CRED Managing Variations Effectively

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Aspects of WS of purely national MAs

Regulation 712/2012 Chapters IV There are two aspects

Section 1 – Special procedures Article 20 – Worksharing - extend worksharing to also include purely national MAs along with other procedure types - [application of the same change(s) across the same product that is only authorised independently in multiple Member States on a purely national basis will be processed as a worksharing.] Worksharing involves: more than one MA across more than one CA (same MAH)

- [application of the same change(s) across multiple purely national MAs in one Competent Authority will be processed as a grouping (13(2)(c))]

This is grouping: more than one MA, in one CA (same MAH)

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