Is a license needed for dietary supplements?
When licensing pharmacy activities, questions often arise about the possibility of selling biologically active additives (dietary supplements). Dietary supplements is a category of substances that are consumed to supplement a person’s diet with those elements that he does not receive from food.
Currently, dietary supplements, despite numerous disputes over their benefits or harms, continue to be successfully sold and consumed. At the same time, dietary supplements do not fall under the definition of “medicinal product”, which means that they can be sold not only through a pharmacy, but also through other trading establishments.
The legalization of dietary supplements is carried out by obtaining expert opinions on a voluntary basis.
From this it can be concluded that a license for dietary supplements does not imply a license to carry out pharmaceutical activities.
At the same time, even if dietary supplements are not subject to licensing, it is still necessary to obtain a hygienic conclusion of the Sanitary and Epidemiological Service (SES) for the product.
Such a conclusion is necessary even in the case of the dietary supplements sales without a pharmacy, since the inspection authorities may have questions about the legality of such additives sales.
When dietary supplements registration is required?
The Law of Ukraine “On the Basic Principles And Requirements For the Safety And Quality Of Food Products” defines dietary supplements not as a medicinal product but as a food product, and, accordingly, cancels the need for licensing the production and trade of such additives, since such activities are not included in the list of Article 7 of the Law “On Licensing of Types of Economic Activity”.
At the same time, there are cases when dietary supplements need to undergo state registration. The registration procedure becomes mandatory in the case when the biologically active additive falls under the term “newest food product” enshrined in the Law “On the Basic Principles And Requirements For the Safety And Quality Of Food Products”, namely:
– if the food product does not have a history of safe consumption in the territory of Ukraine and it can have significant changes and/or affect a person, if:
1) the use of the process of growing animals and/or plants, which was not previously used for these purposes;
2) the production by applying a production process not previously used specifically for this type of product or ingredient;
– if a food product does not have a history of safe consumption in Ukraine, is safely consumed in another country/countries and has significant changes and/or impacts on a person.
In the event that the developed and produced dietary supplement meets one of the above criteria, you must contact the Ministry of Health for mandatory state registration.
Cost and terms of license registration
The term for obtaining a license for a pharmacy for the sale of dietary supplements, which fall under the definition of “medicinal product”, in the case of submitting all the necessary documents, as well as after paying the administrative fee, according to the information of the Portal of Electronic Services of Ukraine, is 10 days.
However, it must be taken into account that the preparation of all documents, equipment of the premises, selection and hiring of personnel can take a lot of time, so make sure that competent lawyers will deal with the issue of legal support, since this will determine not only the terms, but the overall result of obtaining a license.
The cost of obtaining a license for a pharmacy, in addition to the cost of renting premises and covering utility costs, includes the administrative fee, for October 2021 – in the amount of 2379 UAH. This fee is paid within 10 days after the decision of the commission of the Ministry of Health to grant a medical license.