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Highlights from the EMA industry platform meeting held on 9 November 2015 on the operation of the ce

The following records highlights and action points from the 2nd Industry Platform meeting held on 9 November 2015 on topics presented and discussed. The meeting started with an overview of recent changes in the centralised procedure, followed by presentations and discussions on the survey on postauthorisation procedures, special aspects of variations (operational management of RMP updates during post-authorisation), labelling review (challenges in the review of mock-ups and specimens) as well as optimisation of early access tools (revision of the guidelines on Accelerated Assessment and Conditional Marketing Authorisation).

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