The European Medicines Agency (EMA) has stated that it has “serious concerns” over some marketing authorisation holders’ ability to undertake the actions necessary to ensure that their marketing authorisation remains valid once the United Kingdom (UK) leaves the European Union (EU) in March 2019.
From the survey results, the EMA stated that 58% of marketing authorisation holders with a centrally authorised product, with at least one important part of their regulatory process in the UK “are on track with their regulatory planning”. Actions may include making changes to the marketing authorisation itself, for example, transferring the authorisation to a legal entity located in the European Economic Area or moving the qualified person for pharmacovigilance (QPPV) or pharmacovigilance system master file (PSMF) for a product to within the European Economic Area (EEA).
Despite the EMA’s efforts to prepare drug manufacturers for the necessary steps to ensure business continuity following Brexit, the agency has stated that some companies have indicated that they do not plan to submit the required changes to the agency ahead of the 30th March 2019 deadline. The EMA finds this especially concerning for the 16% of the 694 centrally authorised human and veterinary medicines whose sole manufacturing sites are located in the UK. 10% of marketing authorisation holders failed to respond to the survey.
The EMA is planning to liaise directly with marketing authorisation holders who either did not reply to the survey or have indicated that they do not plan to submit the necessary changes by 30th March 2019 and have manufacturing sites in the UK only, as there is potential for supply disruptions if no actions are taken. The EMA plans to monitor changes made to all 694 centrally authorised products to ensure the necessary variations and notifications are being submitted.
The EMA has urged companies to plan for the UK’s withdrawal from the EU and advises companies to regularly check EMA’s dedicated webpage on the consequences of the UK’s withdrawal from the EU. Companies should also refer to the updated questions and answers, and practical guidance for industry which were published on 19th June 2018.
To read more about the gaps in industry preparedness for Brexit, please click here.