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ACNM meeting statement, 7 March 2013

Advisory Committee on Non-prescription Medicines

7 March 2013

Role of the Advisory Committee on Non-prescription Medicines (ACNM) in the TGA's regulatory decision making process

The ACNM is a statutory advisory committee established by the Therapeutic Goods Regulations 1990.

The TGA currently has nine statutory advisory committees from which it can obtain independent expert advice on specific scientific and technical matters to aid the TGA's regulatory decision making and other regulatory processes.

The ACNM provides advice to the TGA on, amongst other things, matters relating to the inclusion, variation, removal or retention of over-the-counter (OTC) medicines on the Australian Register of Therapeutic Goods (ARTG).

The advice provided by the ACNM is an important element in the undertaking of the regulatory functions of the TGA. However, it forms only part of the information that is available to, for instance, a TGA delegate making a regulatory decision under the Therapeutic Goods Act 1989. While appropriate consideration will be given to such advice, it is important to note that neither the TGA nor a TGA delegate is obliged to follow it.

It should also be noted that information about advice provided by the committee may not become publicly available for some time after a committee has provided that advice. The purpose of this Meeting Statement is to describe in general terms the matters considered by the committee at each meeting and for it to be available as soon as reasonably practical after the relevant meeting.

Overview of the therapeutic goods referred for advice

At this meeting, the committee's advice was sought in relation to three new registration applications for OTC medicines before the TGA:

  1. the registration on the ARTG of a new OTC medicine, specifically the suitability of the proposed name and presentation of the medicine and whether there were any risks that could lead to confusion and/or safety concerns
  2. the registration on the ARTG of a new OTC medicine, specifically in relation to the presentation of the medicine and whether there were any associated safety concerns
  3. the inclusion of a new indication for a currently registered OTC medicine, specifically in relation to whether the new indication for the medicine was acceptable.

The committee's advice on these matters has now been provided to the TGA for consideration as part of the TGA's regulatory decision making process.

Other matters considered

A warm welcome was extended to the two new ACNM members, Dr Lisa Pont, a Senior Lecturer in Pharmacology and Clinical Pharmacy at the Sydney Nursing School, University of Sydney, and Dr Maureen Mitchell, a General Practitioner who has worked in a wide range of clinical settings, including Indigenous Health Services in remote settings in the Northern Territory.

Members noted that information on the new ACNM membership is available on the ACNM web page of the TGA website.

Stakeholder engagement

From time to time representatives from other statutory committees and international regulators are invited to attend a TGA statutory advisory committee meeting. In this context, members welcomed the attendance of an officer from Medsafe as an observer at this meeting.

Next meeting

The next meeting of the ACNM is scheduled for 6 June 2013.

Further information

Meeting statements are made publicly available after each meeting.

For further information on the ACNM, please visit the ACNM web page or contact the ACNM Secretary by email: