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.
