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The legal basis for using approved terminology

TGA approved terminology for therapeutic goods

11 November 2019

A number of legislative provisions underpin the use of approved terminology to ensure accuracy and consistency of information about goods on the Australian Register of Therapeutic Goods (ARTG).

Therapeutic Goods Act 1989:

  • specifies the use of Australian Approved Names for ingredients:
    • Section 10 allows the Minister for Health to make an order (by legislative instrument) for matters to constitute a standard. Under this section, the Minister created a Therapeutic Goods Order outlining requirements for labels for medicines, which refers to the Australian Approved Names list.
    • Paragraph 23(2)(ba) requires applications for registration of restricted medicines (i.e. prescription medicines and some over-the-counter medicines) to be accompanied by a product information document which must use Australian approved names for all ingredients.

Therapeutic Goods Regulations 1990:

  • Regulation 2 defines the Australian Approved Names list which refers to this document
  • Schedules 12 and 13 require that the Consumer Medicines Information document be consistent with the Product Information (i.e. uses approved names).

The list of Australian Approved Names is published in the Code Tables and Ingredient Tables on the TGA Business Services website.

Reference to approved terminology is included in a number of Therapeutic Goods Orders, such as the medicine labelling Orders, which require Australian approved names to be used on medicine labels.