A lot is known about the benefits and widespread demand for dietary supplements. These are specialized nutrients that are used with food to help restore healthy internal organs and systems. However, before you start selling such supplements, you need to register them. The obligation of this procedure is due, first of all, to the strict quality control, implemented in the territory of the Russian Federation and the countries of the Customs Union.
In this article, we will describe in detail what the state registration of dietary supplements is. You will find out what documents need to be prepared for the implementation of the above procedure, as well as get acquainted with the scheme of its implementation and existing prices.
How to get a certificate of state registration of dietary supplements in Russia?
Before introducing new food additives to consumers that enrich the human body with useful substances, it is recommended to pay attention to the proper paperwork. This will allow you to avoid problems with law enforcement agencies in the future and exclude the payment of a monetary penalty in the form of a fine.
In what cases is the registration of dietary supplements possible?
The state registration of biologically active additives can be passed only on condition that the declared products meet the requirements of this group of goods, and the active substances that make up it are not included in the list of prohibited components (TR CU 021/2011. Appendix No. 7).
In accordance with the wording of the Customs Union, dietary supplements include biologically active components of natural origin, as well as probiotics that are used with food or are present in its composition.
Thus, the state registration of dietary supplements is considered possible only in the following situations:
- The product description does not indicate that it is intended for medicinal purposes;
- The presented product does not have any medical or medicinal characteristics;
- Advertising of this food supplement (if it is already actively sold in other countries) does not contain incorrect information and calls to abandon a healthy diet.
If any inconsistencies are found, we strongly advise you to correct them before the registration of dietary supplements in Russia begins. In the absence of contradictions, it is important to make sure that the chemical and biological properties of the manufactured product meet the legal requirements (namely, TR CU 021/2011. Appendix No. 8).
documents for state registration of dietary supplements
Since the registration of dietary supplements is carried out in accordance with the requirements of the law, special attention is paid to the presence of all the necessary documentation and its proper compilation. In the absence of any instructions, descriptions, certificates or permits, it is imperative to develop or obtain them.
However, not all manufacturers who require registration of dietary supplements are able to do so within the specified time frame.
Our specialists are ready to provide you with qualified assistance in case of such difficulties. We have solid experience in the registration of dietary supplements in Russia and are able to provide detailed advice on any issues related to this process, or competently draw up the necessary documentation.
Control samples for registration of dietary supplements
When it comes to the registration of dietary supplements in Russia, special attention is paid to clinical trials, since they determine the possibility of a product entering the domestic market.
Therefore, when preparing control samples or test samples, the following important points should be considered:
- Standard lot weight. For one sample, it is 300 g. In the presence of a multicomponent food additive, several research centers can be involved in testing. This indicates the need to have an additional product of the same weight available;
- In the event of multiple changes to the formula of a drug, it is important to make sure that expert studies involve products manufactured in accordance with the updated version. If, after the experiments, results are obtained that do not correspond to those stated in the previously provided documents, you should not wait for a positive expert decision;
- Consideration should be given to the fresh appearance of the control samples and the observance of appropriate storage conditions. In another situation, the manufacturer can only count on a negative conclusion.
Medical device registration rules
Similar to other procedures of national importance, the registration of food additives can have its own problematic points. That is why, during preparation for the above process, it is important to consider the following factors:
- Based on the existing requirements of the Customs Union, the issuance of a registration certificate is carried out only to those organizations that carry out their activities in one of the states present in its composition. As for foreign suppliers, it is a prerequisite for them to conclude an agreement with a representative company;
- The validity period of the registration certificate is unlimited. That is, if earlier the manufacturer was issued a certificate of registration of food additives, then there is no need for an additional procedure;
- Since the state registration of dietary supplements is carried out by Rospotrebnadzor, only the above-mentioned federal body or its accountable structures can issue a corresponding certificate. If you receive a proposal for the preparation of documentation in the shortest possible time and at a low cost from any third-party institution, you can be sure that scammers are dealing with you. To find out information about accredited organizations, we suggest that you visit the official website of Rospotrebnadzor;
- In case of issuing a negative expert opinion or receiving a refusal to enter the manufacturer into the register of certificates of state registration of dietary supplements, funds for services rendered are not refundable. Information about the conditions established by the Customs Unions in relation to the declared product can be found in the public domain. Therefore, concerns about the compliance of the food additive with the requirements are completely borne by the customer;
- If a negative opinion is issued, it is necessary to carefully study the reasons for the refusal. After elimination of all inconsistencies, it is possible to reapply for a registration certificate.
Stages of dietary supplements registration
As you have already noticed, the registration of dietary supplements in Russia is carried out in strict accordance with the law and is a rather complicated process that requires significant time and effort. If it is not possible to complete this procedure, we are ready to provide professional support. To do this, it is enough to contact our specialist by phone or send an application in electronic format. You will receive an answer as soon as possible.
In the future, the state registration of dietary supplements will be carried out according to the following algorithm:
- The customer sends us a package of necessary documents, attaching a sample of dietary supplements to it in a standard mass for which it is planned to obtain a certificate;
- Our employee gets acquainted with the received documentation, conducts a thorough analysis and prepares a dossier for further testing. In addition, at this step, the cost of services is calculated and an accompanying contract is drawn up;
- Further, the product is subjected to the necessary clinical studies. The number of tests, their period and prices are set for each food additive on an individual basis;
- The expert evaluator sends documents to the Rospotrebnadzor authorities. If necessary and based on the requirements of this federal service, additional papers and materials are being prepared;
- After receiving the registration certificate, our specialist sends it to the client;
- If the products do not pass registration, the employees get acquainted with the recommendations provided by Rospotrebnadzor, and participate in the elimination of the declared inconsistencies and shortcomings.
Registration price of dietary supplements in Russia
Many customers who require registration of dietary supplements in Russia are primarily interested in prices for such services. It should be understood that there is no equal cost for registration events. In each individual situation when it is planned to register dietary supplements in Russia, the following factors may affect prices:
- The need for accompanying activities. For each product unit, the cost of services can reach 80 thousand rubles and more. Such works include: appeal to the Rospotrebnadzor authorities, analysis of the submitted papers, registration of applications, etc.;
- Efficiency. Most of the expert procedures are carried out on a first come, first served basis. Moreover, the terms can stretch for weeks and months. If you want to shorten the duration of events, you will have to pay about 5 thousand rubles for the urgency. This cost includes prompt departure of employees;
- The number of clinical trials and the composition of dietary supplements. In this case, it is impossible to determine the cost in advance. Even if the manufacturer has on hand all the necessary test results and protocols, confirmed by third-party institutions, the need for additional checks is not excluded;
- Any fees charged by government agencies are the responsibility of the customer.
If you want to find out in advance the total cost of the work, our specialists are ready to provide detailed information over the phone.
Dates of registration of dietary supplements
As a rule, the period for the implementation of procedures related to the registration of food additives is determined taking into account the employment of regulatory bodies, research centers and other authorized structures. If we talk about approximate terms, then they are set according to the following scheme:
- Clinical trials – over 1 week. If the food additive has a complex composition, then the research period may be prolonged;
- Drawing up an opinion by experts in expert assessment – 4-6 weeks;
- State registration of food additives – about 1 month.
Our registration of dietary supplements is carried out by employees with impressive experience and the highest qualifications, which can significantly reduce the period for providing a certificate. However, be prepared for some additional costs for out-of-order services.
Why clients prefer to work with “Quality” LLC?
Various organizations are ready to provide support in the implementation of procedures related to the registration of dietary supplements. But, unfortunately, only a few of them are able to organize favorable conditions for cooperation.
Our company has been working in this area for a long period of time, which has allowed us to provide registration certificates to thousands of clients. At the same time, by contacting us, you can count on the following privileges:
- Loyal prices. We have established a democratic cost for services. Moreover, if it is necessary to register several dietary supplements at the same time, we are ready to provide the customer with impressive discounts;
- High level of professionalism. Thanks to close cooperation with leading research centers and expert specialists, all organized inspections and tests are carried out with the utmost accuracy and reliability;
- Guaranteed result. The specialists of “Quality” LLC are guided by the full-fledged provision of services. This means that if you have received a refusal to issue a certificate for certain food additives, we will give valuable advice on how to quickly resolve the discrepancies, and provide support for reapplying;
- Short time. We strive to minimize the time spent by clients and carry out all the necessary work in the shortest possible time;
- Availability. Our specialists are in touch around the clock. That is, if you have any questions and need to resolve controversial issues regarding the preparation of the necessary papers, we will advise you on-line.