Environmental risk assessment of medicinal products containing GMOs
Thematic Working Group
The Working Group on “Environmental risk assessment of medicinal products containing GMOs” (MED-OGM WG), reporting to the Expert Committee (CES) on “Biotechnologies”, is tasked with undertaking expert appraisal work within a regulatory framework.
In this capacity, according to current legislation, ANSES can be asked to issue opinions by:
- the DGPR, ANSM or ANMV, in connection with a centralised marketing authorisation (MA) application for a medicinal product containing or consisting of GMOs under Directive 2001/18/EC;
- the ANMV, in connection with an application for a clinical trial for a veterinary medicinal product manufactured in France that contains or consists of GMOs, in accordance with Articles R533-8 and R533-22 of the French Environmental Code;
- the ANSM, in connection with a national application for authorisation of early access or compassionate use for a human medicinal product containing or consisting of GMOs or for authorisation of an advanced therapy medicinal product prepared on an ad hoc basis, in accordance with Article R533-49 of the French Environmental Code.
> Access the list of this Working Group's Opinions and Reports (in French)
2024-2028 mandate
Chair: Marie-Bérengère TROADEC
Vice-Chair: Bernard KLONJKOWSKI
Members:
- Florian GUILLOU
- Maryline KOUBA
- François MEURENS
- Béatrice SEGURENS
- Marion SOURISSEAU