EMA updates template for eCTD cover letters in the Centralized Procedure

The European Medicines Agency (EMA) has published a new version of their template for administrative information to be presented in eCTD cover letters within the EU Centralized Procedure (see link at the bottom of this article).

Additional information has been included in the updated version regarding Supplementary Protection Certificate (SPC) in acc. to Art. 8 of Regulation (EC) 1901/2006.

Furthermore, the requirement to state the MD5 checksum(s) of the index.xml backbone(s) of corresponding eCTD sequence(s) has been removed. 

[Source: EMA website]

<- Back to: News