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11 July 2018Big Pharma

EMA voices ‘serious concerns’ over MA holders’ Brexit preparedness

The European Medicines Agency (EMA) has expressed concerns about how prepared medical marketing authorisation holders are for when the UK leaves the EU.

According to EU law, marketing authorisation holders for centrally authorised products (CAPs) need to be based in the European Economic Area (EEA) to be able to market a medicine in the EU.

CAPs are medicines that have a single marketing authorisation and are valid across the EU.

An EMA  survey showed that the marketing authorisation holders for more than half (58%) of the 694 CAPs based in the UK, or which have facilities in the UK, are on track to ensure that their marketing authorisation is valid when the UK is withdrawn from the EU, on March 29, 2019.

The agency said that marketing authorisation holders for CAPs may have to transfer the marketing authorisation to a legal entity in the EEA once the Brexit process has been completed.

Marketing authorisation holders play an important role in maintaining the continuous supply of medicines once the UK has left the EU, according to the EMA.

While more than half of survey respondents said that they are on track with regulatory plans, the EMA said it has “serious concerns” that 16% of medicine companies with manufacturing sites located only in the UK will not take the necessary actions before Brexit happens.

The agency launched the survey in January 2018 to identify CAPs that are potentially at risk of supply shortages.

Feedback from the survey has been analysed and the EMA said it is now looking into medicines at risk of supply shortages.

The EMA urged companies that have not yet informed the agency of their “Brexit preparedness plans” to do so in order to mitigate any risks to the supply of medicines.

In March, LSIPR reported that the European Council president, Donald Tusk, implied that the UK would not be able to remain a member of the EMA in a set of draft guidelines regarding Brexit negotiations.

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