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

12 January 2018

This consultation closed on 12 January 2018.

The TGA sought comments from interested parties on a proposal to discontinue the process for the pre-market evaluation of Herbal Component Names (HCNs) which are used in relation to listed complementary medicines.

Consultation documents

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Timetable

Documents released for consultation on Friday, 17 November 2017.

Interested parties should respond by close of business Friday, 12 January 2018.

Feedback will be released following consideration of submissions. (see 'What will happen').

About the consultation

Listed complementary medicines may utilise Herbal Component Names (HCNs) as a means to communicate information about the content of the product to consumers. At present, the TGA administers processes for the receipt, scientific assessment and approval of applications for new HCNs. Overall, this activity requires significant TGA resources, is not underpinned by legislation and, importantly, does not provide consumers with an assurance that HCNs are applied consistently across products.

A paper entitled Herbal Component Names (HCNs) – Regulatory review was the subject of an item at the 11th meeting of Complementary Medicines Evaluation Committee in February 1999. The paper included key concerns raised by external stakeholders.

Taking these considerations into account, along with feedback over recent years from the regulated industry, we are proposing to discontinue the receipt and pre-market evaluation of HCN applications.

Submissions

Submissions may address any, or all, of the proposals in the consultation document or other identified issues. Submissions might include, for example, suggested improvements or an assessment of how the proposed change will impact on you.

Regulatory options

We are proposing two options to address the proposal to discontinue the receipt and pre market evaluation of HCN applications.

Option 1

Maintain the status quo.

Consistent with the cost recovery arrangements in place, a fee for such applications may be considered in the future.

Option 2

Industry and the TGA to work together to produce a workable mechanism that allows for discontinuing pre-market evaluation of HCN applications.

  1. Do you support Regulatory Option 1 or 2 as outlined in this paper or would you like to propose an additional option for consideration?
  2. Do you have any specific concerns regarding discontinuation of the HCN evaluation process?

Enquiries

Any questions relating to submissions should be directed to the Director of the Complementary Medicines Evaluation Section by email to Michael.Gardner@tga.gov.au or by telephone to 02 6232 8044.

What will happen

All submissions will be placed on this website unless marked confidential or indicated otherwise in the submission form (see Privacy information).

Submissions will be reviewed by the TGA and feedback on submissions will be provided through this website.

Privacy information

  • The TGA collects your personal information in this submission in order to:
    • contact you if the TGA wants to seek clarification of issues raised in your submission or to check whether you consent to certain information that you have provided being made publicly available.
    • help provide context about your submission (e.g. to determine whether you are an individual or a director of a company or representing an interest group).
    • Seek feedback about how the consultation was undertaken.
  • Please do not include personal information about other individuals in the body of your submission. Personal information in this context means information or an opinion about an individual whose identity is apparent, or can reasonably be ascertained, from the information or opinion.
  • More information on consultations and privacy is included in the submission form and on our website.