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Gene Therapy Legislation in Hungary

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 applications to seek authorization under clinical trials and under GMO frameworks can be submitted in parallel (i.e. the sponsor should apply for GMO authorization but does not need to wait for the GMO authorization before submitting the clinical trial application).

Additional information can be found at:
- https://www.ogyei.gov.hu/gmo_engedelyezes/
- Ministry of Agriculture and Rural Development
- National Institute of Pharmacy, OGYÉI

Application forms to seek authorisation for the GMO aspects
There is no specific application form for the submission, the required documentation is provided on the Institute’s website: https://www.ogyei.gov.hu/gmo_engedelyezes/

Public consultation
A 30 day public consultation is carried out via the OGYÉI’s (NIPN) website: https://www.ogyei.gov.hu/felhivas_tarsadalmi_konzultaciora/

National authorities involved

Authorization of clinical trials:
National Institute of Pharmacy and Nutrition (OGYÉI)
Ms. Ágnes Tamásné Németh
email: This email address is being protected from spambots. You need JavaScript enabled to view it.

Authorisation of GMO aspects:
National Institute of Pharmacy and Nutrition: it is the competent authority responsible for the granting of GMO authorizations
H-1051 Budapest, Zrínyi u. 3
Ms. Dóra Kovács
email: This email address is being protected from spambots. You need JavaScript enabled to view it.

Ministry of Agriculture: it provides an opinion
H-1055 Budapest Kossuth Lajos tér 11

GMO committee (Géntechnológiai Eljárásokat Véleményező Bizottság): it provides an opinion.
H-1024 Budapest Keleti Károly u. 24

(Last reviewed by the Competent Authority: December 2017)