The Rules on Wholesale and Retail Sale of Medicines and Medical Devices were amended by the Order of the Minister of Health of the Republic of Kazakhstan (“RK”) No. 98 dated June 2, 2023 (“Rules on Wholesale and Retail Sale”).

Kazakhstan – May 2023

On May 11, 2023 the Board of the Eurasian Economic Commission approved the Recommendations on General Approaches to Consumer Protection in Electronic Commerce (hereinafter referred to as the "Recommendations").  

The Recommendations were developed in order to unify the legislation of member states of the Eurasian Economic Union (hereinafter referred to as the "EAEU") in terms of protecting consumer rights in the sale of goods (services) intended for personal needs that are not related to entrepreneurial activities through electronic commerce (hereinafter referred to as the “E-commerce”).

Kazakhstan Rules for State Registration of Medicines and Medical Devices have been amended

The Rules for State Registration, Re-registration of a Medicine or a Medical Device, introducing amendments to the Registration Dossier of a Medicine or Medical Device[1] (hereinafter referred to as the “Rules for Registration of Medicines and MD”) have been amended in connection with the introduction of the concept of “Strategically Important Medicines and Medical Devices” in the Code of the Republic of Kazakhstan dated July 7, 2020 No. 360-VI "On the health of the people and the healthcare system" (hereinafter - the "Code").

Strategically Important Medicines and Medical Devices inter alia include Medicines and Medical Devices (hereinafter referred to as “MD”) intended for medical use in the absence or in the threat of absence of Medicines or MD on the markets of the Member States of the Eurasian Economic Union due to introduction of restrictive economic measures against at least one of the Member States[2].

On March 11, 2023 Uzbekistani Anti-corruption Agency approved the Regulations “On Acceptance of Gifts by Public Civil Servants” No.3425 (the “Regulations”).

Under the Regulations, a civil servant may accept gifts during business trips abroad, during international and other official events, including in the Republic of Uzbekistan (“Uzbekistan”), in case if the gift:

The Agency for Protection and Development of Competition of the Republic of Kazakhstan (hereinafter referred to as the “Agency”) has published the final results of the analysis of the state of competition on the market for the sale of medicines on the territory of the Republic of Kazakhstan (hereinafter referred to as the "Analysis").

The Analysis has been carried out in accordance with the Entrepreneurial Code of the Republic of Kazakhstan and the Methodology for analyzing the state of competition on the goods market.

On October 5, 2022, the Cabinet of Ministers of the Republic of Uzbekistan (hereinafter – “Uzbekistan”) adopted the Resolution “On the Approval of Certain Regulatory Legal Acts in the Field of Personal Data Processing” No. 570 (hereinafter – the “Resolution”). The Resolution will come into force on January 7, 2023. Please see below some of the key, from our standpoint, changes provided by the Resolution.

On October 27, 2022, the Resolution of the President of the Republic of Uzbekistan (hereinafter – “Uzbekistan”) “On Additional Measures to Provide the Population with Quality Medicines and Medical Devices” No. PP-411 dated October 26, 2022 (hereinafter – the “Resolution”) came into force. Please see below some of the key, from our standpoint, changes provided by the Resolution.

1. What is digital labelling of medicines?

Digital labelling of a medicine means assigning each medicinal package a unique Data Matrix code, which is a two-dimensional matrix barcode in black and white applied in the form of a square, intended for encoding information about the product suitable for machine reading.

On September 29, 2022 the Law of the Republic of Uzbekistan (hereinafter – “Uzbekistan”) “On Electronic Commerce” No. LRU-792, (hereinafter – the “Law”) was adopted. The Law will enter into force on December 30, 2022. Please see below our summary of some of the key changes provided by the Law.

Amendments have been introduced to the Rules on medicines and medical devices’ advertising

The amendments to the Rules on medicines and medical devices’ advertising[1] (the “Rules”) entered into force on September 23, 2022[2].

The amendments are related to the following:

• The certificate of compliance of the advertisement with the healthcare legislation of the Republic of Kazakhstan (the “RK”) is from now on to be issued by the “National Scientific Center for Health Development named after Salidat Kairbekova”, the state agency under the Ministry of Health of the RK[3];
• A subparagraph stipulating that the logo, trade and (or) international non-proprietary name depicted on the products distributed among medical and pharmaceutical workers (pens, notebooks, bags, medical gowns, calendars, business card holders, flash drives, etc.) shall not be considered as medicines and medical devices’ advertising was omitted from the Rules[4].