API (active pharmaceutical ingredients) registration in the Russian Federation

General notes for the API regulations in Russia

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.

Understanding the Regulations

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:

1) Registered commercial APIs

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.

2) APIs, whose dossiers (ADMF) were approved in frames of state registration of a finished drug product (FDP)

For API of that category, strict limitations apply:

• Such APIs are “linked” only to the registered FDP, being limited only to manufacturing purpose stated in the registration dossier of that particular FDP.
• Any ways of circulation and/or commercial use of such APIs that come outside the quality agreement(s) of the API manufacturer and the MAH (defined in Russia under term “Registration Certificate Holder”) of particular registered FDP are not allowed in Russia.
• In case of contract API manufacturers, while having absence of “exclusive” production and commercial limitations in such quality agreement(s) with the MAH(s) of FDP(s), such APIs cannot be legally marketed in Russia out of the “manufacturing only” limitations presented in that registration dossiers of corresponding registered FDPs.
• In cases of local FDP manufacturing such APIs are expected to be listed in the Russian registration certificates of corresponding registered FDP(s) - in order to be permitted for import only for the purpose of local manufacturing of corresponding bulk drug product(s).

3) Non-registered APIs

Commercial importation and marketing of such APIs is directly prohibited in the Russian Federation.

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