Australia New Zealand
Therapeutic Products
Authority

Information last updated: 11 July 2007
URL: http://www.anztpa.org/label/
   dr-mls.htm

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Proposed Medicine Label Statements – released for stakeholder consultation

Please note: This consultation closed on 18 August 2007.

On 11 July 2007, written submissions were invited on the following consultation document:

Proposed Medicine Label Statements (pdf,512kb)

Background

Currently, medicine labels are required to include advisory statements according to:

• the Required Advisory Statements for Medicine Labels (RASML) in Australia; and
• the medicine label statements in Volume 1 of the New Zealand Regulatory Guidelines for Medicines in New Zealand.

Under the joint regulatory scheme for therapeutic products, to be administered by the Australia New Zealand Therapeutic Products Authority (ANZTPA), it is proposed that certain advisory statements will be required (where appropriate) to be placed on medicine labels.

In anticipation of the scheme's commencement, Medsafe (New Zealand) and the Therapeutic Goods Administration - TGA (Australia) have rationalised the current statements used in their respective countries into a single set of label advisory statements.

This consultation document has been produced to:

• explain the approach behind the rationalisation of the Required Advisory Statements on Medicine Labels (RASML) dataset;
• provide the wording of the proposed rationalised advisory statements;
• describe a possible internet ANZTPA RASML database that will readily inform users of advisory statements;
• detail the circumstances of when the advisory statements are required to be included on medicine labels; and
• seek feedback from stakeholders on the proposals.

The requirements for medicine labels under the ANZTPA Scheme will be detailed in the Order titled General Requirements for the Labelling of Medicines Australia New Zealand Therapeutic Products Authority <http://www.anztpa.org/label/dr-labelorder.htm>. This Order will require labels to contain warning and advisory statements which will be captured in the ANZTPA RASML.

At the time of this consultation, the legal framework for the proposed ANZTPA RASML has not been finalised and cannot be detailed in this document. Therefore, this document has no legal basis of its own, and is not intended to replace either the current edition of the RASML in Australia or the medicine label statements in Volume 1 of the New Zealand Regulatory Guidelines for Medicines in New Zealand. It is intended only to form the basis for:

• Consultation and discussion on whether all the requirements relating to advisory statements are captured;
• Creation of a finalised ANZTPA RASML set; and
• To inform the working party of a direction forward, and to form a basis for a work-plan.

URL: http://www.anztpa.org/label/dr-mls.htm

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