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RUSFARM

 


       Services

Registration of pharmaceutical substances
Registration of drugs
Registration of dietary supplements
Registration of healthcare goods
Post-registration changes in the regulatory documents (RD)
Development of regulatory documents (RD) for substances and drugs
Support of clinical and preclinical studies
Development of corporate design and prototype of drug packaging
Ordering standard samples of substances, additives and chemical agents
Permits of the RF Health Inspection for export of domestic and foreign ready-made drugs, chemical raw materials, agents and healthcare goods

Registration of Dietary Supplements

List of documents required to register domestic dietary supplements:

1. application in a prescribed form;
2. Certificate of registration for tax purposes of the Applicant and the manufacturer of dietary supplements;
3. Regulatory or technical documentation (technical conditions, technological instruction, formulation), approved as prescribed;
4. Sanitation and epidemiological certificate for manufacture of dietary supplements issued by the Centre of the State Sanitary and Epidemiological Inspection in a constituent entity of the Russian Federation (where manufactured);
5. Consumer label or its draft approved by the manufacturer and containing information pursuant to 2.3.2.1290-03;
6. Executive Summary containing scientific rationale for the dietary supplement composition, scientific indications with duration of reception and quantities of the dietary supplements received, counterindications, limitations for dietary supplements, if any; toxicological and hygienic and biological estimates (originals and literature for similar products) for dietary supplements and their clinical efficiency, records or certified copies of the results of clinical trials as compared to the control group with the name of the institution that performed the trial;
7. for dietary supplements that contain:
  • Live microorganisms, genus and species of the microorganism, strain designation should be specified in Latent, and patent availability certifying that the microorganisms have been deposited with the All-Russian Collection of Industrial Microorganisms of the Genetics Research Institute in the collection of microorganisms of Institute of Microorganisms Physiology and Biochemistry of the Russian Academy of Science, and also mode of production of the used culture ( N... or Pharmacopoeia article);
  • GMS, a declaration of usage or absence in the dietary supplements formulation of components obtained from genetically modified sources;
  • Plant parts, botanical name in Latin, form and method of preparation should be specified (e. g.: extract 1:4, infusion 1-10 etc.);
  • Intended for athletes, for building up muscle bulk, for persons with increased physical activity, the manufacturer of the dietary supplements shall present a document certifying absence of substances and components treated as doping.

8. Records of study, trials (if any);
9. Dietary supplement samples in the amount required to perform sanitary and epidemiologic expertise; if toxicological or clinical trials are required, number of samples should be additionally determined;
10. Sampling certificate in a prescribed form containing date and place of sampling, their number, name of the product, address of the legal entity of the manufacturer, date of production of dietary supplements, full names, positions and signatures of persons that took samples;
11. Document authorizing a person to obtain sanitation and epidemiological opinion with respect to a dietary supplement (a power of attorney, an order, a memorandum of incorporation etc.);

List of documents required to register foreign dietary supplements:

1. Application.
2. Sampling certificate in a prescribed form (date and place of sampling, their number, name of the product, address of the legal entity of the manufacturer, date of production of dietary supplements, full names, positions and signatures of persons that took samples).
3. A power of attorney for performance of activities with respect to the registration of dietary supplements specifying recipient and owner of the registration certificate and authority to sign a contract.
4. Certificates of quality and safety data sheets of the manufacturer containing information on the safety indicators, ingredients and their properties, expiry dates, storage conditions.
5. For dietary supplements containing plant parts, plant biological names in Latin and form (extract, infusion etc.) should be specified.
6. Documents of the officially authorized body of the exporting country confirming safety and efficiency of this product, certificate of registration in the country of origin.
7. Resume on manufacturing method, standard of the enterprise for manufacture of dietary supplements.
8. Executive summary describing dietary supplements, applications, recommendations for application, counterindications, limitations for usage of dietary supplements, if any.
9. Consumer label draft.
10. Information for instruction leaflet.
11. Materials (originals or literature on similar products) on toxicity and hygienic and biological evaluation of the dietary supplements and their clinical efficiency; records or certified copies of the results of clinical trials specifying relevant institutions, trial scheme and results as compared to the control group.
12. Hygiene certificate specifying that this product is manufactured in compliance with national and/or international requirement for dietary supplements (requirements of GMP - Good manufacture practice, standards of International Standards Organization: ISO 9000, 9001, 9002); or certificates of national and/or international (EuroNett) organizations confirming compliance with the above-mentioned requirements. ISO may be presented in the form of special signs on the company's letterheads.
13. Certificate of the company's registration (by the registration chamber). All the materials shall be provided in original and (or) translated into Russian and certified by a notary.

*At least 6 samples in consumer packaging (amount of the samples provided should be sufficient for laboratory studies)
*for plant-based products an additional sample should be provided (at least 100 g) for radiological study.
     
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