Some pharmaceutical companies have yet to make full preparations for Brexit, potentially impacting the distribution in Europe of over 100 medicines manufactured only in the UK, the European Medicines Agency (EMA) has said.
A recent EMA survey reveals that marketing authorisation (MA) holders of 58 per cent of the 694 centrally authorised products (CAPs) “with an important step in their regulatory processes in the UK” are on track to ensure their MA remains valid post-Brexit.
However, for 108 medicines – 88 human medicines and 20 veterinary medicines – that are manufactured in the UK only, “there are serious concerns that the necessary actions will not be carried out in time,” EMA says.
The actions needed can include transferring MA to a legal entity established in the European Economic Area (EEA), transferring pharmacovigilance responsibilities to an EEA location, or updating logistics, manufacturing sites, supply chains and contracts.
EMA says it is “liaising directly with the marketing authorisation holders who either did not reply to the survey or have 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.”
The regulator says it “urges those companies who have not yet informed EMA of their Brexit preparedness plans to do so as soon as possible to mitigate any risks” to medicines supply within the EU.