
Contract information :
Identifier of the contract : EMA/2020/46/TDA/L5.08
Title : Pharmacoepidemiological Research
Date of the conclusion of the contract : 15/10/2021
The contract is awarded within a framework agreement : yes
Notice that created the framework agreement : 575628-2021

6.1.4 Statistical information

Received tenders or requests to participate :
Type of received submissions : Tenders
Number of tenders or requests to participate received : 11

6.1 Result lot ldentifier : LOT-0006

No winner was chosen and the competition is closed.
The reason why a winner was not chosen : No tenders, requests to participate or projects were received

6.1.4 Statistical information

Received tenders or requests to participate :
Type of received submissions : Tenders
Number of tenders or requests to participate received : 2

8. Organisations

8.1 ORG-0001

Official name : European Medicines Agency (EMA)
Registration number : European Body
Postal address : PO Box 71010
Town : Amsterdam
Postcode : 1008 BA
Country subdivision (NUTS) : Groot-Amsterdam ( NL32B )
Country : Netherlands
Telephone : 0887816000
Internet address : https://www.ema.europa.eu/
Roles of this organisation :
Buyer
Organisation providing more information on the review procedures

8.1 ORG-0002

Official name : Associação para o Desenvolvimento do Centro Académico de Investigação e Formação Biomédica do Algarve, AD-ABC (Algarve Biomedical Center)
Size of the economic operator : Large
Registration number : n/a
Town : Faro
Postcode : 8005-139
Country subdivision (NUTS) : Algarve ( PT150 )
Country : Portugal
Roles of this organisation :
TED eSender
Tenderer
Winner of these lots : LOT-0001

8.1 ORG-0003

Official name : Fraunhofer-Gesellschaft zur Förderung der angewandten Forschung e.V.
Size of the economic operator : Large
Registration number : VR 4461
Town : Munich
Postcode : 80686
Country subdivision (NUTS) : München, Kreisfreie Stadt ( DE212 )
Country : Germany
Roles of this organisation :
TED eSender
Tenderer
Winner of these lots : LOT-0001

8.1 ORG-0004

Official name : Gezondheidsdienst voor Dieren BV d/b/a Royal GD BV
Size of the economic operator : Medium
Registration number : 08117636
Town : Deventer
Postcode : 7418 EZ
Country subdivision (NUTS) : Zuidwest-Overijssel ( NL212 )
Country : Netherlands
Roles of this organisation :
TED eSender
Tenderer
Winner of these lots : LOT-0002

8.1 ORG-0005

Official name : Utrecht University Faculty of Veterinary Medicine
Size of the economic operator : Medium
Registration number : 30275924
Town : Utrecht
Postcode : 3584 CS
Country subdivision (NUTS) : Utrecht ( NL350 )
Country : Netherlands
Roles of this organisation :
TED eSender
Tenderer
Group leader
Winner of these lots : LOT-0002

8.1 ORG-0006

Official name : Ecole Nationale Vétérinaire de Toulouse
Size of the economic operator : Medium
Registration number : BP87614
Town : Toulouse
Postcode : 31076
Country subdivision (NUTS) : Aude ( FRJ11 )
Country : France
Roles of this organisation :
TED eSender
Tenderer
Winner of these lots : LOT-0002

8.1 ORG-0007

Official name : Stichting Wageningen Research
Size of the economic operator : Medium
Registration number : 09098104
Town : Wageningen
Postcode : 6708PB
Country subdivision (NUTS) : Zuidwest-Gelderland ( NL224 )
Country : Netherlands
Roles of this organisation :
TED eSender
Tenderer
Winner of these lots : LOT-0002

8.1 ORG-0008

Official name : Frontier Science Foundation Hellas (FSF-H)
Size of the economic operator : Medium
Registration number : EL998765877
Town : Athens
Postcode : 15773
Country subdivision (NUTS) : Δυτική Αττική ( EL306 )
Country : Greece
Roles of this organisation :
TED eSender
Tenderer
Winner of these lots : LOT-0003

8.1 ORG-0009

Official name : Medizinische Universität Wien
Size of the economic operator : Medium
Registration number : ATU57469858
Town : Vienna
Postcode : 1090
Country subdivision (NUTS) : Wien ( AT130 )
Country : Austria
Roles of this organisation :
TED eSender
Tenderer
Group leader
Winner of these lots : LOT-0003

8.1 ORG-0010

Official name : Universitätsmedizin Göttingen – Georg-August-Universität Göttingen
Size of the economic operator : Medium
Registration number : DE286005408
Town : Gottingen
Postcode : 37075
Country subdivision (NUTS) : Göttingen ( DE91C )
Country : Germany
Roles of this organisation :
TED eSender
Tenderer
Winner of these lots : LOT-0003

8.1 ORG-0011

Official name : Uppsala Universitet
Size of the economic operator : Medium
Registration number : 2021002932
Town : Uppsala
Postcode : 75105
Country subdivision (NUTS) : Uppsala län ( SE121 )
Country : Sweden
Roles of this organisation :
TED eSender
Tenderer
Winner of these lots : LOT-0003

8.1 ORG-0012

Official name : Österreichische Agentur für Gesundheit und Ernährungssicherheit GmbH
Size of the economic operator : Medium
Registration number : FN223056z
Town : Vienna
Postcode : 1220
Country subdivision (NUTS) : Wien ( AT130 )
Country : Austria
Roles of this organisation :
TED eSender
Tenderer
Winner of these lots : LOT-0003

8.1 ORG-0013

Official name : Stichting Radboud universitair medisch centrum
Size of the economic operator : Medium
Registration number : 80262783
Town : Nijmegen
Postcode : 6525GA
Country subdivision (NUTS) : Arnhem/Nijmegen ( NL226 )
Country : Netherlands
Roles of this organisation :
TED eSender
Tenderer
Group leader
Winner of these lots : LOT-0003

8.1 ORG-0014

Official name : Medizinische Hochschule Hannover
Size of the economic operator : Medium
Registration number : DE115650503
Town : Hannover
Postcode : 30625
Country subdivision (NUTS) : Region Hannover ( DE929 )
Country : Germany
Roles of this organisation :
TED eSender
Tenderer
Winner of these lots : LOT-0003

8.1 ORG-0015

Official name : Universitat Autònoma de Barcelona
Size of the economic operator : Medium
Registration number : ESQ0818002H
Town : Barcelona
Postcode : 08193
Country subdivision (NUTS) : Barcelona ( ES511 )
Country : Spain
Roles of this organisation :
TED eSender
Tenderer
Winner of these lots : LOT-0003

8.1 ORG-0016

Official name : IQVIA Solutions BV
Size of the economic operator : Medium
Registration number : 39062857
Town : Amsterdam
Postcode : 1101CT
Country subdivision (NUTS) : Groot-Amsterdam ( NL32B )
Country : Netherlands
Roles of this organisation :
TED eSender
Tenderer
Winner of these lots : LOT-0003 LOT-0004 LOT-0005

8.1 ORG-0017

Official name : Certara France SARL
Size of the economic operator : Medium
Registration number : B477567739
Town : Paris
Postcode : 75008
Country subdivision (NUTS) : Paris ( FR101 )
Country : France
Roles of this organisation :
TED eSender
Tenderer
Group leader
Winner of these lots : LOT-0003 LOT-0005

8.1 ORG-0018

Official name : Quinten SAS
Size of the economic operator : Medium
Registration number : B508813292
Town : Paris
Postcode : 75017
Country subdivision (NUTS) : Paris ( FR101 )
Country : France
Roles of this organisation :
TED eSender
Tenderer
Winner of these lots : LOT-0003

8.1 ORG-0019

Official name : Karolinska Institutet
Size of the economic operator : Medium
Registration number : 2021002973
Town : Stockholm
Postcode : 17177
Country subdivision (NUTS) : Stockholms län ( SE110 )
Country : Sweden
Roles of this organisation :
TED eSender
Tenderer
Group leader
Winner of these lots : LOT-0003

8.1 ORG-0020

Official name : Università degli Studi di Milano – Bicocca
Size of the economic operator : Medium
Registration number : IT12621570154
Town : Milan
Postcode : 20126
Country subdivision (NUTS) : Milano ( ITC4C )
Country : Italy
Roles of this organisation :
TED eSender
Tenderer
Winner of these lots : LOT-0003

8.1 ORG-0021

Official name : Lægemiddelstyrelsen (Danish Medicines Agency)
Size of the economic operator : Medium
Registration number : CVR37052485
Town : Copenhagen
Postcode : 2300
Country subdivision (NUTS) : Københavns omegn ( DK012 )
Country : Denmark
Roles of this organisation :
TED eSender
Tenderer
Winner of these lots : LOT-0003 LOT-0005

8.1 ORG-0022

Official name : European Organisation for Research and Treatment of Cancer
Size of the economic operator : Medium
Registration number : BE0408292992
Town : Brussels
Postcode : 1200
Country subdivision (NUTS) : Arr. de Bruxelles-Capitale/Arr. Brussel-Hoofdstad ( BE100 )
Country : Belgium
Roles of this organisation :
TED eSender
Tenderer
Winner of these lots : LOT-0003

8.1 ORG-0023

Official name : Stichting Nederlands Instituut vor Onderzoek van de Gezondheidszorg (Nivel)
Size of the economic operator : Medium
Registration number : 41181331
Town : Utrecht
Postcode : 3513CR
Country subdivision (NUTS) : Utrecht ( NL350 )
Country : Netherlands
Roles of this organisation :
TED eSender
Tenderer
Winner of these lots : LOT-0004

8.1 ORG-0024

Official name : Universiteit Utrecht
Size of the economic operator : Medium
Registration number : NL001798650B01
Town : Utrecht
Postcode : 3584CS
Country subdivision (NUTS) : Utrecht ( NL350 )
Country : Netherlands
Roles of this organisation :
Procurement service provider
TED eSender
Tenderer
Group leader
Winner of these lots : LOT-0004 LOT-0005

8.1 ORG-0025

Official name : Rijksinstituut voor Volksgezondheid en Milieu
Size of the economic operator : Medium
Registration number : 30276683
Town : Bilthoven
Postcode : 3721MA
Country subdivision (NUTS) : Utrecht ( NL350 )
Country : Netherlands
Roles of this organisation :
TED eSender
Tenderer
Winner of these lots : LOT-0004

8.1 ORG-0026

Official name : University Medical Center Utrecht
Size of the economic operator : Medium
Registration number : 30244197
Town : Utrecht
Postcode : 3584CX
Country subdivision (NUTS) : Utrecht ( NL350 )
Country : Netherlands
Roles of this organisation :
TED eSender
Tenderer
Winner of these lots : LOT-0004 LOT-0005

8.1 ORG-0027

Official name : Pharmerit Coöperatief U.A.
Size of the economic operator : Medium
Registration number : 67251919
Town : Rotterdam
Postcode : 3068AV
Country subdivision (NUTS) : Delft en Westland ( NL362 )
Country : Netherlands
Roles of this organisation :
TED eSender
Tenderer
Winner of these lots : LOT-0004 LOT-0005

8.1 ORG-0028

Official name : Aetion Germany GmbH
Size of the economic operator : Medium
Registration number : HRB74786
Town : Neuss
Postcode : 41460
Country subdivision (NUTS) : Düsseldorf, Kreisfreie Stadt ( DEA11 )
Country : Germany
Roles of this organisation :
TED eSender
Tenderer
Winner of these lots : LOT-0005

8.1 ORG-0029

Official name : Erasmus University Medical Center Rotterdam
Size of the economic operator : Medium
Registration number : 24485070
Town : Rotterdam
Postcode : 3015GD
Country subdivision (NUTS) : Delft en Westland ( NL362 )
Country : Netherlands
Roles of this organisation :
TED eSender
Tenderer
Winner of these lots : LOT-0005

8.1 ORG-0030

Official name : Syreon Kutató Intézet Kft.
Size of the economic operator : Micro, small, or medium
Registration number : 0109904915
Town : Budapest
Postcode : 1142
Country subdivision (NUTS) : Budapest ( HU110 )
Country : Hungary
Roles of this organisation :
TED eSender
Tenderer
Group leader
Winner of these lots : LOT-0005

8.1 ORG-0031

Official name : Medical University of Lodz
Size of the economic operator : Medium
Registration number : 473073308
Town : Lodz
Postcode : 90-419
Country subdivision (NUTS) : Łódzki ( PL712 )
Country : Poland
Roles of this organisation :
TED eSender
Tenderer
Winner of these lots : LOT-0005

8.1 ORG-0032

Official name : Comenius University in Bratislava
Size of the economic operator : Medium
Registration number : 00397865
Town : Bratislava
Postcode : 81499
Country subdivision (NUTS) : Bratislavský kraj ( SK010 )
Country : Slovakia
Roles of this organisation :
TED eSender
Tenderer
Winner of these lots : LOT-0005

8.1 ORG-0033

Official name : RxTarget Kft.
Size of the economic operator : Micro, small, or medium
Registration number : 1609012263
Town : Szolnok Bacsó Nándor
Postcode : 5000
Country subdivision (NUTS) : Budapest ( HU110 )
Country : Hungary
Roles of this organisation :
TED eSender
Tenderer
Winner of these lots : LOT-0005

8.1 ORG-0034

Official name : National and Kapodistrian University of Athens
Size of the economic operator : Medium
Registration number : EL 090145420
Town : Athens
Postcode : 10561
Country subdivision (NUTS) : Δυτική Αττική ( EL306 )
Country : Greece
Roles of this organisation :
TED eSender
Tenderer
Winner of these lots : LOT-0005

8.1 ORG-0035

Official name : Syreon Research Romania
Size of the economic operator : Micro, small, or medium
Registration number : J26.1023.08.10.2013
Town : Tg-Mures
Postcode : 540004
Country subdivision (NUTS) : Mureş ( RO125 )
Country : Romania
Roles of this organisation :
TED eSender
Tenderer
Winner of these lots : LOT-0005

8.1 ORG-0036

Official name : Agencia Española de Medicamentos y Productos Sanitarios
Size of the economic operator : Medium
Registration number : none
Town : Madrid
Postcode : 28022
Country subdivision (NUTS) : Madrid ( ES300 )
Country : Spain
Roles of this organisation :
TED eSender
Tenderer
Winner of these lots : LOT-0005

8.1 ORG-0037

Official name : Fundació Hospital Universitari Vall Hebron – Institut de Recerca
Size of the economic operator : Medium
Registration number : 808
Town : Barcelona
Postcode : 08035
Country subdivision (NUTS) : Barcelona ( ES511 )
Country : Spain
Roles of this organisation :
TED eSender
Tenderer
Winner of these lots : LOT-0005

8.1 ORG-0038

Official name : Fundación para el Fomento de la Investigación Sanitaria y Biomédica de la Comunitat Valenciana
Size of the economic operator : Medium
Registration number : 501V
Town : Valencia
Postcode : 46010
Country subdivision (NUTS) : Valencia / València ( ES523 )
Country : Spain
Roles of this organisation :
TED eSender
Tenderer
Winner of these lots : LOT-0005

8.1 ORG-0039

Official name : Vaccine Monitoring Collaboration for Europe
Size of the economic operator : Medium
Registration number : 0741674866
Town : Brussels
Postcode : B-1050
Country subdivision (NUTS) : Arr. de Bruxelles-Capitale/Arr. Brussel-Hoofdstad ( BE100 )
Country : Belgium
Roles of this organisation :
TED eSender
Tenderer
Winner of these lots : LOT-0005

8.1 ORG-0040

Official name : University of Verona – Department of Diagnostics and Public Health
Size of the economic operator : Medium
Registration number : 93009870234
Town : Verona
Postcode : 37134
Country subdivision (NUTS) : Verona ( ITH31 )
Country : Italy
Roles of this organisation :
TED eSender
Tenderer
Winner of these lots : LOT-0005

8.1 ORG-0041

Official name : Quinten Health
Size of the economic operator : Micro, small, or medium
Registration number : B-508813292
Town : Paris
Postcode : 75017
Country subdivision (NUTS) : Paris ( FR101 )
Country : France
Roles of this organisation :
Tenderer
Winner of these lots : LOT-0005

8.1 ORG-0042

Official name : General Court of the European Union
Registration number : no
Town : Luxembourg
Postcode : L-2925
Country subdivision (NUTS) : Luxembourg ( LU000 )
Country : Luxembourg
Roles of this organisation :
Review organisation

8.1 ORG-0000

Official name : Publications Office of the European Union
Registration number : PUBL
Town : Luxembourg
Postcode : 2417
Country subdivision (NUTS) : Luxembourg ( LU000 )
Country : Luxembourg
Telephone : +352 29291
Internet address : https://op.europa.eu
Roles of this organisation :
TED eSender

10. Change

Version of the previous notice to be changed : 575628-2021
Main reason for change : Information updated
Notice information
Notice identifier/version : 947ba067-0e9a-4e90-bfc9-1a957aa140a3 - 01
Form type : Result
Notice type : Contract or concession award notice – standard regime
Notice dispatch date : 25/03/2025 12:50 +00:00
Languages in which this notice is officially available : English Danish, German, Spanish, Finnish, French, Greek, Italian, Dutch, Portuguese, Swedish, Czech, Estonian, Hungarian, Lithuanian, Latvian, Maltese, Polish, Slovak, Slovenian, Irish, Bulgarian, Romanian, Croatian
Notice publication number : 00193809-2025
OJ S issue number : 60/2025
Publication date : 26/03/2025