Ingredients permitted in listed complementary medicines – changes just published:

*  liver-related warnings when required for more than one ingredient in the product

* addition of new ingredients: calcium propionate, methyl acrylate, methyl methacrylate and methacrylic acid copolymer dispersion (30 per cent), and polyacrylate dispersion (30 per cent) (restrictions apply).

* numerous changes to existing ingredients.

Read the summary of the changes here, and the revised list of permitted ingredients is here.

TGA guidelines. Guidelines are not law, but are useful guidance documents. As the TGA states “..  Guidelines are not mandatory requirements but rather show sponsors what a TGA delegate considers in a compliance review. However, there may be individual circumstances that justify a departure from these Guidelines and in any circumstance the TGA will consider the merits of each case against the regulatory requirements.” This statement is at the beginning of the probiotic guidelines referenced below.

Probiotics

* Demonstrating the quality of listed probiotic medicines”. This TGA guideline was updated on 25 February. This is a very useful document relevant to any company supplying probiotics, including in countries outside of Australia. The change history of this document indicates it was updated to remove the words “the label must state the name of any stabilisers and other excipients”.

Recalls procedure – don’t forget!: reforms to recall procedure will commence early  March 2025. The new procedure is known as the Procedure for Recalls, Product Alerts and Product Corrections (PRAC). TGA explains that “… new terminology replaces the confusing categories of ‘recall actions’ and ‘non-recall actions’ with one overarching category called ‘market actions’.” Last week the TGA published guidelines “What you need to know” based on a recent webinar.

Nitrosamine impurities – update to acceptable limits. This is relevant to some herbal medicines. – see TGA website

Therapeutic vaping goods: The TGA has just conducted two webinars providing guidance on the notification form. When the webinar notes are released we will provide a link in our newsletter.

Stability testing of biotechnological products – updated in line with EU requirements on 20 February, Learn more from our stability testing course – details above.

Stability requirements for listed medicines: the TGA is now conducting compliance reviews. TGA states that a sponsor of a listed medicine should ensure that

*prior to or at the time of listing, you hold information or evidence to show that your medicine’s specifications will be maintained under the conditions set out on the medicine’s label until the medicine’s expiry date,

* you review the data that you hold with respect to the stability of your medicine against relevant requirements,

* the information or evidence you hold is substantiated by robust scientific justifications; and

* where there is an applicable standard(s), your medicine conforms to that standard(s). Read more here.

All the more reason to book our stability testing course – see details above. It is conducted by ex TGA GMP auditor Andrew Lattimore 

Changes to “exempt goods” – tampons and menstrual cups. These are exempt goods, not requiring to be included on the Australian Register of Therapeutic Goods (ARTG). However they must comply with standards set out in the relevant therapeutic goods orders (TGO 103 and TGO 99). The TGA is proposing that sponsors of these products should notify the TGA of the products they are supplying. Consultation is ongoing, latest notice is here.

Poisons schedules – Camellia sinensis extract (green tea extract), and amygdalin, hydrocyanic acid and Wild Cherry Bark. Green tea extract: read about changes here.  Amygdalin and hydrocyanic acid: read about the changes here.

Medicinal cannabis hub has been updated. Includes

* access pathways and usage data
* information for patients
* information for health professionals
* information for importers, exporters and manufacturers
* vaping devices: Information for importers, exporters and manufacturers
* medicinal cannabis vaping devices that are approved in Australia
* importation and the traveller’s exemption.

Read more here.

How to cancel a product from the Australian Register of Therapeutic Goods – updated guidance. TGA advises “Do not request cancellation if your product is still being supplied in (or exported from or imported to) Australia.” If you do want to cancel your product, the updated form and guidance can be found here.

Consultations – nothing open now

Compliance action
* Nothing much this month! You can always keep up to date on the TGA’s Compliance and Enforcement Hub.

Safety alerts

Nothing relevant

Recalls – none this month

Botanical Adulterants Prevention Programme (BAPP) and other adulteration stories.

* The Undisclosed Presence of Excipients and Diluents in Botanical Extracts

High levels of undisclosed excipients and diluents may give buyers and consumers a misleading sense of botanical extracts’ strength and composition. Read here

* Unmasking food frauds and the way forward for global food importers: published by Dr Vikas Kumar Singh in LinkedIn

To access freely available botanical and technical resources from BAPP, click here 

Foods