Date Published: 30 June 2019

New Zealand medicines safety authority invites views about allergen warnings

Did you know that the allergens you might expect to find highlighted on lists of ingredients of processed food products might not be required to be stated anywhere on medicine labels ? If you live in New Zealand that might be about to change.

Medsafe, the authority for regulation of therapeutic products in New Zealand has opened a public consultation1 about plans to introduce new labelling requirements for non-active substances in medicines (known as 'excipients'), which have been associated with adverse reactions such as allergies in some people. At the moment, unlike food products, most medicines and related products available in New Zealand are not required to list all the ingredients included in the medicine on the package label. Medsafe is inviting opinions about the proposed changes to package labelling requirements.

Medsafe2 regulates medicines, related products, medical devices and controlled drugs used as medicines. It is responsible for administering the Medicines Act 1981 and Regulations 1984. It is accountable to the Ministry of Health, and through the Ministry to the Minister of Health. It is also accountable to the pharmaceutical industry for those activities which are funded by fees collected from the industry.

Through this public consultation, which opened on 27 June, Medsafe is seeking input and opinions about including on labels warnings of the presence of many substances including but not limited to: Aspartame, milk and milk products, peanuts and peanut products, soya beans and soya bean products, crustacea and crustacean products, egg and egg products, pollen, sugar alcohols, fish and fish products, propolis, galactose, Royal jelly, gluten, saccharin, tree nuts and tree nut products, hydroxybenzoic acid esters, sesame and sesame seed products .

Medsafe's Group Manager Chris James stated1 that changes to labelling is an important step to ensure medicines are as safe as possible for all users, saying that:

" The consultation is asking members of the public, healthcare professionals, consumer groups and industry whether a number of different substances should be included on medicine labels.

_ Some of those substances include egg and egg products, gluten, soya beans and soya bean products, tree nuts and pollen. There are a number of other substances listed in the consultation too.

_ The Medicines Regulations 1984 already requires medicines and other related products to include any warning statements required by Medsafe, either on the medicine package or on an information sheet for patients."

He went on to explain that anyone can already use Medsafe's Product / Application search to check the ingredients in their medicine. That facility is available at medsafe.govt.nz/regulatory/DbSearch.asp where people can find out about medical products that have consent to market in New Zealand and new Medicine Applications and Changed Medicine Notifications submitted to Medsafe since 1 Jan 2006. The new proposal is to increase the list of warning statements so that it would include some non-active substances that experts consider might cause a reaction or an allergy in some people.

Mr James emphasized that Medsafe wants to make medicines as safe as possible, and it is also important to consider the views of whoever might be affected, hence this consultation.

The consultation, entitled "Proposed warning statements for substances (eg, allergens) in medicines that may cause undesirable reactions" will take place between 27 June and 8 August 2019. For further information visit consult.health.govt.nz/medsafe/labelling.

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