Conversion of centrally authorized products into national UK Marketing authorisations in case of No Deal Brexit

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4 December 2018

BlueReg

MHRA has sent to Marketing Authorization Holder (MAH) a guidance outlining requirements for submitting baseline information on your product in case of Brexit No Deal Scenario .

As MAH, you should be prepared, and BlueReg can provide regulatory and publishing support whatever the scenario for Brexit (“Deal or No Deal”) .

“In the unlikely event that the UK leaves the EU in a no deal scenario, the UK will need to put in place arrangements for the continued authorisation of medicinal products. This letter is to inform you of the actions we intend to take concerning CAPs and the actions we need you to take as a Marketing Authorisation Holder (MAH) of a CAP in the event of a ‘no deal’ scenario [..].”

Read more :

UK CAP conversion 1st info 26-11-18 MHRA CAP Conversion - eSubmission Requirements Guidance Document

UK CAP conversion 1st info 26-11-18 MHRA CAP conversion Letter

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