art_78__para_7__text_1

Regulation (EU) No 536/2014 of the European Parliament and of the Council of 16 April 2014 on clinical trials on medicinal products for human use, and repealing Directive 2001/20/EC Text with EEA relevance · European Union

The Commission shall specify, by means of implementing acts, the detailed arrangements for the inspection procedures including the qualification and training requirements for inspectors. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 88(2).

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Source: EUR-Lex (Cellar) · retrieved 2026-11-06 · Text as adopted (Official Journal); later amendments are not incorporated in this text.