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Consultation: Fexofenadine and loperamide: proposed advisory statements for medicines
This consultation closed on 4 June 2012.
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- Draft advisory statement for medicine labels - fexofenadine and loperamide (pdf,311kb)
- Draft advisory statement for medicine labels - fexofenadine and loperamide (Microsoft Word,1.78Mb)
The TGA sought comments from interested parties on the proposed advisory statements for fexofenadine and loperamide for inclusion in the Required Advisory Statements for Medicine Labels (RASML) document when it is next updated.
The proposed advisory statements for fexofenadine and loperamide would be required on the 'labels' of non prescription products containing these two ingredients. Advisory statements on the label of medicines assist in the quality use of medicines by consumers.
Through the consultation process, the TGA requested feedback that will help ensure that the proposed advisory statements are considered appropriate and supports the quality use of medicines for non-prescription products containing fexofenadine or loperamide.
Note: 'Label' means a display of printed information upon, or securely affixed to, the container and any primary pack containing the goods.
Document released for consultation on 4 May 2012.
Interested parties to respond by close of business 4 June 2012.
Feedback will be released following consideration of submissions (see 'What will happen').
This consultation will contribute to the update of the RASML document.
The purpose of reviewing the RASML document is to:
- ensure that advisory statements assist in the quality use of medicines by consumers;
- identify any new labelling requirements for non-prescription medicines; and
- include new labelling requirements that have arisen as a consequence of:
- changes to the scheduling of the medicine in the Standard for the Uniform Scheduling of Medicines and Poisons (SUSMP)
- post-market safety reviews
- advice from relevant expert advisory committees
- proposals from internal and external stakeholders
Submissions will be reviewed by the TGA and feedback on submissions will be provided through the TGA's Internet site. Recommendations made by the TGA following consideration of submissions from interested parties will be published on the TGA website.
The proposed advisory statements will then be included in the next update of the RASML document.
All submissions will be placed on the TGA's 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 cover sheet.
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.
Enquiries should be directed via email to firstname.lastname@example.org, or by telephone to 02 6232 8661.
The TGA has specifically invited comment on the proposed amendments from the following organisations. You may wish to consider submitting your response to one of these organisations, for incorporation in its overall response, rather than submission direct to the TGA:
- Australian Self-Medication Industry Inc. (ASMI)
- Consumers' Health Forum (CHF)
- Generic Medicines industry Association (GMiA) of Australia
- Pharmaceutical Society of Australia (PSA)
- Pharmacy Guild of Australia
The RASML Edition 1 including update 4 (dated September 2008) remains the current version which sponsors should continue to refer to.