EXPLANATORY STATEMENT
Therapeutic Goods Act 1989
Order under Subsection 3(1) - Amendment to the Definition of ‘British Pharmacopoeia’
OUTLINE
The delegate of the Minister for Health and Ageing has, by order, amended the definition of ‘British Pharmacopoeia’ contained in subsection 3(1) of the Therapeutic Goods Act 1989 (the Act).
On and from 1 July 2007, the definition of British Pharmacopoeia in the Act shall be the British Pharmacopoeia 2007.
BACKGROUND
The Therapeutic Goods Act 1989 (the Act) provides for the establishment and maintenance of a system of controls for the quality, safety, efficacy and timely availability of therapeutic goods that are used in Australia or exported from Australia. The Therapeutic Goods Administration (the TGA) is responsible for administering the Act.
Section 14 of the Act requires that therapeutic goods which are imported into Australia, supplied for use in Australia or exported from Australia, conform with a standard applicable to the goods. The Act defines ‘standard’ in relation to therapeutic goods, as meaning a standard that is either specified in an order made under section 10 of the Act, or if no such order is applicable to the goods but the goods are the subject of a monograph in the British Pharmacopoeia (in the case of goods for use in humans), then the standard is constituted by the statements in that monograph.
Whilst there are a number of therapeutic goods standards specified in orders made under section 10 of the Act, the British Pharmacopoeia (BP) is the principal (or default) standard applying to medicines and other therapeutic goods that are not medical devices.
Subsection 3(1) of the Act defines ‘British Pharmacopoeia’ as being:
‘the edition of the book of that name, including any additions or amendments, that was in effect for the purposes of the Therapeutic Goods Act 1966 immediately before the commencement of this section and, if additions or amendments of that book are made after that commencement, or new editions of that book are published after that commencement, includes those additions or amendments, or those new editions, from a day specified by the Minister by order published in the Gazette.’
This definition allows the Minister (or his delegate) to determine which edition of the BP will apply. New editions referred to in an order become effective on the day after the order is included on the Federal Register of Legislative Instruments, or such later date as the Minister specifies, which in this case will be 1 July 2007.
Since 1 July 2006, the 2005 edition of the British Pharmacopoeia (British Pharmacopoeia 2005) has had effect in Australia.
The British Pharmacopoeia is published annually, and the 2005 edition now has been superseded by the British Pharmacopoeia 2007.
Adoption under the Act of new editions of the BP is a routine procedure required to allow Australia to maintain consistency with international standards for the quality and safety of therapeutic goods.
Following wide stakeholder consultation, and a recommendation from the Therapeutic Goods Committee (the expert committee established under regulation 34 of the Therapeutic Goods Regulations 1990 to advise the Minister on matters relating to standards for therapeutic goods), the delegate of the Minister has specified in an order made under subsection 3(1) of the Act that, on and from 1 July 2007, the definition of British Pharmacopoeia in the Act shall be British Pharmacopoeia 2007.
CONSULTATION
Stakeholder consultation on this amendment to the definition of British Pharmacopoeia contained in the Act involved an open invitation for comment on the TGA’s website and targeted letters to the following industry associations:
- Advocate for the Consumer, Cosmetic, Hygiene and Specialty Products Industry;
- AusBiotech;
- Australian Dental Industry Association;
- Australian Self Medication Industry Inc.;
- Complementary Healthcare Council of Australia;
- Generic Medicines Industry Association Pty Ltd;
- Medical Industry Association of Australia; and
- Medicines Australia.
Responses received indicated support for amendment of the definition of British Pharmacopoeia 2007 contained in the Therapeutic Goods Act 1989.
REGULATION IMPACT
A preliminary assessment of compliance costs was undertaken in accordance with the revised requirements of the Office of Best Practice Regulation. This preliminary assessment led to the conclusion that the proposal would have a low impact on business, and would not restrict competition. As the impact would be minimal, the Business Cost Calculator has not been used to estimate full compliance costs, nor is a Regulation Impact Statement considered necessary.
Overview
The Therapeutic Goods Act 1989 was enacted by the Commonwealth Parliament to regulate the quality, safety, efficacy, and timely availability of therapeutic goods used in or exported from Australia. The Act establishes a framework administered by the Therapeutic Goods Administration (TGA), which ensures that therapeutic goods conform to specified standards. One of the key aspects of this regulatory framework involves the adoption of standards, such as the British Pharmacopoeia (BP), to maintain international consistency in the quality and safety of therapeutic goods. The Act allows the Minister for Health and Ageing, or their delegate, to determine which edition of the BP applies, ensuring that Australia's standards are aligned with international practices. In response to the publication of the British Pharmacopoeia 2007, an amendment was made to update the definition of 'British Pharmacopoeia' in subsection 3(1) of the Act, effective from 1 July 2007, following consultation with relevant stakeholders and a recommendation from the Therapeutic Goods Committee. This amendment aimed to ensure that Australia continues to adhere to the latest international standards for therapeutic goods.
Scope and Application
The Therapeutic Goods Act 1989, as amended by the order issued under subsection 3(1), applies to entities and individuals involved in the importation, supply, and export of therapeutic goods in Australia. This Act encompasses a broad range of therapeutic goods, including medicines, medical devices, and complementary medicines, ensuring that these products meet specific standards of quality, safety, and efficacy. The Act is administered by the Therapeutic Goods Administration (TGA) and is applicable across the Commonwealth of Australia, ensuring a consistent regulatory environment for the therapeutic goods industry. The amendment to the definition of 'British Pharmacopoeia' in the Act, effective from 1 July 2007, specifies that the British Pharmacopoeia 2007 is to be used as the standard for therapeutic goods that are imported, supplied, or exported from Australia. This amendment is designed to maintain consistency with international standards and follows consultation with various industry stakeholders, who supported the change. There are no exclusions or exemptions specified in this particular amendment, and the order extends the application of the new definition through subordinate legislation.
Key Provisions
The main operative sections of the Therapeutic Goods Act 1989 (the Act) in this context include subsection 3(1), which previously defined the 'British Pharmacopoeia' as the edition in effect before the Act came into force, including any subsequent amendments or new editions specified by the Minister. The amendment by the Minister's delegate changes this definition so that from 1 July 2007, the British Pharmacopoeia shall mean the British Pharmacopoeia 2007. This amendment ensures that Australia aligns with the latest international standards for the quality and safety of therapeutic goods. This change facilitates the continuation of consistent application of standards for therapeutic goods used or supplied in Australia or exported from Australia, ensuring they conform to the latest recognised standards (sections 3 and 14).
Under the Act, entities and individuals involved in the importation, supply, or export of therapeutic goods must ensure compliance with the standards set forth in the British Pharmacopoeia 2007. This requirement is integral to maintaining the quality, safety, and efficacy of therapeutic goods. The Therapeutic Goods Administration (TGA) plays a crucial role in overseeing and enforcing these standards, ensuring that all therapeutic goods meet the necessary criteria before they enter the Australian market or are exported. This obligation extends to pharmaceutical companies, importers, and other stakeholders who must stay updated with the changes in the BP to ensure their products meet the required standards.
Failure to comply with the standards specified in the British Pharmacopoeia 2007 could lead to serious consequences. The Act imposes penalties for non-compliance, which may include fines and other civil or criminal sanctions. The exact penalties are not specified in the provided text, but they can be severe, reflecting the importance of adhering to the standards for public health and safety. Non-compliance may also result in the seizure or recall of non-compliant goods, further emphasising the necessity for entities to adhere strictly to the updated standards.
The Act's requirement to update the definition of the British Pharmacopoeia ensures that Australia remains consistent with international standards, thus protecting public health and safety. By regularly updating the standards, the Act helps maintain the integrity of the therapeutic goods market in Australia. This amendment reflects the ongoing commitment to high standards of quality and safety in the therapeutic goods industry.