What Commission Regulation (EU) No 1235/2010 of 15 December 2010 amending, as regards pharmacovigilance of medicinal products for human use, Regulation (EC) No 726/2004, Regulation (EC) No 1394/2007, Directive 2001/83/EC and Directive 2001/82/EC requires
This regulation requires marketing authorisation holders to submit periodic safety update reports (PSURs) to the European Medicines Agency, as outlined in Article 28a of Directive 2001/83/EC. It applies to all medicinal products for human use authorised in the European Union.
Pillar: Pharmaceuticals & Life Sciences · Authority: European Commission · Version: 1.0.0 · Last updated:
Primary source: https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX%3A32010R1235
SHA-256 integrity: f37f5afcf7a895231bf3e4f102899293c8e6409d123717d278e4aa7871d82a3c
Primary Citations — 5 traced to source
- Commission Regulation (EU) No 1235/2010, Article 1
- Directive 2001/83/EC, Article 28a
+ 3 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-pharmacovigilance-regulation-1235-2010-psur.json — 6-field metadata
- Vault (full node): /api/v1/vault/nodes/eu-pharmacovigilance-regulation-1235-2010-psur.json — full 13-key payload, $0.01 USDC (L402/Skyfire/Direct Base)
- Canonical URL: https://bidda.com/intelligence/eu-pharmacovigilance-regulation-1235-2010-psur
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