NLGeneTherapy object

Specific requirements

Yes

Applicable legal framework

(1) The Medicines for Human Use (Clinical Trials) Regulations 2004
(2) The Medicines for Human Use (Clinical Trials) Amendment Regulations 2006
(3) The Medicines for Human Use (Clinical Trials) Amendment (No.2) Regulations 2006
(4) The Medicines for Human Use (Advanced Therapy Medicinal Products and Miscellaneous Amendments) Regulations 2010
Due to the fact that gene therapy medicinal products are covered by the Medicines for Human Use Regulations 2004 the legal procedure is generally the same as for medicinal products for human use. Exceptions and peculiarities regarding CA and EC procedures are provided in part 3 section 13, 14, 15 and 19 of the Medicines for Human Use Regulations 2004.
(5) 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.

This project (ECRIN Integrating Activity/ECRIN-IA) has received funding from the European Union’s Seventh Framework Programme for research, technological development and demonstration under grant agreement no 284395
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