In accordance with the 14/2008 (IV.17) EÜM decree, OGYÉI (NIPN) is the competent authority regarding medicinal products for human use that contain or consist of genetically modified organisms (GMOs) or genetically modified microorganisms (GMMs), and chemicals that come into direct contact with the human body. Therefore, a GMO permit authorized by OGYÉI is required for every action with medicinal products involving genetechnological activities that are regulated by the XXVIII Genetechnology Act (1985). Such activities may include, but are not limited to: clinical trials, establishing laboratories for pharmaceutical research and development, and establishing manufacturing sites where human medicinal products that contain or consist of GMOs and/or GMMs are manufactured, used, or transported.
There are two major types of GMO legislations for medicinal products:
1. Based on Directive 2001/18/EC on the deliberate release of GMOs into the environment
2. Based on Directive 2009/41/EC on contained use of genetically modified micro-organisms
Clinical trials regarding medicinal products for human use containing or consisting of GMOs are regulated under the deliberate release framework in Hungary. Applications for clinical trials and for GMO legislations are separate, and each can be submitted in parallel or separately to OGYÉI. The GMO legislation procedure takes 130 days, which includes a 30 day public consultation period.
GMO legislation regarding the establishment of laboratories for pharmaceutical research and development, as well as the establishment of manufacturing sites where human medicinal products that contain or consist of GMOs and/or GMMs are manufactured, is regulated under the contained use framework.
Submissions of applications to seek authorisation of transportation of human medicinal products containing or consisting of GMOs should use the Application form for Transportation of GMOs
All submissions for deliberate release must contain the following:
- information relating to the GMO(s)
- information relating to the conditions of release and the potential receiving environment
- information on the interactions between the GMO(s) and the environment
- an environmental risk assessment
It is also required that documentation in the Summary Notification Information Format (SNIF) for the release of genetically modified organisms other than higher plants is submitted, which is added to an EU register available to the public (no confidential information).
GMO authorization applications are required to be translated to Hungarian.
The following links should be carefully studied before submission of applications:
In case of deliberate release -
1. 82/2003. (VII. 16.) FVM rendelet – available in Hungarian only
2. 132/2004. (IV. 29.) Korm. rendeletet,illetve annak 1. számú melléklete – available in Hungarian only
3. 142/2004. (IX. 30.) FVM-GKM együttes rendelet, illetve annak 1-es számú melléklete – available in Hungarian only
In case of contained use –
1. 132/2004. (IV. 29.) Korm. rendelet 2. és 3. sz. melléklete – available in Hungarian only
The following application forms should be used (when applicable) for deliberate release:
Investigational Medicinal Product containing Retro/lentivirus vector:
https://ec.europa.eu/health/sites/health/files/files/advtherapies/docs/gmcells_caf_en.pdf
Investigational Medicinal Product containing AAV vector:
https://ec.europa.eu/health/sites/health/files/files/advtherapies/docs/aavs_caf_en.pdf
Investigational Medicinal Product containing other vectors:
https://ec.europa.eu/health/sites/health/files/files/advtherapies/docs/vvs_caf_en.pdf
Other guidelines for GMO authorization application:
EMA ERA guideline:
Guideline on follow-up of patients administered with gene therapy medicinal products:
ICH Considerations - General Principles to Address Virus and Vector Shedding (EMEA/CHMP/ICH/449035/2009)
Guideline on the non-clinical studies required before first clinical use of gene therapy medicinal products (EMEA/CHMP/GTWP/125459/06).
Good Practice on the assessment of GMO related aspects in the context of clinical trials with AAV clinical vectors
https://ec.europa.eu/health/sites/health/files/files/advtherapies/docs/aavs_gp_en.pdf
Additional information can be found in Hungarian only at:
https://ogyei.gov.hu/gmo_engedelyezes/
