Support the implementation of the new Substances of Human Origin (SoHO) Regulation 1938/2024, including dissemination and training of SoHO professionals to comply with the new technical and regulatory requirements

The scope of the call is to prepare SoHO professionals across the EU for the 2027 implementation of the Regulation (EU) 2024/1938 on Substances of Human Origin. The objectives of this call for tenders are: to develop training programmes, awareness and capacity building activities, technical assistance and supporting measures to …

CPV: 73210000 Servicios de consultoría en investigación
Plazo:
11 de noviembre de 2025 a las 16:00
Tipo de plazo:
Presentación de una oferta
Lugar de ejecución:
Support the implementation of the new Substances of Human Origin (SoHO) Regulation 1938/2024, including dissemination and training of SoHO professionals to comply with the new technical and regulatory requirements
Organismo adjudicador:
Health and Digital Executive Agency (HaDEA) , HADEA - Health and Digital Executive Agency
Número de premio:
HADEA/2025/OP/0043

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 : Support the implementation of the new Substances of Human Origin (SoHO) Regulation 1938/2024, including dissemination and training of SoHO professionals to comply with the new technical and regulatory requirements
Description : The scope of the call is to prepare SoHO professionals across the EU for the 2027 implementation of the Regulation (EU) 2024/1938 on Substances of Human Origin. The objectives of this call for tenders are: to develop training programmes, awareness and capacity building activities, technical assistance and supporting measures to facilitate the implementation of the new SoHO Regulation by the professional sector (Scientific societies and associations).
Procedure identifier : 96a12fae-8e72-489d-a5d5-655060cfe177
Internal identifier : HADEA/2025/OP/0043
Type of procedure : Open
The procedure is accelerated : no

2.1.1 Purpose

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

2.1.2 Place of performance

Anywhere
Additional information : Please consult the procurement documents.

2.1.3 Value

Estimated value excluding VAT : 3 500 000 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

2.1.6 Grounds for exclusion

Sources of grounds for exclusion : Procurement Document

5. Lot

5.1 Lot technical ID : LOT-0001

Title : Support the implementation of the new Substances of Human Origin (SoHO) Regulation 1938/2024, including dissemination and training of SoHO professionals to comply with the new technical and regulatory requirements
Description : The scope of the call is to prepare SoHO professionals across the EU for the 2027 implementation of the Regulation (EU) 2024/1938 on Substances of Human Origin. The objectives of this call for tenders are: to develop training programmes, awareness and capacity building activities, technical assistance and supporting measures to facilitate the implementation of the new SoHO Regulation by the professional sector (Scientific societies and associations).
Internal identifier : HADEA/2025/OP/0043

5.1.1 Purpose

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

5.1.2 Place of performance

Anywhere
Additional information : Please consult the procurement documents.

5.1.3 Estimated duration

Duration : 30 Month

5.1.5 Value

Estimated value excluding VAT : 3 500 000 Euro

5.1.6 General information

Reserved participation : Participation is not reserved.
Procurement Project fully or partially financed with EU Funds.
Information about European Union funds
EU funds programme : EU4Health Programme (2021/2027)
The procurement is covered by the Government Procurement Agreement (GPA) : no
Information about previous notices :
Identifier of the previous notice : 498550-2025

5.1.9 Selection criteria

Sources of selection criteria : Procurement Document

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 : 70
Criterion :
Type : Price
Description : Please consult the procurement documents.
Category of award threshold criterion : Weight (percentage, exact)
Award criterion number : 30

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 : 11/11/2025 16:00 +01:00
Deadline until which the tender must remain valid : 6 Month
Information about public opening :
Opening date : 12/11/2025 11:00 +01:00
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 :
No framework agreement
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 : Health and Digital Executive Agency (HaDEA) , HADEA - Health and Digital Executive Agency

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
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 : 2d0518fa-00dd-4f7f-a76f-fcab0c798344 - 01
Form type : Competition
Notice type : Contract or concession notice – standard regime
Notice dispatch date : 16/09/2025 11:12 +02:00
Languages in which this notice is officially available : English
Notice publication number : 00607246-2025
OJ S issue number : 178/2025
Publication date : 17/09/2025