News
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.
THE LIST OF GUARANTEED MEDICAL CARE HAS BEEN APPROVED
The list of guaranteed medical care was approved by the Order of the Minister of Health of the Republic of Uzbekistan (“Uzbekistan”) “On Approval of the List of Guaranteed Medical Care Provided in Outpatient and Inpatient Conditions at the District (City) Level, Reimbursed from the State Budget” No. 3465 dated 17 October 2023 (the “Order”).
Structural Changes in the Ministry of Health
The President of the Republic of Uzbekistan signed the Decree “On Further Measures to Improve the Activities of the Ministry of Health” No. UP - 156 dated 6 September 2023 (the “Decree”), which, among other things, provides for the structural changes in the Ministry of Health as detailed below.
On July 10, 2023, the Law of the Republic of Kazakhstan No. 18-VIII "On Online Platforms and Online Advertising" (hereinafter referred to as the "Law on Online Platforms and Online Advertising") was adopted in the Republic of Kazakhstan (hereinafter referred to as "Kazakhstan").
On July 11, 2023, the Law on Online Platforms and Online Advertising was officially published and it entered into force from September 10, 2023.
The Law on Online Platforms and Online Advertising regulates online platforms operating on the territory of Kazakhstan, as well as production, placement, distribution and storage of online advertising on the territory of Kazakhstan.
Order of the Minister of Health of the Republic of Kazakhstan (“RK”) No. 124 dated July 3, 2023 (“Order”) introduced amendments into the Order of the Minister of Health of the RK No ҚР DSM-247/2020 dated December 11, 2020 “On Approval of the Rules on Regulation, Formation of Ceiling Prices and Mark-ups for Medicines, as well as Medical Devices within the Guaranteed Volume of Free Medical Care (“GOBMP”) and (or) in the system of Obligatory Social Health Insurance (“OSMS”)” (hereinafter referred to as the "Rules").
The President of the Republic of Uzbekistan (“Uzbekistan”) signed the Law “On Competition” No. ZRU-850 dated July 3, 2023, in a new edition (the “New Law”). The New Law comes into force on October 3, 2023.
General Provisions
Consequently, the Law of Uzbekistan “On Competition” No. LRU-319 dated January 6, 2012 (the “Law on Competition”) and the Law of Uzbekistan “On Natural Monopolies” No. LRU-815-I dated August 19, 1999, are repealed. The New Law introduces a number of new legal concepts such as superior bargaining power, digital platform, state-owned enterprise, affiliates of state-owned enterprises, etc.
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”).