Pharmacovigilance

in Kazakhstan

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Pharmacovigilance

Service available for:

  • 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

We will calculate the final cost and terms of registration at your request

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Questions and Answers

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

1) List of the principal data on the medicine of the product license holder
2) Master-file of the pharmacovigilance system (after signing a contract)