Technical Alerts

The TGA have announced a consultation on proposed changes to the Permissible Indications Determination low-negligible risk ingredients, closing 15 September 2021.

The Proposed changes relate to:

- Peripheral neuropathy associated with lower dose vitamin B6 - a proposed reduction of maximum supplemental daily intake from 200mg/day to 50mg/day; and extension of a warning statement for products providing between 10 – 50 mg of equivalent pyridoxine.

- Artemisinin and pregnancy risk - proposed new label requirements for artemisinin containing products, which may also affect products that have artemisinin in a flavour or fragrance. These changes were anticipated following the ongoing review of Artemisinin containing medicines and pregnancy risk by the TGA.

- Allergen statement for mollusc-derived ingredients - proposal for ingredients on the Permissible Ingredients Determination that are derived from a marine mollusc (substances derived from squid, oyster, green lipped mussel or homeopathic Sepia) be updated to include the warning statement “Contains mollusc” or “Contains mollusc products”, in alignment with FSANZ allergen warnings.

Please read today’s full technical alert for more information

The TGA are seeking applications for a number of remunerated advisory committee appointments from professionals with expertise in relevant medical or scientific fields or consumer health. Applications close 13 August 2021.

For complementary medicines, having relevant experts with a strong understanding of CM including nutritional medicines and traditional medicines in the Advisory Committee for Complementary Medicines can appropriately inform critical TGA decisions relating to Complementary Medicine regulation. Matters this Committee have advised on in the last 2 years include:

• Vitamin B6 (pyridoxine) with peripheral neuropathy and whether the current maximum daily dose for listed medicines (200 mg eqv. pyroxidine) is appropriate.

• The relationship between taste disturbance/loss-of-taste adverse events reported for products with Andrographis paniculata and associated restrictions for listed medicines.

• Whether listed medicines containing higher doses of various forms of magnesium should carry a label warning or have additional restrictions for potential laxative effects.

• Probiotics - characterisation for the purposes of establishing the quality and safety of applications relating to microorganisms.

• Probiotics - What constitutes adequate control of the composition, strength, stability and performance characteristics of a multi-strain probiotic.

• Valeriana officinalis to cause herb-induced liver injury, and whether there is a sufficient evidence to support restrictions to mitigate the risk when used in listed medicines.

• Aspects of clinical trial data that are critical to make publicly available as part of conducting a clinical trial the TGA's proposed data protection scheme for assessed listed medicines.

• Suitability of an herbal ingredient in listed medicines indicated for use during conception, pregnancy and lactation.

Please see today’s member alert for more information on how to apply.

The TGA have published a Notice of interim decisions on proposed amendments to the Poisons Standard on their website, which includes the Delegate's INTERIM decision on hemp seed oil. Consultation is now open on this interim decision until 17 August 2021 so that the Delegate may make a FINAL decision, leading to a planned implementation date of 1 October 2021.

This interim decision would allow hemp seed oil complying with certain conditions on lower limits for cannabidiol and tetrahydrocannabidiols to no longer be scheduled and be sold for internal use in therapeutic goods.

Please note that if the down-scheduling proceeds as proposed, this does not automatically permit use in listed medicines until a successful application is made for the Permissible Ingredients Determination - more information on this is in today’s alert. Please also note that this interim decision includes a limit for cannabidiol in hemp seed oil, however it does not amend the decision for cannabidiol in Schedule 3.

Today’s technical alert includes more details, including the proposed scheduling requirements, the reasons for the decision and potential implications for industry.

The same round of Delegate interim decisions intends to add a new entry for Kambo, a traditional folk preparation derived from tree frogs that has recently attracted media attention in Australia, as a Schedule 10 substance (Substances of such danger to health as to warrant prohibition of sale, supply and use). This substance is not discussed in this technical alert as it is not used in the commercial context, however more information on the substance and the Delegate’s reasons on this interim decision is available on the TGA website.

The TGA have announced the outcomes of the Feb 2021 consultation: ‘Removing redundant processes for entering certain formulation information into a therapeutic goods application.’ As initially proposed, the TGA intend to stop entering three categories of new PI formulations into the Proprietary Ingredients Table before they are selected into an application onto the ARTG:

• ingredient mixtures that contain an active ingredient (known as ‘Active Premixes’ and ‘Active Herbal Extracts’); and

• non-specific ‘Excipient Mixes’, which the TGA consider do not provide sufficient information on the purpose of the mixture.

Existing ARTG entries that use PI numbers with an active ingredient or non-specific purpose in their formulation will remain active. Sponsors do not have to make changes or update ARTG entries if they include PI numbers with these categories in their formulation.

Notifications for new ingredient mixtures with an active ingredient or a non-specific purpose into the Proprietary Ingredients Table will stop being processed by the TGA as of today, 20 July 2021.

Please read today’s full technical alert for more information including the processes for, and impacts of these changes as well as CMA’s communication with the TGA in relation to these changes and associated considerations.

Today's technical alert includes information on:

A. TGA advertising compliance education strategy and plan.

The TGA have published the Advertising Compliance Education Strategy and Plan, intended to provide information and guidance on the advertising requirements, and is proposed to include a range of education materials, resources and stakeholder engagement opportunities.

B. FSANZ call for data – Formulated supplementary sports foods (FSSF).

This call for data is industry's opportunity to increase levels of nutrients in FSSF in Standard 2.9.4 and associated schedules, which means that new food products could be compliantly produced in this space. The call for data closes 6pm (Canberra time) 9 September 2021.

FSANZ are seeking data:

- Based on scientific research – this can be published or unpublished;

- On one or more outcomes relevant for human health and/or sports performance, at different levels of intake (animal and human studies will be accepted); and

- Technical information supporting the characterisation of the commercial preparations of contemporary substances (i.e. specifications, stability data, validated analytical methods).

C. TGA consultation – Remaking Restricted Medicine Specification

This consultation is to re-make the existing sunsetting legislative instrument. It is relevant to sponsors with, or who are intending to include, registered complementary medicines that are in Schedule 3 or Schedule 4 of the Poisons Standard and will mean that these products will continue to be required to submit a Product Information as part of a registration application. Closing 16 August 2021.

Please read today’s full technical alert for more information, including details on how to respond to the aforementioned consultation and call for data.

FSANZ review of titanium dioxide as a food additive - call for data

Food Standards Australia New Zealand (FSANZ) is calling for data on titanium dioxide and its safety when used as a food additive in Australia and New Zealand. information supplied through the call will assist FSANZ in reviewing the safety of titanium dioxide as a food additive. FSANZ are seeking data on: 

- Information on the physico-chemical characteristics of titanium dioxide as currently used as a food additive;

- Genotoxicity studies (in vitro or in vivo) with titanium dioxide; and

- Details of any other studies relevant for the safety assessment of titanium dioxide.

The consultation is open from 8 July 2021 to 17 September 2021.

FSANZ consultation - Review of Standard 2.9.1 Infant formula: Nutrient composition

The second consultation paper in the review of infant formula has been released and focuses on nutrient composition for macronutrients and energy, vitamins and minerals, permitted forms and other nutritive substances. The consultation is open until 19 August 2021. 

Please read today’s full technical alert for more details, including how to respond to the review and consultation

The Australian Government announced that it will introduce a 'patent box' for eligible corporate income associated with new patents in the medical and biotechnology sectors. The Treasury are seeking comment on the patent box consultation and interested parties are invited to comment on the issues raised in the associated discussion paper by 16 August 2021.

‘Patent box’ is a generic term for regimes that apply a concessional tax treatment to profits derived from eligible intellectual property (IP).

The patent box relates to eligible revenue derived from inventions that would fall within the scope of Australian standard patents (including where the invention is protected by foreign patents) and will apply to companies for income years commencing on or after 1 July 2022. Incentives include a concessional tax rate of 17% (reduced from 25% or 30% ) on eligible revenue. 

Please read today's technical alert for more information. 

The Department of Industry, Science, Energy and Resources have announced available funding for eligible businesses under the Manufacturing Collaboration Stream of the Modern Manufacturing Initiative.

Applications are accepted from 11 August 2021 and close on 9 September 2021.

$800 million is available to provide co-funding of up to one third of eligible project costs. This will be through grants between $20 million and $200 million to support large-scale projects that will transform the manufacturing sector by increasing collaboration, and building scale to enhance growth and competitiveness in the National Manufacturing Priority areas, including medical products and food and beverage.

Please read today's member alert for more details, including eligibility criteria and how to apply.

The TGA have published a reminder of important annual charges deadlines for sponsors, available here. 

Sponsors are reminded that if a product is no longer supplied, the entry can be cancelled from the ARTG by this Wednesday, 30 June 2021 to prevent incurring 2021-22 annual charges.

Products on the ARTG from 1 July 2021 will incur a 2021-22 annual charge (unless exempt).

Information on how to request to cancel an entry/entries from the ARTG is available on the TGA website.

The second reading of the Narcotic Drugs Amendment (medicinal cannabis) Bill 2021 ('the Bill') was passed in the Senate without amendment on June 17 2021.

The Bill will introduce a single licence for the cultivation, production and manufacture of and research into medicinal cannabis. This aims to reduce the administrative burden on industry; however, it remains unclear whether these benefits will result in better processing times and reduced costs for patients.