The European Medicines Agency (EMA) on Tuesday updated two guidance documents intended to assist drugmakers in their Brexit preparations.
The two guidances provide questions and answers and practical advice for marketing authorization holders (MAH) who will need to make Brexit-related transitions and adjustments for their centrally authorized products to ensure they are in compliance with EU requirements once the UK exits the EU.
EMA first issued
the question and answers document, which is now on its third revision, in May 2017. The practical guidance
followed in November 2017, and is now on its second revision.
In addition to providing guidance, EMA also launched a survey
of drugmakers in January 2018 to identify the companies that will require the most effort to make Brexit-related transitions.
For the questions and answers guidance, EMA has added seven new items and added new information to several earlier answers.
Many of the new questions and answers cover issues that relate to testing and oversight by UK-based agencies. For instance, the guidance says that the findings of good manufacturing practice, good clinical practice and pharmacovigilance inspections are expected to be valid for inspections carried out before 30 March 2019, as they will have been carried out in accordance with EU legislation.
The new questions and answers also provide information for MAHs whose products are subject to Official Control Authority Batch Release (OCABR) that are currently tested by a UK Official Medicines Control Laboratory.
EMA also clarifies that it will no longer be able to provide consultation or scientific opinions on medical devices with ancillary medicinal substances to UK notified bodies after 30 March 2019, as they will lose their status as EU notified bodies.
For the practical guidance, EMA has added 14 new questions, including who companies should contact at EMA with Brexit-related inquiries; how to consider national scientific advice from UK competent authorities; and how to transfer orphan designations from UK-based sponsors to ones based in the European Economic Area.
, Q&A Guidance
, Practical Guidance