Therapeutic Goods Regulations 2012

Therapeutic Goods Regulations 2012

I, the Governor in and over the State of Tasmania and its Dependencies in the Commonwealth of Australia, acting with the advice of the Executive Council, make the following regulations under the Therapeutic Goods Act 2001 .

PETER G. UNDERWOOD

Governor

By His Excellency's Command,

MICHELLE O'BYRNE

Minister for Health

1.   Short title

These regulations may be cited as the Therapeutic Goods Regulations 2012 .

2.   Commencement

These regulations take effect on 28 August 2012.

3.   Wholesaler of therapeutic goods to comply with Code

A person who supplies therapeutic goods by wholesale must comply with the "Code of Good Wholesaling Practice for Therapeutic Goods for Human Use" published by the Commonwealth Government (as in force from time to time).

Penalty:  Fine not exceeding 20 penalty units.

4.   Labelling of certain therapeutic substances

(1)  A person specified in item 1, 2 or 4 of Schedule 8 to the Therapeutic Goods Regulations 1990 of the Commonwealth must ensure that all unscheduled therapeutic substances that are supplied from his or her business for therapeutic use are labelled in accordance with this regulation or in accordance with Therapeutic Goods Order No. 69 made pursuant to section 10 of the Therapeutic Goods Act 1989 of the Commonwealth.

Penalty:  Fine not exceeding 20 penalty units.

(2)  All details, words and other information that are to be shown on a label on the container of a therapeutic substance must be in the English language.

(3)  Subregulation (2) does not preclude the details, words and other information referred to in that subregulation from being in another language in addition to the English language.

(4)  All symbols, numbers and words must be clearly legible and in durable characters.

(5)  All numbers and letters must be –

(a) at least 1.5 millimetres high; and

(b) in clear and distinct contrast to the background.

(6)  The label on a container containing a therapeutic substance must show the following details:

(a) the name and address of the person or business supplying the substance;

(b) the name or initials of the person dispensing the substance;

(c) the approved name of the substance and its proprietary name unless it is a preparation compounded in accordance with the supplier's own formula;

(d) adequate directions for the use of the substance;

(e) the words "KEEP OUT OF REACH OF CHILDREN" in red on a white background;

(f) 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;

(g) if the substance is intended for the treatment of a person, the name of the person;

(h) if the substance is intended for the treatment of an animal, the species of animal and the name of the animal's owner.

(7)  The label on a container of a therapeutic substance that is supplied on prescription must also show –

(a) the directions for use set out in the prescription; and

(b) the prescription reference number; and

(c) the date on which the prescription was supplied unless that date is clear from the prescription reference number.

(8)  The provisions of subregulations (2) , (3) , (4) , (5) , (6) and (7) are complied with if the information referred to in those subregulations is shown by tags, brands, marks or statements printed or in clear writing on the container.

(9)  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 ;

unscheduled therapeutic substance means a therapeutic substance that is not specified in any of the Schedules to the Poisons List.

Displayed and numbered in accordance with the Rules Publication Act 1953.

Notified in the Gazette on 1 August 2012

These regulations are administered in the Department of Health and Human Services.

EXPLANATORY NOTE

(This note is not part of the regulation)

(a) require wholesalers of therapeutic goods to comply with the "Code of Good Wholesaling Practice for Therapeutic Goods for Human Use"; and

(b) contain labelling requirements for certain therapeutic substances; and

(c) are made consequentially on the repeal of the Therapeutic Goods Regulations 2002 under section 11 of the Subordinate Legislation Act 1992 .