Organisational support to SoHO competent authorities in Member States for the implementation of Regulation 1938/2024

This call for tenders aims to support activities to strengthen the capacities of the European Member States in the implementation of the Regulation on standards for quality and safety of substances of human origin intended for human application (Regulation (EU) 2024/1938). This support will come in multiple forms including tailored …

CPV: 73210000 Research consultancy services, 80000000 Education and training services, 80500000 Training services, 80521000 Training programme services, 80561000 Health training services, 92312212 Services related to the preparation of training manuals, 80510000 Specialist training services, 80522000 Training seminars
Place of execution:
Organisational support to SoHO competent authorities in Member States for the implementation of Regulation 1938/2024
Awarding body:
Health and Digital Executive Agency (HaDEA) , HADEA - Health and Digital Executive Agency
Award number:
HADEA/2024/OP/0057-PIN

1. Buyer

1.1 Buyer

Official name : Health and Digital Executive Agency (HaDEA) , HADEA - Health and Digital Executive 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 : Organisational support to SoHO competent authorities in Member States for the implementation of Regulation 1938/2024
Description : This call for tenders aims to support activities to strengthen the capacities of the European Member States in the implementation of the Regulation on standards for quality and safety of substances of human origin intended for human application (Regulation (EU) 2024/1938). This support will come in multiple forms including tailored gap and needs analysis, change management strategies and action plans, twinning actions and trainings.
Internal identifier : HADEA/2024/OP/0057-PIN

2.1.1 Purpose

Main nature of the contract : Services
Main classification ( cpv ): 73210000 Research consultancy services

2.1.3 Value

Estimated value excluding VAT : 5 400 000 Euro

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/dc186da5-02b5-43e6-ae9b-c3725fb243f3-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 : Organisational support to SoHO competent authorities in Member States for the implementation of Regulation 1938/2024
Description : This call for tenders aims to support activities to strengthen the capacities of the European Member States in the implementation of the Regulation on standards for quality and safety of substances of human origin intended for human application (Regulation (EU) 2024/1938). This support will come in multiple forms including tailored gap and needs analysis, change management strategies and action plans, twinning actions and trainings.

3.1.1 Purpose

Main nature of the contract : Services
Main classification ( cpv ): 73210000 Research consultancy services
Additional classification ( cpv ): 80000000 Education and training services
Additional classification ( cpv ): 80500000 Training services
Additional classification ( cpv ): 80521000 Training programme services
Additional classification ( cpv ): 80561000 Health training services
Additional classification ( cpv ): 92312212 Services related to the preparation of training manuals
Additional classification ( cpv ): 80510000 Specialist training services
Additional classification ( cpv ): 80522000 Training seminars

3.1.3 Duration

Duration : 30 Month

3.1.4 Value

Estimated value excluding VAT : 5 400 000 Euro

3.1.5 General information

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

3.1.6 Procurement documents

3.1.8 Techniques

Framework agreement :
No framework agreement

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 : Health and Digital Executive Agency (HaDEA) , HADEA - Health and Digital Executive Agency
Registration number : HADEA
Department : HADEA - Directorate of HaDEA,HADEA.A - Health and Food,HADEA.A.2 - EU4Health/SMP Food
Postal address : COV2, Place Charles Rogier 16
Town : Brussels
Postcode : B-1210
Country subdivision (NUTS) : Arr. de Bruxelles-Capitale/Arr. Brussel-Hoofdstad ( BE100 )
Country : Belgium
Telephone : +32 2 299 11 11
Internet address : https://hadea.ec.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

11. Notice information

11.1 Notice information

Notice identifier/version : cf5f548e-79fc-4e12-b042-023dc980e26a - 01
Form type : Planning
Notice type : Prior information notice or a periodic indicative notice used only for information
Notice dispatch date : 22/11/2024 10:50 +01:00
Languages in which this notice is officially available : English

11.2 Publication information

Notice publication number : 00717703-2024
OJ S issue number : 229/2024
Publication date : 25/11/2024
Estimated date of publication of a contract notice within this procedure : 20/12/2024