News about GMP/cGMP

12.12.2017

EMA and EC: Update of Brexit Q&A for pharma industry

The EMA (European Medicines Agency) and the European Commission have published an updated version of the Q&A document which is intended to help the pharmaceutical industry to organise the UK’s withdrawal from the EU for their company.

The document now includes additional information on marketing applications and authorisations for different types of medicinal products, e.g. generic, hybrid and biosimilar medicines. This version is an update of the initial questions and answers document that was published at the end of May 2017 (we reported). All updates are marked ‘NEW’. This includes 9 new Q&As as well as supplementary text to the original document.

The questions and answers document follows the publication of the European Commission/EMA notice to marketing authorisation holders of centrally authorised medicines for human and veterinary use on 2 May 2017. It will be further updated when need arises.