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Consolidated advisory statement requirements for medicine labels

Consultation

21 July 2006

This consultation closed on 21 July 2006.

Description

The consultation document Consolidated Advisory Statement Requirements for Medicine Labels (CASRML) consolidates all Australian label advisory statement requirements for medicines in one place.

The document is intended to form the basis for:

  • Agreement that all relevant Australian medicine label advisory statements are captured; and
  • Future consultations on transition to a new document to be introduced at the commencement of the Australia New Zealand Therapeutic Products Authority (ANZTPA) (i.e. the ANZTPA version of Required Advisory Statements for Medicine Labels (RASML).

This document is not intended to replace the current edition of the Required Advisory Statements for Medicine Labels (RASML).

The document includes many label advisory statements from guidelines and other ancillary documents which may not currently apply to all medicines (e.g. medicines that were approved before a guideline was introduced). A decision will need to be made on the types of label statements that should be mandatory in the ANZTPA version of RASML and those which are more appropriately retained in guidelines.

The document incorporates all existing Australian label advisory statements without amendment. In undertaking this exercise it has become apparent that there are significant overlaps in label statements from each of these sources and between these sources, giving considerable scope for rationalisation. While comment would be welcome on the process for rationalisation, the actual rationalisation will be addressed on a Joint Agency basis in future consultations (i.e. after the Australian base document has been agreed).

As well as any general comments you may wish to offer, specific comment is sought as follows:

  • Whether the CASRML incorporates all the TGA's current advisory statement requirements for medicine labels, other than those included in TGO 69 and the Best practice guideline on prescription medicine labelling;
  • What criteria should be used to decide whether which label advisory statements should be mandatory and which should be in guidelines;
  • Agreement that the CASRML is an appropriate starting point for transition to the ANZTPA version of RASML;
  • Whether a lower limit for the quantity of a substance should be included, below which advisory statements would not be required. If so, whether the proposed lower limit is appropriate.

CASRML - consultation document

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Contents of the CASRML

  • Introduction
    • Background
    • Souces of requirements included in this document
    • The document
  • Glossary and interpretation
  • Section 1 Medicines to which advisory statements apply
  • Section 2 Advisory statements
  • Section 3 Additional requirements