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

Recommendation

17/18 September 2024

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A new version of the "Q&A - List for the submission of variations for human medicinal products according to Commission Regulation (EC) 1234/2008" was prepared in December 2021 and published on the HMA (Heads of Medicines Agencies) website. General topics regarding the variation procedures and their submissions for human medicinal products are listed and answered.

The new version of the question and answer catalogue now only refers to medicinal products for human use, so that all previous references and information about veterinary medicinal products are no longer present in this version or have been deleted. As a result, almost all chapters of the document have been revised and thus almost all sections contain changes, which are clearly highlighted by track changes in the text and are thus easy to follow in the new version.

Similarly, updates have been made due to the new developments in the area of "electronic submission". These include, for example, the following questions and sections:

• 2.7. "How is the documentation for a grouped variation or worksharing application to be submitted?"
• 4.16. "Under which category can I submit a variation or worksharing application for a harmonisation of the quality dossier when the products concerned were not part of an Article 30 referral?"
• 4.18. "How should proposed safety variations, such as the addition of a contraindication or a restriction in an indication or in the posology of a product, be submitted to the authorities when the same MAH has several purely national marketing authorisations in the EU? "

Here you can find both versions of the new "Q&A - List for the submission of variations for human medicinal products according to Commission Regulation (EC) 1234/2008" - with and without track changes.