Manufacturing
Information to assist manufacturers understand their regulatory responsibilities, including licensing.
In Australia, the Therapeutic Goods Act 1989 requires, with certain exceptions, that manufacturers of therapeutic goods hold a licence or a conformity assessment certificate.
It is an offence, carrying heavy penalties, to manufacture therapeutic goods for human use without a licence or a conformity assessment certificate unless the manufacturer or goods are exempt from this requirement.
Only Australian manufacturing sites can obtain a manufacturing licence.
Overseas manufacturers can instead obtain GMP certification following a successful on-site inspection by the TGA.
GMP certification applications are required to be submitted by the Australian sponsor or an agent acting on the Australian sponsor's behalf.
Latest articles
- Affinity Corp Australia Pty Ltd fined $66,600 for alleged unlawful advertising of medicinal cannabis productsThe TGA has issued 5 infringement notices to Affinity Corp Australia Pty Ltd for the alleged unlawful advertising of medicinal cannabis products.
- GMP Clearance: Extension processing timesDelays in processing timeframes of applications to extend GMP Clearances.
- Surveys - Medical devices manufactured at the Point-of-CareWe are conducting surveys to collect information about medical devices manufactured at the point-of-care.
Latest publications
- PIC/S Guide to GMP: Manufacturing principles for medicinal productsPIC/S Guide to Good Manufacturing Practice (GMP) for Medicinal Products, PE009-15, 01 May 2021: Current version
- Good Manufacturing Practice annual report 2019-20Insights into manufacturing quality regulatory activity.