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State registration of medicines in Kazakhstan

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State registration of medicines in Kazakhstan

According to the code of the Republic of Kazakhstan, the main purpose of registration is to guarantee the provision of safe, effective, and high-quality medicines to the population

During the registration process in the Republic of Kazakhstan, 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


Which medicines are required to be registered?

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 Republic of Kazakhstan for non-commercial purposes (for personal use, as samples for expert examination, and for demonstration in forums and exhibitions) are subject to state registration. According to the current rules, the following medicines are subject to 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

Preparation and collection of 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 Republic of Kazakhstan, the registration of medicines includes the following stages:

  1. Collection of the dossier
    and receipt of the samples

  2. Signing a contract with
    the state body

  3. Primary expert examination,
    which assesses the completeness, contents, and accuracy of the paperwork submitted by the applicant in the registration dossier

  4. Specialized expert examination,
    which is implemented by studying the documents of the registration dossier for safety, efficacy, and quality of medicines

  5. Analytical expert examination,
    including the testing of medicine samples and determination of the reproducibility of analytical procedures

  6. Inspection of
    medicine manufacturing

  7. Safety Statement,
    which generates a summary report on the safety, efficacy, and quality of the medicine

  8. Assigning a registration number
    and issuing a registration certificate for the medicine

The final cost and terms will be calculated 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

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
1. Kazakhstan Drug Registration Process
2. Kazakhstan List of documents for VIRU-LS

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, 210 calendar 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.