Explanatory notice: Restricted and prohibited representations

In Australia, therapeutic goods that are recommended by their manufacturer to be used for application to non-living objects to kill micro-organisms but not for internal use (disinfectants¹) are regulated under the Therapeutic Goods Act 1989 (the TG Act) as other therapeutic goods (OTG). These are commonly described as 'hard surface disinfectants'. An explanation of the regulatory requirements that apply to these products can be found at Disinfectants & sterilants.

Both hospital grade disinfectants (ie disinfectants that are represented to be suitable for therapeutic use and intended to be used mostly in healthcare facilities²) and household grade disinfectants³ that are claimed to be sterilants, fungicides, sporicides, tuberculocides or virucides must be registered under Part 3-2 of the TG Act on the Australian Register of Therapeutic Goods (ARTG)⁴.

What are prohibited and restricted representations?

A "prohibited representation" includes the following:

• representations regarding the treatment, cure or prevention of sexually transmitted diseases (STD), HIV AIDS and/or HCV⁵
• in relation to therapeutic goods that are disinfectants:
• a representation on any label, containing a reference to the results of laboratory tests on micro-organisms, other than a representation provided by leaflet or on a label enclosed with the goods in their package⁶
• a representation containing a reference to an effect against viruses, except a representation that is approved in writing by the TGA⁷
• a representation containing a reference to an effect against Mycobacterium tuberculosis and related acid fast bacteria, except a representation that is approved in writing by the TGA⁸.

A "restricted representation" is a representation in an advertisement about therapeutic goods that refers to a form of a disease, condition, ailment or defect identified in the Therapeutic Goods Advertising Code as a "serious form" of a disease, condition, ailment or defect⁹ and includes the following:

• gastrointestinal diseases or disorders
• respiratory diseases
• infectious diseases¹⁰

"Advertisement" includes any statement, pictorial representation or design, however made, that is intended, whether directly or indirectly, to promote the use or supply of the goods¹¹.

Under the TG Act, it is an offence to:

• publish or broadcast an advertisement that contains a prohibited representation the use of which has not been permitted by the TGA under subsection 42DK(2) of the TG Act¹² or that contains a restricted representation that has not been approved by the TGA under subsection 42DF(1) or permitted under subsection 42DK(1) of the TG Act¹³;
• publish or broadcast an advertisement that does not comply with the Therapeutic Goods Advertising Code (the Code)¹⁴.

Under section 5 of the Code, an advertisement for therapeutic goods must not contain, expressly or by implication, a prohibited representation specified in Part 1 of Appendix 6 to the Code or a restricted representation, being a representation containing, expressly or by implication, to serious forms of diseases, conditions, ailments or defects specified in Part 2 of Appendix 6 of the Code.

Failure of registered therapeutic goods to comply with an applicable provision of the Code is also a ground for their suspension or cancellation from the ARTG¹⁵.

TGA can give permission for prohibited/restricted representations to be used

The TGA can give permission for specific restricted representations to be used in advertising of therapeutic goods to consumers, including its use on the label of the goods or in information included in the package in which the goods are contained¹⁶.

The TGA also can give permission for specific prohibited representations to be included on the label of therapeutic goods, or in information included in the package in which the goods are contained, if the representation is necessary for the appropriate use of the goods ¹⁷.

Permissions for use of certain restricted and prohibited representations in relation to some disinfectants

The TGA has given permission under subsection 42DK(1) of the TG Act for restricted representations of the kind set out in this notice to be used on the label or in information in the packaging for hospital grade disinfectants and household grade disinfectants that are on the ARTG by reason of being registered under Part 3-2 of the TG Act.

The TGA has given permission under subsection 42DK(2) of the Act for prohibited representations of the kind set out in this notice to be used on the label or in information in the packaging of hospital grade disinfectants and household grade disinfectants that are on the ARTG by reason of being registered under Part 3-2 of the TG Act.

Any claims made about the effectiveness of the hospital grade or household grade disinfectants, are evaluated by the TGA before the product can be registered under Part 3-2 of the TG Act and will only be approved if supported by relevant performance data¹⁸. The requirements for performance of hospital grade disinfectants and household grade disinfectants with specific claims are set out in the Therapeutic Goods Order No 54 - Standard for Disinfectants and Sterilants¹⁹, and the associated Guidelines for the Evaluation of Sterilants and Disinfectants²⁰. The guidelines specify the testing that must be undertaken for registered disinfectants depending on the claims made on their labels and/or packaging.

The effect of the notices is to allow, where it is consistent with the therapeutic uses in relation to which appropriate evidence has been provided to the TGA for the purpose of registration of a disinfectant, specific claims to be included on the label of the disinfectant or in information contained in the package in which the disinfectant is contained, for instance explaining the effectiveness of the goods against viruses (e.g. Adenovirus, Rotavirus, Respiratory Syncytial Virus), or for general virucidal claims to be made²¹. However, they do not authorise the use of such representations in advertising published or broadcast to consumers, including on the internet.

It is a condition of registration that any changes to the information relevant to a decision to register the goods (which includes claims made in relation to the use of the goods) require notification to the TGA and approval prior to implementation²².

Thus notwithstanding that the notices allow certain representations to be made in limited circumstances, it remains an offence under the TG Act for any representation to be made that is not consistent with the TGA's approval for the intended therapeutic use of the goods.

Footnotes

1. See definition in regulation 2 of the Therapeutic Goods Regulations.
2. See definition in regulation 2 of the Therapeutic Goods Regulations.
3. See definition in regulation 2 of the Therapeutic Goods Regulations.
4. Regulation 10 and item 6 in Part 2 of Schedule 3 of the Therapeutic Goods Regulations.
5. Regulation 6B of the Therapeutic Goods Regulations and Part 1 of Appendix 6 to the Therapeutic Goods Advertising Code.
6. Regulation 6B and item 6(b) in Part 1 of Schedule 2 to the Therapeutic Goods Regulations.
7. Regulation 6B and item 6(f) in Part 1 of Schedule 2 to the Therapeutic Goods Regulations.
8. Regulation 6B and item 6(g) in Part 1 of Schedule 2 to the Therapeutic Goods Regulations.
9. Section 42DD of the TG Act.
10. Table 1 in Part 2 of Appendix 6 of the Therapeutic Goods Advertising Code.
11. Subsection 3(1) of the TG Act.
12. Paragraph 42DL(1)(a) of the TG Act.
13. Paragraph 42DL(1)(c) of the TG Act.
14. Subsection 42DM(1) of the TG Act.
15. Paragraphs 29D(1)(b) and 30(2)(ea) of the TG Act.
16. Subsection 42DK(2) of the TG Act.
17. Subsection 42DK(2) of the TG Act.
18. Section 25 of the TG Act.
19. Therapeutic Goods Order No. 54: Paragraphs 3(5)(A)(c) and (d) (Hospital Grade); 3(5)(B)(c) and (d) (Hospital Grade Surface Spray); 3(6)(A)(c) and (d) (Household/Commercial Grade); and 3(6)(B)(c) and (d) (Household/Commercial Grade)
20. Guidelines for the Evaluation of sterilants and disinfectants: Paragraphs 6.7, 6.8 and 6.9.
21. Therapeutic Goods Order No. 54, Clause 2 defines 'virucide as a chemical agent that renders a virus non-infective. Sponsors should note that the document Guidelines for the evaluation of sterilants and disinfectants, February 1998 states that for a general virucidal claim to be made, on a label, the disinfectant must pass tests against Poliovirus/Parvovirus, Herpes simplex and Adenovirus (paragraph 6.7.5). However, this does not include blood borne viruses such as HIV, HBV and HCV.
22. Conditions - Standard and Specific Applying to registered or listed therapeutic goods under Section 28 of the Therapeutic Goods Act 1989, Standard - July 1995, Specific - March 1998, Appendix 4 to DR4