Full-Service Dietary Supplement Registration

Experts in EAEU Technical Regulation for Dietary Supplements & Specialized Foods

What We Do Well

State Registration Certificate (SGR) Acquisition with Full Support

Innovation Management, Team Strategy Consulting, Process, and People Management in R&D

Monitoring of Regulations for the Circulation and Sale of Dietary Supplements

Marketing Texts for Dietary Supplements and Ingredients: Clear, Persuasive, and Compliant with EAEU/RF Legislation

Our Expertise in Dietary Supplement Registration

Over 20 years of experience, working with both domestic and international clients, and in-depth knowledge of regulatory requirements.

From 2 Months: Comprehensive Support from Composition Analysis to SGR Issuance (provided documentation is clearly defined).

We work directly with Rospotrebnadzor (RU FDA) and/or the Institute of Nutrition, as well as with the largest laboratories in the Russian Federation.

Over 1000 products registered in 20 years

Comprehensive R&D and Innovation Development

From Strategy to Operational Efficiency

1

R&D Management

Optimization of Product Lifecycle Processes, Development of Effective R&D Structures, Development Automation, Setting Up Personnel Selection and Development Systems, and R&D Strategy Formulation.

2

Innovation Management

Trend Monitoring, Innovation Idea Generation and Prioritization, Partnership Building, Competency Development, and Digital Tool Implementation.

3

Improving Operational Efficiency

Support for New Product Introduction, Raw Material and Finished Product Portfolio Optimization, Supplier Quality Audits, and Documentation Traceability Assurance.

Dietary Supplement Registration from 2 Months

01

02

03

04

05

Week 1

Formula and Label Analysis

Weeks 2-4

Laboratory Testing

Weeks 3-5

Dossier Compilation for Expert Opinion

Weeks 5-6

Weeks 7-8

Obtaining an Expert Opinion

Obtaining State Registration Certificate (SGR) via Rospotrebnadzor (Russian FDA)

This timeline is applicable if the manufacturer has a compliant label and formulation that meets legal requirements, and product samples are available for testing. Any delays at these stages may impact the overall registration period.

Our team

We are experts specializing in the registration of dietary supplements and specialized nutrition. Our mission is to make the process of bringing your products to the EAEU market simple, fast, and efficient.

Natalia Sxodceva

Technical Regulation Expert and R&D business processes expert

Natalia is the Founder of NutriComply and an expert with over 15 years of experience in major international FMCG companies. Until 2022, she led the R&D department at Amway Russia, overseeing product launches in the Central Asia and Ukraine markets.

Natalia specializes in developing regulatory strategies and successfully registering products across various categories, including dietary supplements and food products. Her expertise also encompasses new product development and quality control.

Education: The Master degree in Organic Chemistry (Mendeleev University of Chemical Technology of Russia) and the Master degree in Organization Management (State University of Management).

Anna Grinchenko

Technical Regulation Expert

Anna is a Key Expert at NutriComply with over 20 years of experience in technical regulation. Anna has experience working in expert organizations (ZAO NЭK MosExpertiza) as well as in large international and Russian FMCG companies.

Anna specializes in the registration of dietary supplements (БАД), specialized food products (including sports nutrition), food products, perfumery and cosmetic products (PCP), and household chemicals.

Education: Specialized education in the food industry (Moscow State University of Applied Biotechnology - Rosbiotech).

Alexey Neumoin

R&D Business Process Expert

Alexey is a NutriComply Expert in R&D for consumer goods, with over 10 years of experience in managing innovation and development within major international and Russian companies.

He holds a PhD in Natural Sciences from the University of Zurich, Switzerland.

Alexey specializes in comprehensive analysis and the establishment of product lifecycle management processes within the FMCG sector. His expertise also includes scouting and scientifically evaluating innovative projects, as well as developing R&D strategies.

Education: Biochemistry (Lomonosov Moscow State University), PhD (University of Zurich).

Service Costs

Cost of Obtaining a State Registration Certificate (SGR) in the EAEU

The cost of obtaining a State Registration Certificate (SGR) for products in the EAEU is determined individually and depends on several factors. The indicative cost for one SRC ranges from 1000 to 2000$ USD. This amount typically includes our comprehensive support, the cost of necessary testing, expert opinion, and the state duty.

Factors Influencing the Price:

Product Composition Complexity: A more complex composition requires more time and resources for analysis, documentation preparation, and laboratory testing.
Number of Product Flavors/Variations: Each additional variation requires separate testing and expert review.
To receive an accurate quote for your product registration, please fill out our inquiry form. We will contact you promptly to discuss details and provide a personalized calculation.

Submit Application

For a quick cost estimate, please complete the form or write a message: natalia.skhodtseva@mail.ru

Enter your First Name and Last Name

Please indicate the number of products you wish to register, for example, 5. Or more than 50.

Please provide a list of biologically active substances (BAS) or the name of the finished product.

For example, capsules, tablets, powder, liquid, etc.

Please indicate the number of flavors/variations for each product listed above. For example: Product 1 - 3 flavors, Product 2 - 1 flavor.

I accept the Terms and Conditions and Consent to the Processing of Personal Data.

Navigating dietary supplement registration

Answers to Key Questions

According to the Technical Regulation of the Customs Union TR CU 021/2011 “On Food Safety,” biologically active additives to food (BASF) are natural and/or nature-identical biologically active substances, as well as probiotic microorganisms, intended for consumption with food or for introduction into food products.

Medicinal products are intended for the diagnosis, prevention, treatment of diseases, rehabilitation, and other purposes related to influencing physiological processes of the body. Their circulation is strictly regulated and requires a much more complex registration procedure.

State registration of dietary supplements is a mandatory procedure aimed at confirming their safety for consumer health, compliance with the declared composition, and quality. This ensures that dietary supplements do not contain harmful substances and indeed correspond to the characteristics declared by the manufacturer.

Main Stages Include:

1. Collection and Preparation of the Document Package: This is the most labor-intensive stage, encompassing technical documentation, information on composition, safety, quality, labeling, etc.

2. Application for Laboratory Testing and Sample Preparation

3. Laboratory Testing: Verification of dietary supplement samples against declared quality and safety indicators.

4. Obtaining an Expert Opinion: Assessment of the completeness, reliability, and compliance of the documentation submitted with regulatory requirements.

5. Submission of the Application for SGR to Rospotrebnadzor: Filing the application for the State Registration Certificate (SGR ) with Rospotrebnadzor.

6. Submission of the Full Document Set (Dossier): Issuance of a decision on state registration or refusal.

7. Inclusion of the Dietary Supplement in the Unified Register and Issuance of the State Registration Certificate

Manufacturer’s Certified Documents for Product Manufacturing:

Copies of specifications, recipes, composition details, etc. (certified by the manufacturer; original + translation required).

Power of Attorney from the Manufacturer to the Applicant for Registration in the EAEU or Russian Federation.

Certificate of Free Sale (CFS)

Manufacturer’s Product Use Document:

Instruction manual, user guide, etc. (or copy, certified by the applicant).

Certified Product Label/Packaging Copies:

Copies of labels, packaging, or mock-ups (certified by the applicant, in Russian).

Sampling Record:

Record of product sampling with customs clearance mark.
Scientific Reports / Expert Opinions.

Confirmation of Manufacturer’s Management System:

Document confirming implemented management system ensuring compliance with technical regulations (certified by applicant, e.g., manufacturer’s letter, GMP/ISO 22000 certificates, HACCP procedures confirmation).
Applicant’s Registration/Identification Number:

Information on the applicant’s registration number in their member state.

Agreement with Foreign Manufacturer (if applicable):
Copy of the agreement ensuring product compliance and liability (for authorized representative, certified by applicant).

Other Supporting Documents:

Any additional documents provided by the applicant to confirm compliance.

The registration timeframe for dietary supplements can vary, but on average, it takes from 2 to 6 months. This duration depends on the completeness and accuracy of the provided documentation, the processing speed of expert organizations and regulatory bodies, and the necessity for additional testing.

Yes, it is possible. To register imported dietary supplements, you need to provide documents confirming their quality and safety in the country of origin, as well as a power of attorney from the manufacturer.

Only properties of dietary supplements that are supported by scientific data and regulatory documents can be indicated on the label. This typically includes information on the content of vitamins, minerals, and dietary fibers, as well as their role in maintaining normal physiological functions of the body.

It is strictly prohibited to indicate therapeutic properties or claim that dietary supplements can prevent diseases.

Any significant changes to the composition, production technology, or labeling of a registered dietary supplement require undergoing the procedure for amending the registration dossier, and possibly, re-registration.

In case of registration refusal, a reasoned conclusion is provided. The client has the right to rectify the identified deficiencies and resubmit the documents for re-registration, or to appeal the decision through the established procedure.

Наверх

info@nutricomply.ru
+7 926 519-35-88