Karanovic & Nikolic

Dietetic products – New rules

New amendments to the Regulation on Health Conformity of Dietetic Products have entered into force on 28 May 2012. Here are some of the most significant changes that are prescribed by these amendments to the Regulation. As a reminder, this is a regulation that introduced the obligation of the registration of dietetic products (including supplements) in July 2010, and is a regulation that regulates the issues of labelling and the composition of these products in details. The list of documents that need to be submitted to the Ministry of Health as part of the request for a registration of dietetic products has been amended. 

One of the changes that we particularly emphasize - a document that now has to be submitted to the Ministry, and which was previously not required at all, is the text of the label approved by the Faculty of Pharmacy. The wording of this provision is quite scant, and therefore it is unclear why this document is required at all. Namely, the Faculty has already been in charge of addressing the issue of the correctness of the existing product labels, in the process of the categorization of dietetic products, and indicates its objections in that respect (as part of a written expert opinion on a specific product) where there was a need to amend an existing label…

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