EAC marking is a conformity mark put on products (or packing, label, regulatory documents) to indicate approval of the product by requirements set by law. Apart from safety and quality...
To supply medical products within the territory of Russia, it is necessary to pass compliance check of the declared drug with the GOST-R certification system. Medical Products Certificate is a document which one needs to acquire to import and produce products and which testifies compliance of the drug declared by a businessperson to requirements of the Russian Federation Legislation.
It should be noted that quality assessment of the drugs launched to market in Russia is carried out according to declaration schemes. It follows that drugs suppliers/manufacturers require issuing a declaration, and not a certificate of quality. Only those enterprises which are registered within the territory of Russia are entitled to declare compliance with GOST-R certification system, as responsibility concerning the data specified in the declaration and checking protocols, falls on the businessperson.
Medical products need to go through declaration as the OKP code (Russian National product classification code), relating to these products, was entered in the uniform list of mandatory declaration of compliance with GOST-R certification system. RF Government Resolution No. 982 regulates this list.
To obtain declaration, a supplier, in certain cases, will need to pass all stages of sanitary certification. It is necessary to obtain a sanitary certificate on medical products (Certificate of State Registration of the Customs Union) only for products from the corresponding section of the Customs Union Commission Decision No. 299.
Voluntary certificate for medical products
Certificate registered at wish of a businessperson should be acquired to enhance competitiveness of the product at the market. As a rule such documentation is also issued with GOST-R certification system. However requirements for the product are set by the applicant. So product suppliers can additionally prove high level of safety of imported goods. It is recommended to fill in declaration for medicines in certification centers. Their staff also carries out all required checks, make test protocols, register declaration at respective agencies and render other required assistance to businesspeople. Consultations at certification centers are free-of-charge. You can obtain a declaration and a certificate for medical products at Rostest Latvia agency. After obtaining such documentation you will be able to import medical products to Russia without obstacles.