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Requesting variations to your manufacturing licence

A step-by-step guide

19 March 2019

This is a step-by-step guide for Australian manufacturers of therapeutic goods (other than medical devices) applying through TGA Business Services to vary an in-force manufacturing licence for an Australian manufacturing site under section 40B of the Therapeutic Goods Act 1989. If you have any questions, contact the Manufacturing Quality Branch.

This process should not be used for requesting:

Please notify us before making any change to your licence, because some changes require prior approval.

You cannot request a variation to your GMP certification via TGA Business Services. You should email these requests to Manufacturing Quality Branch.

You can request to vary details of the manufacturing licence such as the licence nominees (Persons in control of Quality Control and Production) and manufacturing authorisations (e.g. dosage forms and manufacturing steps et cetera). See Section 40B of the Therapeutic Goods Act 1989 for additional information.

Variations made to a manufacturing licence under Section 40B of the Therapeutic Goods Act 1989 will incur a licence variation fee.

The application fees for manufacturing licence variations are published in the Summary of fees and charges.

Requesting variations to your manufacturing licence

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Contents

  • Commencing a licence variation application
  • Variation application types
    • Requesting a change to the licence nominees (Persons in charge of Production and Quality Control)
    • Requesting a change to manufacturing authorisations
    • Changing the manufacturer name or address
    • Adding / removing a secondary site
  • Completing & submitting your licence variation application
  • Reviewing your variation application