The Brexit Package
Brexit Considerations for March 2019
Any pharmaceutical company wishing to hold EU licenses must have a legal entity registered within Europe. Pharmaceutical companies that wish to establish a new ‘EU’ legal entity to hold their licenses, decide on ‘which country’ to choose within Europe. Up until 24th June 2016 (UK referendum result day) the UK was a reasoned choice for many pharmaceutical companies wishing to establish themselves in Europe. Good flight connections, the English language, a traditionally well regarded competent health authority, and of course the current home of the European Medicines Agency (EMA). This has led to many pharmaceutical companies and subsequent Marketing Authorization Holders (MAH) historically choosing UK based legal entities to hold their European medicinal product licenses.
Under current expectations, the UK will leave the European Union on March 29th 2019 and become a so called ‘third country’. The European commission is clear through Article 2 of Regulation (EC) No 726/2004 that holders of European medicinal product licenses must be established in Europe. Due to this it is likely that separate ‘UK’ and ‘EU’ legal entities will be required going forward to hold UK and EU licenses if pharmaceutical companies wish to operate in both markets. Companies should plan for this in advance of March 2019.
Any European medicinal product licenses held by UK legal entities are likely to be required to transfer the marketing authorisation holder (MAH) post-Brexit. This will involve a transfer of ownership of the license from one legal entity (UK) to another (EU). Regulatory Affairs professionals typically deal with this type of change.
Conversely, EU legal entities holding UK medicinal product licenses may be required to transfer the marketing authorisation to a UK based legal entity for the Medicines and Healthcare Regulatory Agency (MHRA) to continue to accept their validity. It is not just the legal entity changes that need to be considered as part of a so called ‘hard’ Brexit scenario.
European regulations also require certain persons with key responsibilities to be based in the European Union. This includes Qualified Persons for Pharmacovigilance (QPPVs) and Qualified Persons in compliance and manufacturing (QPs). Following Brexit, it is quite possible that there will need to be both QPPVs and QPs in the EU and the UK. Some UK persons may well be asked to relocate to continue supporting the European role going forward.
Manufacturing supply chains are also likely to be affected. European legislation determines that medicinal products require a formal site of ‘batch release’ to be based in the European Union. UK batch release sites would no longer fall within this.Similarly, any product arriving into the EU from the UK could require re-testing by an appropriate quality control/batch control site. UK specific batch release sites and UK specific product testing could also be required for products being imported from Europe.
Brexit will also affect the responsibilities of national competent authorities for the assessment of medicinal product licenses. Currently the MHRA act as the lead country in assessing European application submissions for many European medicinal application procedures. This lead role continues once the license is granted as changes to the license are often required in the future. When the UK is no longer in the EU the MHRA will not be able to continue to act as the lead country in EU procedures. One of the other countries will need to take on the lead responsibility of being a reference member state (RMS) for the procedure to continue to be valid.
While the European Medicines Agency (EMA) has taken proactive steps in asking European Marketing Authorisation holders to consider their positions and product portfolios carefully, very little has directly been announced so far from the MHRA. This is potentially down to elections and in consideration of negotiations with Europe prior to March 2019.
Pharmaceutical companies are faced with an unprecedented regulatory concern affecting their portfolio of products and it is essential that they plan well in advance and consider:
- Legal entity requirements
- Pharmacovigilance requirements
- Manufacturing and supply chain requirements
- Changes to workload and resource
For further information on how Diamond Pharma Services can help support you through this period of change, please click here to download the PDF of this information and contact our EU and UK regulatory affairs specialists on +44 (0) 1279 441 616 or +44 (0) 8450 704336 or by email at: firstname.lastname@example.org
About Diamond BioPharm Ltd.
Diamond BioPharm Ltd. was founded in 2005 by Dr Maureen Graham. The company is part of the Diamond Pharma Services group of companies, a leading technical and scientific consulting group serving the biotechnology and pharmaceutical industry, with an emphasis on:
Regulatory Affairs: from product concept to registration and beyond
Product Development: Chemistry manufacturing and control (CMC), non-clinical and clinical
Pharmacovigilance: Clinical trial (phase I-IV), post marketing and QPPV services
Compliance: GLP, GMP, GCP and QP services