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Definitions and Notes

Full Definition List

advertisement

advertisement, in relation to therapeutic goods, 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.

approval number

approval number means the distinguishing number allocated to an approved advertisement by the Secretary under regulation 5J of the Therapeutic Goods Regulations.

approved advertisement

approved advertisement means an advertisement:

(a) approved under regulation 5G, or taken to be approved by the Secretary under subregulation 5H(2), or approved by the Minister on review under regulation 5M, of the Therapeutic Goods Regulations; and

(b) the approval of which has not been withdrawn.

Complaints Resolution Panel

Complaints Resolution Panel means the panel established under regulation 42R. i.e. A committee, to be known as the Complaints Resolution Panel, is established.

complementary medicines

complementary medicines has the same meaning as in section 52F of the Act.

designated therapeutic goods

designated therapeutic goods means therapeutic goods other than:

(a) therapeutic devices; and

(b) goods included in Schedule 3 to the Poisons Standard that are not included in Appendix H of that standard; and

(c) goods included in Schedule 4 or 8 to the Poisons Standard.

generic information

generic information, in relation to therapeutic goods, includes any statement, pictorial representation or design, however made, about the composition, properties or other characteristics of therapeutic goods, but does not include:

(a) an advertisement about the goods; or

(b) generic information included in, or associated (directly or indirectly) with, an advertisement about therapeutic goods; or

(c) bona fide news.

indications

indications, in relation to therapeutic goods, means the specific therapeutic uses of the goods.

label

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.

listed goods

listed goods means therapeutic goods that are included in the Part of the Register for goods known as listed goods.

mainstream media

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

Paragraph 30(2)(e)Therapeutic Goods Act: Cancellation of registration or listing

Subject to subsection (3), the Secretary may, by notice in writing given to a person in relation to whom therapeutic goods are included in the Register, cancel the registration or listing of the goods if:

the goods do not conform to a standard applicable to the goods or to a requirement relating to advertising applicable to the goods under the regulations; or

Presentation (subsection 3(5) Therapeutic Goods Act)

For the purposes of this Act, the presentation of therapeutic goods is unacceptable if it is capable of being misleading or confusing as to the content or proper use of the goods and, without limiting the previous words in this subsection, the presentation of therapeutic goods is unacceptable:

(a) if it states or suggests that the goods have ingredients, components or characteristics that they do not have; or

(b) if a name applied to the goods is the same as the name applied to other therapeutic goods that are supplied in Australia where those other goods contain additional or different therapeutically active ingredients; or

(c) if the label of the goods does not declare the presence of a therapeutically active ingredient; or

(d) if a form of presentation of the goods may lead to unsafe use of the goods or suggests a purpose that is not in accordance with conditions applicable to the supply of the goods in Australia; or

(e) in prescribed cases.

publisher

publisher means a person whose business it is to publish or insert, or to arrange for the publication or insertion of, advertisements in any publication.

Register

Register means the Australian Register of Therapeutic Goods maintained under section 17.

Registered goods

registered goods means therapeutic goods included in the part of the Register for goods known as registered goods.

Reg. 4 This Part not to apply to advertisements directed at health professionals etc

(1) This Part does not apply to advertisements directed exclusively to:

(a) medical practitioners, psychologists, dentists, veterinary surgeons, pharmacists, physiotherapists, dietitians, scientists working in medical laboratories or nurses; or

(b) persons who are:

(i) engaged in the business of wholesaling therapeutic goods; or

(ii) purchasing officers in hospitals; or

(c) herbalists, homoeopathic practitioners, chiropractors, naturopaths, nutritionists, practitioners of traditional Chinese medicine or osteopaths registered under a law of a State or Territory.

Reg. 5L Withdrawal of approval

(1) The Secretary, by written notice to an approval holder, may withdraw the approval of an approved advertisement if the Secretary is satisfied that:

(a) information given by the applicant in the application was false or incorrect and the Secretary or the Minister relied on the information in deciding to approve the advertisement; or

(b) a person has contravened section 42C of the Act in relation to the advertisement; or

(c) there has been a breach of a condition of approval; or

(d) because of a change to the facts or circumstances existing when the advertisement was approved, the advertisement no longer complies with the Therapeutic Goods Advertising Code; or

(e) because of a change to the Therapeutic Goods Advertising Code, the advertisement no longer complies with the Code.

(2) The Secretary, by written notice to an approval holder, may withdraw the approval of an approved advertisement on the recommendation of the Complaints Resolution Panel following a complaint to the Panel under subregulation 42ZCAB (1).

(3) The notice under subregulation (1) or (2) must:

(a) give the Secretary’s reasons for the decision; and

(b) inform the approval holder of the approval holder’s right to have the Secretary’s decision reviewed by the Minister under regulation 5M.

Reg. 5G Approval of advertisements

(1) If an application for approval of an advertisement is made and the prescribed fee is paid, the Secretary must approve the advertisement if the Secretary is satisfied that it:

(a) complies with the Therapeutic Goods Advertising Code; and

(b) does not contain a prohibited representation (whether in express terms or by necessary implication) about the goods; and

(c) contains a required representation about the goods; and

(d) does not contain an unacceptable presentation of the goods within the meaning of regulation 6A; and

(e) does not contain a restricted representation, about the goods, the use of which has not been approved under subregulation 7C (1) or permitted under subregulation 9 (1).

(3) Otherwise, the Secretary must refuse to approve the advertisement.

(4) An approval may be subject to conditions imposed by the Secretary.

Reg. 7A Restricted representations

(1) For the purposes of this Part, a representation in an advertisement about therapeutic goods that refers to a serious form of a disease, condition, ailment or defect specified in Part 2 of Appendix 6 to the Therapeutic Goods Advertising Code is a restricted representation about therapeutic goods.

(2) A person must not use a restricted representation in an advertisement about therapeutic goods unless the Secretary:

(a) has approved its use under subregulation 7C (1); or

(b) has permitted its use under subregulation 9 (1).

Reg. 9AA Orders about advertisements

(1) On the recommendation of the Complaints Resolution Panel under subregulation 42ZCAI (3) in relation to an advertisement about therapeutic goods, the Secretary, by written notice, may order a person to do one or more of the following:

(a) publish a retraction;

(b) publish a correction;

(c) recover any advertisement that is still in circulation;

(d) destroy the advertisement.

(2) An order under subregulation (1) may be subject to conditions imposed by the Secretary.

(3) The Secretary may delegate all or any of the Secretary’s powers under subregulation (1) to the chairperson of the Complaints Resolution Panel.

Reg. 9R Offences — publication of generic information

(1) A person must not publish generic information about therapeutic goods if:

(a) it is false or misleading in a material particular; or

(b) it contains a claim that has not been verified; or

(c) it contains any matter that is likely to lead a person to believe that:

(i) a person is suffering from a serious disease, condition, ailment or defect; or

(ii) harmful consequences may result from the person’s failure to use the goods; or

(d) it contains a claim, statement or implication that the goods are effective treatment for all forms of a disease, condition, ailment or defect; or

(e) it encourages self-diagnosis or self-treatment of potentially serious diseases, conditions, ailments or defects; or

(f) it is directed to persons under 18 years and the information is about therapeutic goods not listed in Appendix 5 to the Therapeutic Goods Advertising Code.

Penalty: 10 penalty units.

(2) A person must not insert in print media generic information about therapeutic goods if:

(a) it is false or misleading in a material particular; or

(b) it contains a claim that has not been verified; or

(c) it contains any matter that is likely to lead a person to believe that:

(i) a person is suffering from a serious disease, condition, ailment or defect; or

(ii) harmful consequences may result from the person’s failure to use the goods; or

(d) it contains a claim, statement or implication that the goods are effective treatment for all forms of a disease, condition, ailment or defect; or

(e) it encourages self-diagnosis or self-treatment of potentially serious diseases, conditions, ailments or defects; or

(f) it is directed to persons under 18 years and the information is about therapeutic goods not listed in Appendix 5 to the Therapeutic Goods Advertising Code. Penalty:

10 penalty units.

(3) A person must not publish generic information about therapeutic goods if:

(a) that information includes or implies an endorsement of the goods by:

(i) a government agency; or

(ii) a health care professional; or

(b) that information:

(i) includes or implies an endorsement of the goods by a body or association that represents the interests of health consumers or health care professions, or conducts or funds research into diseases, conditions, ailments or defects; and

(ii) does not:

(A) disclose the nature of the endorsement; and

(B) identify the body or association making the endorsement; and

(C) indicate that the endorsement has been authenticated; and

(D) acknowledge any valuable consideration received by the body or association for the endorsement. Penalty:

10 penalty units.

(4) A person must not insert in print media generic information about therapeutic goods if:

(a) that information includes or implies an endorsement of the goods by:

(i) a government agency; or

(ii) a health care professional; or

(b) that information:

(i) includes or implies an endorsement of the goods by a body or association that represents the interests of health consumers or health care professions, or conducts or funds research into diseases, conditions, ailments or defects; and

(ii) does not:

(A) disclose the nature of the endorsement; and

(B) identify the body or association making the endorsement; and

(C) indicate that the endorsement has been authenticated; and

(D) acknowledge any valuable consideration received by the body or association for the endorsement. Penalty:

10 penalty units.

Reg. 9S Orders about generic information

(1) On the recommendation of the Complaints Resolution Panel under subregulation 42ZCAI (3) in relation to generic information about therapeutic goods, the Secretary, by written notice, may order a person to do one or more of the following:

(a) publish a retraction;

(b) publish a correction;

(c) recover any generic information that is still in circulation;

(d) destroy the generic information.

(2) An order under subregulation (1) may be subject to conditions imposed by the Secretary.

(3) The Secretary may delegate all or any of the Secretary’s powers under subregulation (1) to the chairperson of the Complaints Resolution Panel.

Reg. 42ZCAK Procedure generally

So far as these Regulations do not provide for the procedure of the Panel, the Panel may determine its own procedure.

Reg. 42ZCAA 42ZCAA Definitions for Subdivision 2

In this Subdivision:

complaint means a complaint about an advertisement or generic information made to the Complaints Resolution Panel in accordance with regulation 42ZCAB.

person apparently responsible, in relation to a complaint about an advertisement or generic information, means the person who, based on the complaint and the assessment of the Complaints Resolution Panel, appears to be responsible for requesting the publication or insertion of the advertisement or generic information in specified media.

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

(a) mainstream media;or

(b) broadcast media; or

(d) cinematograph films;

(e) outdoor displays, including billboards or posters exhibited on or in public transport.

Note: specified media is defined in section 42B of the Act.

Reg. 42ZCAB Complaints about advertisements or generic information

(1) A person may complain in writing to the Complaints Resolution Panel that:

(a) an advertisement about designated therapeutic goods that is published or inserted in specified media contravenes:

(i) subsection 22 (5), or section 42C or 42D, of the Act; or

(ii) these Regulations; or

(iii) the Therapeutic Goods Advertising Code; or

(b) an advertisement about therapeutic devices that is published or inserted in specified media contravenes:

(i) subsection 22 (5) of the Act; or

(ii) these Regulations; or

(iii) the Therapeutic Goods Advertising Code.

(2) A person may complain in writing to the Complaints Resolution Panel that generic information, to which Part 2B applies, that is published or inserted in specified media contravenes regulation 9Q or 9R

Reg. 42ZCAC Procedure on receipt of a complaint

(1) If the Panel receives a complaint, the Panel:

(a) must give, to the complainant (if known) and the person apparently responsible, written notice that the complaint has been received; and

(b) may make initial inquiries so that the details and background of the complaint are available to the Panel when it considers the complaint

(2) The notice must:

(a) give details of the complaint; and

(b) invite the complainant (if known) and the person apparently responsible to send written submissions to the Panel, together with any supporting documents.

Reg. 42ZCAE Powers of Panel

(1) The Panel may inform itself on any matter, and consult such persons, as it thinks fit.

(2) The Panel may require the person apparently responsible or the sponsor to produce evidence in support of a claim made in an advertisement or in generic information that is the subject of a complaint.

Reg. 42ZCAF Withdrawal of complaint

(1) The complainant may withdraw a complaint at any time.

(2) The Panel may treat a complaint as withdrawn if, before dealing with the complaint under regulation 42ZCAD, the Panel is satisfied that:

(a) the complaint is trivial, vexatious, misconceived or lacking in substance; or

(b) the subject matter of the complaint has been dealt with by the Panel or by another authority; or

(c) the subject matter of the complaint can more effectively or conveniently be dealt with by another authority; or

(d) both:

(i) the complainant does not intend to proceed with the complaint; and

(ii) on the basis of the complaint, there does not appear to have been any contravention of the Act, these Regulations or the Therapeutic Goods Advertising Code.

(3) If the complaint is withdrawn under subregulation (1), the Panel must inform the person apparently responsible of the fact.

(4) If the Panel treats a complaint as withdrawn under subregulation (2), the Panel must give written notice to the complainant (if known) and the person apparently responsible of the Panel’s decision and the reasons for the decision.

Reg. 42ZCAG Dealing with subject matter despite withdrawal of complaint

(1) The Panel may deal with the subject matter of a complaint despite the withdrawal of the complaint if it appears to the Panel that there may have been a contravention of the Act, these Regulations or the Therapeutic Goods Advertising Code.

(2) If the Panel decides to deal with the subject matter of a complaint under subregulation (1), the Panel must give written notice of its decision and the reasons for the decision to the person apparently responsible.

Reg. 42ZCAH Dealing with matters not specified in complaint

(1) The Panel may deal with a matter that is not mentioned in a complaint if it is satisfied that the advertisement or generic information to which the complaint relates may contravene the Act, these Regulations or the Therapeutic Goods Advertising Code in some other way

(2) If the Panel decides to deal with a matter under subregulation (1), the Panel must give written notice of its decision to the person apparently responsible.

(3) The notice must:

(a) give details of the matter not mentioned in the complaint and the possible contravention of the Act, these Regulations or the Therapeutic Goods Advertising Code that are to be dealt with by the Panel; and

(b) invite the person apparently responsible to send written submissions to the Panel, together with any supporting documents.

(4) This regulation applies despite the withdrawal of the complaint.

Reg. 42ZCAI Action that Panel may take

(1) If, in relation to a complaint about an advertisement, the Panel is satisfied that there has been a contravention of the Act, these Regulations or the Therapeutic Goods Advertising Code, the Panel may request in writing the person apparently responsible to do one or more of the following:

(a) withdraw the advertisement;

(b) publish a retraction;

(c) publish a correction.

(2) If, in relation to a complaint about generic information, the Panel is satisfied that there has been a contravention of the Act, these Regulations or the Therapeutic Goods Advertising Code, the Panel may request in writing the person apparently responsible to do one or more of the following:

(a) withdraw the generic information;

(b) publish a retraction;

(c) publish a correction.

(3) If the person apparently responsible does not comply with a request under subregulation (1) or (2) within 14 days after the request is made, the Panel may make a recommendation to the Secretary about the advertisement or generic information.

(4) Without limiting subregulation (3), the Panel may recommend that the Secretary do one or more of the following:

(a) if the advertisement is an approved advertisement — withdraw the approval of the advertisement;

(b) cancel the registration or listing of the goods under paragraph 30 (2) (e) of the Act;

(c) order the publication of a retraction;

(d) order the publication of a correction;

(e) order the recovery of any advertisement or generic information that is still in circulation;

(f) order the destruction of the advertisement or generic information.

(5) The Panel must give written notice of a decision under subregulation (1) or (2), or a recommendation under subregulation (3), to the complainant (if known) and the person apparently responsible, setting out its reasons.

Reg. 42ZCAJ Panel not to deal with complaint if court proceedings begun

(1) The Panel cannot deal with a complaint if a proceeding has begun in a court about the subject matter of the complaint and the proceeding has not been finally disposed of.

(2) If, after a complaint has been made to the Panel, a proceeding begins in a court about the subject matter of the complaint, the Panel cannot deal with the complaint until the proceeding is finally disposed of.

restricted representation

restricted representation means a representation referred to in subregulation 7A (1).

sample

sample includes part of a sample.

Secretary

Secretary means the Secretary to the Department.

specified media

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

(a) mainstream media within the meaning of section 42B of the Act; or

(b) cinematography film; or

(c) displays about goods, including posters:

(i) in shopping malls (except inside individual shops);

(ii) in or on public transport; and

(iii) on billboards.

sponsor

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.

State law

State law means a law of a State, of the Australian Capital Territory or of the Northern Territory.

serious

serious, in relation to a form of a disease, condition, ailment or defect, means a form of the disease, condition, ailment or defect that is:

(a) generally accepted as not being appropriate to be diagnosed or treated without consulting a suitably qualified health care professional; or

(b) generally accepted to be beyond the ability of the average person to evaluate accurately, or treat safely, without regular supervision by a suitably qualified health care professional.

s. 22(5)

A person, being the sponsor of therapeutic goods that are included in the Register, must not, by any means, intentionally or recklessly advertise the goods for an indication other than those accepted in relation to the inclusion of the goods in the Register.

s.25(1)(f) Evaluation and registration of therapeutic goods

(1) Where:

(a) an application is made for the registration of therapeutic goods in relation to a person in accordance with section 23; and

(b) there is no part of an evaluation fee under section 24 in respect of those goods that:

(i) is due and payable by the person; and

(ii) remains unpaid; and

(c) the person has complied with any requirements made by the Secretary under section 31 in relation to the goods;

the goods are to be evaluated for registration having regard to:

(f) whether the goods conform to any standard applicable to the goods, or any requirements relating to advertising applicable under the regulations;

s. 26(1)(f) Listing of therapeutic goods

(1) Where:

(a) an application is made for the listing of therapeutic goods in relation to a person in accordance with section 23; and

(b) the person has complied with any requirements made by the Secretary under section 31 in relation to the goods; and

(ba) the goods are not goods which may be listed under section 26A;

then, subject to section 26AA, the Secretary is not to refuse to list the goods in relation to the person except where the Secretary is satisfied that:

(f) the goods do not conform to a standard applicable to the goods or to a requirement relating to advertising applicable under the regulations;

s. 28(1) Conditions of registration or listing

Where the Secretary includes therapeutic goods in the Register in relation to a person the Secretary may, in writing, impose conditions on the registration or listing of those goods.

s. 28(2)(e) Conditions of registration or listing

Conditions referred to in subsection (1) may relate to: (e) such other matters relating to the goods as the Secretary thinks appropriate.

s. 28(6)(c) Conditions of registration or listing (6)

If:

(a) in, or in connection with, an application for the listing of therapeutic goods, a claim is made by the applicant in relation to the goods; and

(b) the claim is included in the Register in respect of the goods; the listing of the goods is subject to the following conditions:

(c) a condition that the sponsor of the goods had, at the time when the claim was made, information or evidence that supported the claim and complied with the requirements (if any) of the regulations;

(d) a condition that the sponsor retains the information or evidence at all times while the goods remain listed;

(e) a condition that, at any time while the goods remain listed, the sponsor will, if asked to do so by the Secretary, give the information or evidence to the Secretary.

s. 30(2)(e)

(2) Subject to subsection (3), the Secretary may, by notice in writing given to a person in relation to whom therapeutic goods are included in the Register, cancel the registration or listing of the goods if:

(e) the goods do not conform to a standard applicable to the goods or to a requirement relating to advertising applicable to the goods under the regulations; or

s. 42C Offences relating to publication of advertisements

(1) This section does not apply to a publisher in respect of an advertisement received by the publisher for publication or insertion in the ordinary course of business.

(2) A person must not publish or insert in mainstream media an advertisement that is not an approved advertisement.

Penalty:100 penalty units.

(3) Subject to subsection (4), a person must not publish or insert in mainstream media an approved advertisement that differs from the advertisement that was approved.

Penalty: 100 penalty units.

(4) Subsection (3) does not apply if the advertisement differs only in respect of a matter mentioned in paragraph 5C(2)(b), (d), (e) or (f) of the Therapeutic Goods Regulations.

(5) A person must not publish or insert in mainstream media an approved advertisement:

(a) without its approval number; or

(b) with a number purporting to be its approval number but which is not its approval number; or

(c) with an approval number that has expired.

Penalty: 50 penalty units.

(6) A person must not publish or insert in mainstream media an approved advertisement in contravention of a condition of its approval.

Penalty:100 penalty units.

(7) An offence against this section is an offence of strict liability.

s. 42D Offences relating to publishers

A publisher must not, knowingly or recklessly, publish or insert in mainstream media an advertisement that is not an approved advertisement. Penalty: 100 penalty units.

The Act

the Act means the Therapeutic Goods Act 1989.

Therapeutic Goods Advertising Code

Therapeutic Goods Advertising Code means the Code known as the Therapeutic Goods Advertising Code as in force from time to time.

traditional use

traditional use has the same meaning as in section 52F of the Act.

therapeutic device

therapeutic device means therapeutic goods consisting of an instrument, apparatus, appliance, material or other article (whether for use alone or in combination), together with any accessories or software required for its proper functioning, which does not achieve its principal intended action by pharmacological, chemical, immunological or metabolic means though it may be assisted in its function by such means, but the expression does not include therapeutic goods declared by the Secretary, by order published in the Gazette, not to be therapeutic devices.

Therapeutic Goods

therapeutic goods means 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 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 in force under section 7; or

(d) goods in respect of which such 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 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 use

therapeutic use means 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.