Quality, safety and efficacy studies of medicines

EMA seeks to procure the services of research organisations to perform pre- and post-authorisation studies on the quality, safety and efficacy of human and veterinary medicines, generating complementary evidence to support regulatory decision-making. The scope of research covers both nationally and centrally authorised medicinal products, as well as non-product related …

CPV: 73110000 Tutkimuspalvelut, 73000000 Tutkimus- ja kehityspalvelut ja niihin liittyvät konsulttipalvelut, 73210000 Tutkimustoiminnan konsulttipalvelut
Määräaika:
30. huhtikuuta 2025 kello 12.00
Määräajan tyyppi:
Tarjouksen jättäminen
Teloituspaikka:
Quality, safety and efficacy studies of medicines
Myöntävä elin:
European Medicines Agency, MED - European Medicines Agency
Myöntämisnumero:
EMA/2024/OP/0016

1. Buyer

1.1 Buyer

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

1.1 Buyer

Official name : European Centre for Disease Prevention and Control
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, safety and efficacy studies of medicines
Description : EMA seeks to procure the services of research organisations to perform pre- and post-authorisation studies on the quality, safety and efficacy of human and veterinary medicines, generating complementary evidence to support regulatory decision-making. The scope of research covers both nationally and centrally authorised medicinal products, as well as non-product related topics. Studies may concern research under 7 Lots: Lot 1 translational research; Lot 2 veterinary research; Lot 3 methodological/statistical research; Lot 4 qualitative research; Lot 5 pharmacoepidemiological research; Lot 6 innovative technologies; Lot 7 computational methods for comparison of molecular structural features in the context of medicines for rare diseases. ECDC is also participating as a contracting authority only with respect to Lot 5 pharmacoepidemiological research.
Procedure identifier : 72456246-9cd8-4978-9703-f90cf4e86227
Internal identifier : EMA/2024/OP/0016
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 ): 73110000 Research services

2.1.3 Value

Estimated value excluding VAT : 16 000 000 Euro

2.1.4 General information

Additional information : In case of unavailability or disruptions in the functioning of the electronic means of communication provided in Section 5.1.11 in the last 5 calendar days before the time limit for receipt indicated in Section 5.1.12, the contracting authority reserves the right to extend this time limit and publish the extension at the Internet address provided in Section 5.1.11, without a preceding publication of a corrigendum to this notice. Economic operators interested in this procurement are invited to subscribe to the call for tenders at the address in Section 5.1.11 in order to get notified when new information or documents are published.
Legal basis :
Regulation (EU, Euratom) 2018/1046

2.1.6 Grounds for exclusion

Bankruptcy : For the full list of exclusion grounds please consult the procurement documents.

5. Lot

5.1 Lot technical ID : LOT-0001

Title : Translational research
Description : Please refer to the technical specifications for the detailed description of the Lot.
Internal identifier : EMA/2024/OP/0016-LOT-1

5.1.1 Purpose

Main nature of the contract : Services
Main classification ( cpv ): 73110000 Research services
Additional classification ( cpv ): 73000000 Research and development services and related consultancy services
Additional classification ( cpv ): 73210000 Research consultancy services

5.1.3 Estimated duration

Duration : 48 Month

5.1.4 Renewal

Other information about renewals : The framework contract is concluded for an initial period of 24 (twenty-four) months, renewable 2 (two) time(s). Please consult the draft framework contract in the procurement documents.

5.1.5 Value

Estimated value excluding VAT : 2 800 000 Euro

5.1.6 General information

Reserved participation : Participation is not reserved.
Procurement Project fully or partially financed with EU Funds.
The procurement is covered by the Government Procurement Agreement (GPA) : no
Information about previous notices :
Identifier of the previous notice : 568568-2024

5.1.9 Selection criteria

Criterion :
Type : Suitability to pursue the professional activity
Description : Please consult the procurement documents.
Criterion :
Type : Economic and financial standing
Description : Please consult the procurement documents.
Criterion :
Type : Technical and professional ability
Description : Please consult the procurement documents.

5.1.10 Award criteria

Criterion :
Type : Quality
Name :
Description : Please consult the procurement documents.
Category of award threshold criterion : Weight (percentage, exact)
Award criterion number : 70
Criterion :
Type : Price
Name :
Description : Please consult the procurement documents.
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 :

5.1.12 Terms of procurement

Terms of submission :
Electronic submission : Required
Languages in which tenders or requests to participate may be submitted : Bulgarian, Czech, Danish, German, Greek, English, Spanish, Estonian, Finnish, French, Irish, Croatian, Hungarian, Italian, Lithuanian, Latvian, Maltese, Dutch, Polish, Portuguese, Romanian, Slovak, Slovenian, Swedish
Electronic catalogue : Not allowed
Deadline for receipt of tenders : 30/04/2025 12:00 +02:00
Deadline until which the tender must remain valid : 9 Month
Information about public opening :
Opening date : 02/05/2025 11:00 +02:00
Terms of contract :
The execution of the contract must be performed within the framework of sheltered employment programmes : No
Electronic invoicing : Allowed
Electronic ordering will be used : no
Electronic payment will be used : yes

5.1.15 Techniques

Framework agreement :
Framework agreement, with reopening of competition
Information about the dynamic purchasing system :
No dynamic purchase system

5.1.16 Further information, mediation and review

Review organisation : Court of Justice of the European Union -

5.1 Lot technical ID : LOT-0002

Title : Veterinary research
Description : Please refer to the technical specifications for the detailed description of the Lot.
Internal identifier : EMA/2024/OP/0016-LOT-2

5.1.1 Purpose

Main nature of the contract : Services
Main classification ( cpv ): 73110000 Research services
Additional classification ( cpv ): 73000000 Research and development services and related consultancy services
Additional classification ( cpv ): 73210000 Research consultancy services

5.1.3 Estimated duration

Duration : 48 Month

5.1.4 Renewal

Other information about renewals : The framework contract is concluded for an initial period of 24 (twenty-four) months, renewable 2 (two) time(s). Please consult the draft framework contract in the procurement documents.

5.1.5 Value

Estimated value excluding VAT : 2 100 000 Euro

5.1.6 General information

Reserved participation : Participation is not reserved.
Procurement Project fully or partially financed with EU Funds.
The procurement is covered by the Government Procurement Agreement (GPA) : no
Information about previous notices :
Identifier of the previous notice : 568568-2024

5.1.9 Selection criteria

Criterion :
Type : Suitability to pursue the professional activity
Description : Please consult the procurement documents.
Criterion :
Type : Economic and financial standing
Description : Please consult the procurement documents.
Criterion :
Type : Technical and professional ability
Description : Please consult the procurement documents.

5.1.10 Award criteria

Criterion :
Type : Quality
Name :
Description : Please consult the procurement documents.
Category of award threshold criterion : Weight (percentage, exact)
Award criterion number : 70
Criterion :
Type : Price
Name :
Description : Please consult the procurement documents.
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 :

5.1.12 Terms of procurement

Terms of submission :
Electronic submission : Required
Languages in which tenders or requests to participate may be submitted : Bulgarian, Czech, Danish, German, Greek, English, Spanish, Estonian, Finnish, French, Irish, Croatian, Hungarian, Italian, Lithuanian, Latvian, Maltese, Dutch, Polish, Portuguese, Romanian, Slovak, Slovenian, Swedish
Electronic catalogue : Not allowed
Deadline for receipt of tenders : 30/04/2025 12:00 +02:00
Deadline until which the tender must remain valid : 9 Month
Information about public opening :
Opening date : 02/05/2025 11:00 +02:00
Terms of contract :
The execution of the contract must be performed within the framework of sheltered employment programmes : No
Electronic invoicing : Allowed
Electronic ordering will be used : no
Electronic payment will be used : yes

5.1.15 Techniques

Framework agreement :
Framework agreement, with reopening of competition
Information about the dynamic purchasing system :
No dynamic purchase system

5.1.16 Further information, mediation and review

Review organisation : Court of Justice of the European Union -

5.1 Lot technical ID : LOT-0003

Title : Lot 3 Methodological/statistical research
Description : Please refer to the technical specifications for the detailed description of the Lot.
Internal identifier : EMA/2024/OP/0016-LOT-3

5.1.1 Purpose

Main nature of the contract : Services
Main classification ( cpv ): 73110000 Research services
Additional classification ( cpv ): 73000000 Research and development services and related consultancy services
Additional classification ( cpv ): 73210000 Research consultancy services

5.1.3 Estimated duration

Duration : 48 Month

5.1.4 Renewal

Other information about renewals : The framework contract is concluded for an initial period of 24 (twenty-four) months, renewable 2 (two) time(s). Please consult the draft framework contract in the procurement documents.

5.1.5 Value

Estimated value excluding VAT : 2 000 000 Euro

5.1.6 General information

Reserved participation : Participation is not reserved.
Procurement Project fully or partially financed with EU Funds.
The procurement is covered by the Government Procurement Agreement (GPA) : no
Information about previous notices :
Identifier of the previous notice : 568568-2024

5.1.9 Selection criteria

Criterion :
Type : Suitability to pursue the professional activity
Description : Please consult the procurement documents.
Criterion :
Type : Economic and financial standing
Description : Please consult the procurement documents.
Criterion :
Type : Technical and professional ability
Description : Please consult the procurement documents.

5.1.10 Award criteria

Criterion :
Type : Quality
Name :
Description : Please consult the procurement documents.
Category of award threshold criterion : Weight (percentage, exact)
Award criterion number : 70
Criterion :
Type : Price
Name :
Description : Please consult the procurement documents.
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 :

5.1.12 Terms of procurement

Terms of submission :
Electronic submission : Required
Languages in which tenders or requests to participate may be submitted : Bulgarian, Czech, Danish, German, Greek, English, Spanish, Estonian, Finnish, French, Irish, Croatian, Hungarian, Italian, Lithuanian, Latvian, Maltese, Dutch, Polish, Portuguese, Romanian, Slovak, Slovenian, Swedish
Electronic catalogue : Not allowed
Deadline for receipt of tenders : 30/04/2025 12:00 +02:00
Deadline until which the tender must remain valid : 9 Month
Information about public opening :
Opening date : 02/05/2025 11:00 +02:00
Terms of contract :
The execution of the contract must be performed within the framework of sheltered employment programmes : No
Electronic invoicing : Allowed
Electronic ordering will be used : no
Electronic payment will be used : yes

5.1.15 Techniques

Framework agreement :
Framework agreement, with reopening of competition
Information about the dynamic purchasing system :
No dynamic purchase system

5.1.16 Further information, mediation and review

Review organisation : Court of Justice of the European Union -

5.1 Lot technical ID : LOT-0004

Title : Qualitative research
Description : Please refer to the technical specifications for the detailed description of the Lot.
Internal identifier : EMA/2024/OP/0016-LOT-4

5.1.1 Purpose

Main nature of the contract : Services
Main classification ( cpv ): 73110000 Research services
Additional classification ( cpv ): 73000000 Research and development services and related consultancy services
Additional classification ( cpv ): 73210000 Research consultancy services

5.1.3 Estimated duration

Duration : 48 Month

5.1.4 Renewal

Other information about renewals : The framework contract is concluded for an initial period of 24 (twenty-four) months, renewable 2 (two) time(s). Please consult the draft framework contract in the procurement documents.

5.1.5 Value

Estimated value excluding VAT : 2 100 000 Euro

5.1.6 General information

Reserved participation : Participation is not reserved.
Procurement Project fully or partially financed with EU Funds.
The procurement is covered by the Government Procurement Agreement (GPA) : no
Information about previous notices :
Identifier of the previous notice : 568568-2024

5.1.9 Selection criteria

Criterion :
Type : Suitability to pursue the professional activity
Description : Please consult the procurement documents.
Criterion :
Type : Economic and financial standing
Description : Please consult the procurement documents.
Criterion :
Type : Technical and professional ability
Description : Please consult the procurement documents.

5.1.10 Award criteria

Criterion :
Type : Quality
Name :
Description : Please consult the procurement documents.
Category of award threshold criterion : Weight (percentage, exact)
Award criterion number : 70
Criterion :
Type : Price
Name :
Description : Please consult the procurement documents.
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 :

5.1.12 Terms of procurement

Terms of submission :
Electronic submission : Required
Languages in which tenders or requests to participate may be submitted : Bulgarian, Czech, Danish, German, Greek, English, Spanish, Estonian, Finnish, French, Irish, Croatian, Hungarian, Italian, Lithuanian, Latvian, Maltese, Dutch, Polish, Portuguese, Romanian, Slovak, Slovenian, Swedish
Electronic catalogue : Not allowed
Deadline for receipt of tenders : 30/04/2025 12:00 +02:00
Deadline until which the tender must remain valid : 9 Month
Information about public opening :
Opening date : 02/05/2025 11:00 +02:00
Terms of contract :
The execution of the contract must be performed within the framework of sheltered employment programmes : No
Electronic invoicing : Allowed
Electronic ordering will be used : no
Electronic payment will be used : yes

5.1.15 Techniques

Framework agreement :
Framework agreement, with reopening of competition
Information about the dynamic purchasing system :
No dynamic purchase system

5.1.16 Further information, mediation and review

Review organisation : Court of Justice of the European Union -

5.1 Lot technical ID : LOT-0005

Title : Pharmacoepidemiological research
Description : Please refer to the technical specifications for the detailed description of the Lot.
Internal identifier : EMA/2024/OP/0016-LOT-5

5.1.1 Purpose

Main nature of the contract : Services
Main classification ( cpv ): 73110000 Research services
Additional classification ( cpv ): 73000000 Research and development services and related consultancy services
Additional classification ( cpv ): 73210000 Research consultancy services

5.1.3 Estimated duration

Duration : 48 Month

5.1.4 Renewal

Other information about renewals : The framework contract is concluded for an initial period of 24 (twenty-four) months, renewable 2 (two) time(s). Please consult the draft framework contract in the procurement documents.

5.1.5 Value

Estimated value excluding VAT : 5 000 000 Euro

5.1.6 General information

Reserved participation : Participation is not reserved.
Procurement Project fully or partially financed with EU Funds.
The procurement is covered by the Government Procurement Agreement (GPA) : no
Information about previous notices :
Identifier of the previous notice : 568568-2024

5.1.9 Selection criteria

Criterion :
Type : Suitability to pursue the professional activity
Description : Please consult the procurement documents.
Criterion :
Type : Economic and financial standing
Description : Please consult the procurement documents.
Criterion :
Type : Technical and professional ability
Description : Please consult the procurement documents.

5.1.10 Award criteria

Criterion :
Type : Quality
Name :
Description : Please consult the procurement documents.
Category of award threshold criterion : Weight (percentage, exact)
Award criterion number : 70
Criterion :
Type : Price
Name :
Description : Please consult the procurement documents.
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 :

5.1.12 Terms of procurement

Terms of submission :
Electronic submission : Required
Languages in which tenders or requests to participate may be submitted : Bulgarian, Czech, Danish, German, Greek, English, Spanish, Estonian, Finnish, French, Irish, Croatian, Hungarian, Italian, Lithuanian, Latvian, Maltese, Dutch, Polish, Portuguese, Romanian, Slovak, Slovenian, Swedish
Electronic catalogue : Not allowed
Deadline for receipt of tenders : 30/04/2025 12:00 +02:00
Deadline until which the tender must remain valid : 9 Month
Information about public opening :
Opening date : 02/05/2025 11:00 +02:00
Terms of contract :
The execution of the contract must be performed within the framework of sheltered employment programmes : No
Electronic invoicing : Allowed
Electronic ordering will be used : no
Electronic payment will be used : yes

5.1.15 Techniques

Framework agreement :
Framework agreement, with reopening of competition
Information about the dynamic purchasing system :
No dynamic purchase system

5.1.16 Further information, mediation and review

Review organisation : Court of Justice of the European Union -

5.1 Lot technical ID : LOT-0006

Title : Innovative technologies for manufacturing and quality control of medicines (advanced manufacturing)
Description : Please refer to the technical specifications for the detailed description of the Lot.
Internal identifier : EMA/2024/OP/0016-LOT-6

5.1.1 Purpose

Main nature of the contract : Services
Main classification ( cpv ): 73110000 Research services
Additional classification ( cpv ): 73000000 Research and development services and related consultancy services
Additional classification ( cpv ): 73210000 Research consultancy services

5.1.3 Estimated duration

Duration : 48 Month

5.1.4 Renewal

Other information about renewals : The framework contract is concluded for an initial period of 24 (twenty-four) months, renewable 2 (two) time(s). Please consult the draft framework contract in the procurement documents.

5.1.5 Value

Estimated value excluding VAT : 1 500 000 Euro

5.1.6 General information

Reserved participation : Participation is not reserved.
Procurement Project fully or partially financed with EU Funds.
The procurement is covered by the Government Procurement Agreement (GPA) : no
Information about previous notices :
Identifier of the previous notice : 568568-2024

5.1.9 Selection criteria

Criterion :
Type : Suitability to pursue the professional activity
Description : Please consult the procurement documents.
Criterion :
Type : Economic and financial standing
Description : Please consult the procurement documents.
Criterion :
Type : Technical and professional ability
Description : Please consult the procurement documents.

5.1.10 Award criteria

Criterion :
Type : Quality
Name :
Description : Please consult the procurement documents.
Category of award threshold criterion : Weight (percentage, exact)
Award criterion number : 70
Criterion :
Type : Price
Name :
Description : Please consult the procurement documents.
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 :

5.1.12 Terms of procurement

Terms of submission :
Electronic submission : Required
Languages in which tenders or requests to participate may be submitted : Bulgarian, Czech, Danish, German, Greek, English, Spanish, Estonian, Finnish, French, Irish, Croatian, Hungarian, Italian, Lithuanian, Latvian, Maltese, Dutch, Polish, Portuguese, Romanian, Slovak, Slovenian, Swedish
Electronic catalogue : Not allowed
Deadline for receipt of tenders : 30/04/2025 12:00 +02:00
Deadline until which the tender must remain valid : 9 Month
Information about public opening :
Opening date : 02/05/2025 11:00 +02:00
Terms of contract :
The execution of the contract must be performed within the framework of sheltered employment programmes : No
Electronic invoicing : Allowed
Electronic ordering will be used : no
Electronic payment will be used : yes

5.1.15 Techniques

Framework agreement :
Framework agreement, with reopening of competition
Information about the dynamic purchasing system :
No dynamic purchase system

5.1.16 Further information, mediation and review

Review organisation : Court of Justice of the European Union -

5.1 Lot technical ID : LOT-0007

Title : Computational methods for comparison of molecular structural features in the context of medicines for rare diseases
Description : Please refer to the technical specifications for the detailed description of the Lot.
Internal identifier : EMA/2024/OP/0016-LOT-7

5.1.1 Purpose

Main nature of the contract : Services
Main classification ( cpv ): 73110000 Research services
Additional classification ( cpv ): 73000000 Research and development services and related consultancy services
Additional classification ( cpv ): 73210000 Research consultancy services

5.1.3 Estimated duration

Duration : 48 Month

5.1.4 Renewal

Other information about renewals : The framework contract is concluded for an initial period of 24 (twenty-four) months, renewable 2 (two) time(s). Please consult the draft framework contract in the procurement documents.

5.1.5 Value

Estimated value excluding VAT : 500 000 Euro

5.1.6 General information

Reserved participation : Participation is not reserved.
Procurement Project fully or partially financed with EU Funds.
The procurement is covered by the Government Procurement Agreement (GPA) : no
Information about previous notices :
Identifier of the previous notice : 568568-2024

5.1.9 Selection criteria

Criterion :
Type : Suitability to pursue the professional activity
Description : Please consult the procurement documents.
Criterion :
Type : Economic and financial standing
Description : Please consult the procurement documents.
Criterion :
Type : Technical and professional ability
Description : Please consult the procurement documents.

5.1.10 Award criteria

Criterion :
Type : Quality
Name :
Description : Please consult the procurement documents.
Category of award threshold criterion : Weight (percentage, exact)
Award criterion number : 70
Criterion :
Type : Price
Name :
Description : Please consult the procurement documents.
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 :

5.1.12 Terms of procurement

Terms of submission :
Electronic submission : Required
Languages in which tenders or requests to participate may be submitted : Bulgarian, Czech, Danish, German, Greek, English, Spanish, Estonian, Finnish, French, Irish, Croatian, Hungarian, Italian, Lithuanian, Latvian, Maltese, Dutch, Polish, Portuguese, Romanian, Slovak, Slovenian, Swedish
Electronic catalogue : Not allowed
Deadline for receipt of tenders : 30/04/2025 12:00 +02:00
Deadline until which the tender must remain valid : 9 Month
Information about public opening :
Opening date : 02/05/2025 11:00 +02:00
Terms of contract :
The execution of the contract must be performed within the framework of sheltered employment programmes : No
Electronic invoicing : Allowed
Electronic ordering will be used : no
Electronic payment will be used : yes

5.1.15 Techniques

Framework agreement :
Framework agreement, with reopening of competition
Information about the dynamic purchasing system :
No dynamic purchase system

5.1.16 Further information, mediation and review

Review organisation : Court of Justice of the European Union -

8. Organisations

8.1 ORG-0001

Official name : European Medicines Agency, MED - European Medicines Agency
Registration number : EMEA
Postal address : Domenico Scarlattilaan 6
Town : Amsterdam
Postcode : NL-1083
Country subdivision (NUTS) : Groot-Amsterdam ( NL329 )
Country : Netherlands
Telephone : +44 20 7418 8400
Internet address : https://www.ema.europa.eu
Roles of this organisation :
Buyer
Group leader
Central purchasing body awarding public contracts or concluding framework agreements for works, supplies or services intended for other buyers

8.1 ORG-0002

Official name : European Centre for Disease Prevention and Control
Registration number : ECDC
Postal address : Gustav III:s Boulevard 40
Town : Solna
Postcode : 169 73
Country subdivision (NUTS) : Stockholms län ( SE110 )
Country : Sweden
Telephone : +44 20 7418 8400
Roles of this organisation :
Buyer

8.1 ORG-0003

Official name : Court of Justice of the European Union
Registration number : CURIA
Postal address : Rue du Fort Niedergrünewald
Town : Luxembourg
Postcode : L-2925
Country subdivision (NUTS) : Luxembourg ( LU000 )
Country : Luxembourg
Telephone : +352 4303-1
Internet address : http://curia.europa.eu
Roles of this organisation :
Review organisation

8.1 ORG-0004

Official name : European Commission
Registration number : EUCOM
Postal address : Mondrian (CDMA), Rue du Champ de Mars 21
Town : Brussels
Postcode : B-1050
Country subdivision (NUTS) : Arr. de Bruxelles-Capitale/Arr. Brussel-Hoofdstad ( BE100 )
Country : Belgium
Telephone : +32 2 299 11 11
Roles of this organisation :
TED eSender
Notice information
Notice identifier/version : 2cd1fb01-cc3b-4f33-99ce-238bd91e2ee5 - 01
Form type : Competition
Notice type : Contract or concession notice – standard regime
Notice dispatch date : 05/02/2025 14:23 +01:00
Languages in which this notice is officially available : English
Notice publication number : 00086413-2025
OJ S issue number : 27/2025
Publication date : 07/02/2025