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:
- https://lakemedelsverket.se/malgrupp/Foretag/Lakemedel/Kliniska-provningar/Ansokan-steg-for-steg/
- 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.

Public consultation
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
e-mail: This email address is being protected from spambots. You need JavaScript enabled to view it.

(Last reviewed by the Competent Authority: December 2017)