Is it possible to use a U.S. dossier when applying for an E.U. marketing authorisation? This is a question that is asked time and again. We first published this article in 2017. We have updated it and included links to other relevant articles that will assist companies in dealing with this issue.
Over the years, we have worked with a significant number of US innovator companies and supported them in getting their ‘US developed medicinal product’ registered as a medicinal product in Europe. In this article, we look at some of the issues we have encountered in taking a US-developed dossier for a new marketing authorisation application in Europe on behalf of a client.