Organisational support to competent authorities in Member States for the implementation of Regulation 1938/2024 on Substances of Human Origin (SoHO)

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 Poradenství v oblasti výzkumu, 80000000 Vzdělávání a školení, 80500000 Školení, 80521000 Vzdělávací programy, 80561000 Zdravotní školení, 92312212 Služby vztahující se k přípravě vzdělávacích příruček, 80510000 Odborná školení, 80522000 Vzdělávací semináře
Místo provedení:
Organisational support to competent authorities in Member States for the implementation of Regulation 1938/2024 on Substances of Human Origin (SoHO)
Misto zadání:
Health and Digital Executive Agency (HaDEA) , HADEA - Health and Digital Executive Agency
Číslo zakázky:
HADEA/2024/OP/0057

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 competent authorities in Member States for the implementation of Regulation 1938/2024 on Substances of Human Origin (SoHO)
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.
Procedure identifier : dc186da5-02b5-43e6-ae9b-c3725fb243f3
Previous notice : 29474-2025
Internal identifier : HADEA/2024/OP/0057
Type of procedure : Open

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 : 5 400 000 Euro

2.1.4 General information

Legal basis :
Regulation (EU, Euratom) 2024/2509

5. Lot

5.1 Lot technical ID : LOT-0001

Title : Organisational support to competent authorities in Member States for the implementation of Regulation 1938/2024 on Substances of Human Origin (SoHO)
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

5.1.1 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

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 : 5 400 000 Euro

5.1.6 General information

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 : 717703-2024

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

5.1.15 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
Organisation signing the contract : Health and Digital Executive Agency (HaDEA) , HADEA - Health and Digital Executive Agency

6. Results

Value of all contracts awarded in this notice : 4 620 577,07 Euro

6.1 Result lot ldentifier : LOT-0001

At least one winner was chosen.

6.1.2 Information about winners

Winner :
Leader of tendering party : KPMG ADVISORY SPA
Official name : ISTITUTO SUPERIORE DI SANITA ZADIG SRL
Tender :
Tender identifier : Consortium KPMG
Identifier of lot or group of lots : LOT-0001
Value of the tender : 4 620 577,07 Euro
Subcontracting : No
Contract information :
Identifier of the contract : HADEA/2024/OP/0057
Date on which the winner was chosen : 23/06/2025
Date of the conclusion of the contract : 30/07/2025
Information about European Union funds
Name of EU-financed project or programme : EU4Health Programme (2021/2027)
Organisation signing the contract : Health and Digital Executive Agency (HaDEA) , HADEA - Health and Digital Executive Agency

6.1.4 Statistical information

Received tenders or requests to participate :
Type of received submissions : Tenders submitted electronically
Number of tenders or requests to participate received : 4

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
Organisation signing the contract

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

8.1 ORG-0004

Official name : KPMG ADVISORY SPA
Size of the economic operator : Large
Registration number : IT04662680158
Postal address : VIA VITTOR PISANI 27
Town : MILANO
Postcode : 20124
Country subdivision (NUTS) : Extra-Regio NUTS 3 ( ITZZZ )
Country : Italy
Telephone : +3906809711
Roles of this organisation :
Tenderer
Group leader
Winner of these lots : LOT-0001

8.1 ORG-0005

Official name : ISTITUTO SUPERIORE DI SANITA
Size of the economic operator : Large
Registration number : IT03657731000
Postal address : Viale Regina Elena 299
Town : ROMA
Postcode : 00161
Country subdivision (NUTS) : Extra-Regio NUTS 3 ( ITZZZ )
Country : Italy
Telephone : +3906809711
Roles of this organisation :
Tenderer
Winner of these lots : LOT-0001

8.1 ORG-0006

Official name : ZADIG SRL
Size of the economic operator : Large
Registration number : 6000379604
Postal address : VIA AMPERE ANDREA MARIA 59
Town : MILANO
Postcode : 20131
Country subdivision (NUTS) : Extra-Regio NUTS 3 ( ITZZZ )
Country : Italy
Telephone : 0039027526131
Roles of this organisation :
Tenderer
Winner of these lots : LOT-0001

Notice information

Notice identifier/version : 052aeb89-67d8-437e-8d55-62123cec05be - 01
Form type : Result
Notice type : Contract or concession award notice – standard regime
Notice dispatch date : 31/07/2025 09:06 +02:00
Languages in which this notice is officially available : English
Notice publication number : 00506093-2025
OJ S issue number : 146/2025
Publication date : 01/08/2025