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
- Cyclotek Queensland fined $93,240 for allegedly breaching conditions of its manufacturing licenceThe TGA has issued 7 infringement notices totalling $93,240 to Cyclotek Queensland Pty Ltd
- Update to the Manufacturing Principles for medicines, APIs & sunscreensUpdate to the manufacturing principles for medicinal products
- GMP approach to overseas manufacturers of medicines and biologicals during the COVID-19 pandemicUpdate to GMP approach to overseas manufacturers of medicines and biologicals during the COVID-19 pandemic.
Latest publications
- Manufacturing principles for medicinal productsPIC/S Guide to Good Manufacturing Practice for Medicinal Products
- Australian manufacturing licences and overseas GMP certificationA step-by-step guide for Australian manufacturers of therapeutic goods.