What Directive 2004/24/EC of the European Parliament and of the Council of 31 March 2004 amending, as regards traditional herbal medicinal products, Directive 2001/83/EC on the Community code relating to medicinal products for human use requires
Establishes a simplified registration procedure for traditional herbal medicinal products (THMPs) in the EU based on at least 30 years of traditional use, including 15 years within the EU, under Article 16a of Directive 2001/83/EC as inserted by this Directive. Applies to herbal product manufacturers and marketing authorization holders seeking market access without full clinical trial data.
Pillar: Pharmaceuticals & Life Sciences · Authority: European Parliament and Council of the European Union · Version: 1.0.1 · Last updated:
Primary source: https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX%3A32004L0024
SHA-256 integrity: 800989b129309d71cc30e37d910bc8a43ea0a78cd73e3bb0b173a68daae56947
Primary Citations — 5 traced to source
- Directive 2004/24/EC, Article 1 - Amendment to Directive 2001/83/EC by insertion of new Article 16a (Traditional herbal medicinal products)
- Directive 2004/24/EC, Article 16a(4) - Requirement of 30 years of medicinal use, including 15 years within the EU
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