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Outcome of consultation: OTC N2 application requirements and OTC medicine monographs

16 August 2013

In June 2013, the TGA sought comments from interested parties on draft documentation for publication as part of the implementation of the OTC Medicines N2 application route trial in Australia.

A total of 5 submissions were received.

The TGA would like to thank those who took the time to prepare a submission and provide helpful comments and suggestions.

The submissions received were considered by the TGA for any changes to the proposed documentation.

In addition to commenting on the documentation itself, each submission provided comment on other aspects of the proposed N2 Monograph application route.

This section of the website provides a summary of the key issues raised, Regulator's comments and outcomes.

The comments received during the consultation fall into five categories:

N2 Monograph application route - concept, trial and documentation

Submissions were generally supportive of the overall concept of the N2 application route. While most submissions supported a trial period, some questioned the benefit of the trial, given the limited number of proposed monographs and the trial duration of only one year. One submission expressed concern that the cost of post-market monitoring might negate any resource saving from reduced evaluation and recommended transparency in assessment of cost-effectiveness.

Responses were generally supportive of the format and content of the monographs and associated documents. One submission suggested minor changes to documentation for improved clarity and noted minor errors for correction.

Regulator's comments

  • Further monographs are to be implemented over coming months (see 'Information regarding release of further monographs'). It is anticipated that the planned set of trial monographs, covering more frequently registered medicines, should provide sufficient coverage for trialling of the N2 application route. While an initial trial period of one year is proposed, this could be extended, depending on outcomes of the trial.
  • Outcomes and assessment of the trial will be communicated to stakeholders. Consideration of the cost-effectiveness of the monograph route should be in the longer-term context of managing the OTC pre-market assessment process into the future rather than being confined rigidly to the 12 month period.


  • The OTC N2 application route will be implemented on 1 October 2013 for an initial trial period of 12 months.
  • Most of the recommended changes to the documentation are to be made as recommended.

Absence of New Zealand from the trial

Industry expressed concern and disappointment regarding the absence of New Zealand from the trial and considered, with ANZTPA approaching, that it was important to be aligning requirements through development of joint monographs. It was strongly recommended that further monographs developed for the trial should apply to both Australia and New Zealand in preparation for ANZTPA.

Regulator's comments

The intention at this stage is to trial the N2 application route within one jurisdiction for simplified logistics and control of the trial environment. While the trial is being conducted in Australia, Medsafe and the TGA are actively working together on harmonisation aspects as part of the N2 application project in preparation for ANZTPA.

Post-market monitoring

Two submissions stressed the need to monitor compliance with requirements. One submission noted that limited information has been provided to date regarding plans for post-market monitoring. The submission suggested that information regarding intended methods to ensure compliance and penalties for non-compliance should be published prior to trial implementation, and that regulations and funding should be in place.

Regulator's comments

  • The TGA acknowledges the importance of post-market monitoring to ensure sponsor compliance and consumer safety. Post-market monitoring will include:
    • the request and evaluation of sponsor data in support of products approved via the N2 route;
    • laboratory testing of product samples;
    • input into Office of Manufacturing Quality (OMQ) manufacturer audit plans where appropriate.

Information regarding release of further monographs

Two submissions expressed desire for clarity on the timeframes and candidates for further monograph development.

Regulator's comments

It is anticipated that OTC Medicine Monographs for Topical nasal decongestants and Topical antifungals will be published for consultation shortly.

Consultation and implementation of the following further monographs is anticipated by the end of 2013.

  • Pholcodine
  • Ranitidine hydrochloride
  • Anaesthetic/antiseptic lozenges
  • Loperamide
  • Mebendazole

Other issues

  • One submission considered that the monograph system should be utilised for product variations and not just as a path to registration.
  • One submission raised concerns regarding lack of transparency of approved limits of use of excipients, but accepted the proposed interim approach for the monograph route.

Regulator's comments

  • Extending the purpose of the OTC monograph system beyond the current proposal may be considered at a later stage, depending on the outcomes of its use as a path to registration.
  • Concerns regarding transparency of approved limits of use of excipients are acknowledged. This issue is separate to implementation of OTC Monographs and will need to be considered separately.