TGA Extends Fee-Free Window for Current Listed Medicines to Update their Permitted Indications

The fee-free period for sponsors to transition existing listed medicines to permitted indications has been extended until 6 March 2021 (previously scheduled to end 6 September 2019). The Permissible Indications Determination came into effect on 6 March 2018 with a three-year transition period for sponsors of existing listed medicines to re-list their products using permitted indications. Listed medicines that have not transitioned to permitted indications will be automatically cancelled from the register on 7 March 2021.    Source: LM fee-free period

TGA Makes Changes to High-Moderate Risk Permissible Ingredients – Caffeine

Responding to an inadvertent fatal caffeine overdose, as reported in the July 2019 edition of this newsletter, the Therapeutic Goods Administration has made immediate changes to the Therapeutic Goods (Permissible Ingredients) Determination. Highly concentrated caffeine in any dosage form will become ineligible for listing and therefore illegal to supply. Caffeine as an individual ingredient is permitted for oral use at a maximum daily dose of 100mg. However, caffeine when present as a component of other herbal ingredients will now have dosage restrictions so that the medicine does not provide more than 400mg total caffeine per day. For comparison, one teaspoon of instant coffee contains about 80mg caffeine. A maximum dose of 100mg per 3 hours will also be required. These limits consider consumption from other sources such as food, and the adverse effects which are seen when caffeine intake exceeds 400mg/day or more frequent dosing. The following requirements have immediate effect: undivided preparations (e.g. bulk powders) must not contain a concentration of total caffeine greater than 4%; and divided preparations (e.g. tablets) must not contain a concentration of total caffeine greater than 33%. Further changes to both dosage requirements and label advisories for all caffeine containing products are available at Source: Caffeine restrictions    (Please see also: Permissible ingredients determination update and SUSMP amendment consultation.  Also - FSANZ Caffeine Report  & SMH Caffeine fatality ).

TGA Makes Interim Decision in Relation to Sanguinaria Canadensis (bloodroot)

Due to safety issues concerning the use of 'black salve', a delegate of the TGA previously made an application to the Advisory Committee of Medicine Scheduling to make Sanguinaria canadensis, or blood root, a Schedule 10 substance when containing 0.01% or more of sanguinarine. S10 are substances of such danger to health as to warrant prohibition of sale, supply and use. This decision is not expected to affect medicines currently listed on the ARTG, including other herbs with sanguinarine as a component such as Greater Celandine (Chelidonium majus), or homoeopathic listings of S. canadensis, but will make ineligible any and all supply, in Australia, of black salve or similar topical preparations or any preparations of blood root with more than 0.01% sanguinarine.   Source: Interim decision-sanguinarine

 

TGA Makes Interim Decision in Relation to Cosmetic Ingredient, Arbutin

A private applicant proposed including arbutin as a specific entry in the Poisons Standard, and to allow its use in oral herbal preparations containing 500mg or less of arbutin per recommended daily dose. Arbutin is currently scheduled as a derivative of hydroquinone. The interim decision is to create a new Schedule 4 entry for arbutin with an exemption for oral herbal preparations containing 500mg or less of arbutin per recommended daily dose. There is no change proposed for cosmetic use (i.e. remains as Schedule 2 or 4). The delegate noted: “As the nature of the current scheduling application and associated toxicological data was in reference to the traditional use of arbutin in herbal preparations, I find that on balance, the topical use of arbutin should be considered in a separate consultation. This would allow for specific consideration of toxicity data on the dermal effects of arbutin”. Comments are due back to the TGA by 10 October 2019.    Source: Interim decision - Arbutin

TGA Proposes Changes for Low-Negligible Risk Permissible Ingredients

The Therapeutic Goods (Permissible Ingredients) Determination specifies all of the ingredients that are available for use in listed and assessed listed medicines and their associated requirements. Currently, the affected ingredients include boron, Withania somnifora, Vitex agnus-castus, Plantago spp, and psyllium husk. The proposed ingredient changes in this consultation have been reviewed and categorised as being of low-negligible risk. The purpose of this consultation is to provide an opportunity to comment on these proposed changes which are due to commence on 2 March 2020     Source: Low risk ingredients     (Please also see: Changes to permissible ingredients determination )

 

TGA Consultation: Increased Online Access to Ingredient Information

The TGA is seeking feedback on a proposal to publish the names of excipient ingredients used in therapeutic goods in the public view of the Australian Register for Therapeutic Goods (ARTG). They are responding to consumers wishing to more easily have access to this information. By making this information available in the public ARTG view, which is available on the TGA website, the TGA hopes to help consumers make more informed and safer choices about their medicines.    Source: Ingredient access

 

TGA Provides ‘Decision Tree’ for Mandatory Information Required When Advertising Therapeutic Goods

This decision tree has been designed to help suppliers identify what information must be included when advertising therapeutic goods to the public in order for the advertising to comply with the Therapeutic Goods Advertising Code (No.2) 2018 (the Code). The decision tree provides sponsors with the minimum set of information required in advertisements under the Code, based on the type of therapeutic good and the type of advertisement. Additional information in the advertisement may also be added, provided these minimum requirements are met. Important Notes: Representations that refer to serious forms of a disease, condition, ailment or defect are ‘restricted representations’ and prior approval from the TGA is required before advertising these goods; Advertisements for medicines intended to appear in 'specified media' (e.g. free-to-air television, radio, newspapers, magazines, billboards) require pre-approval.     Source: Therapeutic goods advertising   (See also: Application form for approval of an advertisement )

 

PharmaCare Fined For Alleged Advertising of Cancelled Therapeutic Good

Australian company PharmaCare has paid penalties of $12,600 after the Therapeutic Goods Administration issued an infringement notice for the alleged advertising of a therapeutic good after it had been cancelled from the Australian Register of Therapeutic Goods (ARTG). The product, Sambucol Cold & Flu Kids Liquid, was audited during a routine compliance review. The TGA found that the application to include the medicine on the ARTG was false or misleading, as the scientific evidence PharmaCare held to support some of the indications for the medicine was inadequate. As a result, the TGA cancelled the product from the ARTG in June 2019, however the product was still being advertised on PharmaCare’s website after the cancellation.    Source: Pharmacare fined

 

TGA Summarises Latest Changes to Medicine Labelling Requirements

The TGA has recently introduced improvements to help bring Australian medicine labels up to date and align them with international best practice. A series of posters are being developed for both professionals and consumers, alerting them to the new labelling system. These posters are a quick reference guide highlighting some of the key medicine labelling changes. You can download these posters to print and display for those wanting to know more about the current labelling designs and their purpose.     Source: Medicine labelling posters    (Please also see: Labelling changes for sponsors )

TGA Report on the Review into the 2016 Medicinal Cannabis Amendments to the Narcotic Drugs Act 1967

The Final Report, tabled in Parliament on 5 September 2019 by Professor John McMillan AO, contains 26 recommendations to improve the regulatory framework for the cultivation, production and manufacture of medicinal cannabis in Australia. Minister Hunt has accepted all 26 recommendations put forward by Professor McMillan, which broadly aim to reduce the regulatory burden on industry, promote and allow greater flexibility in the administration of the legislation to support industry innovation and development.    Source: Medicinal cannabis report

Natural Health Products New Zealand Successfully Challenges Study on Fish Oil Labels

A study, recently published in the New Zealand Medical Journal, that suggested consumers were getting short-changed over fish oil supplements, has been retracted. The study sampled 10 of the most popular fish oil products available in New Zealand and indicated that fewer than half were found to have the same amount of omega-3 fatty acid content (EPA and DHA) indicated on the label, while the rest contained only between 48 and 89 per cent of claimed fish oil. Natural Health Products New Zealand (NHPNZ) contested the study and pointed out three obvious errors in the study: 1 – that there were fundamental calculation errors that significantly skewed the results; 2 – questions over the origin of the input data; and, 3 – methodology errors concerning sample size and product definitions. While the journal claims that it will be publishing a retraction in its next edition, NHPNZ has called for the NZMJ to also issue a media-statement to the general public that this study has been retracted not only from the journal itself but from all other published locations as well. NHPNZ has also asked for a public apology from the journal, to all those parties adversely affected by this faulty journal article.    Source: Jamie Morton, NZ Herald Fish oil study flawed     (Please see also: NHPNZ letter of objection ; and (subscription) NZMJ notice of retraction)

Introducing OneCAM - The Unified Voice of Australia’s Complementary Health Industry

OneCAM is a collaboration between Complementary Medicines Australia (CMAustralia), the Australian Traditional-Medicine Society (ATMS), the Naturopaths & Herbalists Association of Australia (NHAA) and the Complementary Medicine Association (CMAssociation). OneCAM will represent the majority of Australian complementary medicine practitioners and industry, and be the one representative voice when it comes to government policy, the media and the general public.   Source: OneCAM commences

TGA Safety Advisories- Source: TGA current year alerts

Ballerina Anti-Obesity capsules: The capsules contain the undeclared substances phenolphthalein and sibutramine.

Slimina Weight Loss capsules: the capsules contain the undeclared substance phenolphthalein and paracetamol.

 

TGA Safety Advisory Update: Arthrem capsules

The sponsor of this product has cancelled Arthrem capsules from the Australian Register of Therapeutic Goods, meaning that it can no longer be legally supplied in Australia. In addition, a retail level recall was undertaken in relation to this product on 5 September 2019. (In March 2018, Consumers and health professionals were advised that the TGA was monitoring the safety of Arthrem capsules, which contained the herbal ingredient Artemisia annua extract as the only active ingredient. The TGA is monitoring Arthrem capsules due to identification of a safety concern regarding this product and the potential risk of harm to the liver. The New Zealand therapeutic goods regulator, MedSafe, has published an alert regarding this product after receiving 14 reports of liver toxicity associated with the use of Arthrem).    Source: Arthrem capsules deleted

TGA Recall - Jin Gui Shen Qi Wan Pills

Consumers and health professionals are advised that Shen Neng Herbal Medicines Group, in consultation with the TGA, is recalling all batches of Jin Gui Shen Qi Wan - 金 匮 肾 气 丸 - (AUST L 217716) due to potential toxicity. Samples tested by the TGA have been found to contain levels of aconitum alkaloids that are higher than the limit permitted for a listed medicine. Aconitum alkaloids are toxic to humans and an accidental overdose could be fatal in a small child.     Source: Aconite pill recall

Australian Company, Redback SARMs, Pays Fine for Advertising Prescription-Only Substances

Australian business, Redback SARMs, has paid penalties of $15,210 after the Therapeutic Goods Administration issued six infringement notices for the alleged advertising of Schedule 4 (prescription-only) substances, including Selective Androgen Receptor Modulators (SARMs), and Melanotan II. The TGA is reminding businesses that prescription-only medicines cannot be advertised to the public. Online interfaces that allow consumers to review and self-select their desired prescription-only medicines for subsequent prescribing and supply will generally be considered advertising for those medicines. Businesses should also be aware that promoting general classes of prescription-only medicines (like SARMs) is also likely to be considered advertising.    Source: Prescription meds advertising

NZ Deer Velvet Company Sold 11 Million Capsules Containing Filler Instead of Active Ingredient

A New Zealand deer velvet company knowingly sold 11 million deer velvet capsules filled with carob instead of the stated amount of deer velvet, a court has heard. Silberhorn and its sole director, Ian Carline of Invercargill, was originally hit with 101 charges that were laid under the Fair Trading Act in the long-running Commerce Commission investigation, which started in August 2014. The court heard that some 11 million capsules were given a carob filler instead of the stated amount of deer velvet, saving about 500 kilograms of deer velvet with the potential gain for the company being estimated at $1.2 million. Ian Carline previously told the court he would use himself "as a guinea pig" saying that he gauged the potency of his products by conducting tests on himself, including whether he got nose bleeds.    Source: Hamish McNeilly, Stuff Deer-velvet fail

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