Technical Alerts

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- Based on scientific research – this can be published or unpublished;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

The public consultation on proposed changes to the Therapeutic Goods Advertising Code closes today, Friday 18 June 2021.

CMA’s full submission in response to the Advertising Code consultation, including additional information, reasons and references, and the CMA/DSA submission on Endorsements and Testimonials is provided for your reference below:

 - CMA’s full submission is available here (79 pages)

 - CMA and DSA's submission on Endorsements and Testimonials is  available here (10 pages)

Members are welcome to reference all or part of CMA's submission in your own submissions to the TGA public consultation and make additional comments, examples, or provide alternative suggestions.

Your submissions to the Proposed improvements to the Therapeutic Goods Advertising Code consultation can be made via the Department of Health Consultation Hub

Please note: the consultation Hub site is currently down. In the interim, please email advertising.consultation@tga.gov.au   

The public consultation on proposed changed to the Therapeutic Goods Advertising Code closes this Friday, 18 June 2021.

CMA have, in conjunction with our Regulatory Committee, developed a summary submission and recommendations in response to the Advertising Code consultation.

 - Please click to access your member-only Word or PDF copy of CMA’s summary response and recommendations, which includes comparative examples relating to the potential effect of the proposed changes to advertisements.

 - Please click here to also access a CMA document which compares existing and proposed 'health warnings' under the proposed changes to Schedule 1 of the Code (Table 1 and 2 of consultation paper).

Members are welcome to reference all or part of CMA's submission in your own submissions to the public consultation. Members are also welcome to copy certain positions into your submissions and make additional comments, examples, or provide alternative suggestions from the viewpoint of your company.

CMA's full submission on Friday will contain additional information, reasons and research references.

Submissions can be made via the Department of Health Consultation Hub: Proposed improvements to the Therapeutic Goods Advertising Code

The Therapeutic Goods Legislation Amendment (Fees) Regulations 2021 is now in effect.

These regulations amend the Therapeutic Goods Regulations 1990 and the Therapeutic Goods (Medical Devices) Regulations 2002 to increase the fees set out in those respective regulations by 1.05 per cent, for the financial year 2021-22.

Please read today’s technical alert for more information on how the updated charges will be applied, including a summary of CMA’s response to the fees and charges consultation.