Complementary medicines decisions

• Complementary medicines: Cancellations from the ARTG following compliance review
  Lists of complementary medicines cancelled from the Australian Register of Therapeutic Goods

Complementary medicine notices

2021 2020 2019

Older, revoked and superseded notices are available in the TGA Internet site archive.

2021

• Update to listed medicine ingredients in October 2021
  28 October 2021: A new Therapeutic Goods Determination for listed medicine ingredients commences on 25 October 2021.
• Update to listed medicine ingredients in August 2021
  20 August 2021: Listed medicine ingredients and requirements are updated in the Therapeutic Goods (Permissible Ingredients) Determination (No. 2) 2021.
• Sunscreen testing by AMA laboratories - Condition of Listing
  29 March 2021: Sunscreen SPF testing by AMA Laboratories - Regulatory update
• Update to listed medicine ingredients in March 2021
  1 March 2021: Listed medicine ingredients and requirements are updated in the Therapeutic Goods (Permissible Ingredients) Determination (No. 1) 2021.
• Update to listed medicine indications in January 2021
  21 January 2021: Listed medicine indications and requirements have been updated in the Therapeutic Goods (Permissible Indications) Determination (No. 1) 2021.

2020

• Update to listed medicine ingredients in December 2020
  16 December 2020: Listed medicine ingredients and requirements are updated in the Therapeutic Goods (Permissible Ingredients) Determination (No. 4) 2020
• Changes to the Permissible Ingredients Determination
  16 December 2020: The Therapeutic Goods (Permissible Ingredients) Determination has been updated
• Outcomes: Low-negligible risk changes to Permissible Ingredients - 2020-2021
  1 December 2020: Outcomes following review of consultation submissions
• Transition for permitted indications for listed medicines ends 5 March 2021
  13 November 2020: Reminder for sponsors of listed medicines
• Changes to the regulation of sports supplements in Australia
  24 September 2020: From 30 November 2020 certain sports supplements are regulated as therapeutic goods (medicines).
• Update to listed medicine ingredients in August 2020
  17 June 2020: Listed medicine ingredients and requirements are updated in the Therapeutic Goods (Permissible Ingredients) Determination (No. 3) 2020
• Update to listed medicine ingredients in June 2020
  10 June 2020: Listed medicine ingredients and requirements are updated in the Therapeutic Goods (Permissible Ingredients) Determination (No. 2) 2020
• Update to listed medicine ingredients in March 2020
  10 March 2020: Listed medicine ingredients and requirements are updated in the Therapeutic Goods (Permissible Ingredients) Determination (No. 1) 2020
• Outcomes: Low-negligible risk changes to Permissible Ingredients – 2019-2020
  20 February 2020: The outcomes related to boron and Withania somnifera have been updated

2019

• High-moderate risk changes to permissible ingredients - Andrographis paniculata
  2 December 2019: New warning statement for listed medicines containing Andrographis paniculata
• Changes to the label warning statement requirements for menthol & methyl salicylate
  2 December 2019: Updated requirements for listed medicines containing menthol & methyl salicylate
• Safety review of coumarin in topical listed medicines
  2 December 2019: The TGA has conducted a safety review on coumarin in topical listed medicines
• Therapeutic Goods (Listed Medicines - Compliance Reviews) Specification 2019
  27 November 2019: The Therapeutic Goods (Listed Medicines - Compliance Reviews) Specification 2019 commenced on the Federal Register of Legislation on 23 November 2019
• Therapeutic Goods (Permissible Indications) Determination (No.2) 2019
  19 November 2019: The Therapeutic Goods (Permissible Indications) Determination commenced on the Federal Register of Legislation on 14 November 2019
• Information for sponsors on how to apply for consent to supply goods that do not conform to subsection 9(2) of Therapeutic Goods Order No. 92
  31 October 2019: The TGA has published information for sponsors to apply for a Section 14 exemption regarding subsection 9(2) of TGO 92 which relates to the presentation of the medicine name on the medicine label
• Changes to propolis and royal jelly in listed medicine applications
  29 October 2019: The system now allows equivalents in extracts or preparations of propolis and royal jelly to be correctly entered in the ARTG
• High-moderate risk changes to permissible ingredients - Caffeine
  3 September 2019: New requirements for caffeine and caffeine-containing ingredients within listed medicines
• Marketing complementary medicines with soft gel capsules for children
  15 February 2019: This information is still current as at 15 February 2019