As the UK prepares to exit the European Union, regulatory responsibilities for medication manufacturers are shifting. Companies potentially affected by Brexit need to ensure that their marketing authorisation remains valid in the coming months.
A recent survey conducted by the European Medicines Agency (EMA) showed that 58% of marketing authorisation holders with regulatory ties in the UK are on track with planning to ensure their authorisation remains valid. Since May of 2017, companies have been continuously informed by both the EMA and the European Commission of the need to place necessary measures in motion to maintain the proper certification and avoid medical shortages.
For marketing authorisation holders of centrally authorised products (CAPs), changes to the authorisation itself may be necessary. This could include a transfer of the authorisation to a legal entity located in the European Economic Area (EEA), or the relocation of the qualified person for pharmacovigilance, or pharmacovigilance system master file to a location in the EEA. Changes to logistics, manufacturing sites, supply chains, and contracts may also be necessary in order to maintain authorisation; all of which will require significant time and resources to ensure compliance.
16% of companies are falling short
For 16% of the companies surveyed, the EMA has identified “serious concerns” that actions necessary to maintain authorisation will not be carried out in time. A further 10% of surveyed companies did not provide feedback on their progress.
As a result, the EMA is working directly with companies who have manufacturing facilities inside the UK and did not reply to the survey, or indicated they do not plan to submit the required changes by March 30, 2019. These companies would be required to relocate into the EEA to avoid supply disruptions.
The EMA are now assessing how critical the risks of medical supply shortages are. The EMA’s role is to ensure that it has a complete understanding of the potential supply risks, and to keep the relevant marketing authorisation holders informed in order to mitigate risk.
Guidance from the EMA
The EMA is advising that companies who have not yet informed them of their Brexit plans to do so immediately. They will also be providing continued updates on the status of supply chain risks in the coming months. For more information on the EMA’s Brexit-related guidelines for companies, visit: http://var/web/site/public_html.ema.europa.eu/ema/index.jsp?curl=pages/about_us/general/general_content_001891.jsp&mid=WC0b01ac0580cb2e5b
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 EMA, “EMA Identifies Gaps in Industry Preparedness for Brexit”, http://var/web/site/public_html.ema.europa.eu/ema/index.jsp?curl=pages/news_and_events/news/2018/07/news_detail_002985.jsp&mid=WC0b01ac058004d5c1