What Regulation (EC) No 1901/2006 of the European Parliament and of the Council on Medicinal Products for Paediatric Use requires
This regulation requires pharmaceutical companies to submit a Paediatric Investigation Plan (PIP) for new medicinal products, as outlined in Article 7 of the regulation, and provides rewards for compliance, including a 6-month patent extension.
Pillar: Pharmaceuticals & Life Sciences · Authority: European Parliament and Council · Version: 1.0.1 · Last updated:
Primary source: https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX%3A32006R1901
SHA-256 integrity: 231bdd60d80550addd9732b70aa23a3bbcab204ce5fc90efbfeb4f76dd514bc6
Primary Citations — 5 traced to source
- Regulation (EC) No 1901/2006, Article 7: Paediatric investigation plans
- Regulation (EC) No 1901/2006, Article 10: Clinical trials
+ 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-paediatric-regulation-1901-2006-pips.json — 6-field metadata
- Vault (full node): /api/v1/vault/nodes/eu-paediatric-regulation-1901-2006-pips.json — full 13-key payload, $0.01 USDC (L402/Skyfire/Direct Base)
- Canonical URL: https://bidda.com/intelligence/eu-paediatric-regulation-1901-2006-pips
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