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.
During the next 11 months, 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 this transition period, the following entities should be relocated in the EU territory:
- Marketing Authorization Holders and applicants.
- Orphan 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) provide some guidance documentation to help pharmaceutical companies prepare for Brexit and these can be found at: https://www.ema.europa.eu/en/about-us/uks-withdrawal-eu/brexit-related-guidance-companies
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 email@example.com.
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.