Log in

TGA COMPLIANCE DATES

This table combines key TGA compliance changes into one timeline to help remind members of upcoming key dates. The below information is provided for general guidance but is not the definitive sources of requirements. Members must always check the full TGA legislative documents, to ensure regulatory compliance obligations are met.


How to use the legislation: 

  • Before making a decision about a product, it is important to check the most up-to-date versions of legislative documents on the Federal Register of Legislation (FRL).
  • Sources that have copied across the requirements to another document, such as the below list or the the TGA eBS ingredient repository should not be relied on for decision-making purposes.
  • Read the wording of the legislation carefully, particularly for permissible ingredient and indication requirements.
  • Links for searches to direct you to the "in force" versions of the most commonly used regulatory compliance documents for industry are copied below.
 Legislative instruments / Determinations  
 Permissible Ingredients (Determination & amendments)

 Standard for labels of non-prescription medicines (Therapeutic Goods Order No. 92 & amendments)

 
 Permissible Indications (Determination & amendments)  
     
 For a full list of legislative documents, see the TGA website here.  For a more complete list of guidance documents and publications for CMs, see the TGA website here.  

    A note on amendments: The most up-to-date versions of legislation will always be marked "In force Latest Version" on the FRL. However, if the search for a legislative document also reveals an amendment "in force", that must be checked separately to see if it applies to your product. Amendments contain new changes that are not yet incorporated into the main document. If an amendment is in force, it usually only shows for around 4-6 weeks, until it becomes fully incorporated into the main document.


    Below is a summary of upcoming changes. If you are aware of information that should be included below, please email technical@cmaustralia.org.au

    2019  

    1 Jan 2019

    New Advertising Code (No 2 of 2018) in effect.

    The new Code applies to all advertisements from this date.

    March 2019

    New 'Complaints Handling' Process for Advertising including Sanctions & Penalties

    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.

     Sep 2019 CAFFEINE - content changes

     The TGA introduced immediate requirements that ALL listed medicines must not contain more then 4% of caffeine in undivided preparations and not more than 33% in divided preparations as of September 2019.

    Further changes and warning statements are implemented, which must be applied to all new listings. For medicines listed before 2 September 2019, the final compliance date for full compliance is 6 March 2021.

        September 2019 - Fee Free Period to change ARTG Listings to permissible indications extended following CMA actions, new end date for free changes is 5 March 2021.

    Oct 2019

    Andrographis - new alelrgy label warning statement.

    A new warning statement for allergy and anaphylaxis for rapid implementation has been flagged. More information to come.

    2020    

    1 Jan 2020

    Menthol and all menthol-containing ingredients - LAST date to transition medicines for dermal use to new requirements.

    Medicines for dermal use cannot have more than 25% menthol in the final preparation, by this date. Label warning statements also apply. Those medicines with a dermal concentration of 5 - 25% of menthol, when used dermally must carry additional warning statements. See:

      Poliglusam - LAST date to transition medicines containing menthol for dermal use to new requirements.

    All existing listings listed before 1 July 2018 must have transitioned to the requirements that the average molecular mass of poliglusam must be greater than 2 kilodaltons. And, when for internal use, the medicine must not contain more than 1750 milligrams per maximum recommended daily dose. See: Permissible Ingredients Determination and Amendments

      Methyl salicylate and ingredients containing - LAST date to transition medicines for dermal use to new requirements.

    All existing listings listed before 1 July 2018 must have transitioned to the requirements that for dermal application, the concentration of methyl salicylate in the medicine must not be more than 25%, and there are a number of additional warning statements. See: Permissible Ingredients Determination and Amendments

      Cysteine - LAST day to transition to 450mg maximum.

    All existing listings listed before 1 July 2018 must have transitioned to the requirements that the maximum recommended daily dose must contain no more than 450 mg of cysteine. When cysteine, cystine and/or their salts are used in combination, the medicine must not provide more than a total of 450 mg cysteine per maximum recommended daily dose. See: Permissible Ingredients Determination and Amendments

      Poria cocos

    Last date to change name from 'Poria cocos' to 'Wolfiporia cocos'. See: Permissible Ingredients Determination and Amendments

    31 Mar    2020


    Propolis and Royal Jelly - LAST date to make  fee-free changes to expression of content on ARTG.

    The listing facility has been improved, such that the expression of propolis and royal jelly starting materials on the ARTG can be entered in the appropriate way.  Sponsors need to change their listings before 31 March 2020 to avoid a grouping fee.

    30 April 2020

    Ingredient Name Harmonisation

    LAST date by which all labels and packages must carry the updated ingredient name.

    In 2017 the TGA commenced a program to harmonise medicine ingredient names. All medicines released for supply after 30 April must carry the updated ingredient names.

    1 Sept

    2020



    Labelling transition ends

    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, can be released for supply not be released for supply after this date. Until 1 September medicines can comply with either order.

     2021    
     2 March 2021 CAFFEINE - Changes to content and warning statements in Listed medicines

    Sponsors of medicines listed before 2 September 2019 will have a transition period for new requirements. By 2 March 2021 all medicines must comply.

    Caffeine as an individual ingredient for oral use is restricted to a maximum of 100mg daily.
    Caffeine as a component of herbal ingredients will have a dosage restriction of 400mg daily, with a maximum of 100mg caffeine every 3 hrs.
    In undivided preparations, the concentration of caffeine is capped at 1% (down from immediate restriction of 4%).
    For divided preparations, the concentration will remain capped at 33%.

     6 March 2021

    Permissible Indications - LAST date  to change to permitted indications to avoid CANCELLATION by the TGA.

    Fee-free changes for permissible indications until 5 March 2021.


    End of the phase in period to amend ARTG records with only those indications from the permissible indications list.  Any products that do not have updated records by this date may be cancelled from the ARTG. 

    The free-free period has been extended until this date, so that sponsors can make changes to their indications without a grouping fee.

     31 March 2021

    TGO101: Standard for Capsules and Pills   Tablets/Capsules MUST COMPLY with

    -           Residual Solvents

    -           Elemental Impurities

    Pills were not included in the former version of the order, TGO 78. Section 16 sets out new requirements for elemental impurities and residual solvents, for which the final date is 31 March 2021.


    Call us on 02 6260 4022 or fax 02 6260 4122

    Address: PO Box 450 Mawson, ACT 2607 Australia

    Powered by Wild Apricot Membership Software