The Therapeutic Goods Act 1989 contains a range of requirements which govern how a medicine can be advertised. Although it’s easy to assume that a medicine that isn’t be advertised isn’t captured by these requirements; that’s not really the case. The TGA considers a medicine’s label and packaging to be ‘advertising’ so these requirements apply right away.
Arguably, the most important requirements for listed medicines are contained in the Therapeutic Goods Advertising Code which is referenced in eligibility for listing requirements in Schedule 4 to the Therapeutic Goods Regulations 1990. Specifically, sponsors need to make sure that their medicines do not breach the requirements in Appendix 6 of the Advertising Code which regulate claims that can never be made about a medicine, and claims that are restricted and cannot be made without prior approval.
Appendix 6 contains two broad categories of claims, as described below
Prohibited representations – medicines must not make prohibited representations at all. Listed medicines should never refer to prohibited representations. These are:
- any representation regarding abortifacient action (that is, causing abortion) or
- any representation regarding the treatment, cure or prevention of the following diseases:
- Neoplastic (tumours)
- Sexually Transmitted Diseases (STD)
- HIV AIDS and/or HCV
- Mental illness.
Exceptions to this rule are given to sunscreens claiming to prevent skin cancer, contraceptives and products made to prevent the spread of disease. These claims are restricted representations.
Restricted representations – these are the types of claims that can be made but only after pre-approval has been granted by the TGA. Without prior approval, medicines can’t even imply a claim about any of the following:
- Cardiovascular diseases
- Dental and periodontal diseases
- Diseases of joint, bone, collagen, and rheumatic disease
- Diseases of the eye or ear likely to lead to blindness or deafness
- Diseases of the liver, biliary system or pancreas
- Endocrine diseases and conditions including diabetes and prostatic disease
- Gastrointestinal diseases or disorder
- Haematological diseases
- Infectious diseases
- Immunological diseases
- Mental disturbances
- Metabolic disorders
- Musculoskeletal diseases
- Nervous system diseases
- Poisoning, venomous bites and stings
- Renal diseases
- Respiratory diseases
- Skin diseases
- Substance dependence
- Urogenital diseases and conditions
Yes! This does capture a lot of conditions – but there’s a reason for it. TGA takes into consideration public interest and whether claims may:
- target a particularly vulnerable group
- make a consumer think they’re being treated well enough by a medicine and delay seeing professional advice or
- have a negative impact on public health.
Keep in mind that the new complementary medicines framework will no longer allow lower level listed medicines to make restricted representations either because medicines will only be allowed to make claims from a pre-approved list.
Follow the links below to learn more about your regulatory requirements: