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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 49 CELEX: 02024R1938-20240717 Releasing officer
1. In cases where a SoHO establishment releases SoHO, it shall appoint one or more releasing officers. 2. The releasing officer shall be in possession of a diploma, certificate or other evidence of formal qualifications in the field of medical, pharmaceutical or life sciences awarded on completion of a university course of study or a course recognised as equivalent by the Member State concerned and shall have at least 2 years of experience in the relevant field. 3. The releasing officer may delegate the task of releasing SoHO as referred to in paragraph 1 to other persons who shall be qualified by training and experience to perform such a task. In such cases, those persons shall perform that task under the responsibility of the releasing officer who will always be responsible for the release.
The responsibility for releasing SoHO may be delegated to an alternate in the event of short-term absence of the releasing officer, provided that the alternate meets the requirements set out in paragraph 2. |