Schedule 3 advertising guidelines
Guidelines for brand advertising of substances included in Schedule 3 of the Poisons Standard
These guidelines describe the process for determining whether a substance in Schedule 3 of the SUSDP may be advertised.
A person must not include in any advertisements, except those in genuine professional or trade journals to healthcare professionals or the wholesale therapeutic goods trade, any reference to a substance included in Schedule 3 of the SUSDP, unless the substance is listed also in Appendix H to the SUSDP (see Paragraph 32 Part 3 SUSDP) and Regulation 6(1)(e) of the Therapeutic Goods Regulations.
After the NDPSC decides whether a substance is appropriate for inclusion in Schedule 3, using the NDPSC Guidelines which set out the criteria applying for this determination, the NDPSC will then consider whether it is appropriate to advertise to the public preparations containing that substance.
If the NDPSC approves the advertising of the substance, the substance is included in Appendix H to the SUSDP.
The NDPSC may also consider an application to amend the SUSDP by adding to Appendix H a substance already in Schedule 3.
In making a decision, as to whether a substance included in Schedule 3 of the SUSDP may be advertised to the public, the NDPSC will consider the following matters: -
- The potential public health benefit. It is acknowledged it may not always be possible to present data to quantify the extent of any claim of public health benefit. In such circumstances, qualitative data may be acceptable. For example, matters which may be considered might include more appropriate use of scarce health resources, a better informed community, and matters related to decreasing risk of injury due to fewer side effects;
- The likelihood of advertising of the substance leading to inappropriate patterns of medication use;
- The wider regulatory system through both the Therapeutic Goods Advertising Code Council and the therapeutic goods registration process;
- The provisions of the Therapeutic Goods Advertising Code (TGAC) that apply to all brand advertisements, specifically the provisions on:
- the Objects of the Code, Clause 1; Compliance and Application, Clause 3; and Principles, Clause 4;
- the representations listed in Part 1 of Appendix 6 that are prohibited under Regulation 6(1)(a) and item 1, Part 1, Schedule 2, Therapeutic Goods Regulations;
- the restricted representations listed in Part 2 of Appendix 6;
- Whether the application may result in the advertising of goods for an indication other than those included in the Australian Register of Therapeutic Goods (see the note below on how this is an offence under Section 22(5) of the Therapeutic Goods Act 1989);
- The responsibility of pharmacists to be actively involved in the supply of substance(s) included in Schedule 3 of SUSDP;
- Available consumer medicine information;
- The level of patient education necessary to ensure correct use;
- The desire of consumers to manage their own medication; and
- The requirement under Clause 6.2(e) of the TGAC to include words to the effect of:
- "Your pharmacist's advice is required"
Although requests for Schedule 3 advertising will be submitted by sponsors who intend to advertise products containing Schedule 3 substances, the NDPSC will consider the advertising of substances included in Schedule 3 of the SUSDP, not of individual products.
Sponsors applying for the inclusion of Schedule 3 substances in Appendix H should provide information to address the matters to be considered by the NDPSC as outlined above.
Please note that sponsors making a submission in regard to a substance where a Schedule 3 classification may be an outcome are invited to provide additional comments on inclusion of the substance in Appendix H. Inclusion in Appendix H will be a consequential consideration of the NDPSC following a decision to include a substance in Schedule 3.
Some advertisements for products must be approved even though the substance is listed in Appendix H of the SUSDP. SUSDP does not deal with these applications. See Appendix 3 of the TGAC for details of the advertising clearance process.
Advertising off label indications
Section 22(5) of the Therapeutic Goods Act 1989 requires that:
... 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.
Sponsors convicted of breaching this provision face significant penalty. Companies could be fined up to $33 000.