Transcription of Questions and answers for marketing authorisation holders ...
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Questions and answers for marketing authorisation holders ...
Official address Domenico Scarlattilaan 6 1083 HS Amsterdam The Netherlands An agency of the European Union Address for visits and deliveries Refer to Send us a question Go to Telephone +31 (0)88 781 6000 European Medicines Agency, 2021. Reproduction is authorised provided the source is acknowledged. 14 October 2021 EMA/409815/2020 Questions and answers for marketing authorisation holders /applicants on the CHMP Opinion for the Article 5(3) of Regulation (EC) No 726/2004 referral on nitrosamine impurities in human medicinal products Questions and answers for marketing authorisation holders /applicants on the CHMP Opinion for the Article 5(3) of Regulation (EC) No 726/2004 referral on nitrosamine impurities in human medicinal products EMA/409815/2020 Page 2/17 Table of contents Introduction .. 3 1. Should the risk of presence of nitrosamines be considered for all human medicinal products? .. 4 2. What is the call for review ? .. 4 3. For the call for review for chemically synthesised and biological medicinal products, when and how should MAHs report steps 1 and 2 to competent authorities?
nitrosamine impurities in human medicinal products provides general guidance and recommendations on mitigating and preventing the presence of nitrosamines in human medicinal products. In this context all MAHs/Applicants of human medicinal products should work with the manufacturers of their
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