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.
- Manufacturing therapeutic goods
- Manufacture of therapeutic goods
- Manufacturing principles & guidelines
- Manufacturing basics - Medicines and biologicals
- Inspection and audit feedback forms
- The TGA has issued 7 infringement notices totalling $93,240 to Cyclotek Queensland Pty Ltd
- Update to the manufacturing principles for medicinal products
- Update to GMP approach to overseas manufacturers of medicines and biologicals during the COVID-19 pandemic.