State Registration of Products
The product registration is an official permission, which is applied for the Russian Federation by Russian ministry for health and social development. It refers to those products that can present a risk for well being and body of human. The following listed belong to such kind of goods:
Chemical, biological substances and relatively made preparations posing a threat for human life as well as new foods, materials and articles made or imported in the Russian Federation territory are subject of Obligatory State Registration made by Rospotrebnadzor prior to manufacturing application.
The State Registration Certificate could be issued for Russian or foreign manufacturer (although the set of documents to be submitted for registration is different).
The list of the required documents includes (but may vary):
- Power of attorney
- Health certificate, free trade certificate, etc.
- Ingredient composition with the percentage of components and / or recipe,
- The specification for the product (method of application, description, dosage),
- ISO 9001 certificate,
- Invoice or other transport document,
- Package safety document.
State Registration of products includes the following stages:
- examination of study (test) results, toxicological, sanitary and other types of products assessment (so-called laboratory tests);
- review of documents describing products properties and conformity with State Sanitary-and-Eepidemiologic Rules and Norms (according to the list of documents separate for each kind of product); such documents are submitted by an applicant;
- if Rospotrebnadzor would make positive decision with regard to State Registration of the products the information concerning such product is recorded into State Register of products passed through the state registration;
- issue of State Registration Certificate for the products.
RST has the capability of providing the Registration or Expert Approval for any kind of product that requires it.