As the United Kingdom (UK) departure from the European Union (EU) approaches the target date of 29 March 2019, both the UK Medicines and Healthcare Regulatory Agency (MHRA) and the European Medicines Agency (EMA) have updated their guidance to pharmaceutical companies.
Generally, these guidance notes are mirror images, with the common underlying message that any functions performed under the auspices of UK’s current membership of the EU will no longer be recognised in Europe or the UK after Brexit, particularly in the event of departure without a negotiated deal. Non-manufacturing functions currently performed in the UK must be transferred to individuals/facilities within the EU or the European Economic Area (EEA). Those functions currently performed in Europe will need to be replicated in UK, in order to maintain supplies of medicines from the EU. While MHRA provides a transition period until the end of 2020 for such establishment in UK, it appears that EMA will apply this requirement immediately after 29 March 2019.
The most public of these changes is the relocation of EMA offices themselves from London to Amsterdam. After some delays, the interim “SPARK” offices in Amsterdam are now fully-operational; however, the relocation of staff and procedures will limit meetings and product certificates from now until 14 March 2019.
As these circumstances mainly relate to medicines which are already approved in the EU, this is primarily an administrative change, albeit costly for UK-based companies. In contrast, medicines currently supplied in the UK under a European (EMA) product marketing authorisation will require new marketing authorisations licenced by MHRA. Pragmatically, MHRA have provided guidelines on “grandfathering”, whereby a new UK marketing authorisation may be generated on the basis of a pre-existing (pre-Brexit) EU licence. However, there are likely to be long-term cost implications for companies to maintain these additional marketing authorisations only for the UK.
Both EMA and MHRA are adopting a risk-based approach to facilities inspections, while establishing their rights to require EU inspection of UK sites and MHRA inspection of European sites.
During this period of transition, consistent and coherent regulatory submissions, specifications and batch testing are needed to ease pharmaceutical manufacturers’ interaction with both UK and EU agencies. Queen’s House Consulting can provide authoring and checking services for Pharmaceutical and Non-Clinical packages, helping to deliver the additional workload resulting from Brexit. Please contact Queen’s House Consulting to discuss your particular needs.
NOTE: Arrangements for the UK departure from the EU are subject to change. This summary is not binding. Please refer to the official UK and EU websites for definitive information.
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