Regulation and guidance documents
1. Law
Law of 25 March 1964 concerning the medicinal products
(french version)
2. Royal Decree
Royal Decree of 31 March 2009 in execution of Article 6sexies of the Belgian Medicines law of 25-03-1964
3. Guidance document
Detailed guidance for National Scientific-Technical Advice (STA) requests (PDF, 165.85 Kb)