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Contents (2008 - 392)
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Poisons and Therapeutic Goods Regulation 2008
Current version for 1 July 2017 to date (accessed 22 September 2017 at 03:28)
Part 4A Clause 128I
128I   Clinical trials
It is a condition of a licence or authority under Part 8 authorising the use of a designated non-ARTG product in a clinical trial that the holder of the licence or authority must ensure that:
(a)  the product is not supplied for the treatment of a person in the clinical trial unless:
(i)  the product is supplied for the person on the prescription of a medical practitioner who holds an authority under Part 8, or under the Drug Misuse and Trafficking Act 1985, authorising the practitioner to treat the person with the product, and
(ii)  in the case of a medicinal cannabis product—the product is supplied at the place identified in the prescription, and
(b)  a record is made in the records of the clinical trial of the number of the authority of any medical practitioner who prescribes the product for the treatment of a person in the clinical trial.