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Adoption of British Pharmacopoeia 2007 (BP 2007)

Consultation

2 March 2007

This document was released in January 2007 for comment and comments closed on 2 March 2007. It remains on this website as a historical reference.

Background

The British Pharmacopoeia is the principal (or default) standard applying under the Therapeutic Goods Act 1989 (the Act) to medicines and other therapeutic goods that are not medical devices.

The British Pharmacopoeia 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 2006, British Pharmacopoeia 2005 (BP 2005) has had effect in Australia.

Proposal

The British Pharmacopoeia is published annually. In recent years, new editions of the BP have been adopted in Australia on a date as close as practical to the date on which the publication becomes effective in the United Kingdom. This helps to maintain consistency with international standards for the quality and safety of therapeutic goods and allows for the timely update of technical matters such as analytical methods.

The British Pharmacopoeia 2007* (BP 2007) was published in August 2006 and became effective in the United Kingdom on 1 January 2007.

The TGA proposes that BP 2007 also be adopted in Australia, and therefore comment from stakeholders is being sought on the adoption of the BP 2007 as the edition of that standard defined under the Act.

*There is no issue of the British Pharmacopoeia 2006. The title 'British Pharmacopoeia 2007' has been adopted by the BP Commission for the next edition of the BP as more accurately reflecting its effective period.

Comment sought

As usual, the TGA sought comment on any particular difficulties for sponsors that may be associated with the adoption of BP 2007.

The TGA also sought information to allow preliminary assessment of the regulatory impact of this proposal. Specifically information was sought on business compliance costs and impacts on business and individuals, including restrictions on competition, which would be associated with adoption of BP 2007.

Technical information

As well as monographs of British origin, BP 2007 contains all monographs of the 5th edition of the European Pharmacopoeia (Ph. Eur) as amended by Supplements 5.1 - 5.5 inclusive. In contrast, BP 2005 references all monographs of the 5th edition of the Ph. Eur as amended by Supplements 5.1 to 5.2 only.

The Introduction to BP 2007 lists additions, omissions and technical changes to monographs included in this new edition. Amendments to monographs of the Ph. Eur, although not separately identified in the Introduction to the BP 2007, are described in Pharmeuropa, the journal published quarterly by the European Pharmacopoeia Commission. Information on the revised or corrected texts published in Supplements to the 5th edition of the European Pharmacopoeia can be obtained through the Pharmeuropa website.

Two future supplements to the Ph. Eur (Supplements 5.6 and 5.7) are already available and amendments to monographs resulting from these Supplements will also flow through to BP 2007 in due course.