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Monitoring changes in the legislative framework for drugs and medical devices in the EAEU and CIS countries

A range of services for MAH owners

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Monitoring the legislative framework within the framework of pharmacovigilance

A range of services for marketing authorization holders and pharmaceutical factories regarding pharmacovigilance:

Normative documents

Regulatory framework for pharmacovigilance in the Republic of Kazakhstan

CODE OF THE REPUBLIC OF KAZAKHSTAN ON PEOPLE’S HEALTH AND HEALTHCARE SYSTEM (with amendments and additions as of 07/07/2020)
Decision No. 87 of November 3, 2016 “On approval of the Rules of Good Pharmacovigilance Practice of the Eurasian Economic Union”
Decision of the Council of the Eurasian Economic Commission dated May 19, 2022 N 81 "On amendments to the Rules of Good Pharmacovigilance Practice of the Eurasian Economic Union"

Orders of the Ministry of Health of the Republic of Kazakhstan:

Order of the Minister of Health of the Republic of Kazakhstan dated December 23, 2020 No. KR DSM-320/2020. “On approval of the rules for conducting pharmacovigilance and monitoring the safety, quality and effectiveness of medical devices”
Order of the Minister of Health of the Republic of Kazakhstan dated January 27, 2021 No. KR DSM-10 “On approval of the rules for conducting the examination of medicines and medical devices”
Acting order Minister of Health of the Republic of Kazakhstan dated February 4, 2021 No. KR DSM-15 “On approval of good pharmaceutical practices”
Order of the Minister of Health of the Republic of Kazakhstan dated September 10, 2020 No. KR DSM-101/2020 “On approval of the Rules for the preparation and execution of instructions for the medical use of medicines and medical devices and the general characteristics of the medicine”
Order of the Minister of Health of the Republic of Kazakhstan dated January 27, 2021 No. KR DSM-9 “On approval of the rules for conducting pharmaceutical inspections on good pharmaceutical practices”

Benefits of monitoring regulatory changes as part of pharmacovigilance

Quality

Our reputation is of great importance to us, and we are always focused on the successful completion of every project.

Support

Each member of our team has at least 5 years of experience in the pharmaceutical field.

Multidisciplinary

Our company is engaged in various fields of activity, in each of which we have achieved an outstanding professional level.

Experience

Over the course of 15 years, we have accumulated valuable experience in the field of registration and certification, we are aware of all the intricacies and take into account all the important aspects of this process.

Discount

We offer a 10% discount on initial registration.

Individual approach

We take into account the individual characteristics of each client to provide the best service and approach.

Our specialists will bring any project to the end, they will always tell you what strategy to choose and how to prepare the documents correctly!

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Our services:

REGISTRATION

A full range of services to support the process of registration, re-registration, and changes to the registration dossier for medicines.

Marketing

Providing comprehensive marketing services and representing the interests of the manufacturer at the regional level.

PHARMACOVIGILANCE

Providing a wide range of services for marketing authorization holders and pharmaceutical factories in the field of pharmacovigilance and product quality control.

Price formation

Professional assistance in setting wholesale and retail prices for medicines and medical products within the framework of the guaranteed volume of free medical care.

TRADEMARK REGISTRATION

Turnkey trademark registration, full support. All stages of the registration procedure, from registration and submission of an application to receipt of a registration certificate.

Safety and quality assessment

A set of measures aimed at confirming the quality and safety of products.

Would you like to know the price for monitoring changes in the legislative framework within the framework of pharmacovigilance?

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Our presence in other countries

We represent the interests of foreign companies in Kazakhstan, Belarus, Kyrgyzstan, Azerbaijan, Georgia, Armenia, Uzbekistan, Tajikistan, Mongolia and Turkmenistan, in other countries of the EAEU and the CIS.