Variations to prescription medicines: excluding variations requiring evaluation of clinical or bioequivalence data (for chemical entities)
Guidance about the types of notifications and variations for chemically derived (non-biological) prescription medicines.
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Purpose
This guidance outlines the types of variations and changes that can be made to chemically derived (non-biological) prescription medicines currently on the Australian Register of Therapeutic Goods (ARTG). It is split into two parts:
- Part 1: Corrections, notifications and quality information changes
- Part 2: Product information (PI) changes.
Guidance
This guidance is presented as downloadable files because of its length.
Page history
Minor clarifications and corrections to:
- API changes that do not require reporting to the TGA
CCSC: Container/closure system - changes to container components and/or dimensions.
Amended title
Inclusion of Extension of indications to align with a reference product
Additional information on:
- variation types that are associated with a mandatory PAR field update
- changes that do not need to be notified to the TGA
- new variation types (including Associated changes and SARO).
Minor clarifications and corrections to phrasing and layout.
Inclusion of notifiable variations to registered medicines.
Minor amendments to phrasing and layout.
Original publication.
Minor clarifications and corrections to:
- API changes that do not require reporting to the TGA
CCSC: Container/closure system - changes to container components and/or dimensions.
Amended title
Inclusion of Extension of indications to align with a reference product
Additional information on:
- variation types that are associated with a mandatory PAR field update
- changes that do not need to be notified to the TGA
- new variation types (including Associated changes and SARO).
Minor clarifications and corrections to phrasing and layout.
Inclusion of notifiable variations to registered medicines.
Minor amendments to phrasing and layout.
Original publication.