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
- Guideline for requesting a consultation procedure by a notified body regarding an ancillary medicinal substance in a medical device
- Simultanenous National Scientific Advice (SNSA) requests:
1. Guidance on the pilot project for simultaneous national scientific advice (SNSA)
2. SNSA Procedural Flow chart
3. Guidance on SNSA briefing book format and content
4. SNSA Participating NCAs list
5. SNSA Application form for SNSA and pre-CTA Advice
6. SNSA Feedback Questionnaire for Applicants
7. SNSA Meeting Minutes Template for Applicants
8. SNSA Final Advice Report Template
3. Pilot projects
- Repurposing of authorised medicines: European pilot project to support non-profit organisations and academia