Manufacturers and importers of medical devices and medicines are to be required to provide electronic labelling for their products sold or imported into Uzbekistan. This requirement has been set by Decree adopted in April 2022.
Decree of the Cabinet of Ministers of Uzbekistan dated April 2022 No. 149 “On the introduction of a system of mandatory digital labelling of medicines and medical devices” was adopted.
The document provides for the phased introduction in 2022-2025 of a system of mandatory digital labelling of identification means, for groups of medicines (except for substances) and medical devices.
The following dates have been set for the mandatory digital marking of products, by groups:
• group 1 - drugs in secondary (outer) packaging (except for orphan drugs) - from 1 September 2022;
• group 2 - medicinal products in primary (inner) packaging and «angro»-preparations (except for orphan) - from 1 November 2022. Note; “angro” preparations are those packed in large packaging that are to be used, among other things, for the preparation of finished medicines;
• group 3 - orphan drugs (used for the treatment of rare diseases) - from 1 January 2023;
• group 4 - imported medicines included in the special list - from 1 February 2025.
The Decree also approved:
• The List of identification codes for medicines and medical devices subject to the mandatory digital marking;
• the Schedule for the phased implementation of the mandatory digital labelling system by domestic manufacturers of medicines and medical devices;
• Schedule for the phased implementation of the mandatory digital labelling system by foreign manufacturers of medicines and medical devices;
• Schedule for the phased transition of wholesale and retail trade organizations to the system of mandatory digital labelling of medicines and medical devices;
• Schedule for the phased transition of medical organizations in the healthcare sector to a system of mandatory digital labelling of medicines and medical devices;
• Regulations on the procedure for digital marking of medicines and medical devices by means of identification.