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Complementary medicines regulatory decisions and notices (archived)
The information in this section includes regulatory decisions and notices about the regulation of complementary medicines. This information is over 5 years old, revoked or superseded.
2016 2015 2014 2013 2012 2011 2010 2007 2005 2004 2001
2016
- Permissible Ingredients Determination: Frequently asked questions
6 January 2016 : On 1 January 2016, a new legislative instrument under section 26BB of the Therapeutic Goods Act 1989, the Therapeutic Goods (Permissible Ingredients) Determination was introduced
2015
- Marketing complementary medicines with soft gel capsules for children
29 June 2015 : Soft gel capsules may pose a choking hazard for children, especially those aged under five years - New ingredient names available for metal amino acid chelates
6 March 2015 : Specific Australian Approved Names (AANs) for metal amino acid chelates have been made available for use in the Electronic Listing Facility (ELF)
2014
- Complementary medicines reforms
25 June 2014: Therapeutic Goods Administration (TGA) has undertaken a series of reforms to complementary medicines to improve community confidence in the safety and quality of these medicines.
2013
- Compositional guideline: Deer velvet antler powder - amendment
28 March 2013: The acceptance criterion for 'Ash' has been amended to 15.0 - 47.6% (dried basis)
2012
- Indications for Listed medicines that refer to biomarkers
29 June 2012: Listed medicines are restricted to indications and claims relating to health maintenance, health enhancement or non-serious, self-limiting conditions
- Deactivation of superseded herbal ingredient names
7 June 2012 : On 30 May 2012 the TGA completed changes to the ARTG entries of medicines affected by the update to herbal ingredient names and deactivation of superseded herbal ingredient names
- Information about weight loss product 'Undoit'
23 May 2012: The sponsor has cancelled the product's listing on the Australian Register of Therapeutic Goods and the TGA's review of the product is closed
2011
- Cancellation of Sensaslim Solution from the ARTG
24 November 2011 : The TGA has cancelled the product's listing on the Australian Register of Therapeutic Goods
2010
- New process for lodgement of applications for new registered complementary medicines
3 December 2010: The registered over-the-counter medicines online application system accepts applications for new registered complementary medicines
2007
- Serenoa serrulata (renaming)
16 January 2007: The TGA Herbal Ingredient Names Committee considered the naming of Serenoa serrulata at its 28th meeting.
2005
- Hydroxycitrate complex (update)
31 May 2005 : The compositional guideline for hydroxycitric acid and hydroxycitrates derived from Garcinia quaesita has been revised by the TGA.
- Codex
10 May 2005: The proposed Codex Guidelines on Vitamin and Mineral Supplements will NOT apply in Australia and will have NO IMPACT on the way these types of products are regulated in Australia
2004
- Folic acid preparations dissolution requirements
29 March 2004: In 2001, the TGA was advised of reports from the United States that some folic acid-containing tablets failed to release folic acid when analysed by conventional dissolution tests.
- Colloidal silver & related products
26 March 2004: Colloidal products which make therapeutic claims are classified as therapeutic goods
2001
- SAMe ((S)-S-adenosylmethionine)
17 July 2001: Subregulation 9(2) gazette notice relating to the substances (S)-S-adenosylmethionine and ademetionine (also known as 'SAMe')
29 June 2012: Listed medicines are restricted to indications and claims relating to health maintenance, health enhancement or non-serious, self-limiting conditions
7 June 2012 : On 30 May 2012 the TGA completed changes to the ARTG entries of medicines affected by the update to herbal ingredient names and deactivation of superseded herbal ingredient names
23 May 2012: The sponsor has cancelled the product's listing on the Australian Register of Therapeutic Goods and the TGA's review of the product is closed
24 November 2011 : The TGA has cancelled the product's listing on the Australian Register of Therapeutic Goods
3 December 2010: The registered over-the-counter medicines online application system accepts applications for new registered complementary medicines
16 January 2007: The TGA Herbal Ingredient Names Committee considered the naming of Serenoa serrulata at its 28th meeting.
31 May 2005 : The compositional guideline for hydroxycitric acid and hydroxycitrates derived from Garcinia quaesita has been revised by the TGA.
10 May 2005: The proposed Codex Guidelines on Vitamin and Mineral Supplements will NOT apply in Australia and will have NO IMPACT on the way these types of products are regulated in Australia
29 March 2004: In 2001, the TGA was advised of reports from the United States that some folic acid-containing tablets failed to release folic acid when analysed by conventional dissolution tests.
26 March 2004: Colloidal products which make therapeutic claims are classified as therapeutic goods
17 July 2001: Subregulation 9(2) gazette notice relating to the substances (S)-S-adenosylmethionine and ademetionine (also known as 'SAMe')