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

3. Pilot projects

Last updated on 06/06/2024