The main objectives of pharmacovigilance are detection, assessment, and prevention of adverse reactions associated with medicines
Collection and analysis of information in cases of side effects not stated in the instructions for medical use
We guarantee that we provide a complete and highly qualified assistance and that we meet the timing and control requirements of the registration process
List of services
A weekly search of local literature and screening healthcare websites
Work with CIOMs reports of Product License Holders
Work associated with Periodic Safety Updated Reports (PSAR), DSUR, and RMP
Field trips to investigate adverse reactions
Registration as a local authorized person for pharmacovigilance and coordination with an authorized state body
Processing of local reports on adverse reactions
According to the current rules in the Republic of Kazakhstan, pharmacovigilance includes the following steps:
Appointment of an Authorized Person
responsible for pharmacovigilance
Support on pharmacovigilance of
part of the Authorized Person
Reporting to a client on
the status of pharmacovigilance activities
State license fee
5 MCI (monthly calculation index)
We will calculate the final cost and terms of registration 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