Registering a medicinal product
Registration of a medicinal product is a mandatory step to release a drug to the Russian market. In September 2010, a new Federal Law No. 61 "On the circulation of medicinal products" came into effect. This law introduced some major changes to the procedure of the medicinal product registration.
Our specialists can save your time and financial expenses by efficiently performing full set of operations or offering single services:
Registering a medical device
Our company provides a support in preparing the documents required for the registration of a medical device. According to Decree 735 dated October 30, 2006 and other Russian regulations, the Federal Service for Surveillance in Healthcare and Social Development (Roszdravnadzor) is responsible for the registration of medical devices based on the expert evaluation of the normative documents and on the results of the technical and clinical tests of a medical device.
Registering an active pharmaceutical ingredient
When Russian Federal Law No. 61 dated April 12, 2010 "On the circulation of medicinal products" came into effect, the registration of active pharmaceutical ingredients was replaced with listing them in the medicinal product registry. The new procedure is similar to the medicinal product registration except for a few provisions. Our company can assist you in the entry of your ingredient into the registry or suggest you with documents necessary to request from the pharmaceutical ingredient manufacturer.
Registering a dietary supplement
Resolution of the Customs Union Commission No. 299 dated May 28, 2010 approved a list of products subject to the mandatory state registration. On July 1, 2010 this "Unified List of Products" came into effect.
The State Registration Certificate is an official document issued by the Federal Service for Surveillance on Consumer Rights Protection and Human Wellbeing (Rospotrebnadzor) confirming the compliance of the product to the sanitary and hygienic requirements to the regulated products. The state registration of products on this list is a mandatory procedure which requires some experience and knowledge.
The state registration implies:
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