Therapeutic Goods Regulations (Amendment) 1995 No. 320
EXPLANATORY STATEMENT
STATUTORY RULES 1995 No. 320
Issued by Authority of the Minister for Family Services
Therapeutic Goods Act 1989
Therapeutic Goods Regulations (Amendment)
The Therapeutic Goods Act 1989 (the Act) has for its objective the establishment and maintenance of a national system of controls relating to the quality, safety, efficacy and timely availability of therapeutic goods that are used in Australia or exported from Australia.
Section 63 of the Act enables the Governor-General to make regulations prescribing matters necessary or convenient to be prescribed for carrying out or giving effect to the Act.
Section 17 of the Act requires the Secretary to maintain a register, known as the Australian Register of Therapeutic Goods (the Register). The Register is to contain two parts, one for including goods known as "registrable goods" (identified in Schedule 3 of the Therapeutic Goods Regulations) and the other for "listable" goods, identified in Schedule 4 of the Therapeutic Goods Regulations.
"Registrable" drug products, comprising new or prescription drugs and most common overthe-counter pharmaceuticals, are fully evaluated for quality, safety and efficacy before being approved for supply. "Listable" drug products are those that require less intensive scrutiny, such as vitamin and mineral supplements, sunscreen preparations and herbal remedies which contain well-known, nontoxic, ingredients and are intended to treat only simple, medical conditions.
Paragraph 17(4)(a) of the Act enables regulations to be made prescribing what therapeutic goods, or classes of therapeutic goods, are required to be included in each part of the Register.
Accordingly, the amendment enables preparations containing Propolis for dermal use to be listed in the Register.
The need for this amendment has arisen as a result of recommendations made by the Traditional Medicines Evaluation Committee. Following a review of data relating to the quality, safety and efficacy of propolis, the Committee has recommended that when propolis is included as an ingredient in therapeutic goods for dermal use, then such goods may be listed in the Register. All other therapeutic products containing propolis as an active ingredient will continue to be registrable goods.
Propolis is a complex resinous material from various tree species which is collected and processed by bees for use in their hives. It has a well recorded history of use, mainly in Europe, as a traditional remedy for a wide number of ailments. Propolis most commonly appears in dermal preparations as a mild antiseptic in creams or tinctures.
The Regulations commenced on Gazettal.
Overview
The Therapeutic Goods Regulations (Amendment) 1995 No. 320 were enacted to amend the Therapeutic Goods Act 1989, addressing the need for a national system of controls for the quality, safety, efficacy and timely availability of therapeutic goods used in or exported from Australia. This amendment was issued by authority of the Minister for Family Services and was aimed at updating the Australian Register of Therapeutic Goods to include certain preparations containing Propolis for dermal use. These amendments were made in response to recommendations by the Traditional Medicines Evaluation Committee, which reviewed data on the quality, safety and efficacy of propolis, concluding that such products could be listed in the Register when used for dermal applications. The primary objective of these regulations is to provide a clear and effective framework for the inclusion of specific therapeutic goods in the Australian Register of Therapeutic Goods, ensuring public safety and access to beneficial products.
Scope and Application
The Therapeutic Goods Act 1989 applies to all therapeutic goods used or exported from Australia, aiming to ensure their quality, safety, efficacy, and timely availability. This Act mandates the maintenance of the Australian Register of Therapeutic Goods, which lists "registrable goods" that require full evaluation and "listable goods" that require less intensive scrutiny. The scope of the Act extends to individuals, entities, and industries involved in the manufacture, supply, and advertising of therapeutic goods. The Act's jurisdiction covers the entire nation, making it a Commonwealth legislation. The Act's application may be extended or restricted through subordinate instruments, such as the Therapeutic Goods Regulations (Amendment) 1995 No. 320, which specify which therapeutic goods are required to be included in the Register. Notably, this amendment allows preparations containing Propolis for dermal use to be listed in the Register, following recommendations by the Traditional Medicines Evaluation Committee.
Key Provisions
The Therapeutic Goods Regulations (Amendment) 1995 No. 320 introduces specific changes to the Therapeutic Goods Regulations concerning the inclusion of certain therapeutic goods in the Australian Register of Therapeutic Goods (the Register). Section 17(4)(a) of the Therapeutic Goods Act 1989 empowers the Minister to prescribe which therapeutic goods or classes of therapeutic goods must be included in the Register. In this instance, the amendment allows preparations containing Propolis for dermal use to be listed in the Register. This aligns with the recommendation of the Traditional Medicines Evaluation Committee which has reviewed the data regarding the quality, safety and efficacy of Propolis.
The Therapeutic Goods Regulations (Amendment) 1995 No. 320 imposes obligations on the entities and parties it governs by determining the types of therapeutic goods that must be included in the Australian Register of Therapeutic Goods. For instance, products containing Propolis for dermal use, which have been deemed safe and effective by the Traditional Medicines Evaluation Committee, must now be listed in the Register. This amendment ensures that the Register is updated to include the latest therapeutic goods that meet the necessary quality, safety and efficacy standards.
The Therapeutic Goods Act 1989 outlines the consequences of non-compliance with its provisions. Section 34 of the Act provides that any person who contravenes a regulation made under the Act is liable to a penalty. Specifically, the Act provides for both civil and criminal penalties for non-compliance, including fines and imprisonment. For example, if a person supplies a therapeutic good that does not comply with the requirements of the Act or the Regulations, they may be subject to civil penalties such as fines. In more serious cases, criminal penalties such as imprisonment may be imposed. The specific maximum penalties are determined by the nature and severity of the offence, and are outlined in the Therapeutic Goods Act 1989 and the Therapeutic Goods Regulations.