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

Version 3.0, May 2018

30 April 2018

Book pagination

Version history

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
V3.0

Minor amendments to phrasing and typographical errors.

Additional guidance on situations where notifications conditions are not met.

TGA May 2018

Book pagination