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ACNM meeting statement, 5 September 2013

Advisory Committee on Non-prescription Medicines

5 September 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.

Update on matters where the Committee previously provided advice and a TGA decision has been made

The committee's advice was sought previously in relation to an application to register a new OTC product. Members were informed of the Delegate's decision to register the medicine, Movicol Liquid Orange Flavour, and its inclusion on the ARTG with AUST R 212114 on 11 July 2013. Members were also informed that the TGA referred a request for consideration of the scheduling of concentrated macrogol solutions to the Advisory Committee on Medicines Scheduling.

Overview of the therapeutic goods referred for advice

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

  1. the registration on the ARTG of a new OTC medicine, specifically in relation to the directions for use.

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

Other matters considered

At this meeting, the committee's advice was sought in relation to advisory statements for inclusion in the Required advisory statements for medicines labels (RASML) for a number of substances contained in over-the-counter medicines.

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

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: acnm@tga.gov.au.