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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  29

CELEX:  02024R1938-20240717

3. Where the SoHO competent authority receives a request for joint inspection of a SoHO entity, it may decline that request, in particular if:
(a) there has been a joint inspection in that SoHO entity within the previous year; or (b) a joint inspection of that SoHO entity is already being planned.
4. The SoHO competent authorities participating in a joint inspection shall conclude a written agreement prior to carrying out the joint inspection. Such a written agreement shall specify at least the following:
(a) the scope and objective of the joint inspection;
(b) the roles of the participating inspectors during and following the inspection, including the designation of the SoHO competent authority leading the inspection;
(c) the powers and responsibilities of each participating SoHO competent authorities. The SoHO competent authorities participating in the joint inspection shall commit themselves in the agreement referred to in the first subparagraph to jointly accept the results of that inspection. That agreement shall be signed by all the participating SoHO competent authorities, including the respective SoHO national authorities.
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  29

CELEX:  02024R1938-20240717

5. The SoHO competent authority leading the joint inspection shall be a SoHO competent authority of the Member State in which the joint inspection takes place and shall ensure that the joint inspection is carried out in accordance with the national legislation of that Member State. The SoHO competent authority supervising the SoHO entity to be inspected through a joint inspection shall inform that SoHO entity in advance about the joint inspection and its nature, unless there are reasonable and duly justified grounds to suspect that such prior communication would compromise the effectiveness of the joint inspection.
6. Member States may set up joint inspection programmes to facilitate routine joint inspections. Member States may operate such programmes under a single written agreement as referred to in paragraph 4.
7. For the purpose of coordinating and performing joint inspections, 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).
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  29

CELEX:  02024R1938-20240717

Joint inspections
1. At the request of one or more SoHO competent authorities, via their SoHO national authority to another SoHO national authority, inspections pursuant to Article 27(1) and Article 28(1) may be carried out with the participation of inspectors sent for that purpose by another Member State as a joint inspection.
2. With the prior consent of the SoHO national authority, the SoHO competent authority receiving a request for a joint inspection shall make all reasonable efforts to accept such a request, taking into account its available resources, in cases where:
(a) the SoHO entity to be inspected performs SoHO activities in more than one Member State, that have impact in the requesting Member State;
(b) the SoHO competent authorities of the requesting Member State require specialist technical expertise of another Member State for that inspection;
(c) the SoHO competent authorities of the Member State receiving the request agree that there are other reasonable grounds for conducting a joint inspection.