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Consultation: Draft OTC medicine monograph for loperamide hydrochloride

12 September 2014

This consultation closed on 10 October 2014

The TGA sought comments from interested parties on the draft OTC medicine monograph for loperamide hydrochloride. The monograph is 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


Document released for consultation on Friday, 12 September 2014.

Interested parties should respond by close of business Friday, 10 October 2014.

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

About the consultation

On 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 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, followed by topical nasal decongestants, topical imidazole antifungals for dermal use (clotrimazole and miconazole nitrate) and pholcodine, with progressive development and publication of further monographs intended.

The OTC medicine monographs in the present consultation have been developed in collaboration with Medsafe.


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

In addition, submissions might include:

  • Suggested improvements
  • Whether or not you support the draft OTC medicine monograph. If you do not support the draft OTC medicine monograph, 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

All submissions will be placed on the TGA Internet site unless marked confidential or indicated otherwise in the submission cover sheet (see Privacy information).

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

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.

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).
  • The TGA will disclose your name and (if applicable) your designation/work title on the TGA Internet site (i.e. make this information publicly available) if you consent to the publication of your name on the TGA Internet site (please complete the cover sheet).
  • Any text within the body of your submission that you want to remain confidential should be clearly marked 'IN CONFIDENCE'.
  • 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.


Any questions relating to submissions should be directed to the OTC Medicines Evaluation Section by email to