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 version – French 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 version – French 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 on the pilot project for simultaneous national scientific advice (SNSA)
- Guidance on SNSA briefing book format and content
- Guideline for requesting a consultation procedure by a notified body regarding an ancillary medicinal substance in a medical device
3. Pilot projects
- Simultaneous national scientific advice (SNSA) pilot project: launch of phase 2
- Repurposing of authorised medicines: European pilot project to support non-profit organisations and academia