Drug quality certification and quality declaration of medicines in Russia

Registration of a pharmaceutical in Russia does not automatically grant “green light” for the import and distribution.

Quality of every batch of registered medical drug either produced locally or imported should be officially confirmed

by one of two available options: conformity declaration and certification. The choice of the way of confirmation of medicines quality is established by the Government of the Russian Federation and depends on the class of product.

Conformity declaration of a pharmaceutical product

is a special document which confirms that the product putting into circulation meet the requirements of the product’s approved Normative Documentation (ND: product composition, specifications, quality control methods, packaging, labelling, shelf life and storage conditions compilation) – one of key documents that is officially approved by MoH along with registration of any medical drug.

Conformity declaration is supposed to be one of the most progressive forms of drugs’ quality confirmation. Declaration is one of the ways of obligatory confirmation of products’ conformity. When adopting the declaration a producer declares that the product putting into circulation meets the requirements of quality standards of the Russian Federation. Conformity declaration could be adopted on a basis of the producer’s evidences or on a basis of evidences of the third party – certifying authority or independent testing laboratory.

Declaration makes the process of obligatory confirmation of meeting the requirements easier for pharmaceutical manufacturers. Moreover it increases significantly its responsibility for the products delivering to the Russian market. Period of validity of conformity declaration is settled for the period which is not exceeding the storage period of the particular batch of the product. Declaration, in contrast with certification, is the document of producer by which he or she grantees quality and safety of its products.

Obligatory certification of medicines

is carried out by certifying authority whose the area of accreditation extends to the drugs on the basis of the contract between applicant and certifying authority according to the schemes established by technical regulations. Certification of quality system is carried out in accordance with the scheme of obligatory certification. In case of positive tests results, certifying authority processes the Certificate of Compliance for the drug according with a form established by federal authority for technical regulation, registers it and handles to the applicant. Period of validity of Certificate of Compliance is not exceed the storage period of the particular batch of pharmaceutical product.

There are many hidden obstacles in quality confirmation in Russia as well as specific wholesaler and retail market regulations, tender policies and regulatory-based tricks, handling regional quality control  centers quistions and issue and much more in this huge areas of distribution and marketing regulations.

Pharegis team can offer service and expertise to you for any complicated issues or projects that you have on the market, as well as consultation service for certification or declaration procedures.  Also we can handle your activities for numerous topics in quality control and market regulations to prevent possible issues on daily basis, providing Clear Regulatory Answers for your business.