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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 45 CELEX: 02024R1938-20240717 SoHO establishment authorisation
1. SoHO establishments shall not carry out any of the SoHO activities that would qualify them as a SoHO establishment as defined in Article 3, point (35), without prior SoHO establishment authorisation. This shall apply regardless of whether all SoHO activities are carried out by the SoHO establishment itself or whether one or more are contracted to another SoHO entity.
In the case of a decision on the need for a SoHO establishment authorisation under Article 24(4), the SoHO entity shall not carry out the SoHO activity requiring SoHO establishment authorisation as communicated by the SoHO competent authority, without prior SoHO establishment authorisation. |
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 45 CELEX: 02024R1938-20240717 2. In cases where SoHO establishments contract other SoHO entities to perform a part or all of certain SoHO activities, the SoHO establishments shall ensure that those contracted SoHO entities carry out those contracted SoHO activities in compliance with this Regulation. Such contracted SoHO entities may be audited by the contracting SoHO establishment or inspected by the SoHO competent authority, in particular in cases where the contracted SoHO entity has not been accredited, certified or authorised, as part of a national programme, for the specific contracted SoHO activities. 3. The requirement to obtain a SoHO establishment authorisation shall be without prejudice to more stringent measures adopted by a Member State in accordance with Article 4 and directly affecting the SoHO activities carried out in the SoHO establishment or contracted SoHO entities concerned pursuant to paragraph 2 of this Article. |