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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

    APPENDIX 3
09/05/2007
 

(Subsection 3(3) refers)

Approval of mainstream advertisements

Advertisements for complementary healthcare products (other than devices) in specified media, other than broadcast media and cinematograph films are required under the Therapeutic Goods Act and Regulations to be submitted to:           

        Advertising Services
        Complementary Healthcare Council
        PO Box 104
        DEAKIN WEST  ACT  2600

        Ph: (02) 9542 5860
        Fax: (02) 6260 4122
        Email: advertising@chc.org.au

Advertisements for complementary healthcare products advertised in broadcast media or cinematograph films, and all other therapeutic goods (other than devices) advertised in specified media, are required under the Therapeutic Goods Act 1989 and Regulations to be submitted to:

        Advertising Services
        Australian Self-Medication Industry
        PO Box 764
        NORTH SYDNEY  NSW  2059

        (Suite 2202
        Level 22, 141 Walker Street
        NORTH SYDNEY   NSW   2060)

        Ph: (02) 9955 7205
        Fax: (02) 9957 6204
        Email: cath@asmi.com.au

All specified media advertisements, other than broadcast media advertisements,  for therapeutic goods must display the current approval number allocated to that advertisement as required under s.42C(4)(b) of the Therapeutic Goods Act 1989.

Minimum Requirements for the Submission of Advertisements

        1.      Typed copy (no smaller than 10 point), black copy on white background.
        2.      Draft layout or clear description of layout
        3.      For TVC’s, copy of script with storyboard
        4.      For radio, copy of script to include sound-effect descriptions
        5.      Copy of appropriate documentation
                A – Certificate of Listing/Registration
                B – label (enlarged for legibility)
                C – Approved indications of use (where applicable)
                D – Copy of any research/surveys/data referenced in advertisement (note – further evidence to be provided if requested).
                E – Copy of documentation supporting professional recommendations and testimonials [note: further evidence to be provided if requested]

Note:
1.      Substantiation of therapeutic claims to be provided upon request
2.      Substantiation, in line with levels of evidence required to be held by the sponsor at the time of listing or registration, may be required by the advertising services manager
3.      Notwithstanding the above, further substantiation may also be requested
4. Listing or registration of a claim does not automatically mean that the claim may be advertised


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