Section 2: Requirements for Material Directed at Healthcare Professionals

Material directed to healthcare professionals refers to any material that is developed by the Company for distribution to healthcare professionals. Material may be distributed in any manner or form.

1. Companies are responsible for ensuring that materials directed to healthcare professionals covered by this section are only able to be viewed or accessed by healthcare professionals.¹
2. Promotional material must be clearly distinguishable as such.²
3. In all material containing promotional claims, a healthcare professional must have access to sufficient prescribing information for them to appropriately prescribe the product for a person consistent with its approved use.
4. Presentation of Product Information (PI) qualifying statements, and references must be clearly legible.
5. Promotional material should be presented in such a way that visible information is accurate and consistent with the Code when read in isolation.
6. Companies may engage with the healthcare professional media for promotional purposes, including issuing media releases and developing advertorial content.

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2.1 Required Inclusions for Product-related Materials

All promotional material for a product, whether or not the material contains a promotional claim, must include or provide access to sufficient prescribing information for a healthcare professional to appropriately prescribe the product for a person consistent with its approved use.³

All types of promotional materials, in all media, must include:

1. Brand name of the product;
2. Australian Approved Name(s) of the active ingredient(s) placed adjacent to the most prominent presentation of the brand name;
3. Any boxed warnings and/or black triangle statement(s) as required by the TGA;
4. A statement directing healthcare professionals to review Product Information (PI) before prescribing. This statement should include the means for healthcare professionals to access the PI immediately in electronic or other form, or the telephone number for the Company medical information service;⁴
5. A statement indicating the public funding or reimbursement status of the product, with or without details of listing, or a direction to where the relevant information is available;⁵
6. Name of the supplier and the city, town or locality of the registered office; and
7. Date that the material was prepared or last revised.

2.2 Content Hosted Online

1. For materials hosted online that include promotional claims, whether hosted by a Company or a third-party, a mechanism such as password protection for system entry is consistent with ensuring online promotional content is only available to healthcare professionals.
2. Where Company-controlled websites reference and/or link to other information sources or internet sites, the Company is accountable for ensuring that these information sources and internet sites are appropriate and will enhance appropriate prescribing, disease state understanding, dispensing and usage of products in Australia.
3. Readers should be advised when leaving the site or being directed to a site that the Company has not developed, by displaying the following statement before the reference material is accessed:
   
   “The information a reader is about to be referred to may not comply with the Australian regulatory requirements. Further information relevant to the Australian environment is available from the Company or via the Product Information.”
4. It is appropriate for Companies to make known on their websites that they are bound to an ethical standard through the Medicines Australia Code of Conduct and provide a link to the Code. This is to provide information to healthcare professionals and other stakeholders on the Code of Conduct and the standards it sets, enhancing transparency and accountability, but should not imply any endorsement by Medicines Australia.

2.3 Prescribing Software

1. A Company should not place advertisements or promotional statements in prescribing software used by doctors. If such advertisements may be seen by patients/consumers during a consultation, this may contravene the Therapeutic Goods Act, which prohibits advertising prescription medicines to the general public. However, Companies may pay for the inclusion of non-promotional medical education for healthcare professionals, patient educational materials, and/or patient support program materials.
2. Medicines Australia encourages the electronic availability of Consumer Medicine Information (CMI) via prescribing software packages to facilitate the use of this information during consultation with a patient.

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1. #31: Landing pages for HCP portals ↩︎
2. #26: Using product names in the wild ↩︎
3. #47: Mandatories – are they always mandatory? ↩︎
4. #13: Mandatory information… one click, or two? ↩︎
5. #32: PBS statement – in the box or not? ↩︎