Document ID: chunk:federal_register_of_legislation:F2025L00049:clause:10_2:p1
Version: federal_register_of_legislation:F2025L00049
Segment Type: clause
Provision Reference: sch 10 cl 2 (pt 1/9)
Character Range: 7086–10295

2  Additional warning statements for certain human medicines
Appendix M—Additional controls or supply requirements for poisons included in Schedule 3 to allow them to be provided by a pharmacist
Index

Reader's guide

Introduction
This instrument is made under paragraph 52D(2)(b) of the Therapeutic Goods Act 1989 (the Act), and is a compilation of decisions made under section 52D of the Act. This instrument should be read in conjunction with the Scheduling Policy Framework (the SPF) of the Australian Health Ministers' Advisory Council. Further information on the scheduling amendments and the SPF can be viewed on the Therapeutic Goods Administration's website (www.tga.gov.au). Refer to section 6 for definitions of specific terms used in this document including "medicine" and "poison" (noting that the definition of poison includes medicine).
This instrument serves 2 key purposes.
Firstly, this instrument contains the decisions of the Secretary of the Department of Health and Aged Care or the Secretary's delegates regarding the classification of poisons into Schedules, as recommendations to Australian States and Territories. The scheduling classification sets the level of control on the availability of poisons. The scheduling of poisons is implemented through relevant State and Territory legislation. Certain advertising, labelling and packaging requirements may also be a consequence of scheduling, but are the subject of other Commonwealth registration schemes.
Secondly, this instrument includes provisions for labelling, containers, storage, disposal, record‑keeping, supply and possession of poisons in general which are intended to be adopted for use in each jurisdiction of Australia. Other government agencies may also impose controls on certain products.
The requirements for labelling and containers in this instrument are intended to integrate with existing legislative instruments for labelling and containers. Advertising, labelling and packaging of therapeutic goods and agricultural and veterinary chemicals are also dealt with through the respective product registration schemes provided for in Commonwealth legislation.
Poisons which are packed and sold solely for industrial, manufacturing, laboratory or dispensary use are exempt from all labelling requirements included in this instrument as they are covered by labelling requirements under applicable jurisdictional Work Health and Safety laws, as amended from time to time. Note, however that this exemption does not extend to controls on supply of these poisons.
This instrument is presented with a view to promoting uniform:
       * scheduling of poisons throughout Australia; and
       * signal headings on labels for poisons throughout Australia; and
       * labelling and packaging requirements for poisons throughout Australia; and
       * additional controls on the availability and use of poisons in Australia.
The various Commonwealth Acts, legislative instruments and other documents, which integrate with this instrument include the following:
       * the Act;
       * the Agricultural and Veterinary Chemicals Code Act 1994;
       * the Agricultural and Veterinary Chemicals Code Regulations 1995;