NLGeneTherapy object

Specific requirements

Yes

Applicable legal framework

For clinical gene therapy:
- Medical Research Act 488/1999 (including amendment 295/2004) (see also the unofficial translation published by the Ministry of Social Affairs and Health: Finnish Medical Research Act 488/1999, English version)
- Medicines Act and Medicines Decree (see the unofficial translation of Medicines Act and Decree (Finland), English version)
Due to the fact that gene therapy medicinal products are covered by the Medical Research Act 488/1999 the legal procedure is generally the same as for medicinal products for human use. Exceptions and peculiarities regarding EC and CA application procedures are covered in Section 87 (2-4) Medicines Act 395/1987 and Section 10d (10) of the Medical Research Act.

- Gene Technology Act No. 377/1995 (unofficial English translation): regulates genetic research and the use of GMOs (in preclinical research, in particular)

- 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