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Consultation: OTC N2 application requirements and OTC medicine monographs for aspirin, paracetamol and ibuprofen

Related information

18 June 2013

This consultation closed on 16 July 2013.

The TGA sought comments from interested parties on draft documentation intended for publication as part of the implementation of a 12 month trial in Australia of the OTC New Product N2 application (or 'Monograph application') route. The documents are as follows:

  • Requirements for OTC new product N2 applications (using OTC medicine monographs)
  • Assurances to accompany an OTC new product N2 application
  • OTC medicine monograph: Aspirin tablets for oral use
  • OTC medicine monograph: Ibuprofen for oral use
  • OTC medicine monograph: Paracetamol for oral use

Consultation documents

Requirements for OTC new product N2 applications (using OTC medicine monographs)

How to access a pdf or Word document

Assurances to accompany an OTC new product N2 application

OTC medicine monograph: Aspirin tablets for oral use

OTC medicine monograph: Ibuprofen for oral use

OTC medicine monograph: Paracetamol for oral use

Timetable

Document released for consultation on Tuesday, 18 June 2013.

Interested parties responded by close of business Tuesday, 16 July 2013.

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

About the consultation

In September 2012 Medsafe and the TGA sought comments from interested parties on proposed reforms to OTC business processes. Included in the proposed reforms was the introduction of a new 'N2' application route for registration of OTC medicines. This route is to be available for proposed medicines that comply with the requirements of a product-specific OTC medicine monograph. N2 applications will involve significantly reduced requirements for data assessment by the regulator and consequently shorter evaluation timelines. In lieu of providing full supporting data with the application, sponsors will need to complete a list of assurances confirming that the product meets the specified requirements.

As part of the outcomes of the above consultation, the TGA intends to implement the New Product N2 application (or 'Monograph') route as an initial 12 month trial in Australia, to determine the effectiveness of the process and uptake by applicants. Initial implementation will include the publication of three OTC medicine monographs covering the most commonly registered OTC medicine products - those containing aspirin, paracetamol and ibuprofen as single active ingredients. Further OTC medicine monographs are to be developed and implemented during the trial period.

The purpose of this consultation was to seek comments on the five key documents intended for publication as part of the implementation of the N2 application route trial in Australia.

  1. Requirements for OTC new product N2 applications (using OTC medicine monographs)

This document, in conjunction with product-specific OTC medicine monographs, outlines the requirements for market authorisation of OTC medicines applied for via the New Product N2 application route. The requirements have been developed to enable minimal evaluation of supporting data by the TGA, while still providing assurance as to the quality, safety and efficacy of the medicines.

  1. Assurances to accompany an OTC New Product N2 application

This document will need to be completed, signed and submitted by sponsors when submitting an OTC New Product N2 application. The form reflects the requirements specified in the document, Requirements for OTC new product N2 applications (using OTC medicine monographs).

  1. OTC medicine monographs: Aspirin tablets for oral use
  2. OTC medicine monographs: Ibuprofen for oral use
  3. OTC medicine monographs: Paracetamol for oral use

These are the first three OTC medicine monographs to be implemented. The requirements specified in these draft monographs reflect the current TGA requirements for these product types. The scope of the monographs is limited to well-accepted dosage forms, strengths and indications, so as to enable minimal evaluation of supporting data by the TGA, while still providing assurance as to quality, safety and efficacy.

It is important to note that the documents included in this consultation are still in draft form. The final documents for implementation will be finalised on the basis of the outcomes of the consultation (see What will happen).

The principles of the proposed OTC New Product N2 application pathway were considered in the previous consultation and are not the subject of the present consultation. Similarly, administrative aspects of the N2 application process are not the subject of the present consultation and are described in documentation already published on the TGA website, as follows:

Submissions

Submissions may address any, or all, of the proposed requirements detailed in the documentation in relation to the New Product N2 application route, or other identified related issues.

In addition, submissions might include:

  • Suggested improvements
  • Whether or not you support the proposed documentation. If you do not support proposed wording or other aspects, you may make suggestions for alternatives acceptable to you.

Submissions received

These are the submissions received by the TGA in response to the consultation.

How to access a pdf document

What will happen

Submissions have been reviewed by the TGA and feedback provided as part of the outcomes of the consultation.

The five documents will be finalised and published on the TGA Internet site. Once published, applications for medicine registration can then 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 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

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