On the implementation of Subclause 7 of Clause 31 of the “Rules for assessing the safety and quality of medicinal products and medical devices registered in the Republic of Kazakhstan” approved by order of the Minister of Health and Social Development of
In connection with the frequent notifications from the state expert organization on the implementation of Subclause 7 of Clause 31 “Rules for assessing the safety and quality of medicinal products and medical devices registered in the Republic of Kazakhstan” approved by order of the Minister of Health and Social Development of the Republic of Kazakhstan (hereinafter referred to as the MH SD RK) as of 26 November 2014 No. 269 regarding the selection of samples from the market, we decided to clarify and elaborate the procedure.
Please note that one of the main objectives of the safety and quality assessment of medicinal products and medical devices is confirming the safety and quality of products withdrawn from the market by the state body considering the risk-based approach.
According to the order of MH SD RK No. 269 medicinal products and medical devices that have passed the assessment procedure of safety and quality by declaration or serial evaluation, undergo laboratory testing of product samples every two years by sampling from the market by experts of the organization in the presence of a representative of the manufacturer. The sampling schedule is agreed with the manufacturers or an authorized representative of the manufacturer.
The sampling procedure from the market includes the following steps:
1. Calculation of samples (samples of medicinal products and medical devices are selected in quantities sufficient and not exceeding the necessary volumes for conducting single tests defined in the quality regulations, without compensation for the cost of these products by the Contractor. Compensation for the cost of products selected by the Contractor's expert from the subject shall be carried out by the manufacturer on the basis of the contracts (agreements) reached between the Manufacturer and the entity);
2. Coordination of the contract with the state expert organization;
3. Sampling of medicinal products and medical devices (drawn up by an act completed by the Contractor's experts in the presence of a representative of the Manufacturer and an authorized person of the entity);
4. Obtaining an invoice for payment under the contract for laboratory tests (tests are carried out at the expense of the manufacturer or the applicant in accordance with the established prices for services sold by the state monopoly entity approved in accordance with Paragraph two of Clause 2 of Article 63-1 of the Code.);
5. Laboratory testing of products (held within 30 calendar days from the date of delivery of samples or within the time limits established by regulatory documents on quality);
In case of a positive result (meets the requirements) – receiving a notification of compliance of the selected products with the established requirements with an attached copy of the test report (s).
In case of non-conformity of products – receiving a notification of negative results of laboratory tests with a copy of the test report (s) for taking appropriate regulatory measures (amending the registration certificate, withdrawing products from the market or revoking the certificate of conformity, etc.).
Our company offers its professional assistance in this matter and is ready to provide services on the procedure for assessment the safety and quality of medicines and medical devices.