Data Management Services

Provision of data management services for data review, validation, cleansing and maintenance; document redaction and assessment; and customer service. The SPOR (Substances, Products, Organisations and Referentials) programme provides master data services (people, process, data and technology) for all SPOR data for both human and veterinary regulatory domains. The services are …

CPV: 72300000 Data services
Deadline:
Aug. 18, 2025, 4 p.m.
Deadline type:
Submitting a bid
Place of execution:
Data Management Services
Awarding body:
European Medicines Agency, MED - European Medicines Agency
Award number:
EMA/2024/OP/0019

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

2. Procedure

2.1 Procedure

Title : Data Management Services
Description : Provision of data management services for data review, validation, cleansing and maintenance; document redaction and assessment; and customer service.
Procedure identifier : 94a3a18f-b03e-4188-a481-06d3750cfa37
Internal identifier : EMA/2024/OP/0019
Type of procedure : Open
The procedure is accelerated : no

2.1.1 Purpose

Main nature of the contract : Services
Main classification ( cpv ): 72300000 Data services

2.1.2 Place of performance

Anywhere
Additional information : Please consult the procurement documents.

2.1.3 Value

Estimated value excluding VAT : 59 450 000 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) 2024/2509

2.1.5 Terms of procurement

Terms of submission :
Maximum number of lots for which one tenderer can submit tenders : 3
Terms of contract :
Maximum number of lots for which contracts can be awarded to one tenderer : 3

5. Lot

5.1 Lot technical ID : LOT-0001

Title : Data Management Services-SPOR and Veterinary Medicinal Products Data Management
Description : The SPOR (Substances, Products, Organisations and Referentials) programme provides master data services (people, process, data and technology) for all SPOR data for both human and veterinary regulatory domains. The services are intended to support regulatory procedures throughout the European Union and across the whole medicinal product lifecycle. The SPOR programme enables master data to be re-used by EMA, National Competent Authorities (NCAs) and the industry across the different business processes.
Internal identifier : EMA/2024/OP/0019-LOT-1

5.1.1 Purpose

Main nature of the contract : Services
Main classification ( cpv ): 72300000 Data services
Options :
Description of the options : provided they are in conformity with the basic project, new services or works consisting in the repetition of similar services or works, may be entrusted up to 50 % of the initial contract to the initial contractor by negotiated procedure without prior publication of a contract notice.

5.1.2 Place of performance

Anywhere
Additional information : Please consult the procurement documents.

5.1.3 Estimated duration

Duration : 72 Month

5.1.4 Renewal

Maximum renewals : 4
Other information about renewals : The framework contract is concluded for an initial period of 24 (twenty-four) months, renewable 4 (four) time(s). Please consult the draft framework contract in the procurement documents.

5.1.5 Value

Estimated value excluding VAT : 36 000 000 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 : 280627-2025

5.1.10 Award criteria

Criterion :
Type : Quality
Description : Please consult the procurement documents.
Category of award threshold criterion : Weight (percentage, exact)
Award criterion number : 60
Criterion :
Type : Price
Description : Please consult the procurement documents.
Category of award threshold criterion : Weight (percentage, exact)
Award criterion number : 40

5.1.11 Procurement documents

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 : 18/08/2025 16:00 +02:00
Deadline until which the tender must remain valid : 9 Month
Information about public opening :
Opening date : 19/08/2025 10:00 +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 : yes
Electronic payment will be used : yes

5.1.15 Techniques

Framework agreement :
Framework agreement, without reopening of competition
Maximum number of participants : 2
Justification for the duration of the framework agreement : Please consult the procurement documents.
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
Organisation providing more information on the review procedures : European Medicines Agency, MED - European Medicines Agency

5.1 Lot technical ID : LOT-0002

Title : Data Management Services – EudraVigilance and EurEKA
Description : Eudravigilance (EV) is the European data-processing network and management system, established at EMA to support the electronic exchange, management and scientific evaluation of Individual Case Safety Reports (ICSRs) related to all medicinal products authorized in the European Economic Area (EEA). EurEKA is the EMA's tool that encodes the undesirable effect terms from Summaries of (medicinal) Product Characteristics as MedDRA terms.
Internal identifier : EMA/2024/OP/0019-LOT-2

5.1.1 Purpose

Main nature of the contract : Services
Main classification ( cpv ): 72300000 Data services
Options :
Description of the options : provided they are in conformity with the basic project, new services or works consisting in the repetition of similar services or works, may be entrusted up to 50 % of the initial contract to the initial contractor by negotiated procedure without prior publication of a contract notice.

5.1.2 Place of performance

Anywhere
Additional information : Please consult the procurement documents.

5.1.3 Estimated duration

Duration : 72 Month

5.1.4 Renewal

Maximum renewals : 4
Other information about renewals : The framework contract is concluded for an initial period of 24 (twenty-four) months, renewable 4 (four) time(s). Please consult the draft framework contract in the procurement documents.

5.1.5 Value

Estimated value excluding VAT : 17 000 000 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 : 280627-2025
Additional information : All the information provided in this PIN is subject to change. The Contracting Authority anticipates that contract duration can be extended up to 72 months.

5.1.10 Award criteria

Criterion :
Type : Quality
Description : Please consult the procurement documents.
Category of award threshold criterion : Weight (percentage, exact)
Award criterion number : 60
Criterion :
Type : Price
Description : Please consult the procurement documents.
Category of award threshold criterion : Weight (percentage, exact)
Award criterion number : 40

5.1.11 Procurement documents

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 : 18/08/2025 16:00 +02:00
Deadline until which the tender must remain valid : 9 Month
Information about public opening :
Opening date : 19/08/2025 10:00 +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 : yes
Electronic payment will be used : yes

5.1.15 Techniques

Framework agreement :
Framework agreement, without reopening of competition
Maximum number of participants : 2
Justification for the duration of the framework agreement : Please consult the procurement documents.
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
Organisation providing more information on the review procedures : European Medicines Agency, MED - European Medicines Agency

5.1 Lot technical ID : LOT-0003

Title : Data Management- Anonymization and redaction of documents and datasets
Description : The Agency assesses whether any information contained in some documents would constitute commercially confidential information (CCI) or protected personal data (PPD). The services covered by the procedure are intended to support the Agency in assessing the presence of CCI in the documents and to redact them, and in assessing the presence of PPD in the documents and to anonymize them. These services require scientific expertise in order to realize such CCI and PPD assessments.
Internal identifier : EMA/2024/OP/0019-LOT-3

5.1.1 Purpose

Main nature of the contract : Services
Main classification ( cpv ): 72300000 Data services
Options :
Description of the options : provided they are in conformity with the basic project, new services or works consisting in the repetition of similar services or works, may be entrusted up to 50 % of the initial contract to the initial contractor by negotiated procedure without prior publication of a contract notice.

5.1.2 Place of performance

Anywhere
Additional information : Please consult the procurement documents.

5.1.3 Estimated duration

Duration : 72 Month

5.1.4 Renewal

Maximum renewals : 4
Other information about renewals : The framework contract is concluded for an initial period of 24 (twenty-four) months, renewable 4 (four) time(s). Please consult the draft framework contract in the procurement documents.

5.1.5 Value

Estimated value excluding VAT : 6 450 000 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 : 280627-2025
Additional information : All the information provided in this PIN is subject to change. The Contracting Authority anticipates that contract duration can be extended up to 72 months.

5.1.10 Award criteria

Criterion :
Type : Quality
Description : Please consult the procurement documents.
Category of award threshold criterion : Weight (percentage, exact)
Award criterion number : 60
Criterion :
Type : Price
Description : Please consult the procurement documents.
Category of award threshold criterion : Weight (percentage, exact)
Award criterion number : 40

5.1.11 Procurement documents

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 : 18/08/2025 16:00 +02:00
Deadline until which the tender must remain valid : 9 Month
Information about public opening :
Opening date : 19/08/2025 10:00 +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 : yes
Electronic payment will be used : yes

5.1.15 Techniques

Framework agreement :
Framework agreement, without reopening of competition
Maximum number of participants : 2
Justification for the duration of the framework agreement : Please consult the procurement documents.
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
Organisation providing more information on the review procedures : European Medicines Agency, MED - European Medicines Agency

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 ( NL32B )
Country : Netherlands
Telephone : +44 20 7418 8400
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 : 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-0003

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 : 3856ade9-f2c4-4c48-a544-e1a4626a6951 - 01
Form type : Competition
Notice type : Contract or concession notice – standard regime
Notice dispatch date : 14/07/2025 17:41 +02:00
Languages in which this notice is officially available : English
Notice publication number : 00464893-2025
OJ S issue number : 134/2025
Publication date : 16/07/2025