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These regulations may be cited as the Therapeutic Goods Regulations 2022 .
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Tasmania regulation
These regulations require wholesalers to follow the Code of Good Wholesaling Practice for specified medicines and set mandatory labelling rules for therapeutic substances — e.g. “KEEP OUT OF REACH OF CHILDREN” (red on white), patient or animal identification, and, for prescription supplies, directions, prescription reference and supply date. Non‑compliance carries a fine up to 20 penalty units. They apply to persons supplying therapeutic goods (including those listed in Schedule 8 to the 1990 Regulations), shifting compliance costs to suppliers and creating enforcement incentives via fines and cross‑references to other Acts and Orders.
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Direct links to the current provisions in Therapeutic Goods Regulations 2022.
These regulations may be cited as the Therapeutic Goods Regulations 2022 .
These regulations take effect on 1 August 2022.
(1) In this regulation –
Code means the "Code of Good Wholesaling Practice for Medicines in Schedules 2, 3, 4 and 8", first published by the former entity of the Commonwealth known as the National Coordinating Committee on Therapeutic Goods on 1 April 2011, and as republished from time to time by the Therapeutic Goods Administration of the Commonwealth.
(2) A person who supplies therapeutic goods by wholesale must comply with the Code.
Penalty: Fine not exceeding 20 penalty units.
(1) In this regulation –
container, when used in relation to any therapeutic substance, means any vessel, bottle, tube, capsule, tin, box, case, wrapper, cover or other like receptacle or envelope that immediately contains the substance;
Poisons List has the same meaning as in the Poisons Act 1971 ;
therapeutic substance means a substance supplied for therapeutic use;
therapeutic use has the same meaning as in the Commonwealth Act;
unscheduled therapeutic substance means a therapeutic substance that is not specified in any of the Schedules to the Poisons List.
(2) A person specified in item 1, 2 or 4 of Schedule 8 to the Therapeutic Goods Regulations 1990 of the Commonwealth must not supply an unscheduled therapeutic substance for therapeutic use unless the person complies with the standards constituted by the following orders made under section 10 of the Therapeutic Goods Act 1989 of the Commonwealth:
(a) Therapeutic Goods Order No. 91 - Standard for labels of prescription and related medicines;
(b) Therapeutic Goods Order No. 92 - Standard for labels of non-prescription medicines.
Penalty: Fine not exceeding 20 penalty units.
(3) The label on a container containing a therapeutic substance must show the following details:
(a) the words "KEEP OUT OF REACH OF CHILDREN" in red on a white background;
(b) if the substance is intended for external use only, the word "POISON", or the words "FOR EXTERNAL USE ONLY", in red on a white background;
(c) if the substance is intended for the treatment of a person, the name of the person;
(d) if the substance is intended for the treatment of an animal, the species of animal and the name of the animal's owner.
(4) In addition to the requirements of subregulation (3) , the label on a container containing a therapeutic substance that is supplied on prescription must show the following details:
(a) the directions for use;
(b) the prescription reference number;
(c) the date on which the prescription was supplied, unless that date is clear from the prescription reference number.
(5) The provisions of subregulations (3) and (4) are complied with if the information referred to in those subregulations is shown by tags, brands or marks, or statements printed or in clear writing on the container.
Displayed and numbered in accordance with the Rules Publication Act 1953.
Notified in the Gazette on 13 July 2022
These regulations are administered in the Department of Health.
Sourced from Tasmanian Legislation Online (legislation.tas.gov.au), CC BY 4.0.
These regulations may be cited as the Therapeutic Goods Regulations 2022 .
These regulations take effect on 1 August 2022.
(1) In this regulation –
Code means the "Code of Good Wholesaling Practice for Medicines in Schedules 2, 3, 4 and 8", first published by the former entity of the Commonwealth known as the National Coordinating Committee on Therapeutic Goods on 1 April 2011, and as republished from time to time by the Therapeutic Goods Administration of the Commonwealth.
(2) A person who supplies therapeutic goods by wholesale must comply with the Code.
Penalty: Fine not exceeding 20 penalty units.
(1) In this regulation –
container, when used in relation to any therapeutic substance, means any vessel, bottle, tube, capsule, tin, box, case, wrapper, cover or other like receptacle or envelope that immediately contains the substance;
Poisons List has the same meaning as in the Poisons Act 1971 ;
therapeutic substance means a substance supplied for therapeutic use;
therapeutic use has the same meaning as in the Commonwealth Act;
unscheduled therapeutic substance means a therapeutic substance that is not specified in any of the Schedules to the Poisons List.
(2) A person specified in item 1, 2 or 4 of Schedule 8 to the Therapeutic Goods Regulations 1990 of the Commonwealth must not supply an unscheduled therapeutic substance for therapeutic use unless the person complies with the standards constituted by the following orders made under section 10 of the of the Commonwealth:
(a) Therapeutic Goods Order No. 91 - Standard for labels of prescription and related medicines;
(b) Therapeutic Goods Order No. 92 - Standard for labels of non-prescription medicines.
Penalty: Fine not exceeding 20 penalty units.
(3) The label on a container containing a therapeutic substance must show the following details:
(a) the words "KEEP OUT OF REACH OF CHILDREN" in red on a white background;
(b) if the substance is intended for external use only, the word "POISON", or the words "FOR EXTERNAL USE ONLY", in red on a white background;
(c) if the substance is intended for the treatment of a person, the name of the person;
(d) if the substance is intended for the treatment of an animal, the species of animal and the name of the animal's owner.
(4) In addition to the requirements of subregulation (3) , the label on a container containing a therapeutic substance that is supplied on prescription must show the following details:
(a) the directions for use;
(b) the prescription reference number;
(c) the date on which the prescription was supplied, unless that date is clear from the prescription reference number.
(5) The provisions of subregulations (3) and (4) are complied with if the information referred to in those subregulations is shown by tags, brands or marks, or statements printed or in clear writing on the container.
Displayed and numbered in accordance with the Rules Publication Act 1953.
Notified in the Gazette on 13 July 2022
These regulations are administered in the Department of Health.