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.
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
- Requirements
- 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
- Appendix 1 Updating the RASML - Procedural matters
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.
- Australian price (GST inclusive): $30.00
- Overseas price (+ Airmail): $27.25 (+$10.00)
RASML forms
- Proposal Form - Amendment of the Required advisory statements for medicine labels (pdf,85kb)
- Proposal Form - Amendment of the Required advisory statements for medicine labels(rtf,83kb)
RASML gazette notices
- Gazette notice - required advisory statements for medicine labels (RASML)
29 August 2008 - Gazette notice - required advisory statements for medicine labels (RASML)
14 April 2008 - Gazette notice - required advisory statements for medicine labels (RASML)
23 June 2004
RASML updates & proposed updates
- Required Advisory Statements for Medicine Labels - proposed update 5
16 July 2009 - RASML Update 4 record of decisions and reasons (pdf,132kb)
September 2008 - RASML Update 3.1 record of decisions and reasons (pdf,272kb)
April 2008 - Consolidated advisory statement requirements for medicine labels (consultation)
31 May 2006 - RASML Update 2 record of decisions and reasons (pdf,112kb)
April 2006 - RASML Update 1 record of decisions and reasons ([pdf,100kb)
May 2005
