AU: Trans Tasman Harmonisation Clarification of Issues

Trans Tasman Harmonisation – Clarification of Issues
Provided by Robert Forbes & Associates Pty Ltd, Sydney, Australia

Trans Tasman Harmonisation has created much discussion and also at times confusion. In response to requests from clients we have tried to clarify a number of concerns that regularly arise on Trans Tasman Harmonisation – see full story for details. Please feel free to contact Robert Forbes if you wish to discuss any of these items in further detail.


  • Definition of Herbal Substance
    The TGA is now asking for supplier’s manufacturing methods when they are assessing a listing application containing a herbal ingredient with a high concentration ratio or high level of a standardised component. This is to determine if the ingredient is a “herbal substance” or an isolated, treated or modified “new substance”. (full story)
  • Homoeopathic Medicines - New Definition Required
    CMEC has recommended to TGA that the definition of homoeopathy included in Regulation 2 of Therapeutic Goods Regulations "be modified in order to more clearly encompass the principles of homoeopathy" CMEC recommended a definition of "homoeopathic proving" be included.
  • Tamper Evident Packaging Guidelines
    A new guideline for Tamper Evident Packaging of Medicines, Complementary Healthcare Products and Medical Devices – Edition One is now available. There is a phase in period of three years before requirements become mandatory.
  • Export Only Applications
    TGA has issued new applications and guidelines for export only applications and certificates of pharmaceutical product.
  • Internet advertising
    TGA has published WHO guidelines to finding reliable information about medicines on the internet:
  • Sunscreens - Cancer Claims Permitted
    TGA has given notice that claims for prevention of cancer are approved for use for Sunscreens in advertisements directed at consumers.

New Edition Uniform Recall Procedure for Therapeutic Goods (URPTG)
Key revisions include:

  • Changes in responsibility of sponsors reporting incidents in relation to extortion and product tampering
  • “Crisis Management” section
  • Revised responsibilities of State and Territory Recall Coordinators
  • Inclusion of blood products and human tissue – hence Australian Red Cross Blood Service and tissue banks must adhere to URPTG requirements

The 2001 edition of URPTG can be downloaded from TGA website at

Medical Devices – New System
The Medical Devices Amendment Bill is hoped to be in place during 2002. It uses European standards for devices that manufacturers can use to demonstrate safety, performance and quality. This gives more flexibility, however for lower risk devices it will force manufacturers to generate more support documentation. (full story)

GMP Audits - New Classifications
The GMP Audit and Licensing Section now classifies nonconformities observed during GMP audits of medicine manufacturers as "critical" and "significant other". This harmonises with the European approach to classifying nonconformities. (full story)

Sponsor Responsibilities – Records Held
This article is to remind sponsors that it is a condition of listing to keep all records relating to a listed medicine in order to:

  • expedite recall if necessary of any batch of the listed medicine
  • identify the manufacturer(s) of each batch of the listed medicine
  • Where any part of or step in manufacture in Australia of the listed medicine is sub-contracted to a third party – copies of relevant GMP agreements relating such manufacture shall be kept.
  • show records of the distribution of the listed medicine for a period of 5 years and shall provide records or copies of the records to the Director Chemicals and Non-prescription Medicines Branch TGA on request.
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