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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 This information is over 5 years old, revoked or superseded.
- Transition for permitted indications for listed medicines ends 5 March 2021
13 November 2020: On 6 March 2018, the TGA implemented a list of permitted indications for medicines listed under section 26A of the Therapeutic Goods Act 1989.
- Update on proposed clarification that certain sports supplements are therapeutic goods
17 March 2020: Following the public consultation held in October-December 2019, an update to the proposed clarification that certain sports supplements are therapeutic goods has been published.
- Changes to permissible indications for listed medicines
12 September 2019: Outlines changes that were made to the Therapeutic Goods (Permissible Indications) Determination No. 1 of 2018 in February 2019
- List of evaluated registered complementary medicines
11 September 2018: List of registered complementary medicines on the ARTG that have been evaluated by the TGA for safety, quality and efficacy
- Submissions received and TGA response: Reforms to the regulatory framework for complementary medicines
11 July 2017: Consultation outcomes published
- Review and appeal rights for ingredient applicants
3 July 2017: On 1 July 2017 the Therapeutic Goods Act 1989 was amended to provide for review and appeal rights in relation to the assessment of new ingredients for use in listed complementary medicines.
- Catalogue of permitted ingredients for use in listed medicine
4 April 2017: The TGA has published a searchable online catalogue of ingredients approved for use in listed medicines
- Permissible Ingredients Determination: Forecast of updates
4 April 2017: Anticipated timeframe for updates to the Permissible Ingredients Determination in 2017
- 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
- 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)
- 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.
- 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)
- 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
- 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
- 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
- Serenoa serrulata (renaming)
16 January 2007: The TGA Herbal Ingredient Names Committee considered the naming of Serenoa serrulata at its 28th meeting.
- Hydroxycitrate complex (update)
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
- 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
- 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')