FDAnews Drug Daily Bulletin
Pharmaceuticals / Regulatory Affairs

EU Reallocates UK’s Centrally Authorized Medical Product Portfolio

April 13, 2018

The EU reassigned oversight of more than 370 centrally authorized drugs from UK agencies to other EU member states in anticipation of Brexit.

Under the centralized authorization procedure, pharmaceutical companies submit a single marketing-authorization application, allowing the holder to market the medicine throughout the EU. 

As part of the reassignment, officials from the Medicines and Healthcare products Regulatory Agency and the Veterinary Medicines Directorate who serve as “rapporteurs” for the UK’s centrally authorized product portfolio will hand over their work in the EU’s Pharmacovigilance Risk Assessment Committee, the Committee for Medicinal Products for Human Use and the Committee for Advanced Therapies.

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