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Revised requirements for the labelling of medicines

Consultation

18 January 2008

This consultation closed on 29 February 2008.

Background

Therapeutic Goods Order No. 69 General requirements for labels for medicines (TGO 69) specifies current Australian requirements for the labelling of medicines.

A review of TGO 69 was commenced by the Therapeutic Goods Committee (TGC) in late 2003 with the aim of identifying label changes that would help improve product identification in recall situations. Recognition that broader issues relating to the labelling of medicines required consideration, as well as commencement of work to establish the Australia New Zealand Therapeutic Products Authority (ANZTPA), resulted in a recommendation for establishment of a new expert committee on medicine labelling to develop a harmonised standard for the labelling of medicines.

The Joint Expert Committee on Trans Tasman Labelling Requirements for Medicines subsequently was established to develop a draft Order to specify labelling requirements for medicines to be applied by ANZTPA. The development process was iterative, with two rounds of stakeholder consultation being conducted, the first in April 2005 and the second in June 2006. The draft ANZTPA Order was based in large part on TGO 69.

The ANZTPA Order was nearing completion when the postponement of ANZTPA was announced in July 2007. Although it had been intended that the final version of the draft Order would be released to stakeholders for further information, this was no longer possible.

The TGC noted this situation at its November 2007 meeting, and recommended that, despite postponement of ANZTPA, there remained strong justification for progressing the review and revision of labelling requirements for medicines in Australia.

The Committee therefore recommended that a draft new Therapeutic Goods Order including, as far as is consistent with existing therapeutic goods legislation, the same technical requirements as identified in the draft ANZTPA Order, should be released for stakeholder consultation.

Proposal

It is proposed that Therapeutic Goods Order No. 79 General Requirements for the Labelling of Medicines (TGO 79) will supersede TGO 69 as a standard made under section 10 of the Therapeutic Goods Act 1989.

TGO 79 (draft) incorporates a two year transition period for products to comply with the revised requirements. This transition period would commence upon entry of TGO 79 onto the Federal Register of Legislative Instruments.

Rather than incorporate Supplementary Notes, it is proposed that TGO 79 would be accompanied by a guidance document providing explanatory information and a series of questions and answers relating to the practical application of the Order.

Drafts of TGO 79 and the accompanying guidance document are now available for review by stakeholders.

Technical information

The main differences between current labelling requirements as given in TGO 69 and the proposed revised requirements of TGO 79 are summarised in Appendix 1 to the draft guidance document.

Consultation

Stakeholders were invited to provide comment on TGO 79 (draft) and its companion document Guidance on Therapeutic Goods Order No. 79 General Requirements for the Labelling of Medicines, also in draft.

Information that would assist in the assessment of the regulatory impact of the proposal to revise requirements for the labelling of medicines was also sought as part of this consultation process.

Comments received in response to this consultation were referred to the TGC for consideration.

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