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Submissions received: Discontinuing pre-market evaluation of Herbal Component Names (HCNs)

27 August 2018

The TGA thanks all who provided submissions in response to the November 2017 public consultation paper, Consultation: Discontinuing pre-market evaluation of Herbal Component Names (HCNs).

A total of 7 submissions were received, out of which:

  • 4 submissions supported option 2 for industry and the TGA to work together to produce a workable mechanism that allows for discontinuing pre-market evaluation of HCN applications;
  • 2 submissions supported option 1 to maintain the status quo. Consistent with the cost recovery arrangements in place, a fee for such applications may be considered in the future; and
  • 1 submission did not indicate any preferred option.

All respondents that gave permission to be published on the TGA website are now available below in PDF format.

Submissions

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TGA response

The submissions received in response to the consultation showed broad stakeholder support for the approach to consultation taken by the TGA to implement these reforms. Stakeholder feedback has informed our position going forward. TGA will continue to work with industry to discontinue the pre-market evaluation of Herbal Component Names (HCN). The next steps in discontinuing pre-market evaluation of HCNs are as follows:

  • The TGA is no longer accepting new HCN applications effective immediately.
  • Existing HCN forms and links on the TGA website will be archived.
  • TGA will update relevant guidance documents.
  • On 1 October 2018, TGA will make IT system changes to deactivate existing non-mandatory HCNs in the Ingredients Repository so that these HCNs are no longer visible externally or selectable for new applications.

Sponsors may continue to make claims about herbal components on their medicine labels without pre-market evaluation by the TGA as long as they are not confusing or scientifically incorrect.

For further information about discontinuation of TGA pre-market evaluation of HCNs, which includes clarifications requested by stakeholders, please see the frequently asked questions (FAQs) page.