On 4 May 2018, the European Medicines Agency (“EMA”) published another updated version of the guidance document on pre-authorisation for users of the centralised procedure. Menu News & Insights ...

Centralized Procedure Allows for Submission of a Single Marketing Application to the European Medicines Agency that, if Approved, Would Allow D-PLEX100 to be Marketed in All EU Member States D ...

Figures published by the European Medicines Agency (EMA) relating to centralized procedure activities for human medicines show a significant increase in the number of positive opinions made between ...

EMA grants eight years of data exclusivity in an EU member state for reference products whose marketing authorization was submitted as of October 30, 2005, under national, mutual-recognition, and ...

The EMA has now reinforced its commitment to electronic submissions by mandating the use of the eCTD format for the centralized procedure of all electroniconly submissions. ... EMA, EMEA ...

The European Medicines Agency (“EMA”) has published an updated version of the guidance document on pre-authorisation for users of the centralised procedure. The update relates to a new ...