{
  "node_id": "eu-ema-centralised-procedure-regulation-726-2004",
  "title": "Regulation (EC) No 726/2004 of the European Parliament and of the Council of 31 March 2004 laying down Community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European Medicines Agency (Text with EEA relevance)",
  "domain": "Pharmaceuticals & Life Sciences",
  "version": "1.0.1",
  "last_updated": "2026-04-30",
  "bluf": "This regulation establishes the centralised procedure for authorising medicinal products in the European Union, mandating its use for high-technology products (e.g., biotech-derived), orphan medicinal products, and new active substances…",
  "paywall": {
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  "crosswalks": {
    "_available_keys": [
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    "_note": "Full crosswalk values included in vault response"
  },
  "dependencies": [
    "fda-21-cfr-part-314-nda-new-drug-application",
    "fda-biosimilar-pathway-351k-biologics-competition-act",
    "eu-gmp-annex-1-sterile-manufacture-2022",
    "ich-q10-pharmaceutical-quality-system-2008"
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  "primary_citations_count": 5,
  "workflow_steps_count": 10,
  "schema_fields_count": 10,
  "citation_preview": [
    "Regulation (EC) No 726/2004, Article 3(1) - Compulsory centralised procedure for high-technology medicinal products, particularly those derived from biotechnology",
    "Regulation (EC) No 726/2004, Article 3(1)(b) - Compulsory procedure for orphan medicinal products"
  ]
}