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 (April 2008) (pdf,309kb)

Contents of the RASML

Introduction
Glossary and interpretation
How to use this document
How required statements are to be included on the labels
Section 1 Medicines to which advisory statements apply
Section 2 Advisory statements
Section 3 Additional requirements
Appendices
- Appendix 1 Updating the required advisory statements for medicine labels - Procedural matters
- Questions and answers
- Appendix 2 Archived entries

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.

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