EMA frets drug shortages ahead of Brexit
- The European Medicines Agency is worried that U.K. companies are not prepared for their March 2019 exit and are trying to limit the repercussions.
- The European regulatory body is sending out a survey to all U.K. market authorization holders and those companies that have U.K. manufacturing sites to better understand their plans around Brexit.
- The EMA wants to know if U.K. companies plan to "submit transfers, notifications or variations to their marketing authorisations in the context of the U.K.'s withdrawal from the European Union."
Drug regulators in the EU are worried that the planned move of the EMA to Amsterdam could have a negative impact on drug supply and decisions related to marketing authorizations for drugs.
The survey, which is due back to the agency by Feb. 9, is meant to tell the EMA where it needs to beef up resources to address concerns about product supply for both human and animal drug products.
"The survey will also serve to stimulate those companies who have not yet taken any action to start planning for any regulatory steps required for their centrally authorised products to remain on the EU market post-Brexit in order to minimise disruption to medicines supply and avoid shortages," said the agency in a statement.
The U.K.'s decision to leave the European Union has had wide-ranging effects on a number of government agencies. Of direct interest to the pharma industry is the location of the EMA, which is slated to leave its current headquarters in Canary Wharf, London, for Amsterdam. The move is expected to be complete by March 2019.
Yet, the agency has warned that there will likely be disruptions to drug supplies, the approval process, and other functions of the EMA as its 900 employees are displaced — not all current staffers and their families are expected to make the move.
- European Medicines Agency Statement
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