Application for a variation to a manufacturing/importation authorisation or wholesaler's authorisation
19 April 2011
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 submission of a variation to a manufacturing/importation authorisation or wholesaler's authorisation
Application form for variation to a manufacturing/importation authorisation or wholesaler's authorisation