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GMP News

EMA: Q&A document for "Centralised Procedures" updated again

In June 2024 the Q&A documents relating to centralised marketing authorization procedures were updated again and published on the website of the European Medicines Agency (EMA). These Q&A catalogues are intended to provide assistance and guidelines for Marketing Authorization Holders and applicants for centralised procedures and provide answers to possible questions at different stages of the centralized marketing authorization application.

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CMDh/HMA: New Update of the Q&A List on Variations

A new version (Rev. 62) of the "Q&A - List for the submission of variations for human medicinal products according to Commission Regulation (EC) 1234/2008" was created in May 2024 and published on the HMA (Heads of Medicines Agencies) website. The new version of the Q&A catalogue now includes question 3.32. and its answer.

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CMDh/EMA: Appendix 1 for Nitrosamines updated again

In July 2024, new substances were added to Appendix 1 of the Nitrosamine Q&A document "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" and some existing entries in the list were updated.

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