Legislation and guidance documents

1. Legislation

  • Law of 25 March 1964 on medicinal products (Dutch version - French version)
  • Royal Decree of 31 March 2009 in execution of article 6sexies of the Belgian Medicines Law of 25 March 1964 (Dutch versionFrench version)
  • Royal Decree of 16 July 2012 modifying the Royal Decree of 31 March 2009 in execution of article 6sexies of the Belgian Medicines Law of 25 March 1964 (Dutch versionFrench version)

2. Guidance documents

  • Detailed guidance for national scientific-technical advice (STA) requests
  • Guide to accelerated scientific-technical advice for medicines against COVID-19
  • Advice of the FAMHP on procedures for clinical trials and marketing authorisations
  • Belgian regulatory guidance on the use of genetically modified organisms in a clinical trial
  • Guidance: pilot project for simultaneous national scientific advice (SNSA)

3. Pilot projects

Last updated on 02/05/2022