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

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:

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

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


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

Service cost

State license fee

5 MCI (monthly calculation index)

The final cost and terms will be calculated at your request

Questions and Answers

1. How is the document calculated?

1. Why do medical devices undergo testing?

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

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

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

1. List of documents required for registration

1. List of documents required for registration

1. Which documents are required for registration?

1. Which documents on the status of pharmacovigilance activities are required to be submitted?

2. Are illustrations, images and graphics included in the calculation of a document?