Therapeutic goods advertising code: notice of amendments, September 2002
Amendments have been made the Therapeutic Goods Advertising Code. Updated copies of the Therapeutic Goods Advertising Code are available from the ComLaw website <http://www.comlaw.gov.au>.
Published in the Commonwealth of Australia Gazette No. GN38, 25 September 2002
COMMONWEALTH OF AUSTRALIA
THERAPEUTIC GOODS ACT 1989
THERAPEUTIC GOODS REGULATIONS
THERAPEUTIC GOODS ADVERTISING CODE: NOTICE OF AMENDMENTS
The amendments to each clause are highlighted in bold print
Clause 4.2 Scientific information
Any scientific information in an advertisement should be presented in a manner that is accurate, balanced and not misleading. Scientific terminology must be appropriate, clearly communicated and able to be readily understood by the audience to whom it is directed. Publication of research results must identify the researcher and financial sponsor of the research.
Clause 5 - Prohibitions
An advertisement for therapeutic goods must not contain, expressly or by implication, a representation specified in Part 1 of Appendix 6.
Appendix 6 - Prohibited, Restricted and permissible representations
Part 1 - Prohibited representations
A prohibited representation is defined as:
- Any representation regarding abortifacient action
- Any representation regarding the treatment, cure or prevention of the following diseases:
- Neoplastic
- Sexually transmitted diseases (STD)
- HIV, AIDS and/or HCV
- Mental illness
Except for the following representations which are to become restricted representations:
- prevention of skin cancer through the use of sunscreens
- devices used in contraception or in the prevention of transmission of disease between persons
Clause 6 - Minimum requirements
6.2 An advertisement for therapeutic goods shall contain:
- Where applicable, a list of ingredients or the following statement prominently displayed or communicated, i.e standing out so as to be easily read from a normal viewing distance, and/or heard and understood:
ALWAYS READ THE LABEL
Except:- In the case of direct marketing and Internet marketing, which must contain:
- a full list of the active ingredients (where the product name is also the single active ingredient, the pack shot displaying the product name will be sufficient to meet this requirement)
- The mandatory warning statements prominently displayed on each page of the catalogue or Internet that features therapeutic goods.
- Radio commercials which are 15 seconds or less
- In the case of direct marketing and Internet marketing, which must contain:
- Words to the following effect, prominently displayed or communicated i.e standing out so as to be easily read from a normal viewing distance, and/or heard and understood:
USE ONLY AS DIRECTED
and, in all advertisements other than radio commercials that are 15 seconds or less, for claims relating to symptoms of diseases or conditions,
IF SYMPTOMS PERSIST SEE YOUR DOCTOR/HEALTHCARE PROFESSIONAL - In the case of therapeutic goods that are able to be lawfully advertised and are available only directly from, or on the recommendation of, a health care professional (except in the case of S2 and S3), the following statements should be prominently communicated ie standing out so as to be easily read from a normal viewing distance, and/or heard and understood:
YOUR [APPROPRIATE HEALTHCARE PROFESSIONAL] WILL ADVISE YOU WHETHER THIS PREPARATION [PRODUCT NAME] IS SUITABLE FOR YOUR CONDITION
Clause 7 - Special categories
7.1.2 An advertisement for analgesics (other than radio advertisements which are 15 seconds or less) must contain the following warning statement, prominently displayed or communicated ie standing out so as to be easily read from a normal viewing distance and/or heard and understood:
"Use only as directed. Incorrect use could be harmful. Consult your healthcare professional if symptoms persist"
Radio advertisements which are 15 seconds or less must include the following:
"Always read the label. Use only as directed by a healthcare professional"
Clause 7 Special categories
Add special category
7.3 Weight management
Claims for weight management, meaning weight loss, measurement reduction, clothing size loss and weight control/maintenance, can only be made in conjunction with reference to sensible lifestyle factors including diet and exercise.
Appendix 3 - Approval of mainstream advertisements
Advertisements for Complementary Healthcare products (other than devices) in specified media....
The email address of the current Advertising Services Manager.
All mainstream print media advertisements for therapeutic goods must display the current approval number allocated to that advertisement as required under s. 42C(5) of the Therapeutic Goods Act 1989.
Appendix 4 - Appeals and complaints mechanisms
Review of a decision not to approve an advertisement
In the event of an advertisement not gaining approval, a request to review the decision must be submitted to the Minister for Health and Ageing for print advertisements (refer Regulation 5M) and to the Minister for Communication and the Arts for broadcast advertisements.
The request must be made within 30 days after the notice of the decision.
For a decision not to approve a print media advertisement, the applicant must, at the same time, send a copy of the request to the Therapeutic Goods Advertising Code Council.
Appendix 5- Goods that may be advertised to minors
The following are not subject to Clause 4.1.2 (j)
- Tampons
- Acne preparations
- Sunscreens SPF 15 +
- Condoms and personal lubricants
- Bandages and dressings
- Devices for management of chronic conditions under medical supervision
- Cold sore preparations
- Lip balm
- Unscheduled anti-dandruff preparations
Dated this 13th day of September 2002