Application for a variation to a manufacturing/importation authorisation or wholesaler's authorisation
27 February 2013
The purpose of this document is to provide guidance on documentation requirements which should be provided to the IMB when making a submission to vary a manufacturing/importation authorisation (relating to human, veterinary or investigational medicinal products) or a wholesaler’s authorisation.
This guide contains minimum documentation requirements which will facilitate the approval of such variation applications; however, the list of requirements is not exhaustive.
Guide to applications to vary a manufacturing/importation authorisation or wholesaler's authorisation
This guide has been revised to include more details of documentation required to accompany an application, and to include details of invalid applications.
Previous version of guide with changes tracked.
Application form for variation to a manufacturing/importation authorisation or wholesaler's authorisation
The latest version of the form includes a check as to whether the variation affects an API facility.