Licence 1518 views0 applications

Definition: In Australia, the Therapeutic Goods Act 1989 requires, with certain exceptions, that manufacturers of therapeutic goods hold a licence. It is an offence, carrying heavy penalties, to manufacture therapeutic goods for human use without a licence unless the manufacturer or goods are exempt from this requirement. To obtain a licence to manufacture therapeutic goods, a manufacturer must demonstrate, during a factory audit, compliance with manufacturing principles which includes relevant Codes of GMP and Quality Systems.

As per: TGA

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