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Regulation (EU) 2024/1938 of the European Parliament and of the Council of 13 June 2024 on standards of quality and safety for substances of human origin intended for human application and repealing Directives 2002/98/EC and 2004/23/EC (Text with EEA relevance)

article  22

CELEX:  02024R1938-20240717

Joint SoHO preparation assessments
1. At the request of one or more SoHO competent authorities, via their SoHO national authority to another SoHO national authority, SoHO preparation assessments referred to in Article 20 may be carried out by SoHO preparation assessors assigned by more than one Member State, as a joint SoHO preparation assessment.
2. With the prior consent of the SoHO national authority, the SoHO competent authority receiving a request for a joint SoHO preparation assessment shall make all reasonable efforts to accept such a request, taking into account its available resources.
3. The SoHO competent authorities participating in a joint SoHO preparation assessment shall conclude a written agreement prior to carrying out the joint SoHO preparation assessment. Such a written agreement shall specify at least the following:
(a) the scope of the joint SoHO preparation assessment;
(b) the roles of the participating SoHO preparation assessors during and following the joint SoHO preparation assessment;
(c) the powers and responsibilities of each participating SoHO competent authority.
Regulation (EU) 2024/1938 of the European Parliament and of the Council of 13 June 2024 on standards of quality and safety for substances of human origin intended for human application and repealing Directives 2002/98/EC and 2004/23/EC (Text with EEA relevance)

article  22

CELEX:  02024R1938-20240717

The SoHO competent authorities participating in the joint SoHO preparation assessment shall commit themselves in the agreement referred to in the first subparagraph to jointly accept the results of that assessment. That agreement shall be signed by all the participating SoHO competent authorities, including the respective SoHO national authorities.
4. Member States may set up joint SoHO preparation assessment programmes to facilitate frequent or routine joint SoHO preparation assessments. Member States may operate such programmes under a single written agreement as referred to in paragraph 3.
5. For the purpose of coordinating and performing joint SoHO preparation assessments, SoHO competent authorities shall take into account the relevant best practices documented and published by the SCB, as referred to in Article 69(1), point (d).