Sellers' advice. The procedure for state registration of dietary supplements on the territory of the Russian Federation Dietary supplements for cancer and beauty formula

How is the import and sale of dietary supplements in the Russian Federation regulated? How do small stores implement them: are these exclusively gray schemes or are there some ways? The essence of the question: we have been preparing certificates for Japanese dietary supplements for a long time, while a lot of similar products 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 have 2-3 algorithms for bringing dietary supplements to the market with the least loss of budget and time.

Answer

Mikhail Bozhor,

legal advisor at Alta Via

In accordance with the norms of SanPiN 2.3.2.1290-03 “Hygienic requirements for the organization of production and circulation of biologically active food additives (BAA)” dated April 17, 2003, dietary supplements are natural (identical to natural) biologically active substances intended for consumption simultaneously with food or added to food products. Dietary supplements 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, to normalize and/or improve the functional state of organs and systems of the human body, including products, providing restorative, mild diuretic, tonic, sedative and other types of effects in various functional conditions, to reduce the risk of diseases, as well as to normalize the microflora of the gastrointestinal tract, as enterosorbents.

According to Article 24 of the Technical Regulations of the Customs Union “On the Safety of Food Products” (hereinafter referred to as 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 production of products, and when importing dietary supplements - before their import into the territory of the CU. The authorized body in the Russian Federation for the registration of dietary supplements is Rospotrebnadzor. Registration is unlimited, but may be terminated or suspended if the dietary supplement does not comply with the requirements of the TR. The detailed registration procedure is established by Article 25 of the TR and involves submitting to Rospotrebnadzor an application in the prescribed form confirming the safety of dietary supplements, research results and additional documents, as well as information about the purpose of the dietary supplement (a detailed list of documents to be provided is established by clause 29 of the regulations approved by the Order of Rospotrebnadzor dated July 23 2012 N 781). The period for consideration of such an application is 5 working days; if accepted by Rospotrebnadzor, the applicant is issued a certificate of state registration of dietary supplements.

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Registration and receipt of a certificate for the sale of dietary supplements

In accordance with Part 1 of Article 21 of the TR, assessment (confirmation) of the compliance of special food products, including dietary supplements, with the requirements of the TR is carried out, including in the form of state registration. Thus, the mandatory receipt of a certificate of conformity or submission of a declaration of conformity for dietary supplements is not provided for by current legislation. It should be taken into account that, on the basis of Article 39 of the TR, the packaging of registered dietary supplements must necessarily contain the “EAS” marking - a unified mark for the circulation of products on the market of the CU member states.

If the requirements for state registration are not met, manufacturers and sellers of unregistered dietary supplements face the risk of being held accountable on the basis of Part 1 of Article 6.33 of the Code of Administrative Offenses with the imposition on a legal entity of a fine 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 faces the risk of criminal prosecution on the basis of Article 238.1 of the Criminal Code of the Russian Federation - “Circulation of counterfeit, substandard and unregistered medicines, medical devices and circulation of falsified 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 confiscation of unlabeled dietary supplements on the basis of Part 2 of Article 15.12 of the Code of Administrative Offenses.

Rules for selling dietary supplements in 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 trade of dietary supplements is carried out through pharmacies, specialized stores selling health products and grocery stores. Violation of the established rules for the sale of certain types of goods, according to Article 14.15 of the Administrative Code, entails the imposition of an administrative fine on legal entities in the amount of ten thousand to thirty thousand rubles.

Requirements for advertising promoting the sale of dietary supplements

1. create the impression that they are medicines and (or) have medicinal properties;
2. contain references to specific cases of people being cured and their condition improved as a result of the use of such supplements;
3. contain an expression of gratitude by individuals in connection with the use of such additives;
4. encourage people to give up healthy eating;
5. create an impression of the benefits of such additives by referring to the fact that studies have been conducted that are mandatory for state registration of such additives, as well as 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 object of advertising is not a medicine; the above article also establishes additional requirements for the format of 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 Code of Administrative Offenses with a fine of 200 thousand to 500 thousand rubles.

Of course, there are “gray” schemes for selling dietary supplements remotely. Websites for the sale of dietary supplements can be registered under dummies, and the sale of goods can be carried out on behalf of an individual or without even indicating the sender of the dietary supplement. Some existing stores can operate under an agency scheme, ordering unregistered dietary supplements on behalf and at the expense of the buyer abroad for a certain percentage of the cost of the goods, while others can provide exclusively intermediary services, involving the sale of registered dietary supplements to the end buyer through large stores. But all these schemes carry serious risks of prosecution, including criminal liability, for the seller operating within the legal framework.

SELLERS' TIPS

...for the sociable

“It’s good to sell the Company’s new products in a bathhouse or sauna - if in front of other women you take out all the Millenium Alliance bottles and start applying cosmetics, everyone around you immediately shows interest and begins to ask what kind of cosmetics they are. If you don’t mind, it’s better to let everyone try a little of any product - after that I didn’t have enough Booster, I had to go buy more. The July 2006 issue of Planet of Humans helps a lot - I always have it with me. I let you read an article about the properties of Millenium Alliance cosmetics, tell you which website you can go to for more information, and it works. The main thing is to sell with positive emotions, so that people feel what a great product it is and are eager to buy it.”

...for the resourceful

“After Millenium Alliance cosmetics went on sale, I decided to conduct my own marketing research: I visited all the most famous cosmetics stores in Moscow and learned more about luxury products, which includes our new cosmetic line. When going to the next store, I made sure to take my friends with me and, in their presence, asked the sales consultants about different brands. When they saw that cosmetics in stores that had properties similar to Millenium Alliance and were of the same quality level cost about 25-30 thousand, and compared with the price of our cosmetics, they all made a choice in favor of the new product Vision".

...for the attentive

“I remembered some phrases from Tatyana Surova’s training, which was published in Planet of People (No. 11/2006), and tried to use these phrases during the presentation of cosmetics. This was very helpful in making sales and answering any objections. I offer Millenium Alliance luxury cosmetics mainly to wealthy people I know well. In addition, my own visual results after using our cosmetics were sometimes better than any words - people saw how I looked at 59 years old and immediately shelled out money.”

...for the rational

“I addressed those clients who already use dietary supplements Vision and got excellent results. She explained that in combination with the Company’s new cosmetic products, the effect of using dietary supplements would double and this would allow people to look even younger and more beautiful. When I opened Millenium Alliance bottles and my interlocutors smelled the cosmetics, I never had to teach a master class - people immediately made a purchase.”

From the magazine “Planet of People” by VISION

State registration procedure for dietary supplements
on the territory of the Russian Federation

Let's consider the procedure for the actions of a legal entity (manufacturer or seller) who has decided to produce and/or supply to the market a dietary supplement (hereinafter - dietary supplement).

It is worth immediately noting that neither the organization authorized to carry out the retail sale of dietary supplements (according to clause 7.4. SanPiN 2.3.2.1290-03: retail trade in dietary supplements is carried out through pharmacies (pharmacies, pharmacy stores, pharmacy kiosks and others), neither specialized stores selling dietary products, food stores (special departments, sections, kiosks) will accept dietary supplements for sale without the appropriate permitting documents, and exactly:

Certificates of state registration on the territory of the Russian Federation;

Declaration of conformity;

A quality certificate for dietary supplements from the Manufacturer.

The first document that the Manufacturer encounters is SanPiN 2.3.2.1290 - 03“Hygienic requirements for the production and circulation of biologically active food additives (BAA).” He defines a number of main points that lay the foundation for the future fate of dietary supplements, namely:

Requirements for technical documentation for the production of dietary supplements ( chapter III SanPiN 2.3.2.1290 - 03). It’s worth stopping here and emphasizing that you cannot take powdered sugar and citric acid, mix them and register them as dietary supplements. Such a product will be stopped at the stage of examination of technical documentation: technical conditions (TS) and technological instructions (TI);

Requirements for packaging dietary supplements and information on labels ( chapterIV SanPiN 2.3.2.1290 - 03). When submitting dietary supplements for examination, consumer packaging must be equipped with a label on which the information regulated by law is applied; in the future, if the dietary supplement is successfully registered, the Manufacturer will be obliged to put on each label the number of the state registration certificate and the date of its issue;

Sanitary and epidemiological requirements for the production of dietary supplements. This point relates primarily to the Manufacturer. Without receiving a sanitary and epidemiological report, in which the territorial body of Rospotrebnadzor ( Appendix No. 2 to the Administrative Regulations) will give a positive assessment of the conditions (in other words, call them “appropriate”), the production and registration of dietary supplements is impossible.

So, the Manufacturer developed technical specifications, technical specifications, developed and produced a label layout, and received a sanitary and epidemiological conclusion for production.

Now he can proceed to the next stage of registration of dietary supplements: produce a batch of dietary supplements, pack it in consumer packaging that meets SanPiN 2.3.2.1290 - 03 , stick labels in accordance with the same regulatory document, and begin the registration procedure.

An application made in accordance with Appendix 4 to the Administrative Regulations;- TU, TI, recipe for dietary supplements, according to which it is intended to carry out industrial production of products, certified in accordance with the procedure established by the legislation of the Russian Federation;

If the Manufacturer's technical specifications and technical specifications have already been previously examined, it is necessary to provide a sanitary and epidemiological confirmation certificate certified in accordance with the procedure established by the legislation of the Russian Federation;

Sanitary and epidemiological conclusion on compliance of production conditions with the requirements of state sanitary and epidemiological rules and regulations, certified in accordance with the procedure established by the legislation of the Russian Federation;

Instructions for use (insert leaflet, annotation) (in case all the necessary information cannot be placed on the label), certified by the signature of an authorized person and the seal of the Manufacturer;

A consumer (or container) label or its draft, certified by the signature of an authorized person and the seal of the Manufacturer;

Test reports of accredited testing laboratories (centers), conclusions of accredited organizations (organoleptic, physical-chemical, microbiological, radiological studies (tests), studies of the permissible content of chemical, radiological, biological objects, prohibited components and their compounds, microorganisms and other biological agents representing danger to human health in accordance with state sanitary and epidemiological rules and regulations);

An act of sampling (sampling) in the established form; - if there is a trademark - a copy of the certificate for the trademark, certified in the prescribed manner

If the Manufacturer and the Applicant are different legal entities (or the Manufacturer is represented by an individual at the registration authority), when submitting an application and a set of documents, a power of attorney from the Manufacturer is required that he trusts the applicant to represent his interests in the territory of the Russian Federation in carrying out state registration of products manufacturer, as well as a power of attorney for the right to obtain a certificate of state registration of dietary supplements.

Going back a little, we note that we have in our hands all the documents from the list, except for one: a test report from an accredited testing center (laboratory).

Examinations (sanitary and epidemiological examinations, as well as research, testing, toxicological, hygienic and other types of assessments) necessary for state registration are carried out by federal government institutions - centers of hygiene and epidemiology (the list of institutions is posted on the official Internet website of the Federal Surveillance Service in the field of protection of consumer rights and human well-being: www.rospotrebnadzor.ru), other organizations accredited in the prescribed manner (the list of organizations is posted on the official Internet website of the Federal Agency for Technical Regulation and Metrology: www.gost.ru).

However, according to the appendix to Order No. 319 dated November 12, 2007“On the list of organizations carrying out sanitary and epidemiological examinations” Rospotrebnadzor has approved a sample list of organizations that can carry out sanitary and epidemiological examinations, hygienic, toxicological and other types of assessments for the purpose of issuing sanitary and epidemiological conclusions:

Federal State Institution "Federal Center for Hygiene and Epidemiology" of Rospotrebnadzor.

Federal State Institution "Center for Hygiene and Epidemiology in Moscow" of Rospotrebnadzor.

State Research Institute of Occupational Medicine of the Russian Academy of Medical Sciences (as agreed).

State Research Institute of Human Ecology and Environmental Hygiene named after. A.N. Sysina RAMS (by agreement).

Federal Scientific Center of Hygiene named after. F.F. Erisman Rospotrebnadzor.

State Research Institute of Nutrition of the Russian Academy of Medical Sciences (as agreed).

Research Institute of Hygiene and Health Protection of Children and Adolescents of the Russian Academy of Medical Sciences (as agreed).

Research Institute of Physico-Chemical Medicine of Roszdrav (as agreed).

Russian Medical Academy of Postgraduate Education of Roszdrav (as agreed).

Federal State Budgetary Institution "St. Petersburg Research Institute of Radiation Hygiene named after Professor P.V. Ramzaev" Rospotrebnadzor.

Of course, this does not negate the Manufacturer’s right to apply to obtain test reports from any other center or laboratory accredited for such studies, however, the laboratory centers indicated in the list are legitimate and the protocols they issue will certainly be accepted by the state registration authority for dietary supplements.

Thus, the Manufacturer collected all the necessary documents and submitted them to the registration authority. The registration authority registers the application, conducts an examination of the documents and, if there are no complaints, makes a decision on the state registration of dietary supplements. The manufacturer pays the state fee for issuing the certificate, a record of the registered dietary supplement is entered into Federal Register of Dietary Supplements http://fp.crc.ru/gosregfr /, a certificate of state registration is issued to the applicant.

The registration procedure is completed.

Next, the Manufacturer must register a registered dietary supplement in accordance with Decree of the Government of the Russian Federation No. 982 from 01.12. 2009 “On approval of a unified list of products subject to mandatory certification and a unified list of products, confirmation of conformity of which is carried out in the form of acceptance of a declaration and compliance” declaration of conformity and dietary supplements, accompanied by a certificate of state registration, declaration of conformity and quality certificate of the Manufacturer, has a legal basis to enter the counters of authorized organizations for sales to the public.

5.Government of the Russian Federation. REGULATION No. 982 01.12.2009
"On approval of a unified list of products subject to mandatory certification and a unified list of products, confirmation of conformity of which is carried out in the form of a declaration of conformity"(MS Word document 771 KB).

Now they're scamming old people with promises of compensation.

The “Public Reception of the Baltic Media Group” is often contacted by elderly townspeople who have been robbed dry by dietary supplement dealers. All periodicals are replete with instructive stories about gullible old people who gave their last money for supposedly miraculous cures for various diseases, and yet, almost every day, more and more new victims appear, caught in the skillfully placed networks of dietary supplement sellers.

So Lydia Petrovna Petrova (surname changed), a war veteran, fell for their bait. She is a sick person, she suffers from overweight, diabetes and vascular diseases, so when she saw two pretty young women on a regional television program talking about how their company - Harmony LLC - sells amazing products that help you quickly lose weight and cleanse blood vessels , I immediately called this company. And there they treated her kindly. They promised that she would lose weight without changing her eating habits, and that the vessels would be cleaned so that they would be as good as new.

“The woman spoke to me so kindly, encouraged me so much that I simply melted,” says Lydia Petrovna. — Then the courier arrived and brought dietary supplements for 15 - 20 thousand rubles per package.

Indeed, after some time, Lidia Petrovna began to lose weight. I stood on the scales and rejoiced. But for this joy it was necessary to shell out 15 - 20 thousand rubles weekly. The day came when there was no money left at all, and Lydia Petrovna declared to her “benefactors”: she no longer had funds. And this is where the fun began.

“You will be compensated”

- Where will you get them from? - Lidia Petrovna asked.

“And we cooperate with the foundation,” was the answer. — You will be given compensation, but first you need to pay the certificate and commission fee.

- Where can I get money? — The elderly woman sighed doomedly.

“You borrow, and when you receive compensation, you pay back,” they advised on the other end of the line.

And Lydia Petrovna took it - once, twice, and three times.

To open an account at a branch of Impex Bank (as explained by Harmony LLC), she was required to provide all personal data, including the account number to which the pension comes. And she provided. In total, to date Lidia Petrovna has paid the scammers about 500,000 rubles, until she finally realized that no one was going to pay her any compensation. Now she plans to go to court. But it will be difficult to return the money, since dishonest sellers of dietary supplements know how to cleverly get out of such situations. For example, they will take and close Harmony LLC, and open another company - and look for wind in the field.

By the way, the mentioned “Impex Bank” does not exist in St. Petersburg today. The website of this institution reports that it was liquidated back in 2007. That is, scammers do not hesitate to lie to helpless old people, hoping that they cannot check information on the Internet.

Some gentlemen Andrei Viktorovich Kirillov and Natalya Valentinovna Marchenko informed Lidia Petrovna about the opening of an account to which compensation was supposed to be received. The Vecherka correspondent called the phone number Lidia Petrovna called - 224-01-21, and a lively young voice answered, calling herself the dispatcher Oksana. She explained that it is now impossible to contact the named employees, since one of them has a busy phone, and she cannot find the other.

“Leave your phone number and they will call you back,” she suggested.

The correspondent also tried to start a dialogue with the managers of Harmony LLC. She introduced herself to the dispatcher and again asked to speak with one of the managers.

“They are busy,” was the answer. — Leave your phone number, they will call you.

I left my phone number, but never received a call. I tried to find out the address of the company, but the dispatcher refused to give it. In general, the signature is familiar: secrecy and covering up tracks.

How to deal with dishonest sellers of dietary supplements?

If you think that the prices for their goods are unreasonably high, then, as the chairman of the St. Petersburg Society for the Protection of Consumer Rights Evgeniy Vladimirov advises, go straight to the antimonopoly service. There they will determine whether the price is proportional to production costs. If not, such sellers will face huge fines.

In accordance with the Decree of the Chief State Sanitary Doctor of the Russian Federation dated April 17, 2003 No. 50 “On the implementation of sanitary and epidemiological rules and regulations SanPiN 2.3.2.1290-03” and the Decree of the Chief State Sanitary Doctor of the Russian Federation dated May 20, 2009 No. 36 “On the supervision of biologically active food additives (dietary supplements)", the distribution of dietary supplements is possible only through pharmacy chains and specialized stores. If they are brought by some couriers from nowhere, this is a violation. Contact Rospotrebnadzor, they should check the company and also apply appropriate enforcement measures to it.

Well, extortion of money is already a criminal offense, so write a statement to the court. Naturally, in this case it is necessary to seek the help of a professional lawyer. By the way, war veterans have the right to free legal services.

If you are confused and don’t know how to proceed, don’t give up - contact the consumer community - we have several dozen of them in St. Petersburg. There they will tell you what to do.

And once again I would like to warn our respected veterans and pensioners: you can only buy medicines and dietary supplements in pharmacies and specialized departments of stores. Do not listen to any unknown doctors who diagnose you over the phone and “prescribe treatment.” Do not agree to any visits from couriers and do not open your doors to them. Do not shell out money for dietary supplements outside a pharmacy or store. Remember that fraudulent companies are constantly changing tactics. A year ago we wrote that they extort money from old people with threats, but now scammers have come up with some kind of “compensation”. Be alert, do not fall for any tricks, and do not have long conversations on the phone with strangers. Failure to fulfill these conditions usually ends dramatically. There are hundreds of examples of this, including the case described here with Lydia Petrovna.

Context

The Supreme Court (SC) of the Russian Federation stood up for the rights of buyers of dietary supplements, allowing ineffective drugs to be returned to sellers. He took this position on two civil cases involving pensioners from the capital region.

The Supreme Court noted that buyers are not required to understand medicines, therefore any misrepresentation about the properties of tablets should be interpreted in favor of the consumer.

“It is noteworthy that the Supreme Court pointed out to Russian judges the need to take into account the age of the victims, because dishonest companies often manage to persuade elderly people to buy dietary supplements, who spend considerable money on this,” said Pavel Odintsov, head of the press service of the RF Armed Forces.

Dietary supplements for cancer and beauty formula

Cases of attempts to return dietary supplements and funds paid for them that reached the highest court were considered in Moscow and the region; in both cases, pensioners suffered - 81 years old and 95 years old.

Thus, a 95-year-old man was asked to undergo a medical examination, which allegedly revealed a precancerous condition in him. Employees of a private clinic convinced the plaintiff to buy a special device and a set of drugs worth more than 400 thousand rubles.

However, later, at a municipal institution, doctors dispelled the pensioner’s fears, explaining that he did not have oncology and he did not need to use dietary supplements. The applicant immediately asked the seller to return the money and take back the drugs, but his complaint was left unanswered.

Then he tried to resolve the issue in court, but did not find understanding in the courts - the Domodedovo City Court of the Moscow Region rejected the claim, and the Moscow Regional Court recognized this decision as legal and upheld it.

The courts justified their position by the fact that the plaintiff purchased dietary supplements of his own free will, while all the necessary and reliable information about the product was communicated to him by the defendant.

The courts assessed the second case in the same way - an 81-year-old pensioner who heard an advertisement on the radio for the “Formula of Health and Beauty” and purchased drugs for 365 thousand rubles. However, there was no improvement in well-being from taking the medications, and the woman decided to return them, indicating that she planned to buy medicinal products, and not dietary supplements. But the Cheryomushkinsky court and the Moscow City Court left the plaintiff’s claims unsatisfied.

Conscientious seller

The Supreme Court called on the courts to show initiative during the process and themselves establish the dishonest behavior of one of the disputing parties, even if the second participant in the proceedings does not refer to this circumstance.

If the court sees an obvious deviation of the actions of a participant in civil transactions from conscientious behavior, it should not ignore this circumstance, the highest authority emphasizes.

“In this case, the court brings up for discussion circumstances that clearly indicate such dishonest behavior, even if the parties did not refer to them. If dishonest behavior of one of the parties is established, the court refuses to protect the right belonging to it in whole or in part, and also applies other measures to ensure the protection of the interests of the bona fide party (clause 2 of Article 10 of the Civil Code of the Russian Federation),” the court explains.

He also recalls that the Law “On the Protection of Consumer Rights” obliges the seller to promptly provide all necessary and reliable information about the product, including nuances that may affect his choice of purchase (Article 10).

Article 12 of the same law allows the consumer to refuse to execute the sales contract within a reasonable time and demand a refund if it becomes clear that the information communicated to him was not complete.

“It is necessary to proceed from the assumption that the buyer does not have special knowledge about the properties and characteristics of the product. The seller is liable if the non-conformity of the goods is associated with facts that he knew or could not have been unaware of and about which he did not inform the buyer,” notes the RF Armed Forces.

He also explains that the 95-year-old plaintiff bought dietary supplements only because he was misled about the threat to his life. Before this “examination,” the man had no intentions of purchasing such drugs and was not looking for supplements. These circumstances are legally significant, but the courts paid no attention to them, the court was surprised.

It also makes clear that courts must take into account the literal meaning of words and expressions used in contracts to determine its meaning and terms. And in the case of the injured resident of the Moscow region, a literal interpretation shows that he was not given complete information about the drugs he purchased, the highest authority points out.

In addition, the courts did not take into account that a number of additional mandatory requirements were established for biologically active additives: indication of full information about additives on the labels, a warning that dietary supplements are not medicines, a ban on remote or peddling sales, the Supreme Court pointed out.

Burden of Proof

Plenum of the RF Supreme Court No. 17 of June 28, 2012 imposes on the seller the obligation to prove that he fulfilled his obligations properly (clause 28), reminds the RF Supreme Court.

At the same time, the law on the protection of consumer rights obliges the buyer to provide all the necessary and reliable information about goods (works, services), ensuring the possibility of a competent choice, the highest authority points out, noting that the courts must remember that the buyer is not required to thoroughly understand the characteristics of the purchased product.

“When considering a consumer’s claims for damages, the court should proceed from the assumption that he lacks special knowledge about the properties and characteristics of the product,” the court reminds.

Meanwhile, in the case of an 81-year-old woman, the courts referred to the fact that the plaintiff did not prove the fact that she was not provided with adequate information about the drugs purchased.

Thus, the courts, in violation of the direct instructions of the law and the clarifications of the plenum of the Supreme Court, imposed the obligation to prove the lack of proper information on the plaintiff, who does not have special knowledge, while the defendant was obliged to prove the fact of providing appropriate information in a form accessible to the plaintiff, notes the Supreme Court of the Russian Federation.

He points out that the file contains only documents on state registration of products sold and certificates of compliance with uniform sanitary, epidemiological and hygienic requirements for goods.

However, these documents do not contain any information about the composition of the drugs, their properties, side effects, purpose, method of use, contraindications, expected effect of use, etc.

“That is, the conclusions about providing the plaintiff with proper information are not based on any evidence,” the highest authority concludes.

She notes that in both processes, the courts committed a number of significant violations that led to incorrect resolution of disputes. In this regard, the Supreme Court canceled all decisions made in both cases and sent them for new consideration in the appellate courts.

Irina Tumilovich

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