Licensing is a mandatory procedure for implementation of medical activity and production, manufacturing, and sale of medicines and medical products
We guarantee that we provide a complete and highly qualified assistance and that we meet the timing and control requirements of the registration process
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
Analysis of the submitted documents for compliance with the qualification requirements
Preparation and collection of license dossiers
Representation of the client’s interests in the process of obtaining a Public Health and Epidemiology Report
Application filing as per the prescribed format
Interaction with the licensor
Translation of documentation
Obtaining a license for medical or pharmaceutical activities
to the current rules in the Republic of Kazakhstan, licensing of medical and
pharmaceutical activity includes the following stages:
collection of license dossiers
Submission of electronic application
and dossier for the issuance of the license for medical or pharmaceutical activity
Expert examination of license dossier for
the compliance with qualification requirements
Signing and issuance of
the license for medical or pharmaceutical activity
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?
Documents are calculated in characters. One page equals 1800 characters with spaces.
1. Why do medical devices undergo testing?
that the product meets the declared technical characteristics, does not pose a
danger to human health, and has clinical effectiveness
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?
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.
1. List of documents required for registration
List of documents required for the provision of public services on application of an Applicant (or his/her representative by power of attorney) according to the technical regulations of the Customs Union: List of documents-dietary supplement
1. Which documents are required to obtain an import license for medical equipment in Kazakhstan?
According to TR CU 009/2011 requirements, for state registration, it is necessary to submit the following:
• an application
• samples of labels and packages
• certified copies of technical documentation (enterprise standard and instruction)
• documents confirming the quality of the product and compliance with the claimed characteristics
• acts and reports of accredited laboratories and research centers
• copies of documents about all essential attributes of a product (organoleptic, physical, microbiological, chemical, etc.)
• annotations with all information about the properties of the specified preparation, instruction for use, and precaution
• manufacturer’s founding documents