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Variations to prescription medicines - excluding variations requiring evaluation of clinical or bioequivalence data (for biological medicines)

Guidance about the types of notifications and variations for biological medicines.

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Last updated

Purpose

This guidance outlines the types of variations and changes that can be made to biological medicines currently on the Australian Register of Therapeutic Goods (ARTG).

Category 1 applications are not covered by this guidance. These require evaluation of a full dataset, or any combination of quality, nonclinical, clinical and bioequivalence data. See the Prescription medicines registration process for information on how to lodge a Category 1 application.

Legislation

Guidance

This guidance is presented as downloadable files because of its length. 

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Page history

Show all page updates (6)

Migration to new 'Guidance' content type included changes to the following:

  • ‘Legislation’ section to clearly show which laws the Guidance relates to.
  • ‘Page history’ section replaces document version history.
  • New page navigation features.
  • New ‘Save as PDF’ feature.

Minor amendments to phrasing and layout. Hyperlinks updated.

Amended title. 

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 (Associated changes, SARO). 

Minor clarifications and corrections to phrasing and layout.

Minor fixes to typographical errors.

Inclusion of notifiable variations to registered medicines. Minor amendments to phrasing and layout.

Original publication.

Migration to new 'Guidance' content type included changes to the following:

  • ‘Legislation’ section to clearly show which laws the Guidance relates to.
  • ‘Page history’ section replaces document version history.
  • New page navigation features.
  • New ‘Save as PDF’ feature.

Minor amendments to phrasing and layout. Hyperlinks updated.

Amended title. 

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 (Associated changes, SARO). 

Minor clarifications and corrections to phrasing and layout.

Minor fixes to typographical errors.

Inclusion of notifiable variations to registered medicines. Minor amendments to phrasing and layout.

Original publication.

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