You are here Home Guidance and resources Resources Guidance Notifications process: requests to vary registered medicines where quality, safety and efficacy are not affected Version history Version 4.0, May 2023 Last updated 24 May 2023 Listen Print Share LinkedIn (Twitter) Facebook Email Loading... 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 V4.0 Inclusion of export only biologicals TGA May 2023 Previous Notifications for included biologicals
