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Intention to amend the definition of ‘British Pharmacopoeia’ under the Therapeutic Goods Act 1989

Consultation

13 February 2009

This document was released in January 2009 for comment and comments closed on 13 February 2009. It remains on this website as a historical reference.

This notice advises of the intention of the delegate of the Minister for Health and Ageing to make an order for the purposes of the definition of 'British Pharmacopoeia' under subsection 3(1) of the Therapeutic Goods Act 1989 (the Act) to specify British Pharmacopoeia 2009 (BP 2009) as the edition in force, with effect 1 June 2009.

Intended amendment

The British Pharmacopoeia currently is defined in the Act as follows:

British Pharmacopoeia means 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.

Since 1 July 2008, British Pharmacopoeia 2008 (BP 2008) has been the edition of the British Pharmacopoeia in effect under the Act.

The order under subsection 3(1) of the Act will specify that, with effect 1 June 2009, BP 2009 will supersede BP 2008 as the edition in effect.

Reason for the intended amendment

Currently, the British Pharmacopoeia is the principal (or default) standard applying under the Act to medicines and other therapeutic goods that are not medical devices. The edition in force is specified by the delegate of the Minister for Health and Ageing in an order made under subsection 3(1) of the Act.

Arrangements for default standards including the British Pharmacopoeia will change after passage by Parliament of the Therapeutic Goods Amendment (Medical Devices and Other Measures) Bill 2008 (the Bill), at which time the European Pharmacopoeia and the United States Pharmacopeia-National Formulary will become additional default standards.

Although the amendments to the Act relating to default pharmacopoeias will provide for the automatic adoption of new editions of the three pharmacopoeias in the future, the amended definition of 'British Pharmacopoeia' will not recognise BP 2009, which has already been published, as the edition in force under the Act unless it comes into force prior to the commencement of the amending legislation.

The consequence of this would be that BP 2008 would remain in force as a default standard until the effective date for British Pharmacopoeia 2010, as determined by the British Pharmacopoeia Commission (likely to be 1 January 2010).

Timing of the intended amendment

The anticipated commencement date for the changes to the Therapeutic Goods Act 1989 relating to default standards is 1 July 2009. Therefore an order made under subsection 3(1) of the Act to specify BP 2009 as the edition in force must take effect prior to that date. An effective date of 1 June 2009 is proposed.

Supporting recommendation

At its meeting held in October 2008, the Therapeutic Goods Committee noted the publication of BP 2009, and recommended that processes for its adoption in Australia commence. The TGC considered that this action was necessary as a precaution to guard against a superseded edition of the British Pharmacopoeia remaining the default standard for an extended time.

Stakeholder comment

In past years stakeholder consultation has been undertaken on each order proposed to be made under subsection 3(1) of the Act to update the edition of the British Pharmacopoeia in effect in Australia. The purpose of this was to elicit information on any specific difficulties that the new or revised technical requirements of the new edition may pose for sponsors.

Broadening of the meaning default standard under the Act (including the automatic adoption of new editions), which was a key component of the regulatory reforms for therapeutic goods previously consulted on with stakeholders, makes such consultation unnecessary in the future.

In the case of the order now intended to be made under subsection 3(1) of the Act to specify BP 2009 as the edition in force prior to commencement of the amending legislation, stakeholders may have comment on the proposed effective date of 1 June 2009.