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Variations to prescription medicines - excluding variations requiring evaluation of clinical or bioequivalence data, Appendix 1: Variation types - chemical entities

Version 3.0, July 2019

10 July 2019

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The Therapeutic Goods Administration (TGA) takes a risk-based approach to assessing variations to prescription medicines. This means that the higher the risk associated with the variation, the greater the level of assessment required by the TGA for a decision to be made.

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).

Major variations (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.

See also:

Data supporting variations requests

The conditions outlined within each variation type set out the minimum documentation required for regulatory purposes, but depending on the particular circumstances surrounding the change, additional data may be needed. Additional data may also be required to meet Good Manufacturing Practice.

Refer to each type of change for full data requirements.

Variations to prescription medicines - excluding variations requiring evaluation of clinical or bioequivalence data, Appendix 1: Variation types - chemical entities

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Contents

  • Introduction
  • Index of variation types - chemical entities
  • 1. Corrections, Notifications and Quality information changes
    • 1.1 Active Pharmaceutical Ingredient (API) changes
    • 1.2 Drug product manufacture changes - method, batch size or equipment
    • 1.3 Drug product - site of manufacture changes
    • 1.4 Drug product formulation changes
    • 1.5 Drug product specifications or test changes
    • 1.6 Excipients changes
    • 1.7 Container/closure system changes
    • 1.8 Pack size changes
    • 1.9 Product shelf life or storage conditions changes
    • 1.10 Product information (PI) changes: Quality aspects, corrections and self-assessable requests (SARs)
    • 1.11 Product label changes
    • 1.12 Other changes
    • 1.13 Associated changes
  • 2. Product information (PI) changes
    • 2.1 Product information (PI) changes: Minor editorial changes and safety-related requests (SRRs)
    • 2.2 Extension of indications
    • 2.3 Associated changes to product information (PI)

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