Data Exclusivity And Market Protection In The EU / EEA And UK

In order to place a new medicinal product on the market in Europe, it is necessary first to obtain a marketing authorisation. Most applications for marketing authorisations are made through a centralised procedure with the European Medicines Agency (EMA) which effectively leads to authorisation in all EU/EEA member states¹, although other routes are available. Regardless of the route, an application for marketing authorisation must be supported by a dossier, referred to at the EMA as the common technical document (CTD), which demonstrates the quality, safety and efficacy of the medicinal product. The dossier will include non-clinical pharmacology and toxicology data, as well detailed clinical trial reports. Obtaining all of the data required for a new dossier represents a considerable investment of time and resources.