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To ask about about sponsoring an issue of this newsletter contact us on info regulatorytrainingdirect. Product specifications. This course would be of interest to formulators, QA personnel, labelling and regulatory affairs staff, in any company involved in supplying complementary medicines supplements. It includes example specification templates and information on common deficiencies. Course 1. Read more about this course here. Follow us on LinkedIn: we hope you like our newsletter. If you want to receive up-to-the-minute announcements on new courses, new content and vital regulatory updates follow us on LinkedIn. Changes applying to evaluation of new substances for listed medicines. This is the process that is used when a company or person applies to have an ingredient added to the list of ingredients permitted in listed medicines and listed assessed medicines. This applies to both active and non-active ingredients, and to herbal as well as chemical ingredients. This is a complicated procedure that requires safety data and often includes an up-to-date toxicology report. The guidance document details what information is needed for the application to pass through the preliminary review and progress to the evaluation phase. The TGA site includes a list of new mandatory requirements and guidelines. Source: TGA and useful information here. Psilocybin and MDMA may now be prescribed by authorised psychiatrists. The permitted use isMDMA for the treatment of post-traumatic stress disorder and psilocybin for treatment-resistant depression. Currently there is a lack of options for patients with specific treatment-resistant mental illnesses. Source: TGA. The Therapeutic Order of declared certain sports supplements to be medicines — therefore they are NOT foods. NOTE: we have a one hour course on sports supplements, explaining when they are classified as medicines, and when they can be foods, and the differing labelling and claims requirements for each category. Refer to our website. FreeStyle LibreLink Android app used to recognise and manage high or low blood sugar levels. A software update is being sent out to fix the problem. The label did not include the required warning statements advising that the ingredient extracted from fennel, Foeniculum vulgare is not recommended for children under 12 years and should not be taken by women who are pregnant or likely to become pregnant, or breastfeeding women. This infringement notice follows the recall of the product. Database of Adverse Event Notifications has just been updated. This database allows you to search reports of suspected side effects also known as adverse events for medicines, vaccines and biologicals such as cell and tissue therapies. TGA Fees and charges. Opportunity to comment on proposed fees for — closes 20 th March. NSW Health is urging parents to be aware of the dangers of vaping among young people. There is no such thing as a safe vape. Product recalls Curash Nappy Rash Cream. In the press: Australia becomes the first country to recognise psychedelics as medicines. This article quotes various experts in the field. Source: SMH. Prescribing MDMA and psilocybin: who will get the drugs and how will they help? More discussion on this topic. Source: The Guardian. Article published in The Guardian. Facebook ads opposing a ban on vaping in Australia failed to disclose tobacco company backing. Read about it here. Food Standards News February is available here. This issue includes:. Submissions close 6pm Canberra time 3 March Application A Alpha-arabinofuranosidase from GM Trichoderma reesei as a processing aid FSANZ invites written submissions on the assessment a new source microorganism, being alpha-arabinofuranosidase from a genetically modified strain of Trichoderma reesei as a processing aid for use in brewing, fats and oils processing, grain processing and potable alcohol production. Submissions close 6pm Canberra time 22 March Application A Endo-1,4-beta-xylanase from GM Trichoderma reesei gene donor: Talaromyces leycettanus as a processing aid FSANZ invites written submissions on the assessment a new source microorganism, being endo-1,4 beta-xylanase from a genetically modified strain of Trichoderma reesei as a processing aid for use in brewing, fats and oils processing, grain processing and potable alcohol production. Storage instructions missing on labels — product not labelled with directions to keep refrigerated. Failure to refrigerate may lead to microbial growth and biotoxin contamination. Calbee Harvest Snaps Vegemite — incorrect allergen information gluten in the nutrition information panel. In the press : JSHealth Inside Out almond milk recalled Inside Out is recalling its unsweetened almond milk which was found to contain a toxin that can cause a rare but serious paralysing illness after a man was admitted to a Sydney hospital suffering severe symptoms having consumed the milk. The recall is due to potential biotoxin contamination Botulinum toxin. Botulism is a rare but serious illness that causes descending paralysis caused by nerve toxins made by Clostridium botulinum bacteria. Source: news. New decision tool to help complete the categorisation process of your ingredient. Is your introduced chemical in the exempted, reported or assessed category? Decision tool is here. Chemicals added to the Inventory 5 years after issue of assessment certificate. Published by Regulatory Training Direct www. Providing regulatory training courses for complementary medicines, GMP, foods, cosmetics. This newsletter is sent at no charge. You are welcome to forward this to any colleagues who may find it useful. To receive this newsletter regularly click here. Become a sponsor Showcase your business! Become a Current Affairs sponsor today. To find out more contact us on info regulatorytrainingdirect. Username or Email Address. Remember Me. Source: TGA NOTE: we have a one hour course on sports supplements, explaining when they are classified as medicines, and when they can be foods, and the differing labelling and claims requirements for each category. Foods: Food Standards News February is available here. Source: FSANZ In the press : JSHealth Inside Out almond milk recalled Inside Out is recalling its unsweetened almond milk which was found to contain a toxin that can cause a rare but serious paralysing illness after a man was admitted to a Sydney hospital suffering severe symptoms having consumed the milk. To receive this newsletter regularly click here Become a sponsor Showcase your business! Your training partner for regulatory affairs. Our Moss Vale office is on Gundungurra Ngurra country. We would like to acknowledge the Traditional Custodians of this land - the Gundungurra people. This land was cared for by them for thousands of years and we have much to learn from them. We pay our respect to Elders both past and present. How is our training run? What do I get? Regulatory News current affairs issue current affairs issue current affairs issue current affairs issue current affairs issue current affairs Issue Current Affairs issue 1 — December

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