Therapeutic Goods Act 1989 - Order under subsection 3(1) – Definition of British Pharmacopoeia (09/04/2008)

Administered by Department of Health, Disability and Ageing

Legislation au F2008L01091 Not in force Legislative Instrument

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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 2008, the definition of British Pharmacopoeia in the Act shall be the British Pharmacopoeia 2008.

 

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.

 

Sections 14 and 14A of the Act require 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, unless the Secretary or her delegate consent to the importation, supply or exportation of those goods that do not conform with the applicable standard. 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 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 authorises the Minister (or her delegate) to determine which edition of the British Pharmacopoeia 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 2008.

 

Since 1 July 2007, the 2007 edition of the British Pharmacopoeia (British Pharmacopoeia 2007) has had effect in Australia.

 

The British Pharmacopoeia is published annually, and the 2007 edition now has been superseded by the British Pharmacopoeia 2008.

 

Adoption under the Act of new editions of the British Pharmacopoeia is a routine procedure required to allow Australia to maintain consistency with international standards for the quality and safety of therapeutic goods. The use of an international standard benefits industry in their import and export activities. Adoption of the new edition of the British Pharmacopoeia will also benefit patients and consumers, as the new edition provides authoritative standards for a greater number of substances and medicines, and incremental improvements in defining the quality of other medicines.  

 

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 2008, the definition of British Pharmacopoeia in the Act shall be British Pharmacopoeia 2008.

 

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 Red Cross Blood Service ;
  • 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 general support for amendment of the definition of British Pharmacopoeia 2008 contained in the Therapeutic Goods Act 1989.

 

Stakeholders who encounter difficulties complying with the requirements of a specific monograph can apply to the TGA for consent for the non-compliance to the applicable standard. This application for consent will be considered on a case-by-case basis.

INFORMATION ABOUT THE BRITISH PHARMACOPOEIA

 

The British Pharmacopoeia 2008 is a collection of approximately 2900 monographs for pharmaceutical substances and medicinal products for human use. The monographs specify requirements for identification, solubility, uniformity, assay (strength), sterility, impurities, and other parameters. There are monographs for active ingredients, excipients (inert substances that are necessary to manufacture the product), formulated preparations (eg, tablets, injections, ointments), traditional herbal medicinal products, homoeopathic medicines, blood products, vaccines and radiopharmaceuticals. The associated test methods and infrared reference spectra are also included in the British Pharmacopoeia.

The British Pharmacopoeia is generally considered to be an essential reference for anyone concerned with the quality of medicines, including the pharmaceutical and chemical industries, quality control personnel, analysts and academics.

The British Pharmacopoeia 2008 is published by The Stationery Office on behalf of the Medicines and Healthcare products Regulatory Agency of the UK. It is available as a hard copy edition, CD-ROM and online.  

REGULATION IMPACT

 

A preliminary assessment of compliance costs was undertaken in accordance with the 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 (the Act) was enacted by the Parliament of Australia to establish a regulatory framework for ensuring the quality, safety, efficacy, and timely availability of therapeutic goods in Australia, with the Therapeutic Goods Administration (TGA) tasked with administering the Act. To address the need for consistent international standards in the quality and safety of therapeutic goods, the Act includes a provision that allows for the adoption of new editions of the British Pharmacopoeia, a key international standard for pharmaceutical substances and medicinal products. On 1 July 2008, pursuant to an amendment under subsection 3(1) of the Act, the definition of 'British Pharmacopoeia' was updated to reflect the British Pharmacopoeia 2008 edition, thereby aligning Australian standards with the latest international benchmarks. This amendment was made following consultations with relevant industry stakeholders and recommendations from the Therapeutic Goods Committee, aiming to enhance the quality and safety of therapeutic goods available to Australian consumers.

Scope and Application

The Therapeutic Goods Act 1989, as amended by the order under subsection 3(1), pertains to the regulation of therapeutic goods within Australia, ensuring their quality, safety, efficacy, and timely availability. This Act applies to the import, supply, and export of therapeutic goods in Australia, with the Therapeutic Goods Administration (TGA) being the regulatory authority. The amendment to the definition of 'British Pharmacopoeia' affects the standards applicable to these goods, with the adoption of the British Pharmacopoeia 2008 as the default standard for medicines and other therapeutic goods not classified as medical devices. This change is designed to maintain consistency with international standards and facilitate trade by aligning Australian practices with those of other countries. The Act applies to all persons and entities involved in the production, import, supply, or export of therapeutic goods in Australia. The amendment, effective from 1 July 2008, ensures that the British Pharmacopoeia 2008, which includes approximately 2900 monographs for various pharmaceutical substances and medicinal products, will be the governing standard. The amendment was reached following consultations with various industry associations and stakeholders, who generally supported the update. The Act does not exclude any specific entities or goods from this requirement but allows for applications for consent to non-compliance on a case-by-case basis.

Key Provisions

The primary change introduced by this amendment to the Therapeutic Goods Act 1989 (the Act) involves updating the definition of the 'British Pharmacopoeia' under subsection 3(1) (section 3(1)). Effective from 1 July 2008, the definition of British Pharmacopoeia now refers to the British Pharmacopoeia 2008. This revision ensures that Australia aligns with the most recent edition of this international standard, which is essential for maintaining the quality, safety, and efficacy of therapeutic goods used or exported from Australia. This change is a routine procedural update aimed at keeping Australian standards consistent with international benchmarks. Under the Act, entities involved in the importation, supply, or export of therapeutic goods must ensure these goods conform to applicable standards. This requirement is particularly pertinent under sections 14 and 14A of the Act, which stipulate that therapeutic goods must meet a standard unless otherwise consented by the Secretary or their delegate. The British Pharmacopoeia serves as a principal or default standard for medicines and other therapeutic goods, except for medical devices, where applicable. By adopting the British Pharmacopoeia 2008, the Act ensures that Australia continues to leverage authoritative standards for the quality and safety of therapeutic goods, benefiting both industry and consumers. Failure to comply with the standards set forth in the Act can result in various legal consequences. Section 15 of the Act outlines offences related to the non-compliance of therapeutic goods standards, including the potential for criminal charges. Penalties for breaches can be substantial, with fines and imprisonment for individuals found guilty of serious offences. Additionally, section 18AB of the Act provides for civil penalties, including financial penalties for entities that fail to comply with the standards. The maximum penalties can vary depending on the severity and intent behind the breach but underscore the importance of adherence to the Act's provisions. The amendment to the definition of the British Pharmacopoeia in the Act reflects a commitment to maintaining high standards for therapeutic goods in Australia. By adopting the British Pharmacopoeia 2008, the Act ensures that Australia remains aligned with international quality and safety standards, thereby protecting public health and supporting industry compliance. The routine nature of this update highlights the ongoing efforts to integrate international best practices into Australian regulatory frameworks, ensuring that therapeutic goods meet rigorous quality and safety standards.

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