Required advisory statements for medicine labels

Required advisory statements for medicine labels (RASML)

The Required Advisory Statements for Medicine Labels document was established to enable the transfer of all mandatory label advisory statements from the Standard for the Uniform Scheduling of Drugs and Poisons (SUSDP) <http://www.tga.gov.au/ndpsc/susdp.htm> and the Therapeutic Goods Regulations to a new document, separate from but linked to TGO 69 - General requirements for labels for medicines (the Labelling Order) <http://www.tga.gov.au/docs/html/tgo/tgo69.htm>.

The Labelling Order makes it mandatory for medicine labels to include any label advisory statements specified in Required Advisory Statements for Medicine Labels. By physically separating the documents, the advisory statements can be updated at regular intervals without issuing an entirely new Labelling Order each time.

How to access a pdf document

Required advisory statements for medicine labels (September 2008) (pdf,312kb)

Contents of the RASML

Introduction
- Background
- Source of documents
- Application of advisory statements
  - Application to medicines
  - Date of effect
- The document
Glossary and interpretation
How to use this document
- Flow chart 1
How required statements are to be included on the labels
- What needs to be included on the label
- When the statement needs to be included on the label
- Additional requirements
- Multiple statements
- Combination of statements
Section 1 Medicines to which advisory statements apply
- Requirements
  - Date from which requirements apply
- Medicines to which advisory statements apply
Section 2 Advisory statements
Section 3 Additional requirements
Appendices
- Appendix 1 Updating the RASML - Procedural matters
  - Overview
  - Updating the RASML
    - Existing substances
    - New substances
    - Flow chart 2
- Questions and answers
- Appendix 2 Archived entries
  - Appendix 2.1 Archived entries - Section 1 Medicines to which advisory statements apply
  - Appendix 2.2 Archived entries - Section 2 Advisory statements
  - Appendix 2.3 Archived entries - Section 3 Additional requirements

Hardcopies of the RASML

If you require this document in hardcopy please complete a publications order form <http://www.tga.gov.au/pubs/puborder.htm>. Payment must accompany the order. Please note: this document is only available in hardcopy as a double-sided black & white print on plain A4 paper. It does not come with a folder and is not bound in any way.

Australian price (GST inclusive): $30.00
Overseas price (+ Airmail): $27.25 (+$10.00)