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    Information for marketing authorisation holders: risk of the presence of nitrosamine impurities

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    With regard to the Art. 5(3) referral, MAHs are requested to evaluate the risk of the presence of nitrosamine impurities in their human medicinal products containing chemically synthesized active pharmaceutical ingredients (“Information on nitrosamines for marketing authorisation holders”).

    According to the the CMDh practical guidance for Marketing Authorisation Holders of nationally authorised products (incl. MRP/DCP) in relation to the Art. 5(3) Referral on Nitrosamines this evaluation should be performed in 3 sequential steps and the results have to be submitted for all nationally authorised (incl MRP and DCP) products.  

    Depending on the results of the risk assessment additional testing and variations to amend the marketing authorisations may be needed.  

    Step 1 – Risk evaluation- conclusions to be submitted until  26.03.2020

    Step 1: response - no risk identified;

    Step 1: response - risk identified (doc);

    Step 1: response - risk identified (xls);

    Step 2 – Confirmatory testing, deadline 26.09.2022

    Step 2: response - no nitrosamine detected;

    Step 2: response - nitrosamine detected (doc);

    Step 2: response - nitrosamine detected (xls);

    Step 3 Changes to the marketing authorization, deadline 26.09.2022

    The information should be sent to nitrosamines@ravimiamet.ee

    Additional information, incl Q&A and practical guidance has been published on the CMDh homepage “Advice from CMDh”