EMA and CMDh issue Q&As relating to Brexit

In this latest update on Brexit from PharmaLex, we report on the release of the latest, specific Q&As in relation to pharmaceutical regulation and provide our comments.

Both the European Medicines Agency (EMA) alongside the European Council (EC) and Co-ordination Group for Mutual Recognition and Decentralised Procedures – human (CMDh) have now issued Q&A documents relating to the UK’s prospective withdrawal from the European Union (EU). The documents cover the specific considerations for organisations with regards to elements such as the location of marketing authorisation holders, orphan designation holders, Qualified Person for Pharmacovigilance (QPPV), Pharmacovigilance System Master File (PMSF), manufacturing site for active substance and finished product, batch release site, Reference Member State (RMS) for a Mutual Recognition (MRP) or Decentralised Procedure (DCP), Minor Use Minor Species (MUMS) status, as well as status of access to financial and administrative assistance in accordance with EC 2049/2005 (the ‘SME’ Regulation).

Although the negotiations between the UK and the EU with respect to the particular nature of the prospective withdrawal (often referred to as ‘Hard’ or ‘Soft’ Brexit) are at an early phase, PharmaLex has already offered its clients and any other organisations that believe that they could be affected, an initial impact consultation.  It is our opinion that these recent EMA and CMDh communications reinforce the value in acting now, to assess the potential business and operational implications for sustained regulatory compliance and prepare mitigation plans in readiness for the planned implementation of Brexit, currently targeted for end March 2019. With uncertainty at this point in time with respect to the final outcome of these ongoing negotiations between the UK and EU, and the time required to put alternative arrangements in place, it is not unreasonable for companies to prepare for a “hard” Brexit scenario.

At PharmaLex, with our experience and expertise in Regulatory Affairs and attentive evaluation and review of the changing Regulatory environment, we are well positioned to partner with clients in ensuring a systematic evaluation of their Company’s pharmaceutical distribution, development, regulatory and pharmacovigilance operational status with respect to Brexit is achieved, within a reasonable time frame. Under our continued guidance, the outcome of that objective analysis can then be translated into a formal plan for implementation in preparation for Brexit, which can be further attenuated as the political environment becomes clearer over time. As such, organisations can be confident that they are taking constructive steps and assure their stakeholders that they are prepared and acting in a measured and timely manner.

If you would like to discuss your specific requirements relating to the UK’s prospective withdrawal from the EU, please contact us on uk@pharmalex.com or call +44 (0)1628 530554. Alternatively, subscribe to our eNewsletter where we will be providing further updates as they become available.