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New labelling changes aim to warn consumers about potential allergens

The TGA is set to implement new rules to include improved information about potential allergens on medicine labels.

While certain allergens, such as peanuts and gluten, were already required on medicine labels, the new rules include a longer list of substances that must be declared, the TGA says in the latest Medicines Safety Update.

The additional substances include crustacea, fish, eggs, soya, milk and tree nuts, as well as more detailed items such as potassium salts, royal jelly and sesame seeds.

Additionally, for the first time prescription medicines are also required to declare potential allergens on their labels, or include a statement directing consumers to the CMI leaflet for further information.

However, there are some circumstances in which allergens do not need to be declared on the medicine label, the TGA advises.

“For example, some substances may only cause a reaction if they are administered orally and therefore don’t have to be declared if the medicine is only for topical use, and some substances are only declared if there is a certain amount in the product”.

Sponsors will have four years to implement these changes and fully comply with the new rules.

The TGA says that during the transition period it will undertake targeted communications to consumers regarding the changes and specifically advising them to ‘keep asking your doctor, pharmacist or other health professional about food allergen content in medications’.

“If you are treating patients with known allergies, consider discussing these labelling changes with them”, the agency advises, recommending graphics showing where to find allergen information on their medicine’s label now available on the TGA website.

“In particular, it may be important to ensure patients with less common allergies understand that some potential allergens will still not be covered in the new labelling rules. Additionally, during the transition period, you may need to contact the sponsor of a specific medicine to confirm if it contains any potential allergens (these contact details are provided on the medicine label)”.

Click here for a full list of substances that need to be declared.

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