Clarification for the variation or notification procedure for changes to a MA file

The FAMHP notifies marketing authorization holders (MA) of drugs for human use of the necessity of each change made to a file (= modules 1 through 5) being linked to an MA must be the subject of a corresponding variation or notification request.

MA holders must correctly classify each change pursuant to the requirements of directive (EU) no. 1234/2008. The information provided in the electronic Variation Application Form is crucial here and forms the basis for tracing which changes are being requested.

Concretely this means that all changes made to the past file in the electronic Variation Application Form must be notified using the corresponding classification code(s) from the Commission Classification Guideline. The interpretation and method described in point 7.4.1 of the post-authorisation guidance Q&A of the EMA is applicable to “editorial changes” to module 3. As a result, MA holders must indicate these “editorial changes” as such in the electronic application form.

Changes that are indicated nowhere in the electronic Variation Application Form, even if they are made in the underlying file, are not part of the assessment of the file. They will in no way be considered approved.

Last updated on
07/06/2019