Technical Alerts

A new Permissible Ingredients Determination (No.4)2020 has commenced.

This technical Alert (available in Word or PDF) contains a detailed list of changes with a Notes field for sponsors to use to assist in identifying the changes relevant to products, as part of a table which includes

-Each new or changed ingredient

- The original (previous) requirements that applied

- New (amended) specific requirements.

This update also includes information on the following substances with more context provided for members on background information leading to the changes: 

- Fallopia multiflora (He Shou Wu or Fo-Ti)

- Arbutin-containing herbs updated to reflect the poisons Standard and increase market access

- Change of transition periods from 'supply' to 'release for supply'

- Other changes to the Determination, including the addition of 27 new ingredients and the expiration of exclusivity on 3 ingredients

In addition, this technical alert includes information on:

 - Targeted industry consultation via CMA on TGA-proposed removal of Gynura japonica from the Permissible Ingredients Determination in March 2021 (closes via CMA on 6 January 2021).

- Proprietary Ingredient Consultation delayed until January 2021

Today the TGA announced a final decision to down-schedule certain low dose cannabidiol preparations from Schedule 4 (Prescription Medicine) to Schedule 3 (Pharmacist Only Medicine).

The decision allows low-dose CBD containing products, up to a maximum of 150 mg/day, for use in adults that have been pre-approved by the TGA, to be supplied over-the-counter by a Pharmacist without a prescription provided certain controls are followed. Please read today's member alert for more information, including:

- The summary effect of the decision for the public

- A full overview of the scheduling decision

- Information for sponsors interested in pursuing clinical research and registration applications

The TGA are proposing draft "Mandatory"(legislative) Data Requirements  for new substances that undergo evaluation to be entered into the Permissible Ingredients Determination to be used in listed medicines. 

CMA are seeking both member feedback on the proposed mandatory data requirements and expressions of interest for industry member representation on one (or more) of the TGA’s Industry Feedback Groups on the proposed requirements.

This consultation is NOT intended to go public, therefore it is important that CMA receive your member feedback so that we are able to respond to the TGA's proposal and help prevent any issues arising for industry in the future.

Member feedback requested by Tuesday 19th January 2021  

Expressions of interest requested by C.O.B. Thursday 7th January 2021 

Please read today's technical alert for more details. 

CMA are pleased to inform members that updated country of origin regulations are now in effect through the passage of the Competition and Consumer Amendment (Australian Consumer Law-Country of Origin Representations) Regulations 2020 on 10 December 2020.

The passage of these Regulations represents years of work for the Complementary Medicines industry and provides stronger protections for industry by strengthening Country of Origin laws. The regulations prescribe, by law, a process of substantial transformation, rather than providing an example of a process that results in substantial transformation.

The regulations do not, at this stage, require industry members to undertake any technical change or different approach to that which has been taken under the existing safe harbour laws and the initial introduction of 92AA of the Regulations in December 2019. However, members should note that the progress of other changes to labelling where voluntary country of origin representations are made is still under Government consideration and may result in further changes in 2021.

Please read today's member alert for more information.

Complementary Medicines Australia is pleased to announce that a new and improved Data Protection scheme for complementary medicines has entered Parliament as part of the Therapeutic Goods Amendment (2020 Measures No. 2) Bill 2020.

CMA hopes that a new, improved, and fully functional data protection scheme will be a landmark historical turning point in the research and therapeutic claims landscape for complementary medicines, not only allowing better advancement of the Australian sector, but as one that could serve for increased global advancement of models into the future that help stimulate and create recognition into research into non-patentable natural substances. This includes use in important health conditions as well as enhancement of wellbeing.

The updated data protection scheme will enable researchers and sponsors to publish information and important details about their research in full, five years earlier than previously permitted, to gain earlier public recognition of the efficacy of vitamins, minerals, herbal and other complementary medicines.

The new scheme also critically increases the flexibility and breadth of the scheme by expanding the eligibility of indications to ensure that a medicine with the same “intermediate” indication as another medicine but with different active ingredients, may also now access the scheme, to provide far greater certainty and be more effective in encouraging innovation into new therapeutic uses.

A more effective data protection scheme combined with early, visible publication of the evidence-base for complementary medicines is particularly exciting as this recognition may occur in the context of more well known and accessible therapeutic uses including uses relating to certain health conditions currently not permitted to be included on other listed medicines

For more information and details on the updated scheme, please see today's Member Alert

The TGA update to ARTG summaries for listed medicines for both sponsors and the public has been implemented. The changes have now gone live and will be visible. This update will ensure that when herbal ingredients and active proprietary ingredients are used in listed medicines, the information about the active ingredient will be displayed more clearly.

Please see CMA’s 25 November member alert for more information.

The Minister for Industry, Science and Technology, the Hon Karen Andrews MP, today has opened the second round of the Manufacturing Modernisation Fund (MMF2). This is the first program to open under the $1.5 billion Modern Manufacturing Strategy which will assist Australian manufacturers to scale-up, improve their competitiveness and build resilient supply chains.

Please read today's member alert for more information on the MMF, eligibility criteria and how to apply.

Subscribe for updates on the Strategy by completing the linked form on the Department of Industry, Science, Energy and Resources website

Following the August 2020 consultation on Low-negligible risk changes to Permissible Ingredients- 2020-2021, the TGA have published the outcomes on their website for Easily dissociable magnesium salts and Andrographis paniculata.

CMA are pleased to note that the changes to the original consultation proposal for magnesium salts are more aligned to the evidence base and consumer use profiles of these products and therefore, the warning statements will be less restrictive and apply to a lower number of existing products, helping consumers better identify those products that are more or less likely to have a gastrointestinal effect.

Sponsors of Andrographis products need to be aware that a new statement relating to taste disturbances will be introduced.

The changes to the Permissible Ingredients determination will commence on 1 March 2021 for new listings. Sponsors will be provided a 12- month transition period, until March 2022, to make the necessary changes for existing medicines. Please also see the alert for expected changes to how transition dates are implemented which will be clearer and easier to implement for industry.

Please read today's technical alert for more information on these changes.

CMA are pleased to inform members of the registration of the Therapeutic Goods (Standard for Tablets, Capsules and Pills) Amendment Order 2020, which provides a three-month extension to the requirements for elemental impurities and residual solvents in Section 16 of the TGO 101, from 31 March 2021 to the new commencement date of 30 June 2021.

More details on the above, as well as contextual information for sponsors on capsule and tablet size (due to member enquiries), can be found in today's technical alert.

CMA is providing information for members to note, that it is expected there will be changes to the Permissible Ingredients Determination in 2021 to better streamline requirements and ease unnecessary burden.

These changes are expected to be implemented in the first quarter of 2021 if there are no further changes made through consultation. As a targeted industry-only consultation, member feedback on those changes to CMA is welcome until 5pm 14 January 2021. Please read the full technical alert for more information.