The European Medicines Agency (EMA) is going to move from London to Amsterdam in April 2019. EMA is responsible for granting central marketing authorisations that give medicines access to the whole European Union through a single procedure, without any further requirement for national permits. This is essential for creating a single market for medicines. For a large range of biotech medicines, such as medicines based on recombinant DNA-technology and monoclonal antibodies, the EMA even is the only gateway to the European market, as provided in Regulation (EC)726/2004. EMA also facilitates access to medicines and monitors their safety, for which a lot of scientific work is done. Thus, EMA is essential for most innovative life sciences companies.
Bird & Bird has extensive experience in assisting life sciences companies in protecting their innovations and obtaining regulatory approval, as well as all the commercial and corporate legal work involved. Our knowledge of the life sciences industry and the relevant new technologies means that we really understand industry needs and provide targeted support.
The arrival of the EMA in Amsterdam will create a hub of excellence for life sciences in the Netherlands. Bird & Bird has an experienced international team on the ground to provide all the necessary support in dealings with the EMA and for life sciences development and regulatory work in general.