15.02.2021
To the attention of marketing authorisation holders
Request for assessment of the risk of the presence of nitrosamine impurities in human medicinal products containing active substances obtained by chemical and biological synthesis
Regarding the referral procedure initiated according to the provisions of Art. 5 (3) of Regulation no. 726/2004, we remind you that the deadline for marketing authorisation holders to send to the NAMMDR the result of stage 1 – Evaluation of the risk of nitrosamine impurities in medicinal products for human use containing active substances obtained by chemical synthesis is 31 March 2021, and the deadline for medicinal products for human use containing biological active substances if 1 July 2021.
The documents shall be sent to nitrozamine@anm.ro in the format established by the European Medicines Agency (EMA) and the Coordination Group for Mutual Recognition and Decentralised Procedures (CMDh)
Please consult the updated versions:
– https://www.ema.europa.eu/en/human-regulatory/post-authorisation/referral-procedures/nitrosamine-impurities
– https://www.hma.eu