Commonwealth Numbered Regulations - Explanatory Statements

[Index] [Search] [Download] [Related Items] [Help]


THERAPEUTIC GOODS REGULATIONS (AMENDMENT) 1996 NO. 208

EXPLANATORY STATEMENT

STATUTORY RULES 1996 No. 208

Issued by Authority of the Minister for Health and Family Services

Therapeutic Goods Act 1989

Therapeutic Goods Regulations (Amendment)

The Therapeutic Goods Act 1989 ("the Act") has for ifs objective the establishment and maintenance of a national system of controls relating to the quality, safety, efficacy and timely availability of therapeutic goods that ate used in Australia or exported from Australia.

Section 63 of the Act enables the Governor-General, to make regulations prescribing. among other things, matters required or permitted to be prescribed by 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 mostly prescription drugs, are subjected to greater scrutiny and evaluation to establish 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 many over-the-counter products,

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. The product "Propolis" is currently classified as "hatable" if it is for dermal use, otherwise it is required to be registered. 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 did antiseptic in creams or tinctures.

The purpose of the amendment is to make Propolis a hatable product, whether or not it is for dermal use. The amendment gives effect to the recommendation of the Traditional Medicines Evaluation Committee, which reviewed data on the goods and established that the information on its safety profile was sufficient to have it included on the Register as a hatable substance, subject to the inclusion on the label for the product of a warning statement relating to possible allergic reactions.

The Regulation commences on the date of Gazettal.


[Index] [Related Items] [Search] [Download] [Help]