NLGeneTherapy object
Yes
(1) The Law of 7 May 2004 concerning experiments on humans (Loi relative aux expérimentations sur la personne humaine/Wet inzake experimenten op de menselijke person) (see: Law of 7 May 2004, French version (consolidated version) and unofficial translation: Law of 7 May 2004, English version).
Art. 13 § 3 and § 4, Art. 11 § 10 and § 11 and Articles 17 and 18 contain special provisions regarding gene therapy.
(2) As a matter of principle Good Manufacturing Practice (GMP) is required for the manufacture of medicinal products for human use. The EC-GMP-Guideline covers this issue.
Due to the fact that gene therapy medicinal products are covered by the Law of 7 May 2004, the legal procedure is generally the same as for medicinal products for human use. Any specific requirements are indicated in the applicable sections.