The marketing authorisation holders to review their medicinal products for the existence of nitrosamine impurities
European Medicines Agency (EMA) and Co-ordination Group for Mutual Recognition and Decentralised Procedures - Human (CMDh) advise companies on steps to take to avoid nitrosamines in human medicines.
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 nitrosamine impurities and test all products at risk.
A notice to marketing authorisation holders to this effect is being published on the EMA and CMDh websites with information on the actions they should take. A questions-and-answers document is also available on EMA and CMDh websites. Details on the regulatory procedure for the presentation of the information for non-centrally authorised medicines will be discussed at the next CMDh meeting in October.
For more information:
Marjo-Riitta Helle, Head of Unit, tel. +358 29 522 3320
Marketing authorisation procedures:
Päivi Jutila, coordinator for MAs, tel. +358 29 522 3365
Marko Toivanen, Senior researcher, tel. +358 29 522 3445
Elina Jarho, Senior researcher, tel. +358 29 522 3331
Email addresses: email@example.com