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).

Additional information can be found at:
- https://likumi.lv/doc.php?id=192625
- General information on clinical trials: https://www.zva.gov.lv/?id=381&sa=381&top=333
- Minister of Health

Application forms to seek authorisation for the GMO aspects
Applicants should fill in annex 1 of the Cabinet Regulation No 457

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

Authorisation of GMO aspects:
Institute of Food Safety, Animal Health and Environment “BIOR”
Lejupes iela 3, Riga, LV-1076
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)