New Measures for Improving the Supply of Pharmaceuticals and Medical Equipment to State Medical Facilities in Uzbekistan

On November 29, 2024, the President of the Republic of Uzbekistan issued Resolution  
No. PR-408 “On Measures to Improve the Supply of Pharmaceuticals and Medical Equipment System for Medical Facilities” (“Resolution  No. 408”).

Regulation on conducting post-marketing surveillance of pharmaceutical products has been approved.

On October 4, 2024, the Cabinet of Ministers of the Republic of Uzbekistan adopted Resolution No. 628, titled "On the approval of the Regulation on the Procedure for Conducting Post-marketing Surveillance of Pharmaceutical Products" (the "Regulation No. 628"), which came into effect on October 5, 2024.

According to Regulation No. 628, post-marketing surveillance is conducted by the Pharmaceutical Product Safety Center under the Ministry of Health of the Republic of Uzbekistan (the “Center”) without interfering in the financial and economic activities of business entities."

Uzbekistan – September 2024

Amendments to antimonopoly legislative acts

On September 4, 2024, President of the Republic of Uzbekistan Shavkat Mirziyoyev signed the Law (version in Russian is available here) No. ZRU-954 “On amendments and additions to certain legislative acts of the Republic of Uzbekistan in connection with further improvement of the activities of the Committee for Development of Competition and Protection of Consumer Rights of the Republic of Uzbekistan” (hereinafter – the “Law 954”).

Kazakhstan – July 2024

The main change concerns the list of goods subject to digital labelling, which was approved by the Resolution of the Government of the Republic of Kazakhstan (“Kazakhstan”) dated June 28, 2024, No. 516 (“Resolution”).

According to this Resolution, the requirement for mandatory labeling of medicines from July 1, 2024, applies to all medicines manufactured after July 1, 2024. Thus, medicines produced before the specified date can be imported and circulate without labelling.

Improvement of antimonopoly regulation in the commodity and financial markets.

The Cabinet of Ministers of the Republic of Uzbekistan adopted the Resolution on Approval of Normative Legal Acts on Antimonopoly Regulation in the Commodity and Financial Markets No. 256 on May 1, 2024 (the "Resolution 256").

The Resolution will enter into force on August 3, 2024. Please see an overview of the notable novelties introduced by the Resolution 256.

The Law of the Republic of Kazakhstan “On Amendments and Additions to Certain Legislative Acts of the Republic of Kazakhstan on Health Issues” was signed

The President of the Republic of Kazakhstan (“RK”) signed the Law of the RK dated April 19, 2024 No. 74-VIII “On Amendments and Additions to Certain Legislative Acts of the Republic of Kazakhstan on Health Matters” (the “Law on Health Matters”). The Law on Health Matters introduces the following changes:

The Code of the Republic of Kazakhstan dated July 7, 2020 “On the Health of the People and the Healthcare System” (the “Code”)

The Cabinet of Ministers of the Republic of Uzbekistan adopted the Resolution "On Further Improvement of the Public Services Provision System" No. 169 dated March 29, 2024 (the "Resolution No. 169").

Thus, the Resolution No. 169 approved the Unified Administrative Regulation for the provision of public services, which regulates the order of the issuance of a number of conclusions to legal entities and individuals by public authorities (the "Regulation").

Within the framework of the Regulation, the Centers of Public Services (the "CPS") and the Unified Portal of Interactive Public Services (the "UPIPS") will issue the conclusion on the possibility of advertising medicines and biologically active supplements on via TV and radio channels (the "Conclusion").

The Resolution No. 169 entered into the force on 2 April 2024. Nevertheless, public services for issuing the Conclusion should be available through the CPS or UPIPS from 1 May 2024.

Legislative Amendments and Supplements to the Legal Acts Governing Pharmaceutical Activities 

A New Pharmacovigilance System is Introduced

The President of the Republic of Uzbekistan (“Uzbekistan”) signed the Decree “On Additional Measures to Regulate the Pharmaceutical Industry” No. UP-20 dated January 23, 2024 (the “Decree”). According to the Decree, starting from July 1, 2024, organizations engaged in production and sale of medicines and medical products are responsible for the quality, safety, and effectiveness of their products. Activities of these organizations are now governed by special rules of state control.

Amendments and supplements introduced into the pharmaceutical regulatory legal acts

On 22 November 2023, Uzbekistan President signed a Law, "On Amendments and Supplements to Certain Legislative Acts of the Republic of Uzbekistan in connection with the Improvement of Pharmaceutical Activity" No. ZRU – 879 (the “Law No. 879”).

The Law No. 879 amended and supplemented the Law of the Republic of Uzbekistan “On Medicines and Pharmaceutical Activities” No. ZRU-399 dated 4 January 2016 (the “Law on Medicines”) and the Law of the Republic of Uzbekistan “On Blood Donation and its Components" No. 402-II dated 30 August 2002 (the "Law on Blood Donation"). Law No. 879 came into force on 22 November 2023.

On December 11, 2023 the Law of the Republic of Kazakhstan No. 44-VIII "On Introduction of Amendments and Supplements to Certain Legislative Acts on Information Security, Informatization and Digital Assets" (hereinafter referred to as the "Law Amending Legislative Acts on Information Security and Digital Assets") was adopted in the Republic of Kazakhstan (hereinafter referred to as "Kazakhstan").

On December 12, 2023, the Law Amending Legislative Acts on Information Security and Digital Assets was officially published.  It enters into force on February 11, 2024, except for certain provisions that enter into force on July 1, 2024.

We will focus below on the most important legal amendments.