API State Registration

For the purpose of including an API, which is not used in the manufacture of medicinal products, into State Register of Medicinal Remedies, the quality control expertize is carried out.

To carry out the above expertize the Applicant (the API manufacturer or its authorized representative) shall submit to the corresponding authorized federal body of the executive branch - Ministry of Health and Social Development of the Russian Federation (Minzdravsocrazvitiya Rossii) the following documents:

1) an application for including the API into State Register of Medicinal Remedies of RF;

2) a document, confirming payment of State duty for including an API, which is not used in the manufacture of medicinal products, into State Register of Medicinal Remedies;

3) registration dossier for the API.

The quality control expertize of the API and expert quality reports drawn up by the committee of experts upon the results of this expertize and their forwarding to the Ministry of Health and Social Development of the Russian Federation (Minzdravsocrazvitiya Rossii)  is carried out within the time-limit of 60 (sixty) working days upon the date of receiving the corresponding task and the documents from the Ministry of Health and Social Development of the Russian Federation (Minzdravsocrazvitiya Rossi).