European Commission & application

The European Commission updated the Notice to Applicants Volume 2B, Presentation and content of the dossier.
The updates are mainely a revision of the application form of both, Part 1A (1998 edition) and also the Common Technical Document (CTD): section 2.5.1.2 (Batch control / Testing arrangements) and 2.5.3. (Manufacturer(s) of the active substance). A new User Guide for the Application Form updated in section 2.5.1.2 and 2.5.3. has also been released.