Many Suppliers of CMs Caught Out by New TGA Regulations

Suppliers of complementary medicines (CMs) in Australia are in danger, of having their products cancelled as important statutory deadlines draw near. The key dates for the changes affecting listed medicines (LMs) are:  1st September 2020 when labels must comply with Therapeutic Goods Order (TGO) 92; and 6th March 2021: when, in order to avoid cancellation, products must only use indications included in the list of pre-approved ‘permitted indications’. RFA Regulatory Affairs has noticed that many current suppliers of LMs have not yet transitioned to using permitted indications and are in danger of having their products cancelled. To assist with this, we are offering a three-step service to get your product in compliance. This includes:

  1. developing an evidence package for your product based on TGA permitted indications;
  2. revising your label to include only TGA permitted indications and complying with TGO 92; and,
  3. revising your product AUST L listing to only include permitted indications.

You can choose 1-3 or any of the above, which we are offering at a reduced rate. Contact Robert for rates at This email address is being protected from spambots. You need JavaScript enabled to view it.

RFA Regulatory Affairs also provides training modules to help you become compliant in these areas, offering training on label compliance and preparation of evidence packages. For further details about this and all of our training courses, visit RFA Training Courses .

Caffeine Restrictions – Interim Decision and Invitation for Further Consultation

Regular readers of this newsletter will be aware that due to the recent appearance on the Australian market of highly concentrated caffeine products and one reported death, the TGA has been enacting legislation and consulting with industry, in order to restrict the way that these highly concentrated caffeine products can best be managed. In 2019, the TGA began a “first round” restriction of caffeine by making restrictions within the Permissible Ingredients Determination, which affect Listed medicines only. Among other changes, the TGA imposed a limit of 33% of caffeine in divided preparations such as tablets and capsule, and undivided preparations have been restricted to 4%, with an upcoming further restriction to 1% in 2021. Currently, there is a ‘second round’ review of restrictions for caffeine that is occurring via the Scheduling mechanisms which results in inclusion of caffeine in the Poisons Standard. Changes here affect the use of caffeine more widely and can also influence both Listed and Registered OTC medicine policy. On 6 February 2020, an interim decision and invitation for further comment was announced by the TGA. The interim Scheduling decision is open for consultation and will close on 5 March 2020.   Source: Scheduling of chemicals and poisons (caffeine)  

Meeting the Evidence Requirements for Marketing of Medical Devices

This guidance provided by the Therapeutic Goods Administration (TGA), assists researchers of new medical devices, including in vitro diagnostic (IVD) medical devices and software as a medical device (SaMD), to understand the evidence requirements for market authorisation. To supply a medical device in Australia, sponsors need to submit a market authorisation application to the TGA to include their medical device in the Australian Register of Therapeutic Goods (ARTG).    Source: Medical device evidence      (Please also see: Australian regulatory guidelines for medical devices).

Australian Company Fined for Supply and Advertising of Unapproved Dermapen Device

InSkin Cosmedics Group Pty Ltd has paid penalties of $37,800 for the supply and advertising of the Dermapen 4, a medical device that was not included on the Australian Register of Therapeutic Goods (ARTG). Australia's therapeutic goods legislation prohibits the import, export, manufacture, supply and advertising of therapeutic goods for human use that are not included in the ARTG or otherwise the subject of an exemption, approval or authority.   Source: Microneedling fail

Reminder - Changes to Permissible Ingredient - Andrographis paniculata

In 2015, the TGA completed a safety review of Andrographis paniculata and anaphylactic/allergic reactions. Since then, the TGA has received a further 70 Australian reports of allergic reactions related to Andrographis paniculata and an additional 37 reports of anaphylaxis. For 11 of these cases, the sole suspected medicine contained Andrographis paniculata as the single active ingredient, with 4 of the 11 cases involving anaphylactic reactions. The TGA is aware of an additional 193 international reports which detail similar allergic-type reactions in relation to medicines containing Andrographis paniculata. Due to the risk, the following label warning statement is now required on all listed medicines containing Andrographis paniculata: '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). Sponsors of existing listed medicines will need to ensure that medicines containing Andrographis paniculata that are released for supply from 2 May 2020 are compliant with the new requirements. Any new listed medicines need to comply with the new requirements immediately.    Source: Allergy risk statement required

TGA Publishes Outcomes Regarding Changes to Low-Negligible Risk Permissible Ingredients

On 30 August 2019, the TGA sought comments on proposed changes to the following permissible ingredients: Boron, Withania somnifera, Vitex agnus-castus (VAC), Hydroxyisohexyl-3-cyclohexene carboxaldehyde ('HICC'), as well as a number of permissible ingredients relating to Ispaghula, Plantago, Psyllium, Cymbopogon and Malus species. All comments received for this consultation have now been considered and the proposals have now been published. These changes will commence on 2 March 2020.     Source: Low risk ingredients   (Please see also scheduling timetable for low-negligible risk changes for 2019-2020. Low risk ingredient schedule )  

Changes to Propolis and Royal Jelly in Listed Medicine Applications – Free ARTG Entry Soon to End

The TGA has changed the listed medicine application system to allow equivalents in extracts or preparations of propolis and royal jelly to be correctly entered in the Australian Register of Therapeutic Goods (ARTG). Sponsors can now enter propolis and royal jelly preparations with equivalent starting material in a way that accurately reflects the active ingredient contained in their medicine. Sponsors of existing listed medicines should review this information before 31 March 2020 to check if they are eligible for a free correction to their ARTG entry.    Source: Honey & propolis ARTG

Aussie Company Fined for Falsely Claiming to Hold Evidence for Kids Eye Care Medicine

Caruso's Natural Health Pty Ltd has paid penalties of $12,600 in response to an infringement notice issued by the Therapeutic Goods Administration (TGA). The infringement notice was issued to the company for making a false or misleading certification that it held evidence to support some of the indications for the product Caruso’s Kids Eye Care. The TGA reminds all medicine sponsors that they are required to certify/confirm that they hold evidence for all the indications and claims made about their medicine. The TGA conducts post-market compliance reviews of listed medicines, with a proportion of these selected randomly using a computer algorithm. These reviews allow the TGA to determine whether listed medicines comply with relevant regulatory requirements, including the truthfulness and accuracy of the certifications a sponsor makes at the time of listing a medicine. Caruso's Kids Eye Care was randomly selected for a compliance review which involved an assessment of the evidence held by the sponsor to support the efficacy of the medicine.    Source: Caruso's false claim

Multi-Level Marketing Company Fined for Advertising Breaches

The Juice Plus Company Australia Pty Ltd has paid penalties of $37,800 after the Therapeutic Goods Administration (TGA) issued three infringement notices for alleged advertising breaches relating to vitamin products. The TGA alleged the advertisements did not comply with the therapeutic goods advertising requirements, by promoting the products for a condition that is not permitted for this medicine, and by using

health professional endorsement of the products. Direct sellers of these products should be aware that they have the same legal obligations as the company when advertising therapeutic goods and must comply with the Therapeutic Goods Advertising Code.    Source: MLM court fine

“Let Medicine Be Thy Medicine, and Food Be Thy Food” – Hippocrates 460-370 BCE

Just what constitutes a medicine and what is legally categorised as a food can be a tricky point of difference at times; especially at the medicine-food interface (think ‘sports food supplements’). Generally speaking, food is for nutrition, while medicine treats or prevents disease. Whether a product is food or medicine also has important implications for how it is regulated. In Australia, medicines are regulated at a Federal level while food regulation comes under the jurisdiction of the individual states and territories. Any product that is taken orally (eaten) can be classified as food, however, a food cannot be a medicine, and a medicine cannot be a food. A product is classified as a medicine if it is represented to be a therapeutic good, likely to be taken for therapeutic use, or declared to be a therapeutic good. In Australia, we do not have a separate regulatory category for ‘dietary supplements’. All supplements are either foods or medicines, depending on the supplement's individual features. We’ve come a long way since Hippocrates wrote nearly 2,500 years ago, so please remember that foods and medicines are fundamentally different, and you wouldn't expect one to do the job of the other. Then you'll be able to enjoy food at every meal and take medicine when you need it.    Source: Food V Medicine

RFA VIRTUAL OFFICE remains open

RFA continues to provide regulatory compliance advice for you during challenging times.
You can contact us on:

Robert Forbes - Director
P: +61 2 9660 8027 or +61 410 59 60 80
E: robert@robert-forbes.com

Ellie Kim - Regulatory Affairs Manager
P: +61 450 533 129
E: ellie@robert-forbes.com

Our team is working remotely and our virtual office is open.

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