List of steps
Total number of steps : 3
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2Application for pharmaceuticals registration, examination
Contact details
Additional informationOnly registered pharmaceuticals can be manufactured, for sale and in usage in Russia.
All new pharmaceuticals, registered pharmaceuticals made in new forms, in new measuring, with new supplements, reproduced pharmaceuticals, pharmaceuticals for animals’ treatment are to be registered. Application form and supporting documents can be presented in person or by registered mail. Application and all supporting documents are to be presented in Russian language, documents originated from abroad are to be officially translated into Russian language. Documents are to be presented both in papers and in electronic version (formats *doc., *xls., *pdf). Decision on filing an expertise file is to be made within five days, subject of completeness of the documents and data provided. All procedures, including expertises, should not take longer than 210 days. |