After years of waiting and wondering, the UK has finally left the EU. So, in the short term, how will the regulatory and drug safety environment change, and what will stay the same?
The EU Withdrawal Agreement (for those who would like to see the official text, all 198 pages) outlines the terms of the UK’s withdrawal from the EU, including a transition period, which will run until 31 December 2020. During this period EU pharmaceutical law will remain applicable to the UK, allowing pharmaceutical companies to continue activities until the end of the year. Marketing authorisation holders (MAH) will have until the end of this period to make the necessary changes to their authorised medicines to ensure compliance with EU law.
The European Medicines agency (EMA) and UK Medicines and Healthcare Products Regulatory Agency (EMA) have released further information on the transition period. MAHs and applicants will be able to remain in the UK, as will their qualified persons for pharmacovigilance (QPPV), pharmacovigilance system master files (PSMF) and quality control testing sites. The UK will continue to follow the EU rules for medical devices, meaning the incoming Medical Device Regulation (MDR) which comes into effect on 26 May, will apply through until the end of the year at least. Medical device information and adverse event reporting to the MHRA will remain the same, and the UK will continue to report to accessible systems. Additionally, the MHRA has stated that “EU-based authorised representatives will not be required for device makers within the UK and that UK-based notified bodies will continue to conduct third-party conformity assessments in the UK and the results of these tests will continue to be used and recognized for both the UK and EU markets.”
However, the UK is no longer a participant in EU institutions, regardless of the transition period. As of 1 February 2020, there are no UK representatives in any EMA scientific committee, working party of Management Board.
The MHRA have now released a guidance detailing changes in relation to Supplementary Protection Certificates (SPCs) and patent law after the transition period. This includes information on authorisations from the EMA, new applications for paediatric extensions, and manufacturing waivers.
Click here to access more information on the regulatory environment post-Brexit.