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@nngyk.gov.hu email address.