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.