Registration of food supplements is held prior to their manufacturing in the Russian Federation and prior to import of food supplements into the Russian Federation in the case of foreign manufacturing.
Registration of food supplements includes the following steps:
- Hygienic examination including sanitary-chemical and sanitary-microbiological tests for compliance with applicable legislation and regulatory requirements for quality and safety;
- Radiological examination
- Expertise on the use of prohibited substances and their compounds
- Expertise on microorganisms and other biological objects that are hazardous to human health
- Examination of the contents of the main active ingredients and the list of indications for use
- Review of the registration dossier, Russian Federal Consumer Rights Protection and Human Health Control Service (Rospotrebnadzor)
- Issue of certificate of state registration (CSR)
RDG services on registration of food supplements:
- Advising during the collection and processing of documents that form the registration dossier
- Representation in course of the paperwork (without transfer of rights to possession and the use of registration, etc.)
- Collection and submission of documents for examination
- Collection and submission of documents for registration in Rospotrebnadzor
- Obtaining of certificate of state registration
- Translation and notarial certification of documents
- Logistic services
The document confirming that the registration of food supplement has been successfully completed is a Certificate of state registration of food supplement (CSR of Common Customs Union) issued by Federal Consumer Rights Protection and Human Health Control Service .
The document entitles its owner to distribute the food supplements in pharmacies, specialty stores, departments of trade networks. Validity of the Certificate of state registration is not limited. The Certificate gives the right to import and distribute food supplements in the Common Customs Union, additional registration is not required.
The total duration of the registration procedure of food supplements: from 3 months
The registration of food supplements has limitations on the content of labels and consumer leaflet that are tightly controlled by regulatory authorities. In order to expand the data on the packaging and insert sheet, there is a voluntary certification procedure which provides imposition of additional warnings on the packaging including information about the beneficial effects of the additive.