29/30 September 2021
In May of this year, the EU Commission brought together in one document the two guidelines on the handling of variations procedures and categorisation of changes (see our GMP News from 3 July 2013). Now, the application form for variation to a marketing authorisation has been updated too. A respective notification was released on 19 July 2013 on the EMA's News page. Marketing authorisation holders must take into account many more changes in the new application form than before. The most important variations which must be notified or approved in the new application form are listed below:
The introduction of a pharmacovigilance system according to the new pharmacovigilance legislation leads to many more changes.
The new application form has to be used from 4 August 2013 on. The electronic version of the application form will be put online as of 29 July 2013 on EMA's eSubmission page where you can already find a Guideline entitled "Electronic Application Form Data Exchange Standard 3.0" which describes the structure of the electronic application form.
A comparative document presents the modifications between the older version from 2009 and the new one. This comparison is available for ECA members in the ECA members' area.