Therapeutic Goods Regulations (Amendment) 1995 No. 111
EXPLANATORY STATEMENT
STATUTORY RULES 1995 No. 111
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. The application of the Act is limited by the Federal Constitution so that it cannot extend to regulate, for example, individuals who manufacture and supply therapeutic goods within that State or Territory. To achieve uniformity of regulation in respect of the manufacture and supply of therapeutic goods throughout Australia, complementary State and Territory legislation to complement the Act will be required.
Through the Australian Health Ministers' Advisory Council, State and Territory governments have agreed with the Commonweath that they will introduce "complementary legislation" to cover individuals and activities that cannot be covered by the Act under a truly national scheme of legislative controls. The State of Victoria enacted its complementary legislation in December 1994, and the Therapeutic Goods (Victoria) Act 1994 is expected to commence to operate on. 23 May 1995. Under the arrangements agreed to between the Commonwealth and the States and Territories, the Commonwealth is to be delegated the complementary powers and functions under State/Territory legislation. Before this can occur, such State enactments must first be declared to be a "corresponding State law" under the Therapeutic Goods Regulations for the purposes of section 6A of the Act.
Section 63 of the Act enables the Governor General to make regulations prescribing, among other things. matters necessary or convenient to be prescribed for carrying out or giving effect to the Act. Subsection 3(1) of the Act provides, that regulations may be made to declare a State law that corresponds with the Act to be a "corresponding State law" for the purposes of enabling State functions and powers under such laws to be delegated to the Secretary in accordance with section 6A of the Act
Accordingly, the amending Regulations will declare the Therapeutic Goods (Victoria) Act 1994 to be a "corresponding State law".
In addition, the amending Regulations will:
(a) repeal Regulation 3. This regulation currently provides that for the ,purposes of subsection 6(3) of the Therapeutic Goods Act 1989, the State and Territory laws identified under this Regulation may continue to operate in conjunction with the Commonwealth's therapeutic goods legislation. However subsection 6(3) was repealed by the Health and Community Services Legislation Amendment Act (No. 2) 1993. Consequently, R.3 no longer has any effect and should therefore be removed; and
(b) amend the definition of "Poisons Standard" in Regulation 3. Currently this definition identifies the National Health and Medical Research Council to be the publisher of the Poisons Standard. This no longer is correct. The correct publisher of that document is the Australian Health Ministers' Advisory Council. An amendment to the definition of "Poisons Standard" is therefore necessary.
The Regulations. commence on 1 June 1995.
Overview
The Therapeutic Goods Regulations (Amendment) 1995 No. 111 was enacted to amend the Therapeutic Goods Regulations under the Therapeutic Goods Act 1989, with the objective of achieving uniformity in the regulation of therapeutic goods across Australia. The Act itself aims to establish and maintain a national system of controls over the quality, safety, efficacy, and timely availability of therapeutic goods used in or exported from Australia. However, the scope of the Act is limited by the Federal Constitution, necessitating complementary State and Territory legislation for a comprehensive regulatory framework. This amendment serves to declare the Therapeutic Goods (Victoria) Act 1994 as a "corresponding State law" and to repeal and amend certain regulations to reflect changes in the legislative and administrative landscape, ensuring that the regulatory scheme remains effective and up-to-date.
Scope and Application
The Therapeutic Goods Regulations (Amendment) 1995 No. 111 amends the Therapeutic Goods Regulations 1990 to declare the Therapeutic Goods (Victoria) Act 1994 as a corresponding State law for the purposes of the Therapeutic Goods Act 1989. This amendment is in line with the national scheme of legislative controls for therapeutic goods, which requires complementary state and territory legislation to cover activities not regulated by the Commonwealth. The Act applies to the quality, safety, efficacy, and timely availability of therapeutic goods used or exported from Australia. The application of the Act is limited by the Federal Constitution, and therefore, complementary state and territory legislation is required to cover individuals and activities not regulated by the Act. The amending Regulations also repeal Regulation 3, which is no longer effective, and amend the definition of "Poisons Standard" to reflect the correct publisher of that document. The Regulations commence on 1 June 1995.
Key Provisions
The Therapeutic Goods Regulations (Amendment) 1995 No. 111 primarily focus on updating and clarifying the existing regulatory framework for therapeutic goods in Australia under the Therapeutic Goods Act 1989 (the Act). The main sections of these Regulations include amendments to the definition of "Poisons Standard" (Regulation 3) and the repeal of Regulation 3 (Regulation 3). These changes aim to ensure that the regulatory framework aligns with current legislative requirements and accurately reflects the responsibilities of the relevant authorities.
Under these Regulations, the primary obligation imposed on parties or entities governed by the Act is the requirement to adhere to the updated and clarified definitions and repeals outlined in the Regulations. Specifically, entities must ensure that they are aware of and comply with the correct publisher of the Poisons Standard, which is now the Australian Health Ministers' Advisory Council, as opposed to the previously identified National Health and Medical Research Council. Additionally, the repeal of Regulation 3 ensures that the regulatory framework does not continue to operate under outdated provisions, thereby maintaining a coherent and effective system of controls for therapeutic goods.
The Regulations do not explicitly outline specific offences, penalties, or civil/criminal consequences for breaches. However, any non-compliance with the Therapeutic Goods Act 1989 and its regulations could potentially lead to enforcement actions by the relevant authorities. Such actions might include administrative penalties, fines, or other corrective measures as deemed appropriate under the Act. The specific penalties would be determined based on the nature and severity of the breach, in accordance with the provisions of the Act.