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 What is Product Registration?
Application scope
Product Registration: State Registration vs. Medical Registration
Design and content of the certificates
Procedure
Why Choose SGS?
What is Product Registration
The Certificate of Product Registration allows products to be manufactured, imported or sold in Russia.
If Product Registration is required, usually there is no need for a Sanitary-Epidemiological Conclusion Certificate and vice versa. However, this is not the case for medical tools or drugs. Similarly to Sanitary-Epidemiological Conclusion Certificate, the Certificate of Product Registration is a prerequisite for obtaining GOST R Certificate of Conformity.
In many cases (e.g. for new foodstuff or oral hygiene products), Product Registration and Sanitary-Epidemiological Conclusion Certificate are not required simultaneously but both are pre-requisite for obtaining a GOST R Certificate of Conformity. In case of medical tools or drugs, both Product Registration and Sanitary-Epidemiological Conclusion Certificate are required.
The Certificate of Product Registration is checked by Russian customs authorities at the point of customs clearance at the Russian border. They are then checked by trade inspectors when the products are placed on retail shelves.
Product Registration is being regulated by:
- From 06/22/1998 - Federal Law № 86-FZ “About medicines”
- From 01/02/2000 - Federal Law № 29-FZ “About Quality and Safety of Food Products”
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Application Scope
Product Registration at the Russian Ministry of Health and Social Development also known as Mindzdravsotsrazvitiya is required for “new” products within the following product categories:
- Mineral and bottled water
- Foodstuff intended for children;
- Dietetic foodstuff;
- Meat and dairy products enriched with protein and/or other microelements;
- Food additives and biologically active additives;
- Genetically modified food products;
- Food products manufactured according to new technologies, i.e. not used in Russia before;
- Some materials and products in contact with foodstuff;
- Some perfumery and cosmetics;
- Oral hygiene products;
- Tobacco products, including raw material and auxiliary materials and accessories;
- Materials, equipment and other technical tools of water treatment;
- Disinfection, fumigation and disinfestations products (except for those used in veterinary medicine);
- Chemical household goods;
- Medical tools and products for medical application;
- Drugs (except for those used in veterinary medicine).
“New” means these products are those that have never been manufactured on an industrial scale in the Russian territory or have never been imported to and sold in the Russian market.
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Product Registration: State Registration vs. Medical Registration
There are two registration schemes in Russia depending on the product category
- Certificate of State Registration – this is applicable to “new” foodstuff and other product types that present a potential danger for human beings. This includes bottled water, food additives, food and cosmetics for children, disinfection products, among others.
This Certificate is issued by the Federal Service for Supervision in the Area of Consumer Rights and Welfare Protection also known as Rospotrebnadzor. The certificate is valid for the whole period of the product’s industrial manufacture or import deliveries.
- Certificate of Medical Registration – this is applicable to medical tools, drugs and products with medical application.
This Certificate issued by the Federal Service for Supervision in the Area of Health Protection and Social Development also known as Roszdravnadzor. The Certificate is valid for either 5 or 10 years.
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Design and content of the Certificate of Product Registration
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Procedure
Before crossing Russian borders or during its preparation state in the manufacturers, Product Registration has to be implemented first.
Steps for Product Registration:
- Product Manufacturers have to present documents and display product characteristics as well as the products’ and its manufacturing conditions conformity to various sanitary requirements.
- Testing – Toxicological, hygienic, etc.
- Product and Manufacturer information is presented to the Register of Minzdravsotrazvitiya.
- The Certificate of Product Registration is then issued to the applicant.
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Why Choose SGS
With its extensive network of accredited laboratories, SGS has been providing Russian Hygienic Certification services since 1997. SGS is in close cooperation with relevant Rospotrebnadzor and Roszdravnadzor authorities.
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