Brexit Strategies: Adapting to New Regulatory Landscapes

Maintaining Market Presence Amidst Change

The United Kingdom left the European Union on 31st January 2020 and has become a third country to the EU. The transition period ended on 31st December 2020.

As of 1st January 2021, the Protocol on Ireland/Northern Ireland is applicable and has an impact on marketing authorisations for medicinal products in the UK with respect to Northern Ireland.

The Pharma and Biotech industry has been significantly affected by Brexit. The European Commission, the EMA and the CMDh have provided updated guidance on the impact of the withdrawal of the UK from the EU and the applicability of the IE/NI Protocol. However, the complexity of the process and the multiple aspects involved often require careful interpretation of the available guidance on a case-by-case basis.

If your company and future plans are affected by these changes, we recommend that you carefully evaluate the impact of Brexit by performing an appropriate analysis of regulatory aspects based on the available guidance and the experience gained so far with the EU and UK authorities, when dealing with ongoing or new regulatory procedures.

Several aspects have been subject to discussions and decisions by EU and UK regulatory authorities:

• Marketing Authorisation Holdership - A UK located MAH will no longer be accepted in EU Member States while the marketing authorisation holder for a UK MA can be established in the UK (Great Britain or Northern Ireland) or in the EU/EEA.
• Batch release site(s) in the UK – The MAH will need to transfer its current UK batch testing and release site(s) to a location established in the EU (EEA) and remove those sites from the EU dossier. During 2021, this does not apply to MRP/DCP containing both EEA/UK(NI) and UK(GB) batch release sites/batch control sites where an exemption in accordance with Commission Notice C/2021/450 has been granted. However for a UK license a batch release site can be established in the UK or in EU/EEA, although a Responsible Person for import is required.
• PV - PSMF & QPPV location must be inside EU/EEA for EU27 whilst for the UK the PSMF & QPPV location must be in UK.
• Impact on Generic/Hybrid application types in relation to the choice of reference medicinal product for BE studies.

Over the last couple of years, we have been assessing with our clients the different options and alternatives to address these issues and prepare for Brexit. In the last six months we have been gaining experiences on the EU and UK side and helped our clients finding successful solutions to cope with post-Brexit regulatory requirements for their MAs. Every client have their own needs that require ad hoc solutions, including direct queries to the EU and UK agencies and we offer this support. We have offices throughout the EU and UK, as part of our regulanet^® network, and are therefore able to understand the issues and provide solutions dependent on any particular situation and strategy.

Whatever your situation and wherever your legal entity is located within Europe, we are able to help you with tailored solutions with the help of our partners.

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