Law of 25 March 1964 concerning the medicinalproducts (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
Royal Decree of July 16th 2012 modifying the Royal Decree of March 31st 2009 in execution of Article 6sexies of the Belgian Medicines law of March 25th 1964
3. Guidance document
Detailed guidance for National Scientific-Technical Advice (STA) requests
FAMHP advice for CTA and MAA versus STA - Discussion paper 5.0