More than 100 medicinal products could be at risk of supply if marketing authorisation holders do not make the necessary changes to their marketing authorisations in time for Brexit, according to a survey from the European Medicines Agency (EMA).
When the UK leaves the EU in March 2019, some marketing authorisation holders will have to move processes from the UK to EU or European Economic Area (EEA) countries to ensure their authorisation remains valid. But according to companies’ current plans, changes may not be submitted in time for 108 (16%) of all 694 affected products, which the EMA said raises “major concerns” that if plans are not adapted, these products may no longer be available on the EU market.
The EMA contacted more than 180 marketing authorisation holders of 694 human and veterinary centrally authorised medicinal products located in the UK or who have quality control, batch release, importation sites or a qualified person for pharmacovigilance or pharmacovigilance system master files based in the UK. Over 90% of the marketing authorisation holders contacted responded to the survey.
The survey found that 400 medicines will require a transfer of marketing authorisation to a marketing authorisation holder based in the EU or an EEA member state. The majority of companies (94%) plan to submit their transfer applications by 30 March 2019, although this leaves 6% that might be submitted after this date.
A statement from the Association of the British Pharmaceutical Industry said that: “The EMA survey was carried out over six months ago, and we continue to stress the need for companies to make all preparations by March 2019.”
It added: “We are confident that during this period significant progress has been made — our message remains the same — with 45 million packs of medicines leaving the UK for Europe and 37 million coming the other way every month. Companies must be as prepared as possible.”
The EMA said it would follow up with all non-respondents to the survey, as well as with the marketing authorisation holders that have batch release, quality control and/or importation sites located in the UK only and that have indicated in the survey that they do not plan to submit changes required before 30 March 2019, as this could lead to supply disruptions.