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Consultation: Draft OTC medicine monographs for topical imidazole antifungals, topical nasal decongestants and pholcodine

Related information

28 November 2013

This consultation closed on 10 January 2014

The TGA sought comments from interested parties on the draft OTC medicine monographs. The monographs are intended to be published for use in applying to register OTC medicines via the N2 application route.

Consultation documents

How to access a pdf or Word document

OTC medicine monograph: Topical nasal decongestants

OTC medicine monograph: Topical imidazole antifungals for dermal use - clotrimazole and miconazole nitrate

OTC medicine monograph: Pholcodine

Timetable

Document released for consultation on Thursday, 28 November 2013.

Interested parties responded by close of business Friday, 10 January 2014.

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

About the consultation

On the 1 October 2013 the TGA commenced a trial of the N2 application route for registration of OTC medicines. This route is intended to enable faster, more efficient approval to market for well-established, lower risk OTC medicines that are compliant with an applicable OTC medicine monograph. The trial commenced with the publication of OTC medicine monographs for aspirin, paracetamol and ibuprofen, with progressive development and publication of further monographs intended.

The OTC medicine monographs in the present consultation have been developed in collaboration with Medsafe, who are to publish separate but consistent monographs for use in New Zealand.

Submissions

See: Submissions & TGA response

Submissions may address any, or all, aspects of the draft OTC medicine monographs.

In addition, submissions might include:

  • Suggested improvements
  • Whether or not you support the draft OTC medicine monographs. If you do not support the draft OTC medicine monographs, you may make suggestions for alternatives 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.

The three monographs will then be finalised and published on the TGA Internet site. Once published, applications for registration of medicines that are compliant with the relevant monograph can be submitted through the OTC New Product N2 application route.

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 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.

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 cover sheet.

Enquiries

Any questions relating to submissions should be directed to the OTC Medicines Evaluation Section by email to OTC.Medicines@tga.gov.au.