H-1051 Budapest, Zrínyi u. 3.

Tel.: (1) 8869-300, E-mail: ogyei@ogyei.gov.hu

Mail: 1372 P.O. Box: 450.

MAGYAR

Call for Marketing Authorisation Holders

EMA’s human medicines committee (CHMP) and CMDh are requesting as a matter of precaution that marketing authorisation holders for human medicines containing chemically synthesised active substances review their medicines for the possible presence of nitrosamines and test all products at risk. If nitrosamines are detected in any of their medicines, marketing authorisation holders must inform authorities promptly so that appropriate regulatory actions can be taken.

Further guidance with regards the main steps of the mentioned risk evaluation can be found on the webpages of EMA and CMDh.

Please be aware that the Hungarian National Institute of Pharmacy and Nutrition (OGYÉI) imposes further national requirements that you can find in the CMDh practical guidance for Marketing Authorisation Holders of nationally authorised products (incl. MRP/DCP) in relation to the Art. 5(3) Referral on Nitrosamines highlited in red.

Please submit the risk evaluation outcome by using the nitrozamin@ogyei.gov.hu email address.

Last updated: 2020.03.10 14:14