By Order No. KP DSM-107 of the Minister of Health of the Republic of Kazakhstan dated October 19, 2021, changes were made to the list of activities technologically related to services performed by a subject of state monopoly.
According to the new Order, paragraph 4 is added to the following activities:
Pharmaceutical inspection for compliance with the requirements of good laboratory practice (GLP), good clinical practice (GCP), good manufacturing practice (GMP) of entities located outside the territory of the Republic of Kazakhstan,
conducting inspections of medical devices;
inspection of the pharmacovigilance system of the MAH and monitoring of safety, quality, and effectiveness of medical devices.
At the same time, in accordance with the Order, some activities technologically related to the services performed by the National Center for Expertise of Medicines and Medical Devices were excluded from the list:
implementation of control and analytical service and quality control of manufactured dosage forms in the pharmacy, the provision of chemical reagents, titrated solutions;
implementation of expert evaluation of optimal technical characteristics and clinical and technical substantiation of a medical device.
