Medsafe labelling changes to include allergens and excipients
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Medsafe labelling changes to include allergens and excipients New Zealand’s Medicines and Medical Devices Safety Authority (Medsafe) is introducing labelling requirements for substances including allergens, excipients and impurities in medicines and related products which may cause allergies or other adverse reactions. In an open consultation period on proposed warning statements between June and August 2019, Medsafe received 260 responses. Medsafe has now finalised the warning statements which will be implemented by March 2021 for New Medicines Applications, and by March 2024 for existing medicines and health products. The warnings will align with those required in Australia under the Therapeutic Goods Orders. Medsafe is currently seeking views on having warning statements for the following substances to be included in the Label Statements Database: antibacterials, aspartame, benzoates, crustacea and crustacean products, egg and egg products, ethanol, fish and fish products, galactose, gluten, hydroxybenzoic acid esters, lactose, milk and milk products, peanuts and peanut products, phenylalanine, pollen, potassium salts, propolis, royal jelly, saccharin, sesame and sesame seed products, sodium salts, sorbic acid and sorbic acid salts, soya bean and soya bean products, sucralose, sugar alcohols, sugars, sulphites, tartrazine, and tree nuts and tree nut products. After submissions have been reviewed, the Label Statements Database may be updated to include some or all of the new statements. All medicines released for supply in New Zealand after 1 March 2024 must have updated package labels. Medsafe. Outcome of the consultation on the proposed warning statements for substances (eg, allergens) in medicines that may cause undesirable reactions. Internet Document 803506585 : 23 Sep 2020. Available from: URL: https://www.medsafe.govt.nz/consultations/WarningStatementsForAllergens/WarningStatementsforAllergens.asp
0114-9954/20/1825-0001/$14.95 Adis © 2020 Springer Nature Switzerland AG. All rights reserved
Reactions 10 Oct 2020 No. 1825
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