Requesting variations to your manufacturing licence

A step-by-step guide for Australian manufacturers of therapeutic goods (other than medical devices) applying to vary a manufacturing licence.

Last updated

1 December 2021

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:

You cannot request a variation to your GMP certification for an overseas manufacturer 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 may incur a licence variation fee.

The application fees for manufacturing licence variations are published in the Summary of fees and charges, under Manufacturing medicines and OTGs.