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The Therapeutic Goods Act 1989 is an Act of the Commonwealth of Australia which regulates therapeutic goods. The Act is administered by the Therapeutic Goods Administration (TGA), which is part of the Commonwealth Department of Health. [1] The statutory framework set out in the Act is supplemented by the Therapeutic Goods Regulations 1990 and ...
Therapeutic goods include goods that are represented to have a therapeutic effect, are included in a class of goods the sole or principal use of which is (or ordinarily is) a therapeutic use, or are otherwise determined to be a therapeutic good through a legislative instrument under the Therapeutic Goods Act 1989. [5] Goods that are therapeutic ...
The role of therapeutic goods regulation is designed mainly to protect the health and safety of the population. Regulation is aimed at ensuring the safety, quality, and efficacy of the therapeutic goods which are covered under the scope of the regulation. In most jurisdictions, therapeutic goods must be registered before they are allowed to be ...
Download as PDF; Printable version; ... Regulation of therapeutic goods; The Rhetoric of Drugs; S. ... Therapeutic Goods Act 1989; Title 21 CFR Part 11;
“Medical devices are defined as follows by the Therapeutic Goods Act 1989 : a. any instrument, apparatus, appliance, material or other article (whether used alone or in combination, and including the software necessary for its proper application) intended, by the person under whose name it is or is to be supplied, to be used for human beings ...
In New South Wales, poisons are proclaimed in the Poisons List by the Poisons Advisory Committee, under the authority of the Poisons and Therapeutic Goods Act 1966 (NSW). NSW legislation refers to S2 as "medicinal poisons", S3 as "potent substances", S4 as "restricted substances" and S8 as "drugs of addiction".
The Australian Drug Evaluation Committee (ADEC) was a committee that provided independent scientific advice to the Australian Government regarding therapeutic drugs.The committee was originally formed in 1963 and more recently authorised under the Therapeutic Goods Act 1989 (Cth) as part of the Therapeutic Goods Administration (TGA).
Download as PDF; Printable version; ... Genetic Non-Discrimination Act; Gillick competence; ... Therapeutic Goods Act 1989; U.