On January 31, 2020, the United Kingdom (UK) officially left the European Union (EU) making the Brexit come alive. In the light of Brexit, the European Medicines Agency (EMA) and the Medicines and Healthcare products Regulatory Agency (MHRA) have released certain Regulatory guidelines to ensure both pharmaceutical and medical device manufacturers are ready for the transition period. Here are the industry-wise key insights to be aligned with:
According to the EMA, the EU law for pharmaceuticals will still be applicable in the UK throughout the transition period until December 31, 2020. During the transition period, Marketing Authorization Holders (MAHs), applicants and Qualified Person for Pharmacovigilance (QPPVs), Pharmacovigilance System Master Files (PSMFs) and quality control testing sites for the EU registered medicinal and medical products can remain in the UK. However, the MAHs will have until the end of the transition period to make necessary changes to their authorized products in order to align with the EU standards.
For medical devices, the MHRA has notified manufacturers that the Agency will continue to align with the EU regulations (including the upcoming EU MDR regulations that will come into effect from May 26, 2020) for medical devices in the UK through the transition period. However, the Agency will no longer require EU-based representatives for devices placed in the UK market and will continue to perform third-party conformity assessments in the UK. The result of these assessments will still be accepted in both the UK and the EU. Additionally, any information reporting related to medical devices to the MHRA will remain same during the period of transition, including reporting of serious adverse events.
Post Brexit, the UK and the EU have agreed to work on a deal for the future arrangements until the end of the transition period. The negotiations for the terms of Brexit will commence from early March. While both the governments are working towards a harmonized agreement, medical device and pharmaceutical manufacturers must gear themselves for the upcoming Regulatory changes and consult a Regulatory expert for compliant transition. Stay updated. Stay compliant.