Notifications process: requests to vary registered medicines where quality, safety and efficacy are not affected
Version 2.0, December 2017
This guidance is subject to the finalisation of legislative amendments.
|Version||Description of change||Author||Effective date|
|V1.0||Original publication||TGA||June 2017|
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)|