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Notices for manufacturers
These notices are for manufacturers of medicines, biologicals and blood, blood components and HPCs.
For notices about manufacturing medical devices, go to Regulatory decisions and notices (Medical devices and IVDs)
Older, revoked and superseded notices are available in the TGA Internet site archive.
- Updated GMP licence application e-forms
13 March 2019: GMP Licence submission e-forms will be updated on the TBS portal from 15 March 2019 to support the revised fees and charges model
- Changed telephone number for enquiries to Manufacturing Quality Branch
26 September 2018: Streamlining of Manufacturing Quality Branch contact numbers
- Medicine GMP - revised fees and charges effective 1 July 2018
18 June 2018: Changes to Medicine GMP fees and charges will become effective 1 July 2018
- Submissions received: Proposal to change the medicine GMP fees and charges
18 May 2018: Outcome of the TGA's public consulation on proposed Medicine GMP fees and charges published
- Implementation of the PIC/S guide to GMP PE009-13
2 January 2018: On 1 January 2018 the TGA adopted new manufacturing principles to be observed by manufacturers of medicines and active pharmaceutical ingredients