What Regulation (EU) No 536/2014 of the European Parliament and of the Council on clinical trials on medicinal products for human use - Article 38: Temporary halt or early termination by the sponsor for reasons of subject safety requires
Sponsors must notify Member States concerned via the EU portal without undue delay, and no later than 15 days, of any temporary halt or early termination of a clinical trial due to a change in the benefit-risk balance.
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: 68bf0bc862dc8d45d6d7c60ec2bf40cd15de01de4045e4f8f459afb13e2f77c8
Primary Citations — 5 traced to source
- Article 38(1): For the purposes of this Regulation, the temporary halt or early termination of a clinical trial for reasons of a change of the benefit-risk balance shall be notified to the Member States concerned through the EU portal.
- Article 38(1): That notification shall be made without undue delay but not later than in 15 days of the date of the temporary halt or early termination.
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