The GMO aspects of clinical trials with medicinal products for human use containing or consisting of GMOs can be regulated under either the contained use or the deliberate release frameworks (Directive 2001/18- Part B). A decision is taken case-by-case depending on factors such as the replicative capacity of the GMOs and whether specific containment measures are used to limit their contact with the general population and the environment and to provide a high level of safety for the general population and the environment. The applications to seek authorization under clinical trials and under GMO frameworks are not linked (i.e. the applicant can decide the timing of the submission of the GMO application).
Additional information can be found at:
- The Board for Gene Technology
- Gene Technology Act
- Finnish Medicines Agency
Application forms to seek authorisation for the GMO aspects
Contained use: http://geenitekniikanlautakunta.fi/suljettukaytto/mikro-organismit
Deliberate release: http://geenitekniikanlautakunta.fi/avoin-kaytto/hakemuksen-laatiminen
There is no public consultation in the framework of contained use. There is however a public consultation when the deliberate release framework applies (60 days).
National authorities involved
Authorization of clinical trials:
Finnish Medicines Agency FIMEA (CA for clinical trial applications of medicinal products).
Finnish Medicines Agency, Clinical Trials, P.O. Box 55, FI-00034 FIMEA
National Committee on Medical Research Ethics (TUKIJA): an expert on research ethics advising regional ethics committees in matters of ethical principle related to medical research and providing training.
National Supervisory Authority for Welfare and Health (Valvira), P.O. Box 210, FI-00281 Helsinki
Authorisation of GMO aspects:
Board for Gene Technology
P.O. Box 33, FI-00023, Helsinki
(Last reviewed by the Competent Authority: December 2017)