Commonwealth Numbered Regulations - Explanatory Statements

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THERAPEUTIC GOODS REGULATIONS (AMENDMENT) 1995 NO. 320

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.