New order of the Minister of Health and Social Development of the Republic of Kazakhstan «On Approval of the Rules for Assessing the Quality of Medicines and Medical Devices registered in the Republic of Kazakhstan».
On December 30, 2020, the current Order of the Ministry of Health of the Republic of Kazakhstan No. 269 shall cease to be in force.
The new Order of the Minister of Health of the Republic of Kazakhstan No. ҚР ДСМ-282/2020 «On Approval of the Rules for Assessing the Quality of Medicines and Medical Devices registered in the Republic of Kazakhstan» dated December 20, 2020 shall enter into force.
Below are some of the basic requirements under this regulation:
According to the order, the products quality assessment shall be carried out by way of declaration. Namely, obtaining a certificate of conformity by assessing each batch and serial quality assessment is no longer a valid procedure.
Along with the above, a procedure for collecting samples from the market shall be carried out. Products in respect of which a certificate of conformity was issued based on declaration shall be requested or collected from the market annually and subjected to control tests in accredited laboratories of an expert organization.
The term for medicines and medical devices quality assessment for compliance with the requirements of the legislation of the Republic of Kazakhstan has been reduced from 10 calendar days to 5 business days from the date of receipt of the application.
The product quality assessment shall in the course of organizing and carrying out sanitary-anti-epidemic, sanitary-prophylactic and related restrictive activities, including quarantine, be carried out using an accelerated procedure, i.e. within 3 business days from the date of receipt of the application.
Changes have been introduced in the requirements for the list of documents to be provided, one of the main stipulating that instead of EN ISO 13485, ISO 13485 OECD certificate applicants are now permitted to provide ISO 13485, ISO 9001 or GMP.
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