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Variations to prescription medicines - excluding variations requiring evaluation of clinical or bioequivalence data: process guidance

Guidance about how to make variations to Australian Register of Therapeutic Goods (ARTG) entries for prescription medicines.

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Purpose

This guidance describes how to make variations to existing entries for prescription medicines in the Australian Register of Therapeutic Goods (ARTG). The variations included in this guidance are quality and product information (PI) changes where evaluation of clinical and bio-equivalence data is not required. These applications are not lodged under the Prescription Medicines Registration Process.

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Guidance

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

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Show all page updates (3)

Changes included:

  • Amended title.
  • Inclusion of Extension of indications to align with a reference product.
  • Clarification of process for Notifications, Self-assessable requests and Category 3 requests where multiple variation types could be selected.
  • Inclusion of advice regarding advising the TGA of changes made to medicines without the required approval.
  • Minor clarifications and corrections to phrasing and layout.
  • Clarification of mechanism to approve one-off changes to medicines.

Introduction of notifications process and minor amendments.

Original publication.

Changes included:

  • Amended title.
  • Inclusion of Extension of indications to align with a reference product.
  • Clarification of process for Notifications, Self-assessable requests and Category 3 requests where multiple variation types could be selected.
  • Inclusion of advice regarding advising the TGA of changes made to medicines without the required approval.
  • Minor clarifications and corrections to phrasing and layout.
  • Clarification of mechanism to approve one-off changes to medicines.

Introduction of notifications process and minor amendments.

Original publication.

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