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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  30

CELEX:  02024R1938-20240717

Specific requirements concerning inspectors
1. Inspectors shall possess a diploma, certificate or other evidence of formal qualifications in a relevant field, awarded on completion of a university course of study or a course recognised as equivalent by the Member State concerned. In exceptional cases, SoHO competent authorities may consider that a person’s considerable and relevant experience exempts that person from the requirements set out in the first subparagraph.
2. Before inspectors take up their duties, SoHO competent authorities shall provide inspectors with a specific induction training. For the specific induction training, 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  30

CELEX:  02024R1938-20240717

3. SoHO competent authorities shall ensure that the specific induction training includes at least the following:
(a) the inspection techniques and procedures to be followed, including practical exercises;
(b) an overview of relevant Union and national inspection guidance, where applicable, and the best practices documented and published by the SCB, as referred to in Article 69(1), point (d);
(c) an overview of the authorisation systems in the Member State concerned;
(d) the legal framework applicable to the performance of SoHO supervisory activities;
(e) an overview of the technical aspects concerning SoHO activities;
(f) SoHO technical guidelines as referred to in Articles 56 and 59;
(g) an overview of the organisation and functioning of national regulatory authorities in the field of SoHO and related fields;
(h) an overview of the national healthcare system and SoHO organisational structures in the Member State concerned.
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  30

CELEX:  02024R1938-20240717

4. SoHO competent authorities shall ensure that the specific induction training is complemented by specialised training for inspection of specific types of SoHO establishments and by continuous training, as appropriate. SoHO competent authorities shall make all reasonable efforts to ensure that inspectors participating in joint inspections have completed the relevant Union training referred to in Article 70(1) and are included in the list referred to in Article 70(5).
5. Inspectors may be assisted by technical experts provided that the SoHO competent authorities ensure that those experts comply with the relevant requirements of this Regulation.