State registration of medicines

in Russia

Select country for information

State registration of medicines

Service available for:

  • Russia
  • Kazakhstan
  • Kyrgyzstan
  • Uzbekistan

During the registration process in the Russian Federation, medicines are checked for compliance with the claimed characteristics and undergo preclinical and clinical trials as well as pharmaceutical expert examination for identification of all types of risks

The procedure is implemented to exclude the possibility of unexpected side effects and other effects before using new medicine. Registered medicines are guaranteed to be efficient and safe


Items for registration

All medicines except those manufactured according to pharmacy prescriptions, radiopharmaceuticals, as well as medicines that are purchased abroad or manufactured in the territory of the Russian Federation for non-commercial purposes (for personal use, as samples for expert examination, and for demonstration in forums and exhibitions) According to the current rules, the following medicines are subject to mandatory registration:

  • Reference medicines

  • Drugs with new combinations of active substances, with additional dosage or in a different form

  • Generics

What problems may arise if you decide to do the registration yourself?

You will have a lot of work, the nuances of which are unknown to you: 

The procedure may take a long time

You may not know the details of the regulatory environment

You may not know the nuances of communication in regulatory bodies or in the country

The benefits of registration with the MedExpert company:

We will undertake all the routine work.

You save time and therefore money

We have a team of professionals in different areas of regulatory affairs

We select individual solutions for each project

We guarantee confidentiality

We guarantee that we provide a complete and highly qualified assistance and that we meet the timing and control requirements of the process

List of services

Consulting

Introducing changes to the registration certificate

Introducing changes to the registration dossier

Preparation and collection of the registration dossier

Development and analysis of normative documentation

Collaboration with testing centers

Support in testing

Interaction with registration bodies

Registration stages

According to the current rules in the Russian Federation, the registration of medicines includes the following stages:

  1. Inspection of manufacture for
    GMP compliance (for foreign manufacturers)

  2. Preclinical trials

  3. Clinical trials

  4. Preparation and collection of
    the dossier, submission of the application to the State body (Ministry of Health)

  5. Expert examination of
    quality and efficacy of the medicine

  6. Obtaining a registration certificate

State fee

State fee for the issuance of registration certificate of the medicines

10,000 rubles

An expert examination of the quality of the medicine and an expert examination of the ratio of the expected benefit to the possible risk of using the medicine for medical use at its state registration

325,000 rubles

Confirmation of the state registration of the medicine for medical use

145,000 rubles

Inclusion of a pharmaceutical substance manufactured for sale in the state register of medicines

145,000 rubles

Adding changes that do not require examination of medicines into the documents for a pharmaceutical substance manufactured for sale and included in the state register of medicines

5,000 rubles

Adding changes that require examination of medicines into the documents for a pharmaceutical substance manufactured for sale and included in the state register of medicines

75,000 rubles

Adding into the documents, contained in the registration dossier of the registered medicine for medical use, the amendments requiring an expert examination of the medicine concerning the examination of the quality of the medicine

75,000 rubles

Adding into the documents, contained in the registration dossier of the registered medicine for medical use, the amendments that do not require an expert examination of the medicine for medical use

5,000 rubles

The final cost and terms will be calculated at your request

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Questions and Answers

1. Is it possible to suspend or revoke the registration certificate of a medicine?

Yes, registration is canceled if the registration certificate expires or if this medicine has not been in circulation for more than 3 consecutive years. In addition, its effects may be revoked in the following cases:
• new risks or side effects were found during use;
• information specified in the certificate changed (information about the manufacturer, dosing, and form);
• the manufacturer submitted a request to cancel the registration

2. What is the period of registration of a medicine?

By law, the registration period is determined as follows:
If you have a complete package of documents, 160 working days, not including the preclinical period, the period of clinical trials, the time to eliminate remarks, and inspection of the manufacturing site

3. When is it not possible to conduct clinical or preclinical trials?

When the drug is registered and in circulation for more than 20 years. In all other cases, clinical trials are a mandatory part of the procedure.