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Intention to amend TGO 69 - General requirements for labels for medicines
- Therapeutic Goods Order No. 69C - Amendment to Therapeutic Goods Order No. 69 - General requirements for labels for medicines (registered with FRLI 12 March 2009)
This document was released in December 2008 for comment and closed on 30 January 2009.
This notice advises of the intention of the delegate of the Minister for Health and Ageing to:
- amend the definition of 'Required Advisory Statements for Medicine Labels' included in clause 2 'Interpretation' of Therapeutic Goods Order No. 69 General requirements for labels for medicines (TGO 69); and
- make a consequential amendment to subclause 4(13) of TGO 69 to require the content of Vitamin A in medicines to be expressed in terms of retinol equivalents.
TGO 69 currently defines 'Required Advisory Statements for Medicine Labels' as meaning the document Required Advisory Statements for Medicine Labels (April 2006) published by the Therapeutic Goods Administration on its website (http://www.tga.gov.au).
The intended amendment to this definition will update the version of the publication to which the definition refers - specifically it will update the definition to refer to the September 2008 version of Required Advisory Statements for Medicine Labels , rather than the April 2006 version. The September 2008 version incorporates Updates 3.1 and 4 as well as Updates 1 and 2 that were included in the April 2006 version.
Clause 4 of TGO 69 specifies how the quantity or proportion of an active ingredient must be expressed on the label of a medicine. Subclause 4(13) currently specifies that, for preparations containing Vitamin A, the quantity or proportion of Vitamin A must be expressed in terms of International Units (IU).
The intended amendment to subclause 4(13) will remove reference to International Units and substitute retinol equivalents as the unit of quantity.
Effect of the intended amendments
Required Advisory Statements for Medicine Labels (RASML) is referred to in the definition of 'warning statements' contained in TGO 69. The requirement of subclause 3(2)(g) of TGO 69 for the label of a medicine to include warning statements where these apply to the medicine has the effect of requiring labels to show any applicable advisory statements specified in RASML.
The effect of the intended amendment to the definition of RASML contained in TGO 69 will be to give legislative force to those additions and other changes made to advisory statements included in RASML through Update 3.1 (April 2008) and Update 4 (September 2008).
The intended amendment to subclause 4(13) of TGO 69 to require the content of Vitamin A present as an active ingredient in a medicine to be quantified in retinol equivalents is a consequence of changes to the wording of advisory statements for medicines containing Vitamin A that were included in the April 2008 update of RASML.
This change will ensure consistency between the units of measurement used for the declaration of content of Vitamin A and the limits used in advisory statements relating to Vitamin A that are required by RASML.
Supporting recommendation and implementation
Stakeholders were previously consulted on the proposed additions and changes to RASML which were included in Update 3.1 and Update 4, in accordance with the process outlined in RASML (Appendix 1 - Procedural Matters). Records of Decisions and Reasons are available on the TGA internet site for both Update 3.1 and Update 4.
Amendment to the definition of 'Required Advisory Statements for Medicine Labels' contained in TGO 69, and the consequential amendment to subclause 4(13) was recommended by the Therapeutic Goods Committee at its 33rd Meeting held on 15-16 October 2008.
It is intended that an Order amending TGO 69 as described above will be made in February 2009, with the Order commencing to have effect on 23 April 2009.