What Commission Regulation (EC) No 507/2006 of 29 March 2006 on the conditional marketing authorisation for medicinal products for human use falling within the scope of Regulation (EC) No 726/2004 of the European Parliament and of the Council requires
This regulation establishes a framework for granting conditional marketing authorisation (CMA) to medicinal products that address an unmet medical need, based on a positive risk-benefit balance with less than comprehensive clinical data, provided the applicant commits to completing specific post-authorisation obligations. As per Article 4, this authorisation is valid for one year and is subject to annual reassessment.
Pillar: Medical & Healthcare · Authority: European Commission · Version: 1.0.0 · Last updated:
Primary source: https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32006R0507
SHA-256 integrity: ab55f2a47746f5fd675b5764e2dc2edcec7f3ce5e3de9b943894469aa0650959
Primary Citations — 6 traced to source
- Commission Regulation (EC) No 507/2006, Article 2 - Scope
- Commission Regulation (EC) No 507/2006, Article 4 - Conditions for granting a conditional marketing authorisation
+ 4 more citations (full bibliography, deterministic workflow, actionable schema and crosswalks) included in the vault unlock — $0.01 via Skyfire / L402 / Direct Base USDC.
Access
- Discovery (free): /api/v1/nodes/eu-conditional-marketing-authorisation-507-2006.json — 6-field metadata
- Vault (full node): /api/v1/vault/nodes/eu-conditional-marketing-authorisation-507-2006.json — full 13-key payload, $0.01 USDC (L402/Skyfire/Direct Base)
- Canonical URL: https://bidda.com/intelligence/eu-conditional-marketing-authorisation-507-2006
- Back to registry: Browse all 10,090 compliance nodes