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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.

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