- The Power of attorney from manufacturer for registration process of disinfection products at the Russian Federation
- 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.
- 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.
- The letter from the manufacturer with a list of states where registered this disinfection product, stamped and signed by the manufacturer
- The summary of method of disinfection product manufacturing with indicating the use of organic solvents
- The complete description of the quantitative and qualitative control methods with the references to the pharmacopeia and specification
- The stability data of three drug series confirmed the declaring use-by date
- The patterns of the spectrums and chromatograms of the drug
- The report of the specific activity study substantiated the indications for use which are formed and described in the instruction
- The specification of the product
- The test report of the drug toxicity (acute, sub acute, sub chronic, chronic toxicity).
- The color design of internal and external packages (Original and Russian version)
- Instruction for use, recommendations on application of products.
- 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.