CRED Managing Variations Effectively

Brexit: Implementation Period (IP) Starting 30 March 2019 until 31 December 2020 • During the IP, the UK will no longer be an EU MS – but market access will continue on current terms – Same rules and terms remain in place until end 2020 • EU will accept UK batch release, UK QP certification and testing, UK legal establishment of the MAH and other key roles • MHRA will observe and take part in discussions but not vote in EMA and EU committees and groups • MHRA will not conduct assessments as a ‘leading authority’ on behalf of the EU – subject to clarification/discussion – No changes to variations system – same rules and procedures apply – MAHs required to change from UK RMS to another MS (by end March 2019) – this is not a variation (see CMDh guidance) – MAHs to send email to MR-Dcprocedures@mhra.gov.uk – MHRA will continue as a CMS for variations – See UK Government paper, 23 May 2018: Government response to report on Brexit and medicines, medical devices and substances of human origin

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