Renewal of the drug registration within the framework of national regulation

According to the Federal Law No. 61 “On Circulation of Medicines”, a drug, first entered the Russian market, receives a registration certificate for 5 years. During this period, its effectiveness and safety shall be monitored. Further registration must be confirmed. To do this, it is necessary to collect a certain package of documents and send the dossier for expertise. In case of a positive decision, an unlimited registration certificate is issued. This article describes the procedure of passing the registration confirmation, the necessary documents, as well as provides information on the terms and fees.

1. What is the procedure?

Confirmation of a drug registration should be initiated no earlier than 180 days before the RC offset of acton. At the same time, registration cannot be confirmed for drugs that have not been in circulation in the territory of the Russian Federation for three or more years.

This procedure is carried out by the Ministry of Health of the Russian Federation (MoH) in order to identify any negative consequences of the use of the drug, individual intolerance of the drug, etc. In connection with the activities identified during the safety monitoring, the instructions for the use of drug and other documents may need to be adjusted.

Thus, the renewal of a drug consists of the following stages:

1).  Registration dossier submission for examination of the ratio of expected benefit to possible risk of the drug application ;

2). Checking the completeness of the registration dossier by the MoH (10 working days);

There are three possible outcomes at this stage: positive decision on the beginning of the examination, request for additional information (90 working days for elimination ), justified refusal to confirm registration

3). Examination of the ratio of expected benefit to possible risk of the drug application by the expert center — the Federal State Budgetary Institution NCESMP of the Ministry of Health of the Russian Federation (40 working days);

There are three possible outcomes at this stage: positive conclusion, request for additional information (60 working days to be completed by the applicant), justified refusal to confirm registration;

4). Evaluation of the conclusion of the MoH (10 working days);

At this stage, the experts of the MoH either decide to confirm the registration of the drug or issue a justified refusal.

2. What documents are required?

1). Application on confirmation of drug state registration;

2). Documents containing the results of monitoring the efficacy and safety  (PSUR - read more about this in the article called pharmacovigilance);

3). Copy of the manufacturing license;

4). Copy of the GMP certificate issued by the Ministry of Industry and Trade of the Russian Federation;

5). Document confirming payment of state duties;

3. What is the cost?

The fee for renewal of state registration of a drug is  145 000 rubles ;

In conclusion, it is important to note that during the drug renewal process, its circulation on the territory of Russian Federation is not suspended.

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1. Федеральный закон от 12.04.2010 N 61-ФЗ (ред. от 02.08.2019) "Об обращении лекарственных средств"
2. НК РФ Статья 333.32.1.