EMA Updates Guidances in Preparation for Brexit

By Akia Thorpe -

June 21, 2018

The European Medicines Agency (EMA) has updated two guidances designed to help pharmaceutical companies prepare for the United Kingdom's (UK) withdrawal from the European Union (EU) (i.e., Brexit).

The EMA had issued a practical guidance as well as a questions-and-answers guidance for procedures related to Brexit for medicinal products respectively in November 2017 and May 2017.

Updates to the questions-and-answers document include information on how the UK’s withdrawal will affect the status of inspection outcomes by the UK national competent authority and batch-release processes for medicines that are subject to Official Control Authority Batch Release and Official Batch Protocol Review.

The document also clarifies how scientific opinions of the Committee for Medicinal Products for Human Use for ancillary medicinal substances in medical devices requested by UK notified bodies will be affected. In addition, it includes new information on back-up arrangements for Qualified Persons for Pharmacovigilance, which is an individual, usually an employee of a pharmaceutical company, who is p responsible for the safety of the human pharmaceutical products marketed by that company in the EU. The updated guidance further includes information on marketing multi-country packs of medicines, where one of the countries in which the packs will be sold includes the UK.

The agency’s updated version of its practical guidance for industry outlines the steps that companies should follow to make sure that necessary changes to their marketing authorization are made by the end of March 2019 (the UK’s withdrawal), to allow for the continued marketing of their medicine in the EU after Brexit. Specifically, this includes information on the EMA’s primary contact point for Brexit-related activities, how to reflect UK national scientific advice in submissions made after March 29, 2019, and how to change a UK-based applicant to a non-UK-based applicant for an ongoing marketing authorization application.

Source: EMA (announcement of update), EMA (questions and answers), EMA (practical guidance)