NLClinicalTrialsIMP object
Applicable national regulations
Transposition of (CT) Directive 2001/20/EC
Other
Transposition of (CT) Directive 2001/20/EC (or comparable national legal framework)
Law of 7 May 2004 relating to experiments on human people (Loi relative aux expérimentations sur la personne humaine).
This law (“Law 7 May 2004”) is the transposition of the Directive 2001/20/EC into national legislation, but also applies to any other research, such as gene therapy.
It has been modified several times and is only available in French and Dutch.
Applicable to ATMP/ GMO trials
Yes
Other applicable regulations/ implementing provisions (Acts, laws, decrees, ordinances, circulars, etc)
Other applicable legal texts (laws, Royal decrees, Circulars) including corresponding links is provided on the FAMPH website in section: Human medicines > Medicines > Medicines > Research & Development > Clinical trials (Legal texts)
