Consolidated Advisory Statement Requirements for Medicine Labels
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Consolidated Advisory Statement Requirements for Medicine Labels Draft for Consultation Consultation Document May 2006 Table of Contents INTRODUCTION........................................................................................................................... 1 BACKGROUND.........................................................................................................................................................1 SOURCES OF REQUIREMENTS INCLUDED IN Consolidated Advisory Statement Requirements for Medicine Labels .........................................................................................................................................................1 THE DOCUMENT.....................................................................................................................................................3 GLOSSARY AND INTERPRETATION...................................................................................... 5 SECTION 1 MEDICINES TO WHICH ADVISORY STATEMENTS APPLY................... 11 REQUIREMENTS...................................................................................................................................................11 Table 1.1 – MEDICINES TO WHICH ADVISORY STATEMENTS APPLY – by ingredient.............................13 Table 1.2 – MEDICINES TO WHICH ADVISORY STATEMENTS APPLY – by indication ...........................145 SECTION 2 ADVISORY STATEMENTS............................................................................. 175 ADVISORY STATEMENTS..................................................................................................................................175 SECTION 3 ADDITIONAL REQUIREMENTS ..................................................................... 189 ADDITIONAL REQUIREMENTS .......................................................................................................................189 This document is available electronically on the TGA’s web site at http://www.tga.gov.au/label/casrml-dr.htm. Consolidated Advisory Statement Requirements for Medicine Labels i INTRODUCTION BACKGROUND The intention of this document is to consolidate all the advisory statements requirements for medicines into one document. At this stage, it is not intended that this document replace the current edition of the Required Advisory Statements for Medicine Labels (RASML). This document will have no legal basis of its own, but will form the basis for: • Agreement between stakeholders and the Therapeutic Goods Administration (TGA) that all the requirements relating to advisory statements are captured; and • Transition to a new document to be introduced at the commencement of the Australia New Zealand Therapeutic Products Authority (ANZTPA) (ie the ANZTPA version of RASML) The RASML 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 1990 (the Regulations) to a new document, separate from but linked to Therapeutic Goods Order 69 – General requirements for labels for medicines (TGO 69). TGO 69 makes it mandatory for medicine labels to include any label advisory statements specified in RASML. This consolidated document includes many statements that are currently included in guidelines and other ancillary documents which may not necessarily have been applied to medicines existing prior to their introduction. If this document was given legal effect immediately as a new edition of the RASML, sponsors of these products would be required to amend their labels to comply with the new RASML and then amend again to comply with ANZTPA requirements. SOURCES OF REQUIREMENTS INCLUDED IN THIS DOCUMENT The advisory statements included in Consolidated Advisory Statement Requirements for Medicine Labels have been sourced from the following: • RASML, which encompasses: • Standard for the Uniform Scheduling of Drugs and Poisons (SUSDP) Appendix F (Warning Statements and Safety Directions); • 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 Regulations (statements that are applicable to listed goods which contain certain herbal substances); and • Schedule 2 Part 2 of the Regulations (required statements for vitamin and mineral preparations). • Australian Regulatory Guidelines for OTC Medicines (ARGOM) • Australian Regulatory Guidelines for Complementary Medicines (ARGCM) • Electronic Listing Facility (ELF) • SUSDP Appendix E (First Aid Instructions) It is noted that there are significant overlaps in the requirements stemming from each of these sources, and between these sources and TGO 69 (see below – Boundary Issues and Other Consolidated Advisory Statement Requirements for Medicine Labels 1 INTRODUCTION Exclusions). In many cases the requirements are similar but not exactly the same. The intention of this document is to gather all the existing requirements (as they currently apply) into one place, so that they can be reviewed, simplified and inconsistencies resolved during the process of transition to the ANZTPA version of RASML. The definitions included in the Glossary and Interpretation section are those currently in use in Australia. It should be noted that some of these definitions may need to be amended to align with other ANZTPA documents and terminology (eg listed medicines, child-resistant packaging). Inclusion criteria for statements sourced from the SUSDP. The SUSDP includes labelling requirements that apply to drugs and poisons – it does not apply solely to medicines for human use. However, where a medicine meets the criteria set out in the SUSDP the relevant label statements are required. Substances scheduled in the SUSDP may be: • Always included in medicines; • Included in medicines in some circumstances and not others; or • Never included in medicines. To ensure that the existing SUSDP requirements are reflected in this document, the following approach was taken: • Substances included in the SUSDP were checked for inclusion in medicines in the Australian Register of Therapeutic Goods (ARTG). Substances not included in any medicines in the ARTG have not been included in this document (or in RASML). • Where a substance is included in a schedule to the SUSDP and in a medicine in the ARTG, all the SUSDP requirements have been included in this document, regardless of considerations such as the likelihood of them being applicable in the medicines scenario. This is to ensure that the existing requirements would apply in future cases, even if such a scenario does not exist at present. Boundary Issues and Other Exclusions Note that the following sources of requirements for advisory statements on medicine labels have NOT been included in this consolidated list: • Best practice guideline on prescription medicine labeling • Therapeutic Goods Order 69 – General requirements for labels for medicines (TGO 69). The requirements of the Best practice guideline on prescription medicine labeling are not mandatory and therefore have been omitted. There are also boundary issues regarding which requirements properly belong in the RASML and which belong elsewhere (eg TGO 69). Where specific words are required by the source document (or words to the same effect), the statement has been included in this document and, it is anticipated, the statement would be included in the ANZTPA version of RASML (and not in the ANZTPA version of the source document). Where the source document provides that a statement must be included on the label, but the text has not been specified, generally they have not been included in this document, and it is anticipated that they will remain in the ANZTPA versions of the current documents. Consolidated Advisory Statement Requirements for Medicine Labels 2 INTRODUCTION It is noted that the ANZTPA’s Joint Expert Committee on Trans Tasman Labelling Requirements for Medicines has already conducted consultation in relation to the draft ANZTPA Managing Director’s Order – General Requirements for the Labelling of Medicines (the ANZTPA Labelling Order). The outcomes of this consultation process will be taken into account in the drafting of the ANZTPA version of RASML. It should be noted that it is anticipated that the requirements of First Schedule of TGO 69 will be removed from the ANZTPA Labelling Order and included in the ANZTPA version of RASML. The SUSDP applies a general lower limit 10 mg per litre or 10 mg per kilogram (ie 10 parts per million (ppm) - refer SUSDP clause 1(2)(i)). The other sources such as the Regulations and TGO 69 do not have a lower limit. Consideration will be given to the imposition of a general lower limit in the ANZTPA version of RASML. Comment is sought on: • Whether the SUSDP limit is generally appropriate. If not, proposals for what the general lower limit should be will be considered, provided they are supported by scientifically based justification. • Which substances (if any) should have a lower limit different from the general lower limit (this may be either higher or lower than the proposed general limit). Scientific justification for a different proposed lower limit should be provided. Note that signal headings and cautionary statements (required by Part 2 of the SUSDP) continue to be mandatory requirements for labels of medicines, but are governed by State and Territory legislation, not Commonwealth legislation,