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Variations to prescription medicines - excluding variations requiring evaluation of clinical or bioequivalence data, Appendix 2: Variation types - biological medicines

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 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.

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 need to be generated to meet requirements under 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 2: Variation types - biological medicines

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Contents

  • Introduction
  • Index of variation types - biological medicines
  • 1. Corrections, Notifications and Quality information changes
    • 1.1 Cell bank or seed lot changes
    • 1.2 Drug substance or excipient changes
    • 1.3 Site of manufacture changes
    • 1.4 Drug product manufacture changes
    • 1.5 Drug product specifications or test changes
    • 1.6 In-house reference standard changes
    • 1.7 Purification process changes
    • 1.8 Filling changes
    • 1.9 Changes to storage of drug substance
    • 1.10 Changes to storage of drug product
    • 1.11 Fermentation process changes
    • 1.12 Plasma Master File changes
    • 1.13 Plasma fractionation intermediates changes
    • 1.14 Product information (PI) changes: Quality aspects, corrections and self-assessable requests (SARs)
    • 1.15 Product label changes
    • 1.16 Pack size changes
    • 1.17 Drug product packaging changes
    • 1.18 Changes specific to influenza vaccines
    • 1.19 Other changes
    • 1.20 Associated changes
  • 2. Product information (PI) changes
    • 2.1 Product information (PI) changes: Minor editorial changes and safety-related requests (SRRs)
      • 2.1.1 Minor editorial changes to the product information under s. 9D(3)
      • 2.1.2 Safety-related requests (SRRs)

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