EXPLANATORY STATEMENT
Subject: THERAPEUTIC GOODS ORDER NO. 89 Standard for water for injections for parenteral medicines
Section 10, Therapeutic Goods Act 1989
OUTLINE
Therapeutic Goods Order No. 89 Standard for water for injections for parenteral medicines (TGO 89) is an Order made by the delegate of the Minister for Health and Ageing under section 10 of the Therapeutic Goods Act 1989 (the Act).
TGO 89 determines that the matters specified in the instrument constitute the standard for water for injections used in parenteral medicines.
TGO 89 commenced on the day after the day it was registered on the Federal Register of Legislative Instruments.
BACKGROUND
The Act provides for the establishment and maintenance of a national system of controls relating to the quality, safety, efficacy and timely availability of therapeutic goods for use in humans. The Therapeutic Goods Administration (TGA) is responsible for administering the Act.
Section 10 of the Act authorises the Minister, or the Minister's delegate, to determine standards for therapeutic goods, or to amend or revoke existing standards, after consultation with the Therapeutic Goods Committee (TGC), a committee established by the Therapeutic Goods Regulations 1990 (the Regulations) to advise the Minister on matters relating to standards.
Unless consent is granted by the Secretary under section 14 or 14A of the Act, therapeutic goods imported into Australia, supplied in Australia or exported from Australia must comply with any applicable standard.
TGO 89 is a new standard made under section 10 of the Act, and applies to water for injections that is presented as a therapeutic good (e.g. a 10 mL vial alone or as a good in a composite pack) or that is an ingredient or used in the manufacture of another therapeutic good (e.g. the water in an ampoule of sterile saline).
TGO 89 specifies that water for injections complies with the British Pharmacopoeia or the European Pharmacopoeia. There is no difference between the requirements of the British and European Pharmacopoeias.
CONSULTATION
A draft TGO was made available by the TGA for public consultation in September 2009. It was published on the TGA Internet site and key stakeholders were informed. There were three responses.
At its 36th meeting in August 2010, the TGC advised the Minister and the TGA that the draft TGO should be finalised and take effect from the date of its entry onto the Federal Register of Legislative Instruments.
The registered version of TGO 89 is not materially different to the consultation draft.
REGULATION IMPACT STATEMENT
The Office of Best Practice Regulation has agreed that no Regulation Impact Statement is necessary for TGO 89 (OBPR reference number 11770).
REFERENCED DOCUMENTS
Information on the documents referred to in TGO 89 or this Explanatory Statement follows.
- The current definition of the British Pharmacopoeia under subsection 3(1) of the Act is the British Pharmacopoeia 2011, as amended by online updates. The British Pharmacopoeia 2011 is a collection of approximately 3375 monographs for pharmaceutical substances and medicinal products for human use. The monograph for water for injections specifies requirements for the method of manufacture by distillation, microbiological monitoring, aluminium, bacterial endotoxins, particulate contamination and sterility, amongst other things. Associated test methods are also included in the British Pharmacopoeia. The British Pharmacopoeia is published by The Stationery Office, on behalf of the Medicines and Healthcare products Regulatory Agency of the UK. It is available for purchase in hard copy or soft copy (compact disc or online edition). The British Pharmacopoeia reproduces all monographs and requirements of the European Pharmacopoeia.
- The current definition of the European Pharmacopoeia under subsection 3(1) of the Act is the European Pharmacopoeia 7th edition, including supplements 7.1 and 7.2. It includes more than 2000 specific and general monographs. The monograph for water for injections specifies requirements for the method of manufacture by distillation, microbiological monitoring, aluminium, bacterial endotoxins, particulate contamination and sterility, amongst other things. Associated test methods are also included in the European Pharmacopoeia. The European Pharmacopoeia is published by the Directorate for the Quality of Medicines & HealthCare of the Council of Europe. It is available for purchase in three formats - print, online and USB stick.
- The meeting outcomes of the TGC’s 36th meeting referred to in this Explanatory Statement may be viewed and downloaded from the TGA Internet site.