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 application is assessed by the National Environmental Protection Agency ("NEPA") which consults the Biosafety Commission. Authorization of GMO aspects is required prior to the submission of the clinical trial application.
NEPA decides if the notification dossier is accepted within 15 days. After the notification is accepted, NEPA transmits, within 10 days, a copy of the notification dossier to the involved authorities and to BC. The Biosafety Commission gives the written consent within 60 days and sends it to the competent authority and to the involved authorities, which transmit their written consent in 15 days, after the BC to NEPA. Within 90 days of receipt of the notification NEPA gives a favourable or unfavourable notice to the applicant for the deliberate release into the environment of GMOs.
Additional information can be found at:
Application forms to seek authorisation for the GMO aspects
Applicants should present a notification dossier to NEPA containing: the request for authorisation, the technical dossier, the notification summary, the risk assessment on human health and environment, a declaration to assume the responsibility for any harm which the deliberate release could cause, the information for the public, and evidence of payment of the fee.
All the notifications are published on JRC and NEPA’s websites. NEPA starts the public consultation for a period of 30 days. The summary of the notification is published on the NEPA website and at Local Environmental Protection Agencies (LEPAs) or at the local municipality where the deliberate release is intended. If necessary, public debates are organized during the authorization procedure for deliberate release of GMOs. The risk assessments submitted by the applicants and the summary of the decisions taken by the competent authority are published on the NEPA’s website.
National authorities involved
Authorization of clinical trials:
National Agency for Medicines and Medical Devices
Ministry of Health
Authorisation of GMO aspects:
National Environmental Protection Agency
Authorities with an advisory role in the decision making process by NEPA
The Biosafety Commission (BC)
Ministry of Health
(Last reviewed by the Competent Authority: December 2017)