PXL/HO/Cir-030/2022-23 Date: 04.06.2022
Dear Sir / Madam,
Subject: “Digital Labeling of Medicines and Medical Devices by the Republic of Uzbekistan” w.e.f 1st Sep 2022
Pharmexcil is in receipt of the communication from the Indian embassy, Uzbekistan regarding Mandated digital labeling of Medicines and Medical Devices by the Republic of Uzbekistan. As per the resolution of the Cabinet of Ministers of the Republic of Uzbekistan “On the introduction of a mandatory system of digital labeling of Medicines and Medical Devices” (NO. 149 Dtd.: 02.04.2022), In short, a Phased introduction of a mandatory digital labeling system in the Republic of Uzbekistan in 2022-25 is imposed and Decree 149 is annexed herewith.
According to the decree, starting from September 1, 2022, medicines and medical devices of foreign origin can be imported into the territory of the Republic of Uzbekistan only with the presence of mandatory digital labeling (in secondary packaging). A similar requirement comes into force on November 1, 2022 for medicines in primary packaging. At the same time, the possibility of labeling by sticking stickers has been created in addition to the technology of direct application.
Also, a norm has been established according to which, after 12 months from the date of the introduction of mandatory digital labeling, a foreign manufacturer is obliged to open an official representative office in the territory of the Republic of Uzbekistan or sign an agreement with a local (Uzbek) company on the representation of interests and obligations in the field of the introduction of digital labeling in the territory of the Republic of Uzbekistan.
For these purposes, foreign manufacturers must register in the National Information System for Monitoring Labeling and Traceability of Products "Asl belgisi" by July 1, 2022, using an electronic digital signature (EDS). EDS is provided by diplomatic missions and consular offices of the Republic of Uzbekistan with the registration of a personal identification number of an individual (PINI) to representatives of foreign organizations-manufacturers of medicines who have received a taxpayer identification number (TIN) from the state tax service. The Procedure for procuring the TIN, PINI and EDS is assisted by the responsible officials of the State Tax Committee. The contact details of the officials of the Sales Tax Committee for procuring TIN, PINI and EDS is enclosed as Annexure for your reference.
Members may kindly make a note of these important requirements of the Republic of Uzbekistan.
Encl: Decree 149
Annex- contact details of the officials of the Sales Tax Committee