Will Brexit Create Undue Disruptions to Medical Supply in the UK?

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[1] 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

Six Degrees Medical understands the importance of keeping up to date with regulatory changes that impact how healthcare organizations do business. The laws affecting the pharmaceutical industry are evolving – and the Six Degrees Medical knowledge base is evolving with them. Leading pharmaceutical companies around the world rely on Six Degrees Medical for insights that translate into customized medical and scientific communications, tailored to suit client-specific objectives. Click here to learn more.

[1] 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


The Transformational Impact of Artificial Intelligence on the Patient-Physician Relationship

In today’s ever-evolving healthcare landscape, the integration of artificial intelligence (AI) has ushered in a new era of possibilities, presenting…

What is Medical Communications? The definitive guide.

Medical Communications. The demand for clear and integrated dissemination of scientific knowledge is critical for the Pharmaceutical industry. Medical communications—or…

Enhancing engagement with healthcare professionals (HCPs): How AI is transforming Pharma relationships.

Pharmaceutical companies are progressively turning to the use of Artificial Intelligence (AI) as a tool to transform several aspects of…

Six communication trends Pharma needs to watch in 2024.

As we approach 2024, the Pharma industry’s focus on developing and maintaining meaningful relationships with healthcare professionals (HCPs) will only…

The EU Artificial Intelligence Act: A New Era of Regulation 
The EU's proposed AI Act, the world's first comprehensive legal framework for AI, is set to revolutionize global AI regulation. Learn about its risk classification levels and the potential implications for the Life Sciences industry.
0 +



0 +




0 +



Whether you’re looking for effective solutions to transition F2F meetings to a virtual or online environment, support with clinical trials, medical advisory boards, symposia, key opinion leader (KOL) management, internal medical training, medical writing or speaker training programs and more, count on our 16-year experience and expertise over 40 therapeutic areas.

SDM also offers strategic consulting services and can help with communication and engagement of your target audiences as part of market development opportunities.

Discover why over 95% of clients are “Extremely Satisfied” with SDM and over 90% say the agency deliver “Much more than expected”.