Therapeutic Goods Regulations 1990

Overview

The Therapeutic Goods Regulations 1990 were enacted to provide detailed rules for the regulation of therapeutic goods in Australia, including medicines, medical devices, and complementary medicines, under the Therapeutic Goods Act 1989. These regulations were made by the Therapeutic Goods Administration (TGA), an agency of the Australian Government Department of Health. The primary objective of these regulations is to ensure that therapeutic goods available in Australia are safe, of acceptable quality, and perform as claimed. This is achieved by setting out the requirements for the registration, evaluation, advertising, and importation of therapeutic goods, among other things. The regulations aim to protect public health and safety by enforcing strict controls over the therapeutic goods market.

Scope and Application

The Therapeutic Goods Regulations 1990 are subsidiary legislation made under the Therapeutic Goods Act 1989 and govern the regulation of therapeutic goods in Australia. These regulations apply to therapeutic goods, including medicines, medical devices, and biologicals, and to the entities and individuals involved in the manufacture, importation, supply, advertising, and testing of these goods. They cover a wide range of activities and transactions related to therapeutic goods, from the registration and listing of goods in the Australian Register of Therapeutic Goods to the advertising and promotion of these goods. The regulations are applicable at the national level, extending across the Commonwealth of Australia, and they also reference specific state laws as corresponding legislation. Certain therapeutic goods and uses are exempt from various provisions of the regulations, such as those pertaining to registration, listing, and importation controls. The scope of the regulations is further refined through various schedules and amendments, which provide detailed classifications, definitions, and exceptions. Subordinate instruments, such as amendments and specific schedules, extend or modify the application of the primary regulations, offering flexibility and specificity in the regulatory framework.

Key Provisions

• The Therapeutic Goods Regulations 1990 outline several key provisions that govern the therapeutic goods industry in Australia. Firstly, the Regulations establish the Australian Register of Therapeutic Goods (ARTG), which includes registered and listed therapeutic goods (regulations 10 and 10A). This register is crucial for tracking and managing the therapeutic goods that are available in the Australian market. Secondly, the Regulations set out the requirements for advertising therapeutic goods, including prohibited and required representations (regulations 6B, 6AA, and 6AB). This is to ensure that advertisements do not mislead consumers about the safety, efficacy, or quality of therapeutic goods. Thirdly, the Regulations provide for the designation of orphan drugs, which are medicines intended to treat rare diseases (regulations 16H and 16J). This aims to encourage the development of treatments for rare conditions. Fourthly, the Regulations outline the procedures for obtaining scientific advice on the quality, safety, or efficacy of therapeutic goods (regulations 16M and 16P). This enables manufacturers and sponsors to make informed decisions about the development and marketing of their products. Lastly, the Regulations establish the Therapeutic Goods Administration (TGA), which is responsible for regulating therapeutic goods in Australia (regulation 2). This centralised body ensures that therapeutic goods meet the necessary safety, quality, and efficacy standards.
• The Regulations impose various obligations on the parties or entities they govern. For instance, sponsors of therapeutic goods must ensure that the goods are included in the ARTG before they can be supplied (regulations 10 and 10A). Additionally, sponsors must provide information to the TGA about the goods, including their ingredients, manufacturing processes, and clinical trial data (regulations 16AA and 16AB). The Regulations also require sponsors to comply with specific labelling and packaging requirements, such as including a consumer medicine information (CMI) document with the goods (regulations 9A and 9B). Furthermore, the Regulations mandate that certain therapeutic goods, such as medicines and medical devices, undergo evaluation by the TGA before they can be included in the ARTG (regulations 16C, 16D, and 16G). Lastly, the Regulations require sponsors to notify the TGA of any changes to the goods or their manufacturing processes (regulations 16GA and 16GB).
• Breach of the Therapeutic Goods Regulations 1990 can result in significant consequences. For example, supplying therapeutic goods without including them in the ARTG can lead to a civil penalty of up to 10 penalty units (regulation 9A). Similarly, failing to provide a CMI document with the goods can result in a civil penalty of up to 10 penalty units (regulation 9B). The Regulations also establish criminal offences for certain activities, such as importing or exporting prohibited therapeutic goods (regulations 10JA and 10KA). These offences can result in fines of up to $22,000 for individuals and $110,000 for corporations (section 427 of the Therapeutic Goods Act 1989). Furthermore, the Regulations provide for the revocation of therapeutic goods inclusion in the ARTG (regulation 10AA), which can effectively remove the goods from the market. Lastly, the Regulations establish the authority for the TGA to take enforcement action against parties who breach the Regulations, such as issuing infringement notices or initiating legal proceedings (section 128 of the Therapeutic Goods Act 1989).

Legal classification tags

Area of Law

Medical Law

Regulatory Law

Consumer Law

Instrument

Regulation

Concepts

Definitions & Interpretation

Licensing & Registration

Advertising Requirements

Compliance Obligations

Exemptions

Enforcement Powers