UK: MHRA publishes letter about EU-UK approval conversions in the event of a No-Deal Brexit

06-01-2019

UK: MHRA publishes letter about EU-UK approval conversions in the event of a No-Deal Brexit

(Source: RAPS 2019-01-07)

MHRA has published a letter about the handling of marketing authorizations if the UK leaves the EU without a deal in March. The agency plans to automatically convert the authorizations for centrally authorized products (CAPs) to UK approvals within weeks of a no-deal Brexit.

Under its no-deal contingency planning, MHRA wants manufacturers of CAPs to tell it if they plan to opt out of the automatic conversion by the end of the month. The ultimate deadline for informing MHRA of opt out plans in writing is 22 April. After that, MHRA will convert all CAPs not covered by opt-out requests into UK marketing authorizations at no charge to the companies involved.

In converting the CAPs, which do not need to currently be on the market in the UK, MHRA will issue one or more product license numbers based on existing UK licensing practices. As the UK practice is to issue a single marketing authorization number for multiple pack sizes, the conversion may result in a company having fewer authorization numbers in the UK than in the EU.

Ahead of the potential conversion, MHRA wants manufacturers to confirm its records of their CAPs are correct and let it know if they want to exercise any opt outs. MHRA sent that request to companies in late November and shared the letter publicly shortly before the end of 2018.

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