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.
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.
The Department of Health and Aged Care acknowledges First Nations peoples as the Traditional Owners of Country throughout Australia, and their continuing connection to land, sea and community. We pay our respects to them and their cultures, and to all Elders both past and present.