On January 31st 2020, the United Kingdom (UK) officially left the European Union (EU), resulting in a transition period due to end on December 31st 2020, during which EU pharmaceutical laws will still be applicable to the UK.
From 1 January 2021, the Medicines and Healthcare products Regulatory Agency (MHRA) will be the UK’s standalone Competent Authority for the global regulation of Medicines and Medical Devices (including the designation of UK Approved Bodies, equivalent to Notified Bodies in Europe).
As a consequence, the agency released at the beginning of September more than 25 guidances to help companies to get ready for the new requirements.
The guidance encompasses several concepts, such as Clinical Trials, Medical Devices, Pharmacovigilance, Paediatrics, Licensing, Import & Export. The documentation is available at the following address.
On the other side, pharmaceutical companies based in the UK will be responsible for ensuring the necessary changes have been made so their products remain compliant with EU law and remain on the EU market.
After the transition period, the following entities should be relocated in the EU territory:
- Marketing Authorization Holders and Applicants.
- Orphan Drug Designation holders.
- Qualified Persons for Pharmacovigilance (QPPVs).
- Minor Use/Minor Species (MUMS) / Limited markets classification holders.
- Companies’ manufacturing and batch release sites.
The European Medicines Agency (EMA) and the European Commission (EC) provided some guidance documentation to help pharmaceutical companies prepare for Brexit: https://www.ema.europa.eu/en/about-us/uks-withdrawal-eu/brexit-related-guidance-companies
Finally, the Medical Devices Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR) remain in force for Medical Devices and In Vitro Diagnostics registration in Europe.
DDR and Brexit
DDR offers a set of services aimed at ensuring that your company is ready to manage the transition through Brexit, taking into consideration any procedural, legal and organizational impact that this may have on the sponsor. Furthermore, DDR is conveniently based in London to facilitate interactions with UK companies and Regulatory Agencies: our facilities in Canary Wharf’s central business district are right next to the MHRA headquarters.
Brexit’s impact on your company should be assessed as soon as possible. Please contact us for specific Brexit-related information at firstname.lastname@example.org.
How can DDR help?
- DDR will support and advise on conducting clinical trials in the UK.
- DDR will secure the optimal development of your product up until registration in the UK, taking into consideration the possible new requirements.
- If your company is based in the UK, its Small or Medium-Sized Enterprise (SME) status will be challenged after Brexit. DDR will help you manage this situation and act as your SME Representative throughout Europe.
- DDR will manage the transfer of the Orphan Drug Designation (ODD).
- DDR will manage Marketing Authorization Holder (MAH) transfers and other necessary variations related to your company’s products.
- DDR will advise on changes related to the Qualified Person Responsible For Pharmacovigilance (QPPV).
- DDR will help your company on packaging updates required due to Brexit.