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MHRA issues Brexit implementation period guidelines for UK pharma and healthcare firms
The UK Medicines and Healthcare products Regulatory Agency (MHRA) has detailed what pharmaceutical and healthcare companies should expect from the Brexit implementation period.
The Brexit implementation is scheduled to run from March 2019 to December 2020. During this, UK businesses will have the same rights as EU-based businesses to have their cases accepted and processed by EU-based ‘leading authorities'. Pharmaceutical firms will be allowed to continue to undertake batch release testing and Qualified Person certification in the UK. These certificates will be recognised in the EU and EU certification will be recognised in the UK.
Marketing authorisation holders and Qualified Persons for Pharmacovigilance (QPPVs) will be allowed to remain in the UK and will be allowed access to EU markets. There will be continued mutual recognition of manufacturing and distribution licenses and associated inspections.
Companies based in the UK will be able to continue to apply for marketing authorisations via either the centralised or decentralised procedures. However the UK will lose the right to vote in EMA and EU committees during the implementation period.
In regards to the period following the UK's exit from the European Union the MHRA stated: “Progress is being made to finalise the Withdrawal Agreement as a whole. We will aim to agree this by October, alongside the framework for our future relationship with the EU.”
Dr Sheuli Porkess, Deputy Chief Scientific Officer for The Association of the British Pharmaceutical Industry (ABPI) said: “Guidance from Government is welcome, as is the reiteration of the UK’s preference for close cooperation with the EU across all aspects of medicines regulation.”
Porkess continued: "There are still some unanswered questions. We are clear that there needs to be an implementation period but whether there will be one is still subject to negotiation. The document also states that the future role of the MHRA, whose expertise is vital, is also still being discussed. The industry will continue to plan for all scenarios, including ‘no deal’. We believe that the best way to protect patients and public health is for the EU and UK to agree continued cooperation on the regulation of medicines."