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Consultation: Kunzea ambigua: proposed advisory statements for medicines

Version 1.0

7 December 2012

This consultation closed on 18 January 2013

Invitation to comment

The TGA sought comments from interested parties on proposed amendments to the advisory statements for Kunzea ambigua (K. ambigua) when included in listed medicines for topical use. If accepted, the proposed amendments will be included in the Required Advisory Statements for Medicine Labels (RASML) document when it is next updated.

Note: 'Label' means a display of printed information upon, or securely affixed to, the container and any primary pack containing the goods.

Timetable

Document released for consultation on Friday, 7 December 2012

Interested parties should respond by close of business Friday, 18 January 2013

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

About the consultation

Currently, the RASML document requires advisory statements on labels of listed medicines containing K. ambigua. The TGA is considering amending these requirements as some are not relevant when the essential oil of K. ambigua (Kunzea oil) is included in cream preparations.

Advisory statements on the label of medicines assist in the quality use of medicines by consumers.

Through the consultation process, the TGA is requesting comment that will help ensure that the proposed advisory statements are appropriate and support the quality use of medicines for topical use that contain K. ambigua.

This consultation will contribute to the update of the RASML document.

Content of submissions

Submissions may address the proposed advisory statement and other identified issues.

In addition, submissions might include:

  • Whether or not you support the wording of the advisory statement(s). If you do not support the wording of the statement you may make suggestions for an alternative acceptable to you.
  • An assessment of how the proposed change will impact on you. That is, what do you see as the likely benefits or costs to you (these may be financial or non-financial). If possible, please attempt to quantify these costs and benefits.

What will happen

Submissions will be reviewed by the TGA and feedback on submissions will be provided through the TGA's Internet site.

After consideration of all submissions, the TGA will proceed with the proposed amendments or consider further revisions of the advisory statements and seek further consultations.

Confidentiality

All submissions will be placed on the TGA website unless marked confidential. Any confidential material contained within your submission should be provided under a separate cover and clearly marked 'IN CONFIDENCE'. Reasons for a claim to confidentiality must be included in the space provided on the TGA submission coversheet.

For submissions made by individuals, all personal details other than your name will be removed from your submission before it is published on the TGA's website.

In addition, a list of parties making submissions will be published. If you do not wish to be identified with your submission you must specifically request this in the space provided on the submission coversheet.

Enquiries

Enquiries should be directed via email to ocm@tga.gov.au or by telephone to 02 6232 8634.

Background

Consumers rely on information from their health practitioner, pharmacist and medicine 'label' in order to use medicines safely and effectively. In the case of non-prescription medicines, the label of the medicine contains information and directions for appropriate use, as well as any advisory statements (warnings) that are needed for safe and effective use of the medicine.

The need for a new advisory statement or for the amendment or addition to current statement(s) might arise from:

  • The registration of a new medicine
  • When new risks for currently available medicines have been identified
  • A request from external stakeholders and/or expert advisory committees is received
  • When a medicine undergoes a change in scheduling, hence reducing the level of control and making it more widely available to consumers for self-selection or available without a prescription.

Under these circumstances there may be a need to ensure that appropriate advisory statements are included on the labelling of these medicines to ensure consumers are able to self-select and use these medicines safely and effectively.

Note: 'Label' means a display of printed information upon, or securely affixed to, the container and any primary pack containing the goods.

Kunzea ambigua

K. ambigua is only available for use in listed medicines for topical application. These medicines can only be essential oils and the advisory statements included in RASML for this ingredient reflect this availability.

The TGA has recently reviewed the use of this ingredient and determined that these topical medicines are also safe when presented in a cream base.

Currently the RASML document requires the following statements for K. ambigua when the preparation is 'essential oil':

  1. for external use only;
  2. keep out of the reach of children; and
  3. not to be applied undiluted to the skin except on the advice of a health care practitioner.

The TGA considers the advisory statement 'do not apply undiluted to skin except on the advice of a healthcare professional' unnecessary for cream preparations as the essential oil would be already diluted in a cream base. Therefore, the TGA proposes to remove the requirement for inclusion of this advisory statement on topical medicines that are cream preparations containing K. ambigua.

Proposal

The TGA proposes the following advisory statements for K. ambigua when supplied as listed medicines under the conditions stated (See Table 1).

Table 1. Proposed advisory statements for Kunzea ambigua
Which Meet The Following Conditions ... Required advisory statement(s)
where the preparation is 'essential oil' for external use only
keep out of the reach of children
not to be applied undiluted to the skin except on the advice of a health care practitioner
where the preparation is other than 'essential oil' for external use only
keep out of the reach of children

Version history

Version Description of change Author Effective date
V1.0 Original publication Office of Complementary Medicines 16/11/2012

© Commonwealth of Australia 2012
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Submissions received

The consultation period for Kunzea ambigua: proposed advisory statements for medicines closed on 18 January 2013. No submissions have been received.

Currently the RASML document requires the following statements for K. ambigua where the preparation is 'essential oil':

  1. for external use only
  2. keep out of the reach of children, and
  3. not to be applied undiluted to the skin except on the advice of a health care practitioner.

Where the preparation is other than 'essential oil' (for example, creams), the TGA considers the advisory statement 'not to be applied undiluted to skin except on the advice of a healthcare professional' unnecessary as the ingredient would be already diluted. Therefore, the following entry will be included in the next revision of the RASML document.

Which Meet The Following Conditions ... Required advisory statement(s)
where the preparation is other than 'essential oil'
for external use only
keep out of the reach of children

Until the new RASML document is updated to reflect this change, the requirement for the label statements on these medicines will be applied as a condition of listing.