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.

1. REFORMS TO ADVERTISING
CONTROLS OF PHARMACIST ONLY
(SCHEDULE 3) SUBSTANCES
National Medicines Symposium
May 2018
Dr Rebecca Doolan
Regulatory Reforms
Prescription Medicines Authorisation Branch
Therapeutic Goods Administration

2. 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.
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3. 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.
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4. 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
a) Is there potential for inappropriate use, abuse, diversion that may be
exacerbated by advertising?
b) Are there potential interactions with the substances (drug-drug, drug-
food) that require increased patient education to ensure safe use?
c) Are there additional risks associated with the dosage form that may
impact on safe use?
d) Any other information that may be relevant, for example the substance
has sedating properties, or there are safer alternatives available.
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5. 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”
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6. 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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