Procedural guidance to help pharma companies prepare for Brexit

November 28, 2017 – The European Medicines Agency (EMA) has published additional guidance to help pharmaceutical companies prepare for the United Kingdom’s (UK) withdrawal from the European Union (EU). The guidance document outlines the practical and simplified requirements that companies should follow when they apply for changes to their marketing authorisation to allow for the continued marketing of their medicine in the European Economic Area … (leggi tutto)