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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 83 CELEX: 02024R1938-20240717 Transitional provisions concerning SoHO not addressed explicitly in Directive 2002/98/EC or 2004/23/EC
Entities carrying out one or more of the SoHO activities referred to in Article 2(1), points (c)(i), (iv) to (ix) and (xii), of this Regulation, in respect of SoHO not addressed explicitly in Directive 2002/98/EC or 2004/23/EC, before 7 August 2027 ◄ shall be allowed to continue such activities until 8 August 2028 ◄ , without applying this Regulation, except for the following requirements: (a) registration as SoHO entities pursuant to Article 35 of this Regulation; (b) application for any and all relevant SoHO preparation authorisations, where required pursuant to Article 38 of this Regulation; (c) application for a SoHO establishment authorisation, where required pursuant to Article 45 of this Regulation; (d) compliance with the standards referred to in Chapters VI and VII of this Regulation for the SoHO activities carried out during the transition phase.
Such SoHO entities shall comply with the requirements referred to in the first paragraph, points (b) and (c), by 8 November 2027 ◄ . |