United States: EMA Publishes Results Of Study On Brexit Preparedness

In January 2018, the European Medicines Agency (the EMA), as part of its Brexit preparations, launched a survey to gather information from companies on their Brexit preparedness plans, and to identify concerns that may impact public or animal health. The results of the study were published earlier this week.

Implications of Brexit

The implications of Brexit for the life sciences industry are huge. A survey by EFPIA noted that medicines across the EU have integrated supply chains: over 2,600 final products have some stage of manufacture in the UK, while 45 million patient packs are supplied from the UK to the EU27 each month, and over 37 million patient packs are supplied from the EU27 to the UK each month. Further, over 12,000 centrally authorised marketing authorisations (MA) will require separate UK authorisations, and 17% of such authorisation are currently held by UK MA holders and so will need to be transferred. Each of these products and authorisations will be affected by the changing regulatory landscape.

EU law requires that centralised MA holders are established in the EU or EEA (EU plus Norway, Iceland or Liechtenstein), and that certain activities must be performed in the EU or EEA, for example activities relating to pharmacovigilance, batch release and quality control. Following the UK's notification of its intention to leave the EU, and subject to any arrangement being agreed during the ongoing negotiations, on 30 March 2019, all EU law ceases to apply to the UK, and UK entities and MA holders will no longer be part of the EU. Therefore, MA holders will need to amend certain processes and/or terms of their MAs so they remain valid post-Brexit. Further, as of the date of Brexit, medicinal products manufactured and placed on the market in the UK will be considered imported products when moved to other countries in the EU. MA holders will therefore need to specify an authorised importer established in the EU or EEA, and submit the corresponding variation to their centralised MA.

The EMA's survey

The EMA sent two questionnaires to a number of companies to gather information on their intentions to amend MAs or manufacturing sites as a result of Brexit. These included over 180 MA holders of 694 human and veterinary products that are located in the UK, or which have quality control, batch release, and/or importation sites or a qualified person for pharmacovigilance (QPPV) or pharmacovigilance system master file (PSMF) in the UK. The EMA received feedback from over 90% of MA holders surveyed.

The results of the survey show that for the 694 affected products:

• 58% of products are on track to ensure their MAs remain valid once the UK leaves the EU.
• 400 products require an MA transfer to an MA holder based in the EU or EEA. Of these, 373 MA holders (93%) intend to submit the transfer application so the transfer is fully implemented before 30 March 2019.
• 335 products have a QPPV based in the UK, and 376 have their PSMFs in the UK. 282 of QPPVs (84%) and 152 of PSMFs (40%) are on track to make the requisite changes before Brexit.
• Batch releases sites of 119 medicines, and quality control sites for 41 medicines, need to be transferred. 96 (81%) and 35 (85%) of submissions respectively are expected to be submitted on time.
• For 18 products, the importation site into the EU is currently the UK, which will need to be relocated, and only 4 of these (22%) are expected to be amended in time.
• For 108 medicines (16%), all or a major part of the medicines' batch release sites, quality control sites and/or importation sites are in the UK, but changes are not on course to be submitted in time. This raises major concerns that if plans are not adapted, these products may no longer be available on the EU market after Brexit.

A summary of the position was set out in the report as follows:

The EMA will follow up directly with the MA holders that have batch release, quality control and/or importation sites located in the UK, but that have indicated they do not plan to submit requests for the changes required before 30 March 2019, as this could potentially lead to supply disruptions.

The EMA will also monitor and track the submissions of required changes for the affected centrally authorised medicines, and conduct a workload analysis to ensure adequate resource planning within the EMA. However, the survey identified that the majority of the necessary submissions to the EMA are scheduled for Q1 2019, which is the same time as the EMA will be relocating to the Netherlands. Pharmaceutical companies are, therefore, advised to submit their change requests as early as possible, and before the end of Q4 2018, to ensure processing in due time.

In the meantime

The EMA has a dedicated webpage on the consequences of the UK's withdrawal from the EU, and has prepared Q+As and practical guidance for industry addressing many of the key questions for MA holders to assist with their preparations for Brexit.

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