TGA News: You can now request consent not to comply with labelling order requirement

Subsection 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) and
  • the use of trademarks, graphics or additional text must not disrupt the medicine name.

Some sponsors who are struggling to meet this requirement can now apply to the TGA for consent to not comply with this section. The TGA has provided the following eligibility criteria:

  • 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.

This is an interim measure only to allow sponsors to transition their products into compliance with the new order. The TGA has stated that consent will generally be limited until 1 September 2021 but may be longer in exceptional circumstances.

For more information visit the TGA’s website.

If you require assistance with applying for this consent or generally bringing products into compliance, please contact us.