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CMDh: Update of Q&As for Generic Drug Submissions
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After the necessary adjustments were made in October 2025 as a result of the new 'Variations Regulation' (Commission Delegated Regulation (EU) 2024/1701 of 11 March 2024 amending Regulation (EC) No 1234/2008 as regards the examination of variations to the terms of marketing authorisations for medicinal products for human use), the document 'Q&A - Generic Applications' has been updated again in January 2026.
In the new revision (Revision 8), changes and additions were made exclusively to the question and answer texts for question '8.b. Is it possible for generics to apply for fewer modes of administration than the originator?' First, the word "oral" in connection with 'administration' was deleted from the above question. Furthermore, additional requirements for generics in the area of enteral administration were added and explanations were included. A few formal adjustments were also made.
Pleas see the website of the CMDh (Co-ordination Group for Mutual Recognition and Decentralised Procedures - Human) for the Revision 8 of the 'Q&A - Generic Applications' can be found in both versions (with and without change tracking).
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