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Compliance with ministerial and default standards

21 February 2011

The information below is intended for industry organisations applying to add a medicine to the Australian Register of Therapeutic Goods (ARTG).

All medicines, and therapeutic goods in general, must comply with certain standards before they can appear in the ARTG.

In most cases these are 'default standards', which are publicly available authoritative standards provided by the British Pharmacopoeia, European Pharmacopoeia, and United States Pharmacopeia – National Formulary. In some cases a minister may, by legislative instrument, specify an alternative 'ministerial standard', whether or not a default one exists.

There has been some confusion about the application of default standards and, in particular, whether compliance with a default standard is sufficient in itself to assure the quality of a product for the purposes of registration or listing in the ARTG, as specified under Part 3-2 of the Therapeutic Goods Act 1989 ('the Act').

The information below is intended to clarify how ministerial and default standards are applied to medicines.

Application of ministerial and default standards to medicines

Chapter 3 of the Act relates to regulatory and other requirements applying to medicines and other therapeutic goods that are not medical devices (referred to below as 'medicines'). The chapter is divided into three parts:

  • Part 3-1 Standards
  • Part 3-2 Registration and listing of therapeutic goods
  • Part 3-3 Manufacturing of therapeutic goods

A medicine must comply with Part 3-1 unless consent to the importation, supply, or export of the medicine that does not comply with applicable standards has been given by the Secretary under sections 14 and 14A of the Act.

A medicine must comply with Part 3-2 unless:

  • the medicine is exempt under section 18 or 18A of the Act;
  • the medicine is the subject of an approval or authority to import, export or supply goods for individual patient use or clinical trials under section 19 of the Act; or
  • the medicine is the subject of an approval to import or supply substitutes for goods that are unavailable or in short supply, where approval is necessary in the interests of public health, under section 19A of the Act.

A medicine must comply with Part 3-3 unless the medicine or person manufacturing the medicine is exempt under section 34 of the Act.

Exemption from compliance with specified requirements under any one of these Parts of Chapter 3 does not automatically grant exemption from compliance under the other Parts. For example, a medicine that is exempt from specified requirements under Part 3-2 and/or Part 3-3 must still comply with any applicable default standards or standards determined by the Minister under section 10 of the Act (Part 3-1), unless the Secretary has given appropriate consent under sections 14 and 14A.

Demonstration of quality, safety and efficacy

Section 25 of the Act requires the Secretary to evaluate goods for registration having regard to, among other things:

  • whether the quality, safety and efficacy of the goods for the purposes for which they are to be used have been satisfactorily established (paragraph 25(1)(d)); and
  • whether the goods conform to any standard applicable to the goods (paragraph 25(1)(f)).

Under section 25, demonstration of quality, safety and efficacy of goods is expressed as a different requirement from conformity with any standards imposed under Part 3-1. Thus, compliance with standards imposed under Part 3-1 is not necessarily sufficient to demonstrate quality, safety and efficacy for the purposes of registering or listing a medicine under Part 3-2.

'Quality', in relation to a medicine, refers to the composition, strength, potency, stability, sterility, purity, bioburden, design, construction and performance characteristics of the medicine.

'Standard' refers to a standard constituted by:

  • an order under section 10 of the Act ('Ministerial standard')
  • statements in monographs in the British, European or United States Pharmacopeia ('default standards').