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Guide to the Advertising of Non-prescription Medicines to Consumers

Amendments

Restricted Representations

Guidelines for the Levels and Kinds of Evidence to Support Claims for Therapeutic Goods

Industry Codes

    2. DEFINITIONS
09/05/2007
 

advertisement in relation to Therapeutic Goods as defined in the Therapeutic Goods Act 1989 includes any statement, pictorial representation or design, however made, that is intended, whether directly or indirectly, to promote the use or supply of the goods.

Broadcast media in relation to an advertisement or generic information, means any means (other than a means declared in the Therapeutic Goods Regulations to be an exempted means) by which the information is disseminated electronically in a visible or audible form or a combination of such forms.

Healthcare Professional includes a person that meets the description of a healthcare professional in subsection 42AA(1), (2), (3) of the Therapeutic Goods Act 1989 (see Appendix 2) and any other person represented directly or indirectly to be a healthcare professional.

label in relation to therapeutic goods, means a display of printed information:

(a)           on or attached to the goods; or
(b)          on or attached to a container or primary pack in which the goods are supplied; or
(c)           supplied with such a container or pack.

mainstream media means any magazine or newspaper for consumers   containing a range of news, public interest items, advertorials, advertisements or competitions.

specified media in relation to an advertisement or generic information, means:

(a)           mainstream media, within the meaning of s.42B of The Act; or
(b)          broadcast media, within the meaning of s.42B of the Act; or
(c)           cinematograph films; or
(d)          displays about goods, including posters:
        (i)      in shopping malls (except inside individual shops);
        (ii)  in or on public transport; and
        (iii) on billboards.

sponsor in relation to therapeutic goods, means:

(a)           a person who exports, or arranges the exportation of, the goods from Australia; or
(b)           a person who imports, or arranges the importation of, the goods into Australia; or
(c)           a person who, in Australia, manufactures the goods, or arranges for another person to manufacture the goods, for supply (whether in Australia or elsewhere);

but does not include a person who:

(d)          exports, imports or manufactures the goods; or
(e)           arranges the exportation, importation or manufacture of the goods;

on behalf of another person who, at the time of the exportation, importation, manufacture or arrangements, is a resident of, or is carrying on business in, Australia.

Therapeutic goods are defined in the Therapeutic Goods Act 1989 as goods:

(a)           that are represented in any way to be, or that are, whether because of the way in which the goods are presented or for any other reason, likely to be taken to be:
        (i)             for therapeutic use; or
        (ii)           for use as an ingredient or component in the manufacture of therapeutic goods; or
        (iii)          for use as a container or part of a container for goods of the kind referred to in subparagraph (i) or (ii); or

(b)          included in a class of goods the sole or principal use of which is, or ordinarily is, a therapeutic use or a use of a kind referred to in subparagraph (a) (ii) or (iii);

and includes medical devices and goods declared to be therapeutic goods under an order in force under section 7, but does not include:

(c)           goods declared not to be therapeutic goods under an order of force under section 7; or

(d)          goods in respect of which an order is in force, being an order that declares the goods not to be therapeutic goods when used, advertised or presented for supply in the way specified in the order where the goods are used, advertised or presented for supply in that way; or

(e)           goods (other than goods declared to be therapeutic goods under an order in force under section 7) for which there is a prescribed standard in the Australia New Zealand Food Standards Code as defined in subsection 3(1) of the Australia New Zealand Food Authority Act 1991; or

(f)            goods which, in Australia or New Zealand, have a tradition of use as foods for humans in the form in which they are presented.

Therapeutic Goods Advertising Code Council - means the broadly representative body of peak stakeholder groups, established in the Regulations to the Therapeutic Goods Act 1989 to:

(a)           consider the requirements for the advertising of therapeutic goods and changes to this Code, to accept submissions for this purpose and to advise the Minister accordingly; and

(b)          to make recommendations to the Minister for achieving greater uniformity in approval processes and standards for the advertising of therapeutic goods,

amongst other matters (as outlined in the Regulations).

Therapeutic use is defined in the Therapeutic Goods Act 1989 as meaning use in or in connection with:

(a)           preventing, diagnosing, curing or alleviating a disease, ailment, defect or injury in persons or animals; or

(b)          influencing, inhibiting or modifying a physiological process in persons or animals; or

(c)           testing the susceptibility of persons or animals to a disease or ailment; or

(d)          influencing, controlling or preventing conception in persons; or

(e)           testing for pregnancy in persons; or

(f)            the replacement or modification of parts of the anatomy in persons or animals.

Typical means that which reflects the characteristic of a group ie. a result obtained from the use of a product which would be likely to be attained by most people using the product within the audience to which the advertisement is directed.


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