State registration of medicines

Select country for information

State registration of medicines

Service available for:

  • Russia
  • Kazakhstan
  • Kyrgyzstan
  • Uzbekistan

The purpose of the state registration procedure is to protect the country’s inner market from poor-quality medicines

During the registration process in the Kyrgyz Republic, medicines are examined 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 a new medicine. Moreover, registered medicines are guaranteed to be efficient and safe

Items subject to registration

All medicines except those manufactured according to pharmacy prescriptions, radiopharmaceuticals, and medicines that are purchased abroad or manufactured in the territory of the Kyrgyz Republic for non-commercial purposes are subject to state registration
  • New medicines and new combinations of medicines registered before

  • Medicines that were registered previously but manufactured in other dosage forms

  • Reproduced medicines

  • Homeopathic medicines

  • Food supplements

  • Medical immunobiological medicines

  • Medicinal cosmetics

  • Medicines for veterinary use

Medicines manufactured in pharmacies according to prescriptions of doctors and medicines imported into the Kyrgyz Republic through humanitarian aid are not subject to registration

Registration of medicines with various medicinal substances under the same trade name and registration of medicines from the same manufacturer having the same composition of medicinal substances under different trade names is not allowed

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 registration proces

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

Interactions with registration bodies

Registration stages

According to the current rules in the Kyrgyz Republic, the registration of medicines includes the following stages:

  1. Submission of an application
    in the form approved by the authorized body

  2. Submission of the registration dossier in
    duplicate or on electronic media

  3. Primary expert examination for
    the completeness and contents of the registration dossier

  4. Payment for state registration

  5. Specialized expert examination

  6. Assessment of
    the quality assurance system of the manufacturer

  7. Assessment of
    the manufacturer conditions for research implementation

  8. Decision on state registration of
    medicine

  9. Obtaining a registration certificate

We will calculate the final cost and terms of registration at your request

By pressing the “Send” button, you confirm that you give the company your consent for processing your personal data

Questions and Answers

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

3. How much time does the registration of the medicine take?

4. When is it not possible to conduct the laboratory tests?