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.
Overview
The Therapeutic Goods Act 1989, enacted by the Australian Parliament, was introduced to establish a national system of controls aimed at ensuring the quality, safety, efficacy, and timely availability of therapeutic goods used in or exported from Australia. The Act establishes the Australian Register of Therapeutic Goods, which includes two categories of goods: registrable goods, which undergo more rigorous evaluation, and listable goods, which are subjected to less intensive scrutiny. The Therapeutic Goods Regulations (Amendment) 1996 No. 208, issued by the Minister for Health and Family Services, seeks to amend the classification of Propolis, a resinous material collected by bees, from a registrable to a listable product, irrespective of its intended use, based on the findings of the Traditional Medicines Evaluation Committee that its safety profile is sufficiently established. This amendment aligns with the policy objective of facilitating access to traditional remedies while maintaining safety standards.
Scope and Application
The Therapeutic Goods Regulations (Amendment) 1996 No. 208 applies to the Therapeutic Goods Act 1989, which is a Commonwealth Act that establishes a national system for regulating therapeutic goods used or exported from Australia. This includes products such as medicines, medical devices, blood, and tissues. The Act applies to entities and individuals involved in the manufacture, import, supply, and advertising of these goods. The amendment in question specifically pertains to the classification and regulation of Propolis, a resinous material produced by bees, altering its classification from registrable to listable irrespective of its application, whether dermal or otherwise. This change is in response to a recommendation by the Traditional Medicines Evaluation Committee, which found sufficient safety data to warrant the inclusion of Propolis on the Australian Register of Therapeutic Goods as a listable substance, with the caveat of a warning label regarding potential allergic reactions. The amendment reflects a broader effort to balance traditional medicine practices with contemporary safety standards. The regulation commences on the date of its gazette, extending its reach across the nation as part of the federal legislative framework.
Key Provisions
The Therapeutic Goods Regulations (Amendment) 1996 No. 208 amends the Therapeutic Goods Regulations by adding a new entry for Propolis in Schedule 4, thus classifying it as a listable good. This change applies regardless of whether Propolis is intended for dermal use. This amendment aligns with the findings of the Traditional Medicines Evaluation Committee, which determined that Propolis has an acceptable safety profile for inclusion on the Australian Register of Therapeutic Goods as a listable substance. The inclusion of this amendment ensures that the regulatory requirements for Propolis are appropriately tailored to its traditional uses and the evidence available regarding its safety.
Under the Therapeutic Goods Regulations, any party seeking to supply Propolis in Australia must now ensure that it is listed on the Australian Register of Therapeutic Goods. This listing requirement entails the submission of relevant data and information to demonstrate compliance with the standards set for listable goods. The amendment also mandates that any labelling for Propolis products must contain a warning statement about potential allergic reactions. These obligations are crucial for maintaining the safety and quality standards expected by consumers and healthcare providers.
Failure to comply with the requirements of the Therapeutic Goods Act and the amended Therapeutic Goods Regulations can lead to significant consequences. If a party is found to be supplying Propolis without proper listing on the Register or without the required warning label, they may face enforcement actions. Such actions can include fines, product recalls, or even legal proceedings. The penalties for non-compliance are intended to ensure that therapeutic goods in the Australian market meet the necessary safety and quality standards, thereby protecting public health.
In terms of specific penalties, the Therapeutic Goods Act provides that any person who contravenes a provision of the Act or the Regulations can be subject to fines. For example, under section 28A of the Act, an individual can be fined up to $11,100 for a single offence, while a body corporate can face fines up to $55,500 for the same offence. These penalties reflect the seriousness of ensuring that therapeutic goods are safe for public use and that regulatory requirements are strictly adhered to. The enforcement of these penalties serves as a deterrent against non-compliance and promotes adherence to the regulatory standards set forth by the Act.