Legal Alert for Uzbekistan - March-April 2022 (Mandatory Digital Labeling of Medicines and Medical Devices)

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.

Introduction of mandatory digital labeling of medicines and medical devices will be carried out within the following timeline:

the first group (from 01.09.2022 – medicines produced in secondary (outer) packaging (except for orphan medicines);
the second group (from 01.11.2022) – medicines produced in primary (inner) packaging (in the absence of secondary (outer) packaging) and medicinal agro-products (except for orphan medicines);
the third group (from 01.03.2023) – orphan medicines and medical devices for the treatment of rare diseases;
the fourth group (from 01.02.2025) – medical devices according to the list approved by the State Tax Committee of Uzbekistan and the Ministry of Health of Uzbekistan.

From the above dates of introduction of mandatory digital labeling the followings are prohibited:

production (except for export) of local medicines and medical devices without digital labeling, as well as customs clearance of imported medicines and medical devices without specifying information on the aggregated import code in the customs cargo declaration;
certification of medicines and medical devices without digital labeling, except for the cases described further.

Products manufactured before the date of introduction of mandatory digital labeling are allowed for the sale before the expiration date, but for no more than 3 (three) years from the date of introduction of mandatory digital labeling. At the same time, from the date of the introduction of the mandatory digital labeling:

within 90 days certification of medicines and medical devices without digital labels and produced by residents before the date of introduction of mandatory digital labeling; and
within 180 days, certification and import of medicines and medical devices manufactured by non-residents before the date of introduction of mandatory digital labeling are allowed.

Foreign manufacturers may be registered with Uzbekistan tax authority with the assignment of a local taxpayer identification number in order to obtain certificates of local electronic digital signature keys.

Digital labeling codes for medicines, the maximum selling price of which does not exceed 1 (one) percent of the Specified Base Value (hereinafter – the “SBV”)^[1], will be provided free of charge. A separate mechanism will be developed for approving the list of medicines for which digital labeling codes will be provided free of charge.

The procedure for recognition of foreign digital labeling codes should be developed by 01.07.2022.

Digital labeling codes may be applied by way of stickers in a way that does not allow separation of the sticker from the package without damaging it. The Resolution provides for the application methods of digital identification tools.

It is possible to apply digital labeling codes to imported medicines and medical devices after they are imported into the territory of Uzbekistan. The application in this case may be carried out during storage of products in a customs warehouse and placement of paper inserts in Uzbek language in products’ group package.

Amendments to the registration documents (MAs) of medicines and medical devices in connection with the introduction of mandatory digital labeling will be carried out free of charge and within no more than 20 (twenty) business days.

In case of frequent violations of mandatory digital labeling requirements (3 (three) times within 1 (one) year) by a representative office of a foreign manufacturer or a legal entity-resident of Uzbekistan, the operator “CRPT TURON” LLC terminates cooperation with these offenders at the instruction of the State Tax Committee of Uzbekistan.

The definition of participants in the turnover of products has been expanded to include non-residents.

Foreign registration certificate holders (MAHs) within 12 (twelve) months from the date of introduction of mandatory digital labeling shall open a representative office on the territory of Uzbekistan or conclude an agreement with local legal entities on the implementation of mandatory digital labeling.

The Resolution also provides for the:

List of identification codes for medicines and medical devices subject to mandatory digital labeling;
Schedule for the step-by-step introduction of a system of mandatory digital labeling of medicines and medical devices (hereinafter – the “System”) by local manufacturers;
Schedule for the step-by-step introduction of the System by foreign manufacturers;
Schedule for the step-by-step transition of wholesale and retail trade enterprises to the System;
Schedule for the step-by-step transition of medical organizations in the healthcare sector to the System;
Regulations on the procedure for digital labeling of medicines and medical devices by means of identification.

Amendments to the Code of Uzbekistan on Administrative Liability

Law of the Republic of Uzbekistan “On Amendments and Additions to Certain Legislative Acts of Uzbekistan in Connection with the Improvement of Tax Administration” No. ZRU-758 dated 11.03.2022 provides for the following amendments to the Code of Uzbekistan on Administrative Liability:

Liability of business entities for the sale and purchase for the purpose of sale of food and industrial goods (products) without documents certifying quality and production mark of goods (products) has been strengthened and entails a fine in the amount of:

for individuals from 3 (three) to 5 (five) SBV, and if repeated within a year – from 5 (five) to 10 (ten) SBV;
for officials from 5 (five) to 10 (ten) SBV with confiscation of goods (products), and if repeated within a year –from 10 (ten) to 15 (fifteen) SBV with confiscation of goods.

In addition, the violation of the rules for mandatory digital labeling of goods (products) by means of identification by manufacturers and importers for which mandatory digital labeling is established by law – entails a fine on officials in the amount of 100 (one hundred) SBV.

[1] 1 SBV = 270 000 soums ≈ 24 US dollars