What Regulation (EU) No 536/2014 of the European Parliament and of the Council on clinical trials on medicinal products for human use - Article 44: Assessment by Member States requires
This article requires Member States to cooperate in assessing safety information received from the Agency and to involve responsible ethics committees in this assessment where mandated by national law.
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: 4d780e57a305fc3427af6fb384624c7bbfa1ffb4e6be6f677a4aae748278af2e
Primary Citations — 5 traced to source
- Article 44(1): The Agency shall, by electronic means, forward to the Member States concerned the information reported in accordance with Article 42 and 43.
- Article 44(2): Member States shall cooperate in assessing the information reported in accordance with Articles 42 and 43.
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