CRED Managing Variations Effectively

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reporting : Article 7.2(a) + Article 8 Article 7.2(a) where the same minor variations of type IA to the terms of one or several marketing authorisations owned by the same holder are notified at the same time to the same relevant authority , a single notification as referred to in Articles 8 and 14 may cover all such variations.

… and Article 8 annual reporting: • allows submission as a single annual ‘report’ of a group of changes • not a ‘report’ as such (no summary overview) • compilation of Type IA changes However: • max.12 month (post-implementation of first Type IA) for notifying changes • makes sense to submit earlier if opportunity arises within a related submission (IA IN , IB etc)

108 MHRA has not seen any annual reports: Industry reluctant/no systems in place/can’t use for Type IA (in) /issues with eCTD sequencing - little benefit ?