TGA TIMELINES
This pages combines key TGA compliance changes into a timeline for your general reference.
Please not that full and in-force TGA legislative documents must be relied upon to ensure compliance obligations are met when making product decisions. Please see below for how to use the legistration and relevant links. If you are aware of information that should be included below please email technical@cmaustralia.org.au.
How to use the legistation:
Federal Register of Legislation Current Documents:
2024
Ingredients / Issue
Resources
1 January
Pharmacovigilance responsibilities and obligations
Reporting requirements for safety issues – Outcomes
24 February
Foods – Plain English allergen labelling (PEAL)
Transition period ends – New requirements for allergen labelling on packaged foods
28 February
Valerian – warning
End of transition period to include a new warning for valerian ingredients.
Outcomes: low-negligible risk changes to permissible ingredients 2022-23
28 February
Chelidonium; Chaparral – warning
End of transition period to include amended warning for Chelidonium; Chaparral.
Outcomes: low-negligible risk changes to permissible ingredients 2022-23
12 August
Electrolyte drinks (FSANZ)
FSANZ has approved an amended final draft variation to electrolyte drinks containing a number of changes to 30content and claims
From 1 May 2026
IHIN Dual Name Labelling – Mecobalamin
From 1 May 2026, all medicines containing mecobalamin (comethylcobalamin) released for supply must reflect the single name ‘mecobalamin’.
2023
Ingredients / Issue
Resources
28 February
Vitamin B6 – maximum dose and warnings
End of transition period for existing products that contain pyridoxine to change from 200mg to 100 mg MRDD; and for the inclusion of warning statements on labels for products containing > 10 mg pyridoxine per MRDD.
Outcomes: Low-negligible risk changes to Permissible Ingredients – 2021-2022
28 February
Artemisinin containing ingredients – pregnancy warning statement
End of transition period to include a pregnancy warning for certain existing artemisinin containing ingredients
Outcomes: Low-negligible risk changes to Permissible Ingredients – 2021-2022
30 November
Sports Supplements
Tablets, Capsules and pills for oral administration which are (expressly or implicitly) represented for the improvement or maintenance of physical or mental performance in sport, exercise or recreational activity are Therapeutic Goods.
Changes to the regulation of sports supplements in Australia
2022
Ingredients / Issue
Resources
1 March
Transition period ends for changes to inorganic magnesium salts and Andrographis paniculata
New warning statement for Andrographis “(ANDROT) Andrographis may cause taste disturbance including loss of taste. If you develop any adverse symptoms, stop use and seek medical advice (or words to that effect).· New warning statement for inorganic magnesium salts
Outcomes: Low-negligible risk changes to Permissible Ingredients – 2020-2021 ·
30 June
Transition period ends for compliance with 2018 advertising Code.
The end of the transition period for transition from complying with the 2018 Code to the 2021 Code is 30 June 2022.
TGA website: Transitioning to the new Advertising Code – mandatory statements update
2021
Ingredients / Issue
Resources
1 March
Inorganic magnesium salts and Andrographis paniculata
12-month transition period begins for existing medicines
New medicines must comply with the new requirements from this date.
New warning statement for Andrographis “(ANDROT) Andrographis may cause taste disturbance including loss of taste. If you develop any adverse symptoms, stop use and seek medical advice (or words to that effect).
New warning statement for inorganic magnesium salts.
Outcomes: Low-negligible risk changes to Permissible Ingredients – 2020-2021
2 March
CAFFEINE Final transition date for requirements including:
– Concentration limits
– Dosage limits
– Direction for use limits
– New warning statements
CAFFEINEFinal transition date for requirements including:concentration limitsdosage limitsdirection for use limitsnew warning statements
5 March
PERMISSIBLE INDICATIONS TRANSITION ENDS
FINAL date to change ARTG entries to permitted indications to avoid CANCELLATION by the TGA.
End of the phase in period to amend ARTG records to permissible indications. Any products that do not have updated records by this date may be cancelled from the ARTG. Changes to indications only are free until this date.
Permissible Indications Determination and Amendments
30 June
TGO 101 – Final date for compliance: ELEMENTAL IMPURITIES RESIDUAL SOLVENTS PILLS
Section 16 sets out new requirements for elemental impurities and residual solvents. Pills were not included in the former version of the order, TGO 78. The final transition date has been extended from 31 March 2021 to 30 June 2021 due to a number of disruptions associated with the COVID-19 pandemic.
https://www.tga.gov.au/publication/guidance-tgo-101
Therapeutic Goods Order for Tablets, Capsules and Pills
30 June
Introduction of PIC/S Guide to GMP Version 14
Version 14 of the PIC/S Guide to GMP is intended to be introduced from 1 July 2020 as the Manufacturing Standards for therapeutic goods manufacture. The new version will be subject to a 12 month transition period to at least 30 June 2021. The first 6 months (July-Dec 2020) will permit time for manufacturers to assess and initiate changes.
The current version “PE 009-13” (Version 13) will be replaced by “PE 009-14” (Version 14)
https://www.tga.gov.au/update-manufacturing-principles-medicines-apis-sunscreens
2020
Ingredients / Issue
Resources
1 January
MENTHOL as an ingredient or componentFinal transition date for requirements including:
– Concentration limits
– New warning statements
1 January
POLIGLUSAM Final transition date for requirements including:
– Dosage limits
– Average molecular mass
1 January
METHYL SALICYLATE as an ingredient or component Final transition date for requirements including:
– Concentration limits
– New warning statements
1 January
CYSTEINE Final transition date for requirements including:
– dosage limits (450mg maximum RDD)
1 January
PORIA COCOS Final transition date for name change:
WOLFPORIA COCO
30 April
INGREDIENT NAME HARMONISATION Final transition date for affected ingredients.
In 2017 the TGA commenced a program to harmonise medicine ingredient names. All medicines released for supply after 30 April 2020 must carry the updated ingredient names.
https://www.tga.gov.au/updating-medicine-ingredient-names
https://www.tga.gov.au/updating-medicine-ingredient-names-list-affected-ingredients
2 May
ANDROGRAPHIS PANICULATA Final transition date – all medicines supplied after this date must have the new warning statement.
(ANDROG) ‘Andrographis may cause allergic reactions in some people. If you have a severe reaction (such as anaphylaxis) stop use and seek immediate medical attention’ (or words to that effect)
1 September
TGO 92
Final transition date· ALL labels released for supply must comply with TGO 92.
The four year period to transition labels from TGO 69 to TGO 92 ends. Product labels that are TGO 69 compliant cannot be released for supply after this date. Until 1 September medicines can comply with either order. Sponsors who have experienced disruptions in transitioning due to COVID-19 may be eligible to apply for a S14 consent for TGO 92 until 6 March 2021. Details about what information is needed to apply for consent is yet to be provided by the TGA.
https://www.tga.gov.au/medicine-labels-guidance-tgo-91-and-tgo-92
1 September
Advertising Code Schedule – Additional Allergen Warnings required in Advertisements (Health Warnings)
Part 4 of Schedule 1 contains additional allergens which apply as “health warnings” from 1 September 2020.
These warnings are CONTAINS: SOYA – EGG – NUT – SESAME
Please see Therapeutic Goods Advertising Code and Amendments
2019
Ingredients / Issue
Resources
1 January
ADVERTISING CODE (No 2 of 2018) IN EFFECT. New requirements for advertisers.
Therapeutic Goods Advertising Code and Amendments
1 March
New Advertising Complaints Handling Process
New Advertising “Complaints Handling” process implemented managed by TGA after removal of the Complaints Resolution Panel. Sanctions and penalties may now apply to more serious breaches or repeat offenders.
https://www.tga.gov.au/reforms-therapeutic-goods-advertising-framework
2 September
CAFFEINE as an ingredient or component. New requirements, including:
Some requirements are effective immediately.
Transition dates to March 2021 are available for some requirements on existing medicines.
https://www.tga.gov.au/high-moderate-risk-changes-permissible-ingredients-caffeine
Permissible Ingredients Determination and Amendments
12 December
CAFFEINE – Restrictions placed on retail foods and food imports
Restrictions on concentrated caffeine commenced on 12 December 2019. The retail sales of foods, or imported foods, cannot contain more than:
– 5% caffeine in solid or semi-solid foods,
– or 1% caffeine if in a liquid.
Pure caffeine raw material, used for manufacture, is excluded from this mandate.
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