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 Servizi di elaborazione dati
Luogo di esecuzione:
Data Management Services
Ente di assegnazione:
European Medicines Agency, MED - European Medicines Agency
Numero di premio:
EMA/2024/OP/0019-PIN

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.
Internal identifier : EMA/2024/OP/0019-PIN

2.1.1 Purpose

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

2.1.4 General information

Additional information : This prior information notice announces the intention of the contracting authority to publish a future call for tenders. No other information or documents are available at this stage. Interested economic operators are invited to subscribe at the link https://ec.europa.eu/info/funding-tenders/opportunities/portal/screen/opportunities/tender-details/94a3a18f-b03e-4188-a481-06d3750cfa37-PIN in order to get notified when the contract notice and all the procurement documents, including the tender specifications, are published.
Legal basis :
Regulation (EU, Euratom) 2018/1046

3. Part

3.1 Part technical ID : PAR-0001

Title : Data Management Services-SPOR and Veterinary Product 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.

3.1.1 Purpose

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

3.1.3 Duration

Duration : 48 Month

3.1.5 General information

The procurement is covered by the Government Procurement Agreement (GPA) : no
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.

3.1.6 Procurement documents

3.1.8 Techniques

Framework agreement :
Framework agreement, without reopening of competition

3.1.9 Further information, mediation and review

Review organisation : Court of Justice of the European Union -

3.1 Part technical ID : PAR-0002

Title : Data Management Services – Eudravigilance (EV) 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.

3.1.1 Purpose

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

3.1.3 Duration

Duration : 48 Month

3.1.5 General information

The procurement is covered by the Government Procurement Agreement (GPA) : no
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.

3.1.6 Procurement documents

3.1.8 Techniques

Framework agreement :
Framework agreement, without reopening of competition

3.1.9 Further information, mediation and review

Review organisation : Court of Justice of the European Union -

3.1 Part technical ID : PAR-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.

3.1.1 Purpose

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

3.1.3 Duration

Duration : 48 Month

3.1.5 General information

The procurement is covered by the Government Procurement Agreement (GPA) : no
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.

3.1.6 Procurement documents

3.1.8 Techniques

Framework agreement :
Framework agreement, without reopening of competition

3.1.9 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

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 : 695431b6-7a4a-4f02-a158-11c722409bc0 - 01
Form type : Planning
Notice type : Prior information notice or a periodic indicative notice used only for information
Notice dispatch date : 28/04/2025 16:47 +02:00
Languages in which this notice is officially available : English
Notice publication number : 00280627-2025
OJ S issue number : 84/2025
Publication date : 30/04/2025
Estimated date of publication of a contract notice within this procedure : 17/06/2025