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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 47 CELEX: 02024R1938-20240717 Importing SoHO establishment authorisation
1. SoHO establishments shall not import SoHO without a prior importing SoHO establishment authorisation. 2. In the case of import of human plasma that is intended to be used for the manufacture of medicinal products regulated by other Union legislation and which is included in a plasma master file (PMF) as referred to in Directive 2001/83/EC, paragraph 1 of this Article shall not apply as the importers are to be authorised by other Union legislation. In those cases, the importers shall be registered as SoHO entities. 3. SoHO entities responsible for human application to a specific SoHO recipient may submit a request to their SoHO competent authorities for a derogation from the requirement for an importing SoHO establishment authorisation in the circumstances referred to in Article 26(6). 4. The Commission shall adopt delegated acts in accordance with Article 77 to supplement this Regulation by laying down obligations and procedures for importing SoHO establishments regarding the import of SoHO in order to verify equivalent standards of quality, safety and effectiveness of such imports. |