Variations: Important Changes in the New Application Form

Recommendation

20/21 February 2024
Munich, Germany

GMP meets Regulatory Affairs
Applying for and maintaining marketing authorisations: What you need to know from a GMP perspective

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:

• Excipients: new excipient, new manufacturer, submission of a new / or updated CEP or deletion of a CEP.
• API: change in the date of a GMP audit at the manufacturer, another site for batch testing, other storage location for master and working cell bank, other batch size of the API / intermediates, amending changes to an approved Change Management Protocol, submission of a new / or updated CEP or deletion of a CEP (also applies to starting materials, reagents and intermediates).
• Finished products: another site for batch testing, changes in the manufacturing process including other intermediates, changes due to updated Pharmacopoeial monographs, changes in an approved stability testing plan, amending changes to an approved Change Management Protocol.

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.