What Regulation (EU) No 536/2014 on clinical trials on medicinal products for human use - Article 5: Submission of an application requires
Sponsors seeking authorisation for a clinical trial must submit a complete application dossier to the relevant Member States via the central 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: a16d2f6e67720b282f3aa969dfa884472b8fcbbd6fb7b9c75b43a822814647c9
Primary Citations — 5 traced to source
- Article 5(1): In order to obtain an authorisation, the sponsor shall submit an application dossier to the intended Member States concerned through the portal referred to in Article 80 (the 'EU portal').
- Article 5(1): ...the sponsor shall submit an application dossier...
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