Gene Therapy Legislation in Sweden
The GMO aspects of clinical trials with medicinal products for human use containing or consisting of GMOs are regulated under the deliberate release framework- Part B of Directive 2001/18. A single submission procedure applies to seek authorization under the clinical trials framework and under the GMO framework (submission to Medical Products Agency).
Additional information can be found at:
- Medical Products Agency (MPA)
- Swedish Gene Technology Advisory Board
- Ministry of Health and Social Affairs
Application forms to seek authorisation for the GMO aspects
There is no formal application form for GMO. Applicants should submit a SNIF and an ERA according to Directive 2001/18.
The ERA and SNIF is referred to members of the Swedish GMO network. The referral time is 30 days. In total, the maximum approval time for a clinical trial including a GMO is 90 days. A short summary about the trial (non-confidential information) is also published on the MPA webpage.
National authorities involved
Medical Products Agency (Lakemedelsverket)
Uppsala Science Park, Dag Hammarskjölds väg 42, 75237 Uppsala
(Last reviewed by the Competent Authority: December 2017)