EMA Finds Gaps in Drugmakers' Brexit Preparedness

Regulatory NewsRegulatory News
| 10 July 2018 | By Michael Mezher 

After surveying industry on its preparedness for Brexit, the European Medicines Agency (EMA) says it has "serious concerns" over some drugmakers' ability to take the actions necessary to smoothly transition once the UK exists the EU in March 2019.
Based on the survey results, EMA says that 58% of drugmakers with a centrally authorized human or veterinary medicine with at least one important part of their regulatory process in the United Kingdom "are on track with their regulatory planning" to ensure their marketing authorization remains valid once Brexit occurs.
Those steps may include making changes to a marketing authorization, such as transferring the authorization 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 EEA.
However, despite EMA's efforts to prepare drugmakers for the steps necessary to ensure business continuity following Brexit, the agency says that some drugmakers have indicated that they do not plan to submit the required changes to the agency ahead of the 30 March 2019 deadline.
According to EMA, this is especially concerning for the 16% of the 694 centrally authorized human and veterinary medicines whose sole manufacturing sites are located in the UK. The marketing authorization holders for another 10% of centrally authorized products failed to respond to the survey.
To head off potential supply disruptions, EMA says it is working directly with the companies that did not reply to the survey or which said they do not expect to submit the necessary changes by 30 March 2019.
"EMA has analysed feedback from the survey and is now looking in detail at those medicines where there are risks of supply shortages and will assess how critical these are," the agency says, noting that it plans to monitor changes made to all 694 centrally authorized products to ensure the necessary variations and notifications are being submitted.


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