Rules for Wholesale and Retail Sale of Medicines and Medical Devices

The Rules for the Wholesale and Retail Sale of Medicines and Medical Devices (i) (hereinafter, the “Rules”) enter into force on 3 October 2020.

The new Rules introduce the following key changes:

• Under the amendments, medicines and medical devices (“MMDs”) that, among other things, do not comply with accompanying documentation or have expired shelf life must be placed in a designated storage area protected from unauthorised access.
• Wholesale distribution of MMDs must now comply with the following requirements:

• MMDs may be purchased only from manufacturers or entities that, among others, have notified the authorities of the commencement of their activities through a medical device warehouse.

• MMDs may be supplied to entities that, among others, have notified the authorities of the commencement of their activities through optical and medical device stores.

• It should also be noted that retail sale of prescription medicines during a state of emergency, restrictive measures, including quarantine, must be conducted in accordance with paragraph 5 of Article 233 of the Code (ii).
• Upon receipt of MMDs, among other requirements, the presence of a certificate of conformity for the products in the accompanying documentation must now be verified.

i Order of the Minister of Healthcare of the Republic of Kazakhstan dated 17 September 2020 No. ҚР ДСМ-104/2020 “On Approval of the Rules for the Wholesale and Retail Sale of Medicines and Medical Devices.”

ii Code of the Republic of Kazakhstan dated 7 July 2020 “On Public Health and the Healthcare System.”