Regulation and guidance documents

1. Regulation

Law of 25 March 1964 concerning the medicinalproducts (french version)

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

2. Guidance documents

Detailed guidance for National Scientific-Technical Advice (STA) requests

FAMHP advice for CTA and MAA versus STA - Discussion paper 5.0 

Belgian regulatory guidance on the use of genetically modified organisms in a clinical trial (April 2019)

SNSA Guidance document

Last updated on 05/02/2020