MHRA: Brexit Won’t Change EU Drug Market Access
UK drug manufacturers will retain access to EU markets during the Brexit implementation period, the MHRA said in an update Monday, noting EU authorities will continue to recognize the UK’s manufacturing and distribution licenses as well as inspections.
Manufacturers in the UK will be able to continue to apply for marketing authorizations, and UK labeling requirements will stay the same.
Drugmakers will also be able to continue UK batch release testing during the implementation period, which is set to end in December 2020.
The UK will continue to discuss concerns with its EU counterparts and share information, such as vigilance data and access to EMA and European Commission databases but will lose its voting rights in EMA and EU committees, MHRA said.