The Medicines and Healthcare products Regulatory Agency (MHRA) have released technical information on what the implementation period means for pharmaceutical and healthcare companies, and what they should expect from the Brexit implementation period that will run from March 2019 to December 2020.
The United Kingdom (UK) will remain a full member of the European Union (EU) before the implementation period, meaning that the UK will retain all of the rights and obligations that are associated with EU membership. During the implementation period, pharmaceutical firms will be allowed to continue to undertake batch release testing and Qualified Person certification in the UK. The 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. Also, there will be continued mutual recognition of manufacturing and distribution licences and associated inspections.
Companies that are based in the UK will be able to continue to apply for marketing authorisations via the centralised or decentralised procedures. Although, the UK will lose their right to vote in European Medicines Agency (EMA) and EU committees during the implementation period.
During the implementation period industry will be able to continue to submit information to the MHRA using the existing submission routes, and the UK will continue to access all EU databases and systems that we can currently access.
Regarding the period following the UK’s exit from the European Union, the MHRA have stated that “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.”
To read the guidance on what the implementation period could mean for the life science sector, please click here.