Technical Alerts

Please read today's full member alert for details on:

- Upcoming TGA annual charge deadlines for Sponsors and    Manufacturers, including key dates for:

- requests for cancellation of goods from the ARTG;

- requests for revocation of manufacturing licences;

- submitting turnover declarations; 

- due dates for payment of annual charge invoices for active ARTG   entries and manufacturing licences; and 

- The end of the transition period for certain sports supplements (presented in the form of tablets, capsules or pills) on 29 November 2023, including additional information for sponsors, manufacturer, retailer and advertiser consideration. 

A new Therapeutic Goods (Permissible Ingredients) Determination (No. 2) 2023 commences on Monday 1 May 2023.

This Technical Alert contains all details of new, deleted and changed ingredients, and a comparison table of all changes to the Determination for members. Please note that the information in this alert is included in a comparison table and is more detailed than the description published on the TGA website.

This alert details:

·       NEW ingredients and specific requirements that apply to that ingredient, including;

-the addition of the ingredient, ‘galactooligosaccharides’ with exclusive use provisions for 2 years;

-the addition of the following two ingredients for use in flavour and fragrance proprietary excipient formulations:

- disodium pyrophosphate; and

- N-(2-(pyridin-2-yl)ethyl)-p-menthane-3-carboxamide;

·       CHANGED ingredients with the original requirements and the new or changed requirements, including:

- an update to the ingredient name, ‘mecobalamin (co-methylcobalamin)’, to the sole ingredient name, ‘mecobalamin’, to reflect the end of the International Harmonisation of Ingredient Names (“IHIN”) dual labelling period requirements for this ingredient on 30 April 2023;

- updates to the Approved Herbal Names (“AHN”) of seven ingredients to the current taxonomically accepted names for those ingredients;

- updates to applicable requirements for 2’-fucosyllactose

- clarification of the requirements for lacto-N-tetraose regarding the applicable age groups for the required warning statements for this ingredient;

- updates to applicable requirements for caffeine to allow for its use as an active ingredient for topical administration following identification that this use has been inadvertently removed; and

·       DELETED ingredients, including:

- the removal of twenty five ingredients in the Approved Food Name (“AFN”) category that are not in use in any listed medicine products in Australia, and which remain available for use in listed medicines under synonyms or alternative names.

The TGA has released a Public Consultation and invitation to comment on Proposed amendments to the Poisons Standard, closing Wednesday 17 May 2023, including a proposal for low levels of amygdalin and hydrocyanic acid (HCN) to be excluded from scheduling when present in preparations of wild cherry bark (Prunus serotina) on the ARTG.

This technical alert provides important information and details for members, beyond what is provided by the TGA website and related documents, including background, context and further details on the application proposal.

CMA strongly recommend members read this alert and make a submission to the Scheduling consultation on this matter to support ongoing consumer access to important traditional herbs within the remit of appropriate labelling and regulatory controls.

The Department of Agriculture Department of Agriculture, Fisheries and Forestry (DAFF) are seeking comment on proposed increases in fees and charges, closing Monday 24 April 2023.

Importers of goods will be affected by the proposed increases in fees and charges that relate to inspection, assessment and management of the biosecurity risks associated with imported goods and packaging, including air and sea cargo, containers, food and plants.

Please read the full alert for more information and details, including how to respond to the consultation. 

The TGA has published the outcomes of the public consultation, which closed on 7 November 2022, that sought views on TGA proposed options to allow references to the TGA in therapeutic goods advertising.

References to the TGA in therapeutic goods advertising (and on product labels) have not been made a mandatory requirement.

Please click here for more information, including on CMA’s response to the consultation.

This technical alert provides members with an update on nitrosamines, including updated information and resources on nitrosamine impurities in medicines from the TGA, and a recent EFSA opinion of nitrosamines in food. Please read the full alert for more details and information for sponsor, manufacturer and raw material supplier consideration. 

Please see below for the update on Labels Allergens and Other Substances of Concern.

Labels - Allergens and Other Substances of concern

The TGA's GMP Forum held on 21 March 2023 has generated discussion in industry regarding the declaration of allergenic substances or other substances of concern (‘allergens’) that do not have any cut-off specified in Column 2 of Schedule 1 of the Standard for labels of non-prescription medicines (currently the TGO 92.)

CMA previously sought clarification for these substances with the TGA after the publication of TGO 92, which resulted in additional information being published in Section 1.5.9 of the Guidance on TGO 92, in particular the part titled 'Determining when a substance is present'.

The complementary medicines industry is a complex one manufacturing many different types of substances. Recent discussions have highlighted that it is very likely that we need improved information, especially in regards to risk assessments and compliance expectations, to ensure that there are fair and transparent labelling expectations which do not inadvertently become inconsistent across the sector, or with the general expectations of allergen peak bodies, or with the labelling approaches taken for foods that are either mandatory (Food Standards) or voluntary (Precautionary Allergen Labelling and the VITAL program).

CMA will continue to work with TGA, our relevant internal committees, and allergen groups where available, about these matters. There are two main opportunities for further clarification or policy improvement:- in the short term through guidance, and at the next remake of the TGA's labelling Standard which is due in 2026.

All member comments, insights and suggestions to CMA are welcome to Lucy.Lang@cmaustralia.org.au

The TGA has published the outcomes of the public consultation, which closed on 19 December, that sought views on whether the required dual-naming of certain ingredients should end on 30 April 2023. 

In relation to listed medicines, only sponsors of medicines containing 'mecobalamin (comethylcobalamin)' (a form of vitamin b12) are affected.

For new or existing sponsors of mecobalamin products, plaease see the full tech alert for more information and CMA activity in relation to this consultation.

The TGA has published an updated web page on Guidance on applying the Advertsising Code rules.  The web page provides temporary guidance in Word and PDF format while the TGA website is being redeveloped. The TGA have stated that the searchable webpage guidance resources will be published by them as soon as practicable.

Please read today’s tech alert  for more information, including comparisons between the newly published guidance and the previously available 2022 versions.

The TGA is conducting a public consultation, closing Monday 20 March 2023, on the TGA’s proposed increase to fees and charges for the 2023-24 financial year by a total of 11.56% for medicines and 11.1% for manufacturing licenses.

This technical alert provides further information on the TGA Fees and Charges Proposal 2022-24, which describes the reasons for the proposed fee increases, including an increase of the indexation factor by 5.2% and the proposal to apply additional percentage increases on fees and charges relating to TGA building, laboratory, and digital transformation costs among others.

This alert also contains reference to CMA’s draft positioning relating to the increased fees and charges proposal.

Members may respond to the public consultation independently and may also provide any feedback to the consultation to CMA by Wed 15 March 2023  via technical@cmaustralia.org.au.

Further to CMA's 20 February tech alert, which provided a summary of changes to the Permissible Ingredients Determination (No. 1 of 2023), this technical alert provides members with a comparison table of all changes to the Determination, including: 

- NEW ingredients and specific requirements that apply to that ingredient.

- CHANGED ingredients with the original requirements and the new or changed requirements; including the end of the transition period, on 28 February 2023, for certain ingredients.

- DELETED ingredients if applicable.

Please read today’s full alert for more details.