Approaching deadline for reporting the outcome of nitrosamine risk evaluations

09.01.2020

Risk evaluations that have been required for EU medicinal products, after potentially carcinogenic nitrosamines were identified in some classes of medicines, are still ongoing.

MAHs are required to conduct a risk evaluation in order to identify products at risk of N-nitrosamine formation or (cross-)contamination. The requirement applies to all medicines in EU that contain chemically synthesized active substances, including generic medicines and OTC products.

The outcome must be reported to concerned Competent Authorities by 26 March 2020 at the latest. If any findings indicate an immediate risk to public health, you should inform the Authorities immediately.

Further details and templates for reporting can be found on the following links:

Centrally authorized products:

https://www.ema.europa.eu/en/human-regulatory/post-authorisation/referral-procedures/nitrosamine-impurities

Nationally authorised products:

https://www.hma.eu/226.html