Member Article

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 .
However, according to the unofficial information we have received from the Faculty in the meantime, it seems that the purpose of introducing this provision is that the whole product labelling process (i.e. all the amendments that potentially need to be made) is completed before the Faculty. Therefore, contrary to the practice so far, the accredited health institutions that perform the laboratory analysis of these products and that issue expert opinions (after the Faculty performs the categorization of the products and issues its expert opinion) are no longer involved with the issue of labelling of these products (which they were up until now). It remains to be seen whether this policy will be consistently implemented in practice, but if it is, its introduction should significantly simplify and shorten the procedure conducted before the authorized laboratories.

The Faculty is, in certain cases, obliged to request the expert opinion of the Agency for Medicines and Medical Devices (ALIMS) prior to categorising a product and issuing its expert opinion.

Although the number of documents that need to be submitted to the Faculty in order for it to perform a product categorization and for it to issue its expert opinion has been reduced (for example, is no longer required to submit the result of the verification of the composition and health conformity of the finished product from an accredited laboratory), a new obligation has been placed on the Faculty - to request and receive an expert opinion from ALIMS that the product is not a medicine, prior to it issuing its own expert opinion. This obligation exists whenever the product contains, as an active ingredient, a plant, plant raw material, plant raw material preparation or an ingredient extracted from plant materials, which are not commonly used in nutrition. It is not clear what the term "commonly" includes or excludes and how narrowly or broadly will this term be interpreted in practice, but we believe that it is almost certain that the introduction of such an obligation on the Faculty will result in the further lengthening of the procedure before the same, and therefore also in the lengthening of the timeframe required for product registration before the Ministry (since a registration is not possible without first obtaining an expert opinion of the Faculty).

Requests for expert opinions which are submitted to the Faculty and the accredited laboratory regarding dietetic products may no longer be submitted in “free form”

On the procedural side, in addition to the existing form of the request for the registration of a product in the data base that is submitted to the Ministry, the requisite form of the requests that are to be submitted to the Faculty and the certified laboratory have also now been introduced.

The rules on the composition of dietetic products and on microbiological criteria for the determination of their health conformity have been amended

A series of changes have been made in the tables which represent the integral part of the Regulation, in the Appendices. These tables contain the specific rules on the composition of dietetic products (for example, rules on nutritional substances, amino acids and other nitrogen compounds, on proteins used in the production of initial infant formulas, on the reference values for nutritional labelling of food for infants and young children, on the maximum permitted amounts of vitamins and minerals in daily doses of food supplements for adults, etc) and on microbiological criteria for the determination of the health conformity of certain dietetic products and food supplements.

A new time-limit has been specified for the completion of the procedure for the registration of dietetic products that have been sold on the Serbian market before 11 July 2010

The Regulation on Health Conformity of Dietetic Products initially entered into force on 11 July 2010. Taking into consideration that it introduced the obligation to register dietetic products before the Ministry as a precondition for their marketing, any dietetic product which had not already been on the market in Serbia before the day when this Regulation entered into force (i.e., until 11 July 2010) could not have been sold prior to it being registered before the Ministry.
However, those dietetic products that were sold in Serbia even before the introduction of the registration obligation (i.e. before 11 July 2010) could still have been sold, regardless of the fact that they were not registered, but under the condition that a request for registration was submitted and that the procedure upon the submitted request was completed by 31 December 2011. Bearing in mind that the practice has shown that this process lasts a very long time (several months), primarily because it takes a long time to get the expert opinions from the Faculty and the accredited laboratory in Serbia, the deadline has been extended. The new deadline is 1 January 2013. The sale of products that have not been registered until then will not be possible on the Serbian market after this date.

If you have any questions or concerns, please contact us on the following email addresses:


→ Marjan Poljak, Partner, Commercial & Healthcare
[email protected]

→Sanja Spasenovic, Senior Associate, Commercial & Healthcare
[email protected]