Pursuant to Article 241 of the Code on Public Health and Healthcare System of the Republic of Kazakhstan, the quality assessment of pharmaceutical products and medical devices is carried out by determining their compliance with the information contained in the registration dossier.
- Consultation on requirements and timelines;
- Preparation and review of the complete documentation package;
- Assistance with application submission and interaction with the expert organization;
- Monitoring deadlines and obtaining the Certificate of Conformity.
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Quality Assessment Process
Participating Authorities
Legal Basis for Quality Assessment
The following organizations participate in the quality assessment process:
- National Center for Expertise of Medicines and Medical Devices RSE on REM;
- Medical and Pharmaceutical Control Committee of the Ministry of Health of the Republic of Kazakhstan.
Timeframes and Key Features
The quality assessment procedure for pharmaceutical products and medical devices includes the following stages:
Regulatory Framework
4. Issuance of the Certificate of Conformity
Preparation of the Certificate of Conformity by the expert organization and receipt of the electronic document through the obk.dari.kz portal.
Preparation of the Certificate of Conformity by the expert organization and receipt of the electronic document through the obk.dari.kz portal.
3. Submission of the Application and Documentation Package
Completion of the application form and submission of the documentation package for quality assessment through the obk.dari.kz portal.
If deficiencies are identified, the applicant receives a notification specifying the corrective actions required within the established timeframe.
Completion of the application form and submission of the documentation package for quality assessment through the obk.dari.kz portal.
If deficiencies are identified, the applicant receives a notification specifying the corrective actions required within the established timeframe.
2. Preparation of the Agreement Appendix
Completion of the appendix form within the expert organization’s information system, receipt of the invoice, and payment for the expert assessment.
Completion of the appendix form within the expert organization’s information system, receipt of the invoice, and payment for the expert assessment.
1. Execution of an Agreement for Quality Assessment
Registration of the applicant in the expert organization’s database and execution of an agreement for quality assessment services through the expert organization’s information system at obk.dari.kz.
Registration of the applicant in the expert organization’s database and execution of an agreement for quality assessment services through the expert organization’s information system at obk.dari.kz.
The quality assessment procedure is carried out in accordance with the following regulations:
- Order No. KR DSM-282/2020 of the Minister of Health of the Republic of Kazakhstan dated December 20, 2020 On Approval of the Rules for Quality Assessment of Pharmaceutical Products and Medical Devices Registered in the Republic of Kazakhstan;
- The Code on Public Health and Healthcare System of the Republic of Kazakhstan;
- The Code of Administrative Offenses of the Republic of Kazakhstan (as amended).
Time required to obtain a Certificate of Conformity: up to 1 month
Certificate validity period: until the expiration date of the product
Certificate validity period: until the expiration date of the product
Quality assessment of medical devices is a mandatory procedure aimed at confirming that medical devices registered in the Republic of Kazakhstan comply with the information contained in the registration dossier.
If nonconformities related to labeling or packaging are identified, repeat sampling of the same pharmaceutical product or medical device marketed in the Republic of Kazakhstan is conducted. Laboratory testing is then performed (excluding labeling and packaging indicators) to assess compliance with the requirements of the applicable quality standard for pharmaceutical products and the quality documentation for medical devices.
Initial testing of products sampled from the market is carried out to assess labeling and packaging compliance with the template(s) approved in the State Register of Medical Devices.
Sampling is conducted annually by specialists of the expert organization responsible for quality assessment of medical devices.
Market Sampling Market sampling is an important post-market surveillance activity conducted after products have been placed on the market.
Its purpose is to verify that products available for sale or used in healthcare organizations comply with their declared characteristics and safety requirements.
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