Medicinal products containing GMOs
In addition to pharmaceutical regulations, manufacturing of medicinal products containing GMOs and their pre-clinical and clinical trials in Finland are covered by the Gene Technology Act (377/1995), unless the product already has a marketing authorisation in the EU. The same applies to such GMO medicinal products that have no marketing authorization, but are used in individual cases for special therapeutic reasons. The characteristics of the GMO and its use and the proposed risk management procedures will then determine whether the intended GMO use is considered as contained use or deliberate release (“field trial”) in accordance with the gene technology regulations.
More detailed information on the procedures for medicinal products can be found in the guidance document prepared by the Board. We recommend the operator to contact the Secretariat of the Board before submitting a notification or application.
Medicinal GMO products intended to treat or prevent coronavirus are temporarily exempted from the notification and application procedures of gene technology regulations when these products are used in clinical trials or under certain conditions in the treatment of patients. This derogation, which does not apply to the manufacturing phase of the product, is valid for the duration of the pandemic situation and is based on Regulation (EU) 2020/1043 of the European Parliament and of the Council.
Guidelines on medicinal products containing GMOs
- Production and research use of medicinal products containing genetically modified organisms from the perspective of the Gene Technology Act (updated 12 May 2017, please note that the English version is currently outdated)
The forms and other material that are needed to draft a notification or application can be found at the contained-use page or the field test page accordingly.