“Dietary supplements under reform pressure: market operators call for changes and extension of the transition periodSince March, a Register of Dietary Supplements has been operating in Ukraine, where all dietary supplements must be entered by the
end of September. Market representatives consider the allotted time insufficient, comparing it with European practice.
”, — write: unn.ua
Europe gives years, Ukraine – a few monthsThe insufficiently long “window” for adapting to the new rules became a key topic of discussion. Thus, according to the new regulation, the Register of Dietary Supplements began operating on March 26, 2025. At the same time, a transitional period has been established for dietary supplements that were in circulation before this date – dietary supplements must be entered into the register by September 27, 2025. Otherwise, the sale of unregistered dietary supplements will be illegal and prohibited.
The congress participants emphasize that in Europe, which Ukraine looks to for many issues, similar business changes are given from three to ten years. In Ukraine, only six months were left for process restructuring.
The current regulation, in the form in which it was adopted in December 2024, needs to be changed. The transitional period introduced for this regulation must definitely be extended. That is, officials do not have the resources, and businesses do not have the opportunity to resolve all these issues so quickly. This is a common problem of Ukrainian legislation. When we have any changes, we are then given a few months. While in Europe, for example, three, seven, ten years are allotted for this. Because people there think about business, because they understand that business does not live in a time frame of two months. There are some production plans, some sales plans, they are calculated for years
The lawyer also noted that the changes require more serious work with Ukrainian legislation. After all, the issue is not only to create a large database of dietary supplements, but also to simultaneously create a national Ukrainian register of active substances and dosages, according to which dietary supplements can be sold or not sold.
In addition, Mykola Orlov drew attention to the fact that while the state regulates the circulation of dietary supplements through pharmacies, they are sold uncontrollably on the Internet. Therefore, domestic manufacturers may suffer from the regulation, while importers and online stores are not controlled by anyone.
“No systemic approach”According to Orlov, the pharmaceutical reform in the context of dietary supplement regulation is taking place without a thorough analysis of the experience of other countries and without developing Ukraine’s own position.
In Europe, many issues are left to the discretion of each state. Here, we selectively take examples from Poland, Bulgaria, or Denmark – without explaining why these particular countries. This creates chaos and uncertainty in the market, which is especially painful during the war.
Meanwhile, Daniil Pyshnohraiev, a representative of the drug manufacturer “Multispray”, notes that attempts to regulate the dietary supplement market look like an attempt to lobby the interests of large manufacturers.
For example, vitamin C – there is a dietary supplement, and there is a medicinal product. This is due to the long history of registration back in Soviet times. Both types of products, both medicinal products and dietary supplements, are safe in Europe. Vitamin C, there is no upper consumption level for it, but usually it is sold in 500-1000 milligrams. And in Ukraine, some pharmaceutical manufacturer, for example, who has vitamin C in some large dosage, registered as a medicinal product, and he understands that he has another competitor who produces dietary supplements. To produce dietary supplements, you do not need to obtain a license, you do not need to do pharmacovigilance. Many processes are not needed because this substance is safe. Therefore, it seems to me that such reforms are lobbied by large manufacturers of medicinal products.
The participants of the congress, including representatives of state bodies, pharmaceutical companies, scientists, and associations, outlined their vision for the development of the dietary supplement market in a joint resolution.
Dietary supplements are not medicinesAt the same time, the medical community is also not thrilled with the attempt to strictly regulate the supplement market. The main thing here should be product quality, not formalized sales procedures.
Doctors, commenting on initiatives for stricter regulation of the dietary supplement market, emphasize that these are food products that supplement the diet, not medicinal products. This refers to vitamins, microelements, and other substances that support the body during periods of stress or nutritional deficiencies.
Moreover, doctors are against selling food additives by prescription and through separate cash registers.
This will create confusion, burden doctors and pharmacies, but will not improve healthcare
At the same time, the main risk in the dietary supplement market is quality, not sales. Doctors are unanimous: instead of restricting sales, control over production and product quality on the market should be strengthened.
It is very important that crap is not sold. Prescriptions will not help here in any way
ConclusionRepresentatives of the pharmaceutical market emphasize that without harmonization with European norms, clear rules, and real quality control, the reform of dietary supplement circulation risks turning into an instrument of lobbying, rather than market development and consumer protection.