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.
Good manufacturing practice
More information
Latest articles
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Consent relating to listed medicines that contain whole live microorganisms as an active ingredient
This consent is given under sections 14 and 14A of the Therapeutic Goods Act 1989. -
Automatic extension of Mutual Recognition Agreement (MRA) Good Manufacturing Practice (GMP) clearances
MRA GMP clearances that are expiring on 31 December 2024 will be automatically extended. -
Nitrosamine impurities acceptable intakes update - October 2024
The TGA is updating information for nitrosamine impurities in medicines including acceptable intakes (AI).
Latest publications
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A meeting statement from the second meeting of the Point-of-care Manufacturing of Medical Devices Steering Committee is now available.
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A meeting statement from the first meeting of the Point-of-care Manufacturing of Medical Devices Steering Committee is now available.
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