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Guidelines for advertisements for medicines containing Schedule 3 substances
About this guidance
This guidance is for those interested in the advertising of pharmacist-only medicines.
- provides information on how the TGA decision maker (the Delegate of the Secretary of the Department of Health) may determine that a Schedule 3 substance is not suitable for advertising
- provides additional information for parties advertising medicines containing Schedule 3 substances.
The purpose of Appendix H
Advertisements to the public for therapeutic goods must not contain any reference to a substance included in Schedule 3 of the Poisons Standard, unless the substance is also listed in Appendix H of the Poisons Standard.
Advertisements for Schedule 3 substances are required to comply with other relevant provisions of the Therapeutic Goods Advertising Code (the Code), the Therapeutic Goods Act 1989 (the Act) and the Regulations.
The process of inclusion in Appendix H
Up until 2018, substances in Schedule 3 were not usually included in Appendix H, unless a good justification was presented as to the reasons for including the substance in Appendix H.
In 2018, it was decided that Schedule 3 substances would be included in Appendix H, unless there was a good reason not to do so. This decision is documented in the Scheduling policy framework for medicines and chemicals, endorsed by AHMAC December 2017. Following this decision, the TGA conducted a review of all Schedule 3 substances, and the Delegate considered whether there is justification not to include the Schedule 3 substances in Appendix H.
Where a substance has been determined by the Delegate to be unsuitable for advertising, interested parties may make an application to the Delegate to request reconsideration of the substance addressing the reasons given for not adding the substance to Appendix H. These applications should be submitted in accordance with the scheduling timetable.
Substances being considered for Schedule 3
For substances being considered by the Delegate for inclusion in Schedule 3, their suitability for inclusion in Appendix H will be considered concurrently. Applicants may choose to include any relevant information for the Delegate's consideration in their scheduling application.
When a Delegate decides to include a substance in Schedule 3, in accordance with the Scheduling Policy Framework, they will consider if there are any reasons, in the interests of public health, to not permit a substance to be advertised directly to consumers.
Decisions to include or not in Appendix H
The Delegate may:
- make a Delegate-only decision to include a substance in Appendix H
- choose to seek advice from the Advisory Committee for Medicines Scheduling (ACMS) regarding inclusion in Appendix H.
If ACMS advice is sought, stakeholders may comment on the potential inclusion of the substance in Appendix H during the public consultation phase of the scheduling process.
If the Delegate decides it is appropriate for a substance to be advertised, it will be added to Appendix H of the Poisons Standard.
When considering reasons to not permit a substance to be advertised directly to consumers, the Delegate will consider the potential impact on public health. The following questions may be relevant:
- Is there potential for abuse, inappropriate use and/or diversion that may be exacerbated by advertising?
- Are there potential interactions with the substance (drug-drug, drug-food) that require increased patient education to ensure safe use and therefore patient choice could be adversely influenced by advertising?
- Are there additional risks associated with the dosage form that may impact on safe use that may be exacerbated by advertising?
- Is there any other information that may be relevant, for example the substance has sedating properties, or there are safer alternatives available and therefore patient choice could be adversely influenced by advertising?
Additional factors might be relevant in specific cases. The reasons for a decision not to include a substance in Appendix H will be published prior to amending or not amending the current Poisons Standard.
Mandatory requirements for S3 product advertising
In accordance with the Code, advertisements for products containing Schedule 3 substances must include the following statement:
'Ask your pharmacist - they must decide if this product is right for you'
Advertisements to the public for Schedule 3 products must also comply with all other applicable requirements specified in the Code - see analgesics for example.
Some indications for Schedule 3 substances may also contain a prohibited or restricted representation as defined in the Therapeutic Goods Act 1989 and the Code. Advertisers must ensure the required permissions or approvals are available to use such representations before these indications are used in any advertising.
Inclusion of adverse event information
The inclusion of detailed adverse event information in advertisements for medicines containing Schedule 3 substances is not mandatory. However, for stakeholders who wish to include side effects or adverse events in their advertisements, we recommend the following:
- Inclusion of adverse events in an advertisement should not obscure the message that the pharmacist must determine if a medicine containing a Schedule 3 substance is right for the patient.
- Any presentation of adverse events should be clear and easily understood. This means that the font should be easily read and understood, or audio delivery can be clearly heard and understood. The Code also includes requirements for the presentation of scientific information in advertising.
|||Advertisements available exclusively (e.g. through genuine professional or trade journals) to healthcare professionals or persons engaged in the wholesale therapeutic goods trade are not subject to this requirement.|
|||See also Sections 42AA and 42DL of Part 5-1 of the Therapeutic Goods Act 1989; Part 3 Miscellaneous Regulations, Section One – Advertising, in the Poisons Standard and Part 2 of the Therapeutic Goods Regulations 1990.|
|Version||Description of change||Author||Effective date|
|V1.0||Publication as Appendix 1 to the public consultation about proposed Schedule 3 substances to be added to Appendix H of the Poisons Standard||Therapeutic Goods Administration||May 2018|
|V1.1||Editorial changes||Therapeutic Goods Administration||October 2018|