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In order to market commercial active pharmaceutical ingredient (API or “pharmaceutical substance not for production” - national term), manufacturer or API rights holder should officially register that API in Russia.
In contrary to finished drug products, where Eurasian Economic Union (EAEU) registration Rules apply, API registration (officially named "Enrollment to the State Register of the Russian Federation") undergo National registration only, and in this review we will focus on the API registration in Russia.
First, not all APIs are needed to be registered, but only the commercial APIs. For understanding of that principle, API classification in Russia should be considered.
As per legislation of the Russian Federation and applicable National regulations, all APIs in Russia can be classified into three categories:
Once registered, APIs of this type can be legally imported and marketed, their circulation is regulated by the Federal Law 61-FZ “On circulation of medicinal drugs”.
Manufacturer of registered API can contract any number of local FDP manufacturers for use of the registered API in their production.
For API of that category, strict limitations apply:
Commercial importation and marketing of such APIs is directly prohibited in the Russian Federation.
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