Pharmacovigilance in Kazakhstan

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Pharmacovigilance in Kazakhstan

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

Pharmacovigilance stages

According to the current rules in the Republic of Kazakhstan, pharmacovigilance includes the following steps:

  1. Appointment of an Authorized Person responsible for pharmacovigilance

  2. Support on pharmacovigilance of part of the Authorized Person

  3. Reporting to a client on the status of pharmacovigilance activities

Service cost

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?

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?