To date, all that is related to the registration of medicines in the Russian pharmaceutical market is regulated by the Federal Law of 12.04.2010 N 61-FZ "On the circulation of medical products." Specialists of our company, guided by the law, are fluent in the material and that is why our company can guarantee its customers high quality consulting services and project support for registration and bring to market drugs and pharmaceutical substances, including for veterinary applications.
Handling of medical devices is regulated by Federal law N 323-FZ of 21.11.2011 "On the basis of public health protection", and certain types of products that pose a potential hazard to humans - Federal Law N 52-FZ of 30.03.1999 "On the sanitary and epidemiological welfare of population "and the Federal Law N 29-FZ of 01.02.2000" On the quality and food safety." In this legal framework is constantly making changes and additions.
In this case the work with the Russian authorities (Ministry of Health and Social Development, Federal Service for Veterinary and Phytosanitary Supervision, the Federal Service on Surveillance in Healthcare and Social Development, the Federal Service for Supervision of Consumer Rights Protection and Human Welfare) is a very labile process. Our employees keep track of all changes to the legal framework that allows us to adapt the registration process.
Our company provides services for registration of medicines, medical devices and certain types of products that pose a potential risk to human (biogical active food supplements, perfumes and cosmetics, personal care products, baby food, etc.).
Registration of medicinal products
In accordance with Paragraph 1 of Article 13 of the Federal Law of April 12, 2010№ 61-FZ "On circulation of medicinal products", "the medicinal products are introduced into civil circulation in the territory of the Russian Federation if they are registered by the appropriate authorized federal body of executive power".
Authorized federal executive body governing the issues of registration of medicinal products is the Ministry of Health of the Russian Federation. The Department of state regulation of the medicinal products circulation of the Ministry of Health is involved in the registration of new products and circulation of already registered medicinal products.
Registration of pharmaceutical substances
In accordance with Part 4 of Article 45 of the Federal Law of the Russian Federation on April 12, 2010 № 61-FZ «On Circulation of Medicines», «in the production of medicines used pharmaceutical substances, included in the State register of medicines».
Our company will help you with the design and preparation of documents for inclusion of substance in the National Register. We will calculate the amount of drug substance required for pharmaceutical expertise and resolve all the issues that arise in cooperation with the Ministry of Health of the Russian Federation in the process of making a pharmaceutical substance in the National Register.
Registration of veterinary medicinal products and feed additives
Our employees will help to carry out properly and fully preclinical and clinical studies, bioequivalence studie for veterinary medicinal products, draw up normative documents and complement the registration dossier. Monitoring of each phase of registration, starting from studies to the inclusion of the veterinary medicinal product to the National Register of medicinal products, enables to achieve maximum quality of services provided and conducting the expertise and obtaining a registration certificate in a timely manner.
Registration of perfume and cosmetic products
Perfume and beauty products under the Federal Law of the Russian Federation of March 30, 1999 N 52-FZ “On the sanitary-epidemiological welfare of population” is subject to sanitary - epidemiological surveillance, which can be implemented in the form of state registration, certification or declaration of conformity.
Organization of research, data collection and preparation of all necessary documents - a long and time-consuming, so the RusClinic CRO offers services for the organization of the process of collection, analysis and documentation of registering your product.
Registration of Biologically active food supplements
Biologically active food supplements (BAFS) to food are compositions of natural or identical to natural biologically active substances intended for direct taking with food, or introduction into food products in order to enrich the diet with individual food or biologically active substances and their complexes;
Turnover of BAFS and raw materials for BAFS production is regulated by the Federal Law of the Russian Federation of March 30, 1999 N 52-FZ “On the sanitary-epidemiological welfare of population”, and the Technical Regulation of the Customs Union of Eurasian Economic Community of Customs Union CU TR 021/2011 “On safety of food products” according to which the BAFS and raw materials for BAFS production are subject to obligatory state registration.
We will help you to quickly and cost-effectively register vaschi Biologically Active Food Supplements in Russia.
Registration of medical devices
Registration is required for all medical devices intended for use in the Russian Federation. Registration of medical devices (MD) is a serious, time-consuming, multistep regulated process.
The registration certificate is issued in the case of positive conclusion on the results of the examination for an indefinite period and is valid while maintaining all the information unchanged on a medical device, contained in it.
The key to success is competent and responsible approach to both development of the necessary documents and selection of test centers. Our company strives to facilitate maximally and expedite the registration process for our clients.
Registration of baby food products
It is known, that since birth the best food for newborns is breast milk. As children get older, their need for nutrients increases, and breast milk alone is not enough that can be compensated with the introduction into the baby diet of baby food. It is established that the minimum age at which it is allowed to introduce the first products of complementary foods is 4 months. Prior to this age a child is prepared only to the absorption of breast milk and adapted milk formulas. Later, in the diet of children an important place dairy products occupy (butter milk for children, bio-butter milk, yogurt), as well as children's herbal tea of commercial production that contain medicinal herbs.
Our company provides a full range of services for registration of products for baby food from the development of regulatory documents and organizing the necessary research till obtaining a registration certificate.
Registration of sports nutrition
Food products for the athletes nutrition (sports nutrition) is a specialized food products with a given chemical composition, high nutritional value and (or) targeted efficiency, consisting of a product complex and presented with their separate types, which has a specific effect on increasing the adaptive capacity of human to physical and nervous-emotional stress.
Specialists of the RusClinic CRO provide consulting services, covering all the questions on the registration of sports nutrition.
Registration of personal hygiene items
Personal hygiene is the guarantee of health of each person. Personal hygiene includes sanitary rules for care of the body, mouth, compliance with intimate hygiene, and also use of footwear, linen, clothes, being one of the most important components of hygiene at home and in public places. Properly selected personal care products are the first step to health maintaining.
According to the Customs Union Agreement on Sanitary Measures and the Resolution of the Government of the Russian Federation of 30.06.2004 № 322 “On Approval of the Federal Service for Surveillance in Consumer Rights Protection and Human Welfare”, personal care products subject to obligatory state registration.
Registration of disinfecting agents
Disinfecting agents are chemical compounds used for the destruction in the environment of etiological agents of infectious diseases of humans and animals.
Nowadays, disinfecting agents are used extensively in many areas of human activity. The increase in population and industrial centers and intensification of production technological processes violate sanitary-hygienic well-being and increase the probability of epizootics. That, in turn, requires extensive use of disinfectants.
Obtaining the certificate of registration is a multi-step process that requires close cooperation with regulatory bodies and expert organizations, which requires a perfect knowledge of the regulatory framework and understanding of the registration procedure.
