News
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].
On June 7, 2022, the Law of the Republic of Uzbekistan (hereinafter – “Uzbekistan”) “On Advertising” No. LRU-776 (hereinafter – the “Law”) was adopted. The Law will enter into force on September 9, 2022. Please see below some of the key, in our opinion, changes provided by the Law.
General Provisions
The Law provides for an expanded definition of the advertising term. After adoption of the Law advertising is the special information the content of which is addressed to users within Uzbekistan and distributed through any advertising means, not only for the purpose of direct or indirect profit (income), but also to draw attention to the advertising object, to generate or maintain interest in this object, as well as to promote it on the market.
Resolution of the Cabinet of Ministers of the Republic of Uzbekistan “On Adoption of the Regulation “On the Procedure for Issuing an Electronic Digital Signatures through Consular Offices of the Republic of Uzbekistan Abroad” No. 413 dated 29.07.2022 (hereinafter referred to as the “Resolution”) establishes the long-awaited procedure for obtaining an electronic digital signature (hereinafter referred to as the “E-signature”) through the consular departments of diplomatic missions and consulates of the Republic of Uzbekistan (hereinafter referred to as "Uzbekistan") abroad (hereinafter referred to as the “Consulate”).
On July 9, 2022 the amendments to Order of the acting Minister of Health of the Republic of Kazakhstan dated June 23, 2022 No. ҚР ДСМ-56 “On the amendments and additions to Order of the Minister of Health of the Republic of Kazakhstan dated December 11, 2020 No. ҚР ДСМ-247/2020 “On approval of the Rules for Regulation, Formation of the Ceiling Prices and Markups for Medicines, as well as Medical Devices within the Guaranteed Volume of Free Medical Care and/or in the system of Obligatory Social Health Insurance” (“Order No. 56”) took effect[1].
According to the Decree of the President of the Republic of Uzbekistan (hereinafter referred to as “Uzbekistan”) “On Additional Measures for the Accelerated Development of the Pharmaceutical Industry of the Republic in 2022–2026” No. UP-55 dated 21.01.2022 (hereinafter referred to as the “Decree No. UP-55”), from 01.04.2022 it is planned to introduce a mechanism for guaranteed procurement of pharmaceutical products subject to localization (hereinafter referred to as the “Procurement”) by concluding a contract for a 3 years period. The Procurement will be carried out at the expense of the State budget, which will be allocated for the procurement of pharmaceutical products.
Uzbekistan | March- April 2022
CHANGES IN THE LEGISLATION OF THE REPUBLIC OF UZBEKISTAN
Mandatory Digital Labeling
On 02.04.2022, the Cabinet of Ministers of the Republic of Uzbekistan adopted a Resolution “On the Introduction of a System of Mandatory Digital Labeling of Medicines and Medical Devices” No. 149 (hereinafter – the “Resolution”). The long-awaited Resolution finally provides for the important terms for launching mandatory digital labeling in the Republic of Uzbekistan (hereinafter – “Uzbekistan”). Please see below some of the changes provided for in the Resolution.
Amendments to the Health Code
On 3.01.2022, the President signed a law aimed at enhancing competition in the Republic of Kazakhstan (hereinafter – “RK”). The Law of the RK No. 101-7 ZRK dated 3.01.2022 “On Amendments and Additions to Certain Legislative Acts of the Republic of Kazakhstan on the Development of Competition” (hereinafter – the “Law”), among other things, introduces amendments to the Code of the RK No. 360-VI ZRK dated 7.07.2020 "On Public Health and Healthcare System" (hereinafter – "Health Code").
Cash Register and Digital Labeling
The Resolution of the President of the Republic of Uzbekistan (hereinafter – “Uzbekistan”) “On Additional Measures to Improve the Use of Cash Register in the Field of Retail Trade and Provision of Services” No. RP-5252 dated 04.10.2021 provides for:
Customs exemptions
The Decree of the President of the Republic of Uzbekistan “On Additional Measures to Support the Service Sector” No. PD-6318 dated 30.09.2021 extends until 1.01.2024 the customs duty exemptions for certain types of goods and vehicles imported into the territory of the Republic of Uzbekistan (hereinafter – “Uzbekistan”), including: