The European Medicines Agency (EMA) has warned that some companies need to take further action to safeguard the EU medicine supply once the UK leaves the EU.
Both regulatory authorities and marketing authorisation holders have an important role to play in preparing for the consequences of Brexit to protect the EU medicine supply after the withdrawal of the UK from the EU.
How might Brexit affect the EU medicine supply?
Since May 2017, the European Commission and the EMA have been informing companies and raising awareness of the need to put the necessary measures in motion.
For marketing authorisation holders of centrally authorised products (CAPs), this may imply changes to the marketing authorisation itself; for example:
- A transfer of the marketing authorisation to a legal entity established in the European Economic Area (EEA);
- A change of the qualified person for pharmacovigilance (QPPV) or pharmacovigilance system master file (PSMF) to a location in the EEA; and
- Adaptations to their logistics, manufacturing sites, supply chains and contracts.
Are marketing authorisation holders prepared?
According to a recent EMA survey, however, marketing authorisation holders for just 58% of the 694 CAPs with an important step in their regulatory processes in the UK are on track with their regulatory planning to ensure that their marketing authorisation remains valid post-Brexit.
For 108, or 16%, of these medicines with manufacturing sites located in the UK only, there are serious concerns that the necessary actions will not be carried out in time.
The survey, which was launched in January 2018, was sent to marketing authorisation holders of the 694 CAPs who are located in the UK or who have quality control, batch release and/or import or manufacturing sites, or a QPPV or PSMF in the UK.
According to EU law, the marketing authorisation holder, the QPPV, the PSMF and certain manufacturing sites need to be based in the EEA for a company to be able to market a medicine in the EU.
What are the EMA’s next steps?
The EMA is liaising directly with the marketing authorisation holders who either did not reply to the survey or indicated in the survey that they do not plan to submit the changes required by 30 March 2019 and have manufacturing sites in the UK only, as this could potentially lead to supply disruptions.
It is also looking in detail at those medicines where there are risks of supply shortages and will assess how critical these are, as well as regularly monitoring the submission of changes to marketing authorisations for all 694 products to check if the relevant variations/notifications are being submitted.
The EMA is urging those companies who have not yet informed the agency of their Brexit preparedness plans to do so as soon as possible to mitigate any risks to the EU medicine supply.
Read the survey report in full here.