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TGA presentation: National Medicines Symposium, 30 May 2018

Presentation: Reforms to advertising controls of pharmacist only (schedule 3) substances

6 July 2018


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  • Presented by: Dr Rebecca Doolan
  • Presented at: National Medicines Symposium 2018
  • Presentation date: 30 May 2018
  • Presentation summary: This presentation covers the revised requirements for advertisements for medicines containing Schedule 3 substances, and the process for adding current and future Schedule 3 substances to Appendix H of the Poisons Standard.


Reforms to advertising controls of pharmacist only (schedule 3) substances

Dr Rebecca Doolan
Regulatory Reforms
Prescription Medicines Authorisation Branch
Therapeutic Goods Administration

National Medicines Symposium, 30 May 2018

Slide 1 - The Reform

The new policy intention for the advertising of medicines containing Pharmacist Only (Schedule 3) substances direct to consumers (DTC) is that this should be permitted unless actually deemed unsuitable for specific substances.

Slide 2 - Role of the Delegate

  • If there is no overriding reason to prevent medicines containing the S3 substance from being advertised DTC, the substance will be added to Appendix H of the Poisons Standard.
  • For substances being considered by the Delegate for inclusion in Schedule 3, their suitability for inclusion in Appendix H will be considered concurrently.
  • No separate application will be needed and no additional criteria will need to be addressed by the applicant.
  • During the public consultation phase of the scheduling process, stakeholders will be asked to provide comment on the potential inclusion of the substance in Appendix H.
  • Referral to the Advisory Committee for Medicines Scheduling will be at the Delegate's discretion.

Slide 3 - Role of the Delegate

Factors the Delegate will consider when deciding if there is a reason for not permitting DTC advertising:

  1. The potential impact on public health
    1. Is there potential for inappropriate use, abuse, diversion that may be exacerbated by advertising?
    2. Are there potential interactions with the substances (drug-drug, drug-food) that require increased patient education to ensure safe use?
    3. Are there additional risks associated with the dosage form that may impact on safe use?
    4. Any other information that may be relevant, for example the substance has sedating properties, or there are safer alternatives available.

Slide 4 - Mandatory requirements

  • Advertisements for therapeutic goods must comply with the Therapeutic Goods Advertising Code (the Code)
  • The revised Code is due to take effect on 1 July 2018
  • There is a specific requirement in the draft revised Code for Schedule 3 substances:
    • "Ask your pharmacist - they must decide if this product is right for you"

Slide 5 - Transition

  • Currently, there are only 19 of 85 Schedule 3 substances included in Appendix H. The current Schedule 3 substances will be considered in bulk.
  • The current Schedule 3 substances have been classified into two lists - those that can be advertised (added to Appendix H), and those that are not suitable for advertising.
  • These lists will be published for public comment in the near future.
  • Based on the consultation responses, the Delegate will do one or more of the following for each substance:
    1. Make a decision to add a substance to Appendix H
    2. Decide not to add a substance to Appendix H
    3. Reconsider the initial proposal and seek further comment on an alternative proposal
    4. Refer the substance to the ACMS for further advice.

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