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Consent to supply therapeutic goods that do not comply with subsection 9(2) of Therapeutic Goods Order No. 92

Standard for labels of non-prescription medicine - requirements for presentation of the medicine name

31 October 2019

The TGA has established a process for sponsors of non-prescription medicines (which include complementary and OTC medicines) to request consent for non-compliance with subsection 9(2) of Therapeutic Goods Order No. 92 - Standard for labels of non-prescription medicine (TGO 92) relating to the presentation of the name of the medicine on product labels.

This is an interim measure to assist industry to transition to the requirements for TGO 92. Consideration of potential amendments to the requirements relating to the presentation of the name of the medicine on product labels will occur in 2020-21.

The application form can be found here:

Overview

Therapeutic Goods Order No. 92 - Standard for labels of non-prescription medicine (TGO 92) is a standard made under section 10 of the Therapeutic Goods Act 1989. TGO 92 mandates information that must be on labels of over-the-counter and complementary medicines and the format and placement in which it must be presented, to contribute to the quality use of medicines by Australian consumers and healthcare professionals.

Following extensive consultation, TGO 92 was implemented in September 2016 with a 4-year transition period. All medicines released for supply after 1 September 2020 must be labelled in accordance with TGO 92.

It is an offence to import, supply or export therapeutic goods that do not comply with a standard applicable to the goods, unless the prior consent in writing of the Secretary has been given (see section 14 the Therapeutic Goods Act 1989) or a civil penalty may be payable (see section 14A of the Act).

For more information, see:

TGO 92 requirements for presentation of the medicine name

TGO 92 includes requirements to ensure easy readability and identification of key health information such as active ingredients. These requirements aim to address key concerns from consumers, health practitioners and Poison Centres around easy identification of medicines and the active ingredients in those medicines.

To achieve this subsections 9(2) of TGO 92 requires that:

  • the medicine name be presented in an uninterrupted and continuous manner (i.e. the complete name all in one place on the label).
  • the use of trademarks, graphics or additional text must not disrupt the medicine name. This will ensure that the medicine name is clearly recognisable.

The name of the medicine is defined in section 6 of TGO 92 as the name that appears on the ARTG certificate. For more information, see Medicine labels: Guidance on TGO 91 and TGO 92.

Some non-prescription medicines sponsors are having difficulty complying with the TGO 92 requirements for the presentation of the medicine name because their label includes a long standing brand name or branding either within or adjacent to the name of the medicine that uniquely identifies a range of products from that sponsor.

In some cases, inclusion of a 'distinguishing mark' such as a registered trademark, a graphic image, icon or logo, a brand name, slogan or tagline, within or adjacent to the medicine name may cause the medicine’s label to be non-compliant with subsection 9(2) of TGO 92. Some sponsors have of raised concerns that they will be required to remove their distinguishing mark when they transition to comply with TGO 92.

The TGA will consider requests for consent to supply in situations of non-compliance with subsection 9(2) of TGO 92 relating to the presentation of the name of the medicine on product labels.

A consent may be granted where the following are satisfied:

  • the label of the goods contains a distinguishing mark such as a registered trademark, a graphic image, icon or logo, a brand name, slogan or tagline
  • the same distinguishing mark is used by the sponsor to uniquely identify a range of therapeutic goods
  • the distinguishing mark was established in the market place before the commencement of TGO 92 in September 2016
  • the presentation of the name of the medicine, when this comprises the name of the brand and a name for the medicine, is interrupted or broken by the distinguishing mark
  • the use of the brand name or other distinguishing mark on the label separates (within or adjacent to) the words that comprise the name of the medicine
  • the labels of the goods comply with all other requirements of TGO 92.

The name of the medicine must be easily identifiable and legible on a medicine label - the distinguishing mark must not obscure or have greater relative prominence than any other part of the name of the medicine.

The types of non-compliances that could be considered include:

  • graphic effects applied to text disrupt the co-location of multiple parts of the medicine name
  • logos are included between words or in letters that comprise the brand name
  • logos, images or taglines between words that identify the brand and the remainder that together comprise the medicine name.

The delegate will continue to have discretion to refuse to grant a consent where consumers could be confused about the content or proper identification of the medicine, for example:

  • graphics that interfere with legibility of the label
  • medicine name not being clearly discernible or easy to identify as a cohesive unit
  • graphic effects applied to text that disrupt the co-location of the medicine name or that make legibility difficult
  • a graphic image, icon or logo, a brand name, slogan or tagline that is not consistent with the use of the goods or is misleading.

The applicant should address any real or potential risks associated with the non-compliance in the application.

How to obtain consent

The person in relation to whom the goods are on the ARTG or an authorised representative of the person needs to:

  • complete and sign the application form;
  • attach all relevant documentation, including the product label for each product proposed to be covered by this consent

The applicant has the responsibility of satisfying the TGA that consent should be given. It is a serious offence to give information to the TGA that is false or misleading in a material particular for the purposes of making an application for consent under section 14/section 14A (see sections 136 and 137 of the Commonwealth Criminal Code)

An application can include goods in multiple ARTG entries provided:

  • the goods have the same sponsor
  • the goods have the same distinguishing mark
  • all the issues in relation to granting consent are the same for all the goods, and
  • the non-compliance in relation to the goods only relate to non-compliance with subsection 9(2) of TGO 92, i.e. the requirements for the name of the medicine.

If granted, the consent will only apply to the products included in the application. A separate consent will be required to import, supply or export any additional products using the distinguishing mark.

Fees

An application will not be considered unless the relevant processing fee has been paid. The fee is payable in relation to each application. This means one fee can cover multiple ARTG entries in the circumstances described above.

Duration of consent

In general, the duration of the consent will be limited to 1 September 2021 to allow time for potential amendments to TGO 92 to be considered and consulted on. In exceptional circumstances, consent can be granted for a longer period. In all circumstances the proposed duration must be justified in the application.