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Labelling requirements for medicines under the Australia New Zealand Therapeutic Products Authority

Report on stakeholder consultation and Revised Draft Managing Director's Order

13 June 2006

Please note: This consultation closed on 22 August 2006.

The information on this page relates to the following documents:

Background

The consultation document Draft Labelling Requirements for Medicines under a Joint Australia New Zealand Therapeutic Products Agency was released for stakeholder comment on 14 April 2005.

This consultation document had been developed by the Joint Expert Committee on Trans Tasman Labelling Requirements for Medicines (the Expert Committee) over the period October 2004 to March 2005 with the aim of providing a single, harmonised set of labelling requirements for medicines to be applied in both Australia and New Zealand by the Australia New Zealand Therapeutic Products Authority.

Background to development of this document, the document itself, and information on the Expert Committee, can be found at http://www.anztpa.org/label/labeldraft.htm.

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Report on stakeholder consultation

Stakeholder consultation closed at the end of June 2005. In total 72 submissions were received, originating from a wide range of organisations and individuals, including industry associations, individual sponsors and manufacturers, consumer organisations and individual consumers, government departments, government advisory committees, the professions, pharmacy guilds and retail organisations.

Review of stakeholder responses by the Expert Committee occurred over the course of two meetings held in late 2005. Consideration of the issues raised through the consultation process resulted in a number of amendments to the content of the draft Order as well as some re-formatting to enhance clarity and intent. Not all issues raised by stakeholders were considered to fall within the scope of the Expert Committee's Terms of Reference while other matters were not able to be addressed through the labelling Order.

The outcomes of the Expert Committee's consideration of stakeholder responses are reflected in the updated version of the Australia New Zealand Therapeutic Products Authority draft labelling Order, General Requirements for the Labelling of Medicines (draft - May 2006), which is available above. The linked document Draft Labelling Requirements for Medicines under the Australia New Zealand Therapeutic Products Authority - Report on Stakeholder Consultation and Consideration by the Joint Expert Committee on Trans Tasman Labelling Requirements for Medicines of Issues Raised in Stakeholder Responses provides an overview of the major issues raised in stakeholder responses, and the outcomes of the Expert Committee's consideration of these.

On many issues, the Expert Committee had to balance considerations of practicality (such as space constraints, manufacturing practices, market size) with the needs of consumers and health professionals in Australia and New Zealand for appropriate and relevant label information.

With the exception of proposed labelling requirements for opaque intermediate packaging, and completion of requirements for herbal, homoeopathic and anthroposophic medicines, no new requirements (beyond those in the draft Order released in April 2005) have been included in the draft Order.

In relation to opaque intermediate packaging, it is proposed that the labelling Order specify minimum labelling requirements for this level of packaging. However in recognition of this proposal potentially representing a major change for industry, the Expert Committee wished to obtain information on current practices for labelling of intermediate packaging, and seek stakeholder comment on the impact of this proposal. Further information on the proposal to specify minimum labelling requirements for opaque intermediate packaging is included in the Report on Stakeholder Consultation.

Stakeholders should note that although the First Schedule to the draft Order (which specifies those excipients that must be declared on the labels of medicines) has been retained in the draft now being released, this is for ease of finalisation of this consultation. It is likely that these substance-specific requirements will be transferred in due course to the separate regulatory document specifying required advisory statement for medicines.

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Issues relating to complementary medicines

The original version of the draft labelling Order, released in April 2005, contained a number of gaps reflecting aspects of the joint regulatory scheme that were still to be finalised, including many definitions and specific regulatory requirements relating to herbal, homoeopathic and anthroposophic medicines.

In its considerations, the Expert Committee was aware of concurrent processes being undertaken by the TGA and Medsafe to consult with stakeholders on facets of the joint regulatory scheme relating to complementary medicines. By necessity, these concurrent consultations also addressed aspects of labelling specific to these types of medicines.

As the responses to these concurrent consultations were to be considered by other groups with expertise in complementary medicines (including the Complementary Medicines Evaluation Committee and the Office of Complementary Medicines / Industry Consultation Group), the Expert Committee considered it appropriate to accept the advice of those other expert groups in relation to specific labelling requirements for complementary medicines.

Attachment 4 to the Report on Stakeholder Consultation describes these consultation processes, and subsequent outcomes relevant to the labelling of complementary medicines, in more detail. The version of the draft labelling Order now available reflects these outcomes.

Opportunity for further stakeholder input

The updated version of the draft labelling Order and Report on Stakeholder Consultation are being released to inform stakeholders of the outcomes of the consultation process, and the reasons for the Expert Committee’s various conclusions in relation to the major issues raised by stakeholders.

In addition to this, release of the updated draft labelling Order is intended to provide industry stakeholders with an opportunity to assess the practicality of the final proposed requirements in relation to existing products, particularly those with limited label space. Industry stakeholders are welcome therefore to provide information (supported by practical examples) on any difficulties anticipated with application of the proposed requirements to their particular products.

Stakeholders are also invited to provide comment on the new proposal that the labelling Order specify minimum labelling requirements for opaque intermediate packaging, together with relevant information on current industry practices in this regard.

Similarly, other stakeholders may provide comment on any significant aspects of the proposed labelling requirements that may affect the effective and safe use of medicines, and that have not previously been considered by the Expert Committee.

However, all stakeholders should note that as comprehensive consultation on the proposed requirements has already been undertaken, it is not intended that issues already considered by the Expert Committee will be re-opened unless new information is available for consideration or unless the changes made to the draft Order give a different significance to original submissions. Responses merely duplicating comment made in previous submissions will not be further considered.

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