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. The applications to seek authorization under clinical trials and under GMO frameworks can be submitted in parallel (i.e. the sponsor should apply for GMO authorization but does not need to wait for the GMO authorization before submitting the clinical trial application).
Application forms to seek authorisation for the GMO aspects
Applicants should fill in annex 1 of the Cabinet Regulation No 457
There is a web-based consultation (see Section 5 of the Cabinet Regulation No. 457).
National authorities involved
Authorization of clinical trials:
State Agency of Medicines of the Republic of Latvia
Jersikas street 15, Riga, LV-1003
Authorisation of GMO aspects:
Institute of Food Safety, Animal Health and Environment “BIOR”
Lejupes iela 3, Riga, LV-1076
(Last reviewed by the Competent Authority: December 2017)