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.
EMA: News and events