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
- GMP Clearance: Additional countries added to MRA pathwayMore applications for Good Manufacturing Practice (GMP) clearances can now be assessed under the TGA’s MRA pathway.
- Australian manufacturer fined almost $160,000 for allegedly breaching conditions of its medicines manufacturing licenceThe TGA has issued 12 infringement notices totalling $159,840 to a manufacturer of listed complementary medicines after a recent inspection of the company’s premises identified unacceptable manufacturing practices.
- Aus Labs, Smart Labs, iSARMs and Director Christopher Ramsey plead guilty to over 200 charges for illegal manufacture, supply and advertising of SARMs and nootropicsOn 25 October 2022, Natural Franchises Pty Ltd pleaded guilty in a Sydney court to over 200 offences of the Therapeutic Goods Act 1989 for the manufacture, supply and advertising of unapproved therapeutic goods.
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.