Draft labelling requirements for medicines under a joint Australia New Zealand therapeutic products agency
- This consultation closed on 17 June 2005.
- Background
- Joint Expert Committee on Labelling Requirements for Medicines
- Consultation papers
Background
The information currently required to be present on the labels of medicines regulated by the Therapeutic Goods Administration (TGA) in Australia, and by Medsafe in New Zealand, is specified in Therapeutic Goods Order 69 (TGO 69) General requirements for labels for medicines (as amended by TGO 69A), and in the Regulations to the Medicines Act (1981), respectively.
With the proposed formation of a joint Australia - New Zealand agency for the regulation of therapeutic products, to commence operation by 1 July 2006, it was agreed by the responsible Ministers that a single, harmonised standard for medicine labels be established. It was further decided that an expert committee, comprising members from both countries and having a variety of relevant backgrounds, be established to develop and make recommendations on such a standard.
Joint Expert Committee on Labelling Requirements for Medicines
The Terms of Reference and Membership of the expert committee are available on this website. Please note that the date of 1 July 2005 shown in the Terms of Reference has been changed to 1 July 2006.
The expert committee met on three occasions towards the end of 2004 and developed a draft set of requirements for the labelling of medicines. This draft takes into account existing requirements for medicine labels in both Australia and New Zealand, and in developing the draft, the committee considered ways of improving the quality of medicine labels, as well as problems identified with the current requirements.
Consultation papers
Draft labelling requirements for medicines under a joint Australia New Zealand therapeutic products agency
Comment from stakeholders was invited on the document Draft Labelling Requirements for Medicines Under a Joint Australia New Zealand Therapeutic Products Agency.
Medsafe and the TGA encouraged all stakeholders to review in detail the draft requirements, as it is intended that these will form the basis of the legally binding standard for medicine labelling to become active from commencement of the joint agency.
Comments received will be considered by the Joint Expert Committee on Labelling Requirements for Medicines, which will then finalise its recommendations to the Ministerial Council on the requirements for medicine labelling to be applied by the joint agency as a legally binding standard.
Please note that the draft labelling requirements make reference in some parts to aspects of the proposed joint agency regulatory scheme that have still to be finalised. These areas are marked in the text in grey highlight. An example is reference to a 'unique identifier' being required on product labels. At the time of sending out this draft document for consultation, details such as the format of the 'unique identifier' have yet to be finalised. However, it is considered that these gaps in the draft labelling requirements should have no significant influence on the ability of stakeholders to provide comment on the content of the document.
Draft best practice guideline on prescription medicine labelling
Consultation outcome
Original consultation
Stakeholders were also invited to comment on the content of the Draft Best Practice Guideline on Prescription Medicine Labelling, which is intended to complement the mandatory standards for medicine labelling.
It is recognised that the standard for medicine labels, as set out in the draft requirements referred to above, will represent the minimum requirements for regulatory purposes and that improvements in the effectiveness, or performance, of labels can be achieved by various means. An example of this is the industry code of practice entitled Labelling Code of Practice: Designing usable non-prescription medicine labels for consumers, which is referenced in the introductory section of the draft labelling requirements for medicines.
A similar approach is being developed for prescription medicines. The document Draft best practice guideline on prescription medicine labelling was developed by a working party of stakeholders coordinated through the TGA. It is intended that this guideline, when finalised, will be referenced in the introductory section to the standard specifying labelling requirements for medicines under the joint agency.