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MHRA has recently published a guidance on the regulation of medicines …

 

MHRA has recently published a guidance on the regulation of medicines, medical devices and clinical trials if there’s not Brexit deal.

Updated 4thJanuary 2019

 

The UK will continue to recognise existing approvals – both for regulatory and ethics approvals – and there will be no need to re-apply.

If there’s no deal, the UK’s current participation in the European regulatory network for clinical trials would end, and the MHRA would take on the responsibilities for the UK that are currently undertaken through the EU system. This link provides further detail on how we propose the UK system would operate.

 

https://www.gov.uk/government/publications/further-guidance-note-on-the-regulation-of-medicines-medical-devices-and-clinical-trials-if-theres-no-brexit-deal/further-guidance-note-on-the-regulation-of-medicines-medical-devices-and-clinical-trials-if-theres-no-brexit-deal#medical-devices

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