News about GMP/cGMP


EMA Updates Two Brexit Guidance Documents

On 19 June 2018 the European Medicines Agency (EMA) published

  • Revision 2 of its practical guidances for procedures related to Brexit for medicinal products for marketing authorisation holders (MAH) and
  • Revision 3 of the related Q&A document.

Both documents shall assist pharmaceutical manufacurers in preparing for Brexit.

For the Practical Guidance, EMA has added 14 new questions (marked as “NEW”) 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.

The Practical Guidance has been developed taking into consideration that as of 30 March 2019 the United Kingdom will become a third country. As a result, MAHs and applicants of centrally authorised products for human or veterinary use need to ensure that the necessary changes are made by the 30 March 2019, to allow for the continued marketing of their medicine in the Union after Brexit.

The document complements the EC/EMA Q&A which is now in its third revision. The Q&As provide procedural and practical guidance regarding submission of changes and related fees. Seven new questions were added and some earlier answers were updated. All changes are indicated as “NEW”. According to EMA the document now includes 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 (OCABR) and Official Batch Protocol Review (OBPR). The document also clarifies how scientific opinions of the Committee for Medicinal Products for Human Use (CHMP) 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 (QPPVs) and on marketing multi-country packs of medicines, where one of the countries in which the packs will be sold includes the UK.

A template containing a standard statement for change of applicant due to Brexit is also provided.


EMA: What's new?