Sale of dietary supplements law phorum. Can an individual entrepreneur sell dietary supplements? About distance selling of dietary supplements

If the management of the pharmacy has decided to sell biologically active additives (dietary supplements), you should decide whether you need an additional license for this.

But what if the pharmacy sells such substances using the services of a commission agent who does not have a license to conduct pharmaceutical activities? We will answer these questions, and also tell you about the conditions that must be met when selling dietary supplements.

Does a pharmacy need a license?

In accordance with the legislation, pharmaceutical activities are also subject to licensing. It includes the wholesale, retail trade of drugs and their manufacture. The basis is subparagraph 47 of paragraph 1 of article 17 of the Federal Law of August 8, 2001 No. 128-FZ, paragraph 1 of the Regulation on the licensing of pharmaceutical activities.

At the same time, dietary supplements - natural (identical to natural) biologically active substances - are intended to be consumed simultaneously with food or introduced into the composition food products... This is stated in Article 1 of the Federal Law of January 2, 2000 No. 29-FZ "On the quality and safety of food products."

Thus, dietary supplements do not belong to drugs. And in accordance with Law No. 128-FZ, their production and sale are not subject to licensing. That is, no special permission is required for the implementation.

Terms of sale of dietary supplements

When selling dietary supplements for each type of supplement, a sanitary and epidemiological conclusion must be obtained. After all, the substance must comply with state sanitary and epidemiological rules and regulations. The basis is clause 7.4.6 of SanPiN 2.3.2.1290-03, approved by the Chief State Sanitary Doctor of the Russian Federation on April 17, 2003. In addition, the characteristics of dietary supplements, the requirements for them, as well as the criteria and methods for determining their safety are given in Methodical instructions MUK 2.3.2.721-98.

So, organizations that sell biologically active additives are obliged to ensure the conditions of sale in accordance with the regulations agreed upon during registration.

At the same time, in addition to the above requirements for the sale of dietary supplements, the following are established. It is not allowed to sell biologically active food additives:

Without quality certificate;
- expired;
- in the absence of proper conditions for implementation;
- without information on the mandatory registration of dietary supplements;
- without a label, as well as in the case when the information on the label does not correspond to the information agreed upon during registration;
- which is not possible to identify.

Please note: clause 7.4.6 of SanPiN 2.3.2.1290-03 indicates another condition that the organization must comply with when selling dietary supplements. The label of each of them must contain information applied in accordance with the requirements of current legislation.

WHO CAN SELL SUPPLEMENTS?

Retail sale of dietary supplements is possible through:

Pharmacies (pharmacies, pharmacy stores and kiosks, etc.);
- special stores selling dietary products;
- grocery stores (special departments).

This is stated in clause 7.4.1 of SanPiN 2.3.2.1290-03.

So, it is clear that, for example, shops do not need a pharmaceutical license.

After all, they do not sell drugs or manufacture them.

In this case, the store can also act as a commission agent if the pharmacy concludes an agreement with it. This means that he has the right to sell dietary supplements without any special permission (license).

In accordance with the Russian federal laws on the territory of the country, some industries are allowed to manufacture and sell dietary supplements. These are not medicines, therefore, the requirements for them are completely different. A dietary supplement is understood as an active substance consumed with food.

The dietary supplement is used exclusively with food products; when registering a PI, you can get information about the effective action of the additive. Before registration, the safety of the substance is necessarily checked, for this an examination is appointed. If you plan to resell the funds, then you do not need to take care of this, everything Required documents draws up the manufacturer of dietary supplements.

Additional actions

Like any entrepreneurial activity the sale of dietary supplements to individual entrepreneurs should be carried out only after registration and receipt of the relevant documentation from the Tax Office. Moreover, each product must go through SanPiN 2.3.2.1290-03, according to which not only individual entrepreneurs can trade in goods, there are pharmacies, pharmacy kiosks and even a grocery store on the list.

In other cases, the sale of dietary supplements is considered illegal. That is, selling goods at home is strictly prohibited, however, as well as delivering it by courier, selling it in a doctor's office, through an online store, and so on. In accordance with Federal Law No. 36, doctors cannot prescribe a drug as the main drug, because in its essence it is not.

What is dietary supplement and the truth about it

Even if the product is distributed through a well-organized premises in accordance with the law, then it cannot be advertised from the position that it is able to cope with any problems and can be a panacea for all problems. The drug has no healing properties, but only is an active food supplement.

Inside, as a rule, simple dried herbs, different uses, fees. In medicines, the main components are more often chemically active substances, they have an intense effect on the focus of the disease. there will be no significant effect from taking dietary supplements.

Number of products on the market

To date, there are about 7 thousand different types of dietary supplements registered on the market. The number of distributors is also increasing, but to a greater extent this business is not legal. Entrepreneurs do not want to work in the conditions of modern legislation and deliver the product by courier via the Internet portal.

In fact, there is nothing difficult in organizing legal activities. The list of documents and the registration procedure is no worse than when organizing any other business.

Unfortunately, the majority of even legal sellers continue to deceive buyers and claim that their products do a lot to improve health and are able to replace even drugs. For such actions, the legislation punishes sellers, literally it sounds like this:
Production, storage, transportation for the purpose of marketing, or the sale of counterfeit medicines, - shall be punishable by a fine in the amount of up to five hundred thousand rubles or in the amount of wages or any other income of the convicted person for a period of up to three years, or restraint of liberty for a term of two to four years, or imprisonment for a term of up to four years.

Production, storage, transportation for the purpose of marketing, or the sale of counterfeit dietary supplements, including under the guise of medicines, - shall be punishable by a fine in the amount of up to four hundred thousand rubles or in the amount of the wage or salary or other income of the convicted person for a period of up to three years, or restraint of liberty for a term of two to three years, or imprisonment for a term of up to three years.

Application of incorrect information

There is no need to invent a clinic or a specialized center in order to sell dietary supplements. To do this, today it is quite enough to issue an individual entrepreneur and work within the framework of the law, so that later you do not face quite serious problems.

IN recent times the government has toughened the punishment for non-compliance with the norms, and all because several thousand people have died from the use of low-quality dietary supplements in several years and this amount is starting to increase. It is not even necessary to create an LLC, it will only be required if the entrepreneur wants to create several outlets.

For distributing the drug as an expensive means as a medicine, you will simply be deprived of your activity and imprisoned for quite an impressive number of years.

OKVED codes

Among the main OKVED codes that should be indicated when organizing entrepreneurship for the distribution of dietary supplements:

Similar materials

Health - main value person.

Of the factors that affect the duration and quality of life, three main ones can be distinguished

• Harmful external environment
• Pathological heredity
• Imperfect health care system

A common factor that affects well-being is the individual lifestyle of a person.

The absence of bad habits, a balanced diet, the consumption of a sufficient amount of vitamins and minerals, the guarantee of good health.

Regular intake of dietary supplements will improve the quality of life, provide a continuous flow of essential micronutrients.

Effects on the body

Dietary supplements are not medicines or food.Dietary supplements are obtained from plants.Designed to be taken together with food.Supplements enrich the human body with essential trace elements, minerals, and vitamins.However, not all supplements are healthy.

In order to save money, people often buy products from dubious manufacturers. Such drugs can cause allergies and poisoning of the body.When choosing a product, focus on the products of trusted manufacturers.

Supplements presented on our website have passed mandatory certification and comply with the quality standardHalal. We personally check the products for their quality and effectiveness.We offer dietary supplements for sale only if they are effective and safe.

Contraindications

The active substances in the supplements have no contraindications, except for individual intolerance.For example, if a person is allergic to pollen, then you should refuse to take funds that include the allergen.

There are many life situations when supplementation is needed.Having bought dietary supplements, a person in a short time restores the deficiency of vitamins, trace elements, minerals.

Slimming Supplements Promote Weight Loss

Supplements for Athletes Accelerate Post-Workout Recovery

Supplements for immunity increase resistance to colds and viral diseases.

An example of an effect on sexual function

Some men experience sexual dysfunction as they age.The problem is associated with disruption of the cardiovascular system and disorders of the gastrointestinal tract.

In this case, it is recommended to buy dietary supplements for men based on Epimedium and Tribulus.Specially developed complex, stimulates testosterone production, prolongs erection, improves the reproductive system.

Types of supplements presented on our website

• In capsules
  
• Honey syrups with herbs
• Cold pressed oils
• Natural powders based on seeds and herbs

For what

• for immunity and general strengthening
• to cleanse the stomach and improve digestion
• complexes for women and men
• for beautiful, healthy skin
• for the prevention of cardiovascular diseases
• for joints, bones
• for respiratory health
• for a clear mind, memory

The advantage of dietary supplements from chemicals

Taking medications and others drugs relieve a person from the symptoms of the disease, without eliminating the causes of their occurrence. Most synthetic drugs are not absorbed by the body, damaging the digestive tract.

Unlike chemical drugs, the drugs presented on the site have no side effects. Stimulates resistance, prevents complications. A person has been given a great potential for self-healing from birth, but health weakens with age. In order to prevent the development of diseases and maintain vital functions, it is necessary to compensate for the deficiency of minerals and vitamins.

Daily intake of dietary supplements will ensure the normal functioning of the body, and prevent the occurrence of serious diseases. It is better to buy dietary supplements, to take them regularly as a preventive measure, than to spend a lot of money on fighting diseases.

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Updated: 28 August 2018

How is the import and sale of dietary supplements regulated on the territory of the Russian Federation? How do small shops implement them: are these exclusively gray schemes or are there any ways? The crux of the matter: we have been preparing certificates for Japanese dietary supplements for a long time, while a lot of similar funds are sold by small online stores here and now. In the absence of serious budgets, how are they legalized in Russia? Are there any ways to simplify the procedures for preparing dietary supplements for sale? As an answer, it would be great to get 2-3 algorithms for bringing dietary supplements to the market with the least loss of budget and time.

Answer

Mikhail Bozhor,

Legal Counsel for Alta Via

In accordance with the norms of SanPiN 2.3.2.1290-03 " Hygiene requirements to the organization of production and circulation of biologically active food additives (BAA) ”dated 17.04.2003, biologically active additives are natural (identical to natural) biologically active substances intended for consumption simultaneously with food or for incorporation into food products. BAA are used as an additional source of food and biologically active substances to optimize carbohydrate, fat, protein, vitamin and other types of metabolism in various functional states, for the normalization and / or improvement of the functional state of organs and systems of the human body, including products that provide fortifying, mild diuretic, tonic, soothing and other types of action in various functional states, to reduce the risk of diseases, as well as to normalize microflora gastrointestinal tract, as enterosorbents.

According to Article 24 of the Technical Regulations Customs Union"On food safety" (hereinafter - TR), dietary supplements are allowed for production, storage, transportation and sale only after their state registration... When manufacturing dietary supplements on the territory of the Customs Union (hereinafter referred to as the CU), state registration is carried out at the stage of preparation for the production of products, and when importing dietary supplements - before their import into the territory of the CU. The authorized body for the registration of dietary supplements in the Russian Federation is Rospotrebnadzor. Registration is unlimited, but it can be terminated or suspended if the dietary supplement does not meet the requirements of TR. The detailed registration procedure is established by Article 25 of the TR and involves the submission of an application to Rospotrebnadzor in the prescribed form, confirming the safety of dietary supplements, research results and additional documents, as well as information on the purpose of dietary supplements (a detailed list of the documents provided is established by clause 29 of the regulations approved by the Order of Rospotrebnadzor dated July 23 2012 N 781). The term for consideration of such an application is 5 working days, if Rospotrebnadzor accepts the applicant, a certificate of state registration of dietary supplements is issued.

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Registration and obtaining a certificate for the implementation of dietary supplements

In accordance with part 1 of article 21 of the TR, the assessment (confirmation) of the compliance of special food products, including dietary supplements, with the requirements of TR is carried out, including in the form of state registration. Thus, the obligatory receipt of a certificate of conformity or the submission of a declaration of conformity for dietary supplements is not provided for by the current legislation. At the same time, it should be borne in mind that, on the basis of Article 39 of the TR, the packaging of registered dietary supplements must necessarily contain the EAC marking - a single sign of product circulation on the market of the CU member states.

If the requirements for state registration are not met, for manufacturers and sellers of unregistered dietary supplements there is a risk of prosecution on the basis of Part 1 of Article 6.33 of the Administrative Code with the imposition of a fine on the legal entity in the amount of 1 million to 5 million rubles or administrative suspension of activities for up to ninety days. If the violation is committed on a large scale (the cost of sold dietary supplements exceeds 100 thousand rubles), then the seller risks being prosecuted on the basis of Article 238.1 of the Criminal Code of the Russian Federation - "Circulation of counterfeit, substandard and unregistered drugs, medical devices and circulation of counterfeit dietary supplements" ... The sale of dietary supplements without the required labeling creates for a legal entity the risk of a fine in the amount of 50 thousand to 300 thousand rubles with the confiscation of unmarked dietary supplements on the basis of Part 2 of Article 15.12 of the Administrative Code.

Rules for the sale of dietary supplements on the territory of Russia via the Internet

Remote sale of dietary supplements is not allowed. According to clause 7.4.1. SanPiN 2.3.2.1290-03, retail Nutritional supplements are carried out through pharmacies, specialized stores selling dietary products and grocery stores. Violation of the established rules of sale certain types goods, in accordance with Article 14.15 of the Administrative Code, shall entail the imposition of an administrative fine on legal entities in the amount of ten thousand to thirty thousand rubles.

Requirements for advertising stimulating the sale of dietary supplements

1. create the impression that they are drugs and / or have medicinal properties;
2. contain links to specific cases of curing people, improving their condition as a result of the use of such additives;
3. contain expressions of gratitude by individuals in connection with the use of such additives;
4. encourage the rejection of a healthy diet;
5. create an impression of the benefits of such additives by referring to the fact that research is required for state registration of such additives, and also use the results of other studies in the form of a direct recommendation for the use of such additives.

In addition, advertising of dietary supplements in each case must be accompanied by a warning that the advertised object is not drug, the above article also establishes additional requirements for the format advertisements... In case of violation of the requirements for advertising dietary supplements, the advertiser or advertising distributor may be held liable under Part 5 of Article 14.3 of the Administrative Code with a fine from 200 thousand to 500 thousand rubles.

Of course, there are "gray" schemes for the implementation of dietary supplements in a remote way. Sites for the sale of dietary supplements can be registered on front persons, and the sale of goods can be carried out on behalf of natural person or without specifying the sender of the dietary supplement at all. Some of the existing stores can operate according to the agency scheme, ordering unregistered dietary supplements on behalf of and at the expense of a buyer abroad for a certain percentage of the cost of the goods, part - to provide exclusively intermediary services, involving the sale of registered dietary supplements to the end customer through large stores... But all these schemes carry serious risks of prosecution for a seller acting in the legal field, including criminal liability.