Minor variations to prescription medicines, Appendix 2: Variation change types - biological medicines

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Version 2.0, December 2017

4 December 2017

Introduction

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 following types of minor variations and changes that can be made to biological medicines currently on the Australian Register of Therapeutic Goods (ARTG):

  • Changes that do not require prior approval. These are:
    • changes that can be implemented without informing the TGA and
    • changes that can be implemented before you inform the TGA of the change.
  • Corrections to an ARTG entry – a minor change to correct or complete information that was inadvertently recorded incorrectly or omitted in the ARTG entry, including the product information (PI).
  • Notifications – very low risk variations with specific conditions. TGA approval for these variations is made automatically upon lodgement and payment of the application. The applicant must provide legal assurances that all conditions are met and submit supporting data using the approved electronic form.
  • Minor Editorial Changes to product information (MEC).
  • Self-Assessable Requests (SARs) – lower risk variations for which the sponsor can provide an assessment of their own data for the TGA to verify.
  • Safety Related Requests (SRRs) – requests to either reduce the patient population that can receive the medicine or add a warning or precaution.
  • Category 3 requests – variations that require evaluation of quality-related data only. The change types listed in this guidance are representative and are not intended to be an exhaustive list of all quality-related changes requiring evaluation of data.

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.

Data supporting minor 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.

Some of the types of data that may be needed are listed below, but refer to each type of change for full data requirements.

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