What Regulation (EU) No 536/2014 on clinical trials on medicinal products for human use - Article 79 requires
This article establishes the European Commission's authority to conduct controls to verify Member State supervision and the compliance of non-EU clinical trial regulatory systems, requiring cooperation and the reporting of findings via the EU portal.
Pillar: Biotech & Genomics · Authority: European Parliament and Council of the European Union · Version: 1.0.0 · Last updated:
Primary source: https://eur-lex.europa.eu/legal-content/EN/TXT/HTML/?uri=CELEX:32014R0536
SHA-256 integrity: a71e105e3094b46e340ab44e7fe2835768f9823b4fd839565782262af5af0101
Primary Citations — 5 traced to source
- Article 79, paragraph 1: The Commission may conduct controls in order to verify: (a) whether Member States correctly supervise compliance with this Regulation;
- Article 79, paragraph 1(b): ...whether the regulatory system applicable to clinical trials conducted outside the Union ensures that point 8 of the Introduction and general principles contained in Annex I to Directive 2001/83/EC is complied with;
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