The State Agency of Medicines would like to remind you about the approaching deadline for submission of risk assessment regarding potential presence of nitrosamine impurities in medicines containing chemical active substances. The deadline for submission of the risk assessment in 26 March 2020. The requirement is applicable to all authorised medicinal products containing a chemical active substance (active substances).
Information regarding the procedure, requirements, template forms, question‑and‑answer documentation and deadlines are indicated and published on the websites of both the European Medicines Agency (https://www.ema.europa.eu/en/human-regulatory/post-authorisation/referral-procedures/nitrosamine-impurities) and the Co-ordination Group for Mutual Recognition and Decentralised Procedures – Human (CMDh) (https://www.hma.eu/226.html#c6548).
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Additional information regarding the plan of action established by the European Directorate for the Quality of Medicines and HealthCare (EDQM) in relation to nitrosamine impurities is available on the EDQM website https://www.edqm.eu/en/edqms-response-nitrosamine-contamination.
