Notifications process: requests to vary registered medicines where quality, safety and efficacy are not affected

Version 2.0, December 2017

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23 November 2017

Version history

This guidance is subject to the finalisation of legislative amendments.

Version history
Version Description of change Author Effective date
V1.0 Original publication TGA June 2017
V2.0

Inclusion of second set of notifiable variations to registered medicines.

Inclusion of notifiable changes to biologicals.

Minor amendments to phrasing to clarify conditions.

TGA December 2017 (pending legislative amendments)

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