Guidelines for marketing authorisation holders for notifying nitrosamine evaluation outcomes

The European Medicines Agency (EMA) and the Co-ordination Group for Mutual Recognition and Decentralised Procedures - Human (CMDh) working under the Heads of Medicines Agencies (HMA) have requested all marketing authorisation holders to evaluate the potential risk of the presence of nitrosamine impurities.  The request concerns all human medicinal products containing chemically synthesised active pharmaceutical ingredients. The evaluation is to be performed in 3 steps:

• Step 1 – Risk evaluation
• Step 2 – Confirmatory testing
• Step 3 – Changes to the marketing authorisation

EMA and CMDh have jointly agreed on the use of predefined templates for submitting the outcome of the risk evaluation (step 1) and confirmatory testing (step 2) to the competent authorities.

Press release and guidelines for submitting the responses concerning nationally authorised and MRP/DCP products are available on the CMDh website.

CMDh press release on the subject

Templates and guidance on the CMDh website

Step 1 responses shall be submitted to Fimea by e-mail at [email protected] no later than 26 March 2020. Responses concerning different strengths of the same medicinal product can be submitted to Fimea with a single notification if the outcome is the same for all strengths.

Any questions you may have should be sent to: [email protected]

Further information:

https://www.ema.europa.eu/en/news/ema-advises-companies-steps-take-avoid-nitrosamines-human-medicines

https://www.fimea.fi/web/en/-/the-marketing-authorisation-holders-to-review-their-medicinal-products-for-the-existence-of-nitrosamine-impurities