Required Advisory Statements for Medicine Labels document Edition 1 Including update 1 Historical June 2005 Table of Contents INTRODUCTION....................................................................................................................1 BACKGROUND ...................................................................................................................1 SOURCE DOCUMENTS ......................................................................................................1 Application to Medicines ...................................................................................................2 Date of Effect .....................................................................................................................2 THE DOCUMENT ................................................................................................................2 GLOSSARY AND INTERPRETATION ..............................................................................5 HOW TO USE THIS DOCUMENT ....................................................................................13 Flow Chart 1 ................................................................................................................15 HOW REQUIRED STATEMENTS ARE TO BE INCLUDED ON THE LABELS ......17 What Needs to be Included on the Label .........................................................................17 When the Statement Needs to be Included on the Label ..................................................17 Additional Requirements..................................................................................................17 Multiple Statements..........................................................................................................18 Combination of Statements ..............................................................................................18 SECTION 1 MEDICINES TO WHICH ADVISORY STATEMENTS APPLY...........19 REQUIREMENTS...............................................................................................................19 Date from Which Requirements Apply.............................................................................19 MEDICINES TO WHICH ADVISORY STATEMENTS APPLY......................................20 SECTION 2 ADVISORY STATEMENTS........................................................................45 ADVISORY STATEMENTS ..............................................................................................45 SECTION 3 ADDITIONAL REQUIREMENTS................................................................53 ADDITIONAL REQUIREMENTS.....................................................................................53 APPENDICES............................................................................................................................ APPENDIX 1 UPDATING THE REQUIRED ADVISORY STATEMENTS FOR MEDICINE LABELS - PROCEDURAL MATTERS........................................................................................................57 Overview ..........................................................................................................................57 Updating the Required Advisory Statements for Medicine Labels ..................................57 Existing Substances .....................................................................................................57 New Substances ...........................................................................................................59 Flow Chart 2 ................................................................................................................60 QUESTIONS AND ANSWERS ...................................................................................................61 HistoricalPROPOSAL FORM - AMENDMENT OF THE REQUIRED document ADVISORY STATEMENTS FOR MEDICINE LABELS ……………………………………………………………………63 APPENDIX 2 ARCHIVED ENTRIES......................................................................................73 Appendix 2.1 - Archived Entries - Section 1 Medicines to Which Advisory Statements Apply ................................................................................................................................73 Appendix 2.2 - Archived Entries - Section 2 Advisory Statements ..................................76 Appendix 2.3 - Archived Entries - Section 3 Additional Requirements ...........................77 Required Advisory Statements for Medicine Labels (June 2005) i Historical document INTRODUCTION BACKGROUND 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) 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). 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. SOURCE DOCUMENTS The advisory statements included in Required Advisory Statements for Medicine Labels have been sourced from the following documents: • SUSDP Appendix F; • SUSDP schedules where a reverse scheduling situation applies (this means that a substance is placed in an SUSDP schedule except when it is labelled with a relevant statement); • Schedule 4 of the Therapeutic Goods Regulations (statements that are applicable to listed goods which contain certain herbal substances); and • Schedule 2 Part 2 of the Therapeutic Goods Regulations (required statements for vitamin and mineral preparations). Where these source documents required statements that were more than one sentence long (eg. SUSDP Appendix F warnings 34 and 35), the warnings have been separated into single sentences in this document. At the commencement of operation of this document (1 July 2004), the requirements imposed by this document are identical to those previously required by the source documents. Other label advisory statements currently included in guidelines (e.g. the Australian Regulatory Guidelines for OTC Medicines) and in the Electronic Lodgement Facility (ELF) will be reviewed at a later stage, in consultation with stakeholders, to determine whether they are suitable for transfer into Required Advisory Statements for Medicine Labels. Signal headings and cautionary statements (required by Part 2 of the SUSDP) continue to be Historicalmandatory requirements for labels of medicines. Sponsorsdocument should refer to the most recent edition of the SUSDP for further information. Required Advisory Statements for Medicine Labels (June 2005) Page 1 of 77 INTRODUCTION APPLICATION OF ADVISORY STATEMENTS Application to Medicines Advisory statements apply to all medicines for supply in Australia (i.e. registered prescription, non-prescription and complementary medicines, listed and exempt medicines) by virtue of the operation of the Labelling Order. Unless otherwise specified in Column 2 of the table in Section 1, the requirements apply only if the substance is included in the medicine as an active ingredient. Date of Effect The requirements of the Required Advisory Statements for Medicine Labels come into effect on 1 July 2004. This coincides with the date of full implementation of the Therapeutic Goods Order 69 – General requirements for labels for medicines (TGO 69). Unless otherwise specified, the initial transition period for existing products as at 1 July 2004 will run until 30 June 2005, that is, 12 months from the date of effect of the RASML (rather than from Gazettal). Appendix F of the SUSDP will continue to apply until May 2005 to ensure there are no legislative gaps during the transition period. In all other cases, unless otherwise specified in this document, the requirements apply: • in relation to applications for new products, from the date of Gazettal shown in Column 4; and • in relation to existing products, from a date 12 months from the date of Gazettal shown in Column 4 of the table (the Implementation Date). THE DOCUMENT The Required Advisory Statements for Medicine Labels is divided into sections. These are: Introduction Preliminary and background information. Glossary and interpretation Explanation of acronyms and other terms. How to use this document This section provides detailed instructions on how the document works. How statements are required to be included on the labels This section explains in detail how required statements should be included on medicine Historicallabels. document Section 1 – Medicines to which advisory statements apply This section specifies the advisory statements that are required on the labels of particular medicines. Details on how to use this section are provided in the section ‘How to use this document’. Required Advisory Statements for Medicine Labels (June 2005) Page 2 of 77 INTRODUCTION Section 2 –Advisory statements This section gives the wording of the advisory statements to be included on the labels of medicines. Details are provided in the section ‘How statements are required to be included on the labels’. Section 3 –Additional requirements This section gives details of additional requirements (such as font, letter height, capitalisation, position of statement etc) which are required in certain cases. Further details are