The LIST of documents required for certification of disinfection products at the Federal Supervision Service in the sphere of consumer rights and human wealth protection (Rospotrebnadzor)

  1. The Power of attorney from manufacturer for registration process of disinfection products at the Russian Federation
  2. Certificates of conformity of disinfection product to Directive 93/42/EEC and safety of product (EC Certificate, declaration of conformity) or documents of conformity to national standards – original documents.
  3. The certificate confirming system of quality of manufacture to national, international, European standards – original documents (for example, ISO certificate, GMP certificate).

Documents (1-3) should be in the notary’s copies, certified by consular establishments of the Russian Federation or with assurance the Apostille according to the Hague convention.

  1. The letter from the manufacturer with a list of states where registered this disinfection product, stamped and signed by the manufacturer
  2. The summary of method of disinfection product manufacturing with indicating the use of organic solvents
  3. The complete description of the quantitative and qualitative control methods with the references to the pharmacopeia and specification
  4. The stability data of three drug series confirmed the declaring use-by date
  5. The patterns of the spectrums and chromatograms of the drug
  6. The report of the specific activity study substantiated the indications for use which are formed and described in the instruction
  7. The specification of the product
  8. The test report of the drug toxicity (acute, sub acute, sub chronic, chronic toxicity).
  9. The color design of internal and external packages (Original and Russian version)
  10. Instruction for use, recommendations on application of products.
  11. Samples for the technical, toxicological, clinical tests.

Documents in foreign languages should be translated in Russian, copies of documents and their translations should be certified when due hereunder.

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