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Safety and quality assessment in Kazakhstan

Ensuring the protection of public health and improving patient safety

Supporting the process of assessing the safety and quality of medicines and medical devices in Kazakhstan

Selection of standard samples for medicines and medical devices

Assessment of the quality of medicines registered in the Republic of Kazakhstan is carried out by determining the compliance of the quality of medicines with the data of the registration dossier, regulatory documents on the quality of medicines, on the basis of which they were registered in the Republic of Kazakhstan and is carried out in accordance with the requirements of the Rules for assessing the quality of medicines and medical devices registered in the Republic of Kazakhstan, approved by order of the Minister of Health of the Republic of Kazakhstan dated December 20, 2020 No. KR DSM-282/2020.

The service is provided in accordance with the annual plan for sampling to assess the quality of medicines and medical devices in circulation on the territory of the Republic of Kazakhstan.

Product quality assessment is carried out for the purpose of:
1) determining the quality of registered products;
2) determining the quality of products selected from the market taking into account the risk-based approach;
3) preventing the circulation of counterfeit products on the market of the Republic of Kazakhstan.

Quality assessment is carried out for each series (batch) of products produced and imported into the Republic of Kazakhstan during the period of validity of the registration certificate, including those registered in accordance with the Rules for registration and examination of medicinal products for medical use, approved by the decision of the Council of the Eurasian Economic Commission dated November 3, 2016 year No. 78 and the Rules for registration and examination of the safety, quality and effectiveness of medical devices, approved by decision of the Council of the Eurasian Economic Commission dated February 12, 2016 No. 46

The test results are documented in a test report in the form in accordance with Appendix 5 to these Rules.

Safety and quality assessment steps

1

Conclusion of an agreement with the regulatory authority

2

Coordination of the product sampling schedule

3

Payment support

4

Selection of standard samples and finished products

5

Receiving notification of compliance of products selected from the market

Advantages of safety and quality assessment for medicines and medical devices:

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 of drugs

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

REGISTRATION of medical devices and medical devices

Comprehensive support for the process of registration, re-registration and updating of the registration dossier for medical devices and medical equipment in the Eurasian Economic Union (EAEU).

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.

Safety and quality assessment

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

Do you want to know the price of assessing the safety and quality of medicines and medical devices?

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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.