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Regulation Impact Statement: Regulation of herbal and homoeopathic medicines


23 May 2006

This consultation closed on 15 August 2006

This Regulation Impact Statement (RIS) was prepared to address the changes that are proposed in the draft Medicines Rule, to the way in which herbal and homoeopathic medicines are currently regulated in Australia.

The draft Medicines Rule was published for consultation on 23 May 2006 on the ANZTPA Internet site.

Stakeholders were invited to provide written comment on this Consultation (Draft) Regulation Impact Statement.

In particular, stakeholders were asked to comment on the costs and benefits of the proposed and alternative options including:

  • effects on small business and restrictions on competition;
  • the effect that the proposed regulation would have on the supply of affected products;
  • the time and cost imposts on industry;
  • the effects of any perceived increase in the complexity of regulatory requirements; and
  • a quantification of compliance costs (particularly from Homoeopathic manufacturers and importers in relation to GMP).

How to access a pdf document

Consultation (Draft) Regulation Impact Statement - An impact statement on the proposed amendments to the current regulatory system for herbal and homoeopathic medicines in Australia (pdf,204kb)


  • Acronyms/Abbreviations
  • Introduction
  • Background
  • Problem
  • Objective
  • Consultation
  • Overall assessment of costs
  • Implementation
  • Regulation of homoeopathic medicines
  • Regulation of herbal medicines
  • References