Medicines and Medical Devices: Cabinet of Ministers Resolution No. 149 - Stages of Implementing Mandatory Digital Labeling and List of HS Codes

Диёр Расулев

Medicinal products within the territory of the Republic of Uzbekistan are subject to mandatory certification by applying a labeling code to each unit of the product.

Mandatory labeling of medicines in Uzbekistan starts from September 1, 2022. According to established labeling rules, a phased introduction of labeling for medicinal products is planned for 2022-2025.

In this article, you will learn:

List of Cabinet of Ministers Resolutions in the field of labeling medicinal products
List of identification codes for medicinal products and medical devices subject to mandatory digital labeling
Schedule for phased implementation of the mandatory digital labeling system for medicinal products and medical devices by domestic manufacturers
Schedule for phased implementation of the mandatory digital labeling system for medicinal products and medical devices by foreign manufacturers
Schedule for phased transition of wholesale and retail trade organizations to the mandatory digital labeling system for medicinal products and medical devices

List of Cabinet of Ministers Resolutions in the field of labeling medicinal products

Presidential Decree of the Republic of Uzbekistan No. PP-4389 dated 07/10/2019 "On additional measures to improve tax administration";
Cabinet of Ministers Resolution of the Republic of Uzbekistan No. PKM-737 dated 11/20/2020 "On the introduction of a mandatory digital labeling system for certain types of goods";
Cabinet of Ministers Resolution of the Republic of Uzbekistan No. PKM-833 dated 12/31/2020 "On measures to ensure the gradual introduction of a mandatory digital labeling system for certain types of products";
Cabinet of Ministers Resolution of the Republic of Uzbekistan No. PKM-322 dated 05/20/2021 "On measures to implement pilot projects to expand the list of goods subject to mandatory digital labeling";
Cabinet of Ministers Resolution of the Republic of Uzbekistan No. PKM-149 dated 04/02/2022 "On the introduction of a mandatory digital labeling system for medicinal products and medical devices".

List of identification codes for medicinal products and medical devices subject to mandatory digital labeling

The list is provided in Annex No. 1 to Cabinet of Ministers Resolution No. 149 dated 04/02/2022 "On the introduction of a mandatory digital labeling system for medicinal products and medical devices".

When certifying medicinal products in the territory of the Republic of Uzbekistan, the HS codes used in the Republic of Uzbekistan are indicated in the Certificate of Conformity. The HS code of a medicinal product can be determined by the certificate of conformity issued for that medicinal product.

No.	Product Name	Start of Mandatory Labeling	HS Code	Product Identification Code
First Group
1	Medicinal products released in secondary (outer) packaging (excluding orphan drugs) - from September 1, 2022	09/01/2022	3003, 3004	03003, 03004
Second Group
2	Medicinal products released in primary (inner) packaging (if secondary (outer) packaging is absent) and medicinal bulk products (excluding orphan drugs) - from November 1, 2022;	11/01/2022	3003, 3004	03003, 03004
Third Group
3	Orphan medicinal products intended for the treatment of rare diseases, approved by the Ministry of Health of the Republic of Uzbekistan, and medicinal products included in the list of medicines intended for diagnosis and treatment of rare (orphan) diseases, as well as those included in the State Register of Medicinal Products, Medical Devices, and Medical Equipment under the procedure of recognition of registration results carried out outside the Republic of Uzbekistan - from March 1, 2023;	03/01/2023	3003, 3004	03003, 03004
Fourth Group
4	Medical devices included in the list approved in the prescribed manner - from February 1, 2025. The list of medical devices is approved by the State Tax Committee and the Ministry of Health based on the results of the pilot project on digital labeling of this product.	02/01/2025	3005, 3006	03005, 03006

Schedule for phased implementation of the mandatory digital labeling system for medicinal products and medical devices by domestic manufacturers

The labeling implementation schedule for medicinal products by domestic manufacturers is presented in Annex No. 2 to Cabinet of Ministers Resolution No. 149 dated 04/02/2022 "On the introduction of a mandatory digital labeling system for medicinal products and medical devices".

No.	Name of Activities	Implementation Deadlines
No.	Name of Activities	First Group	Second Group	Third Group	Fourth Group
Stage 1. Conducting preparatory work for the transition to the digital labeling system
1.1	Registration in the NIS "Asl belgisi" and signing of the respective contract	By May 1, 2022	By August 1, 2022	By December 1, 2022	By January 5, 2024
1.2	Training responsible employees on digital labeling rules and procedures for working in the NIS "Asl belgisi"	By May 15, 2022	By August 15, 2022	By December 15, 2022	By January 10, 2024
1.3	Entering product data into the "Labeled Product Catalog" system	By May 20, 2022	By August 20, 2022	By December 20, 2022	By January 20, 2024
1.4	Certification and release into circulation of medicinal products and medical devices without digital labeling	By December 1, 2022	By February 1, 2023	By June 1, 2023	By May 1, 2025
Stage 2. Allocating a special place for product packaging. Purchasing and installing necessary equipment
2.1	Studying production, storage, and logistics systems of products	By June 20, 2022	By August 20, 2022	By December 20, 2022	By November 1, 2024
2.2	Providing a special place for applying the identification means on the consumer packaging of the product	By July 1, 2022	By September 1, 2022	By January 5, 2023	By November 1, 2024
Stage 3. Introduction of mandatory digital labeling
3.1	Establishing mandatory digital labeling of medicinal products and medical devices by direct application or sticker labeling	By September 1, 2022	By November 1, 2022	By March 1, 2023	By February 1, 2025
3.2	Organizing the entry of information about digital labeling of products into the NIS "Asl belgisi"	By September 10, 2022	By November 10, 2022	By March 10, 2023	By February 10, 2025
Stage 4. Implementation of the aggregation system
4.1	Studying the procedure and rules of the aggregation system	By December 25, 2022	By March 25, 2023	By July 25, 2023	By July 1, 2025
4.2	Signing contracts for purchasing hardware and software products for system implementation	By January 5, 2023	By April 5, 2023	By August 5, 2023	By July 5, 2025
4.3	Ensuring installation of hardware and software products	By March 1, 2023	By June 1, 2023	By October 1, 2023	By September 1, 2025
4.4	Implementation of the aggregation system for finished products	By May 1, 2023	By August 1, 2023	By December 1, 2023	By November 1, 2025
Stage 5. Sale of unlabeled products, providing product information in the NIS "Asl belgisi"
5.1	Ensuring the sale and/or withdrawal from circulation of remaining unlabeled medicinal products and medical devices	By August 1, 2025	By October 1, 2025	By March 1, 2026	By February 1, 2028
5.2	Ensuring attachment of information about digital labeling codes to electronic invoices	By May 1, 2023	By August 1, 2023	By December 1, 2023	By November 1, 2025
5.3	Entering information about the sale of medicinal products to trade entities and medical organizations into the NIS "Asl belgisi"	By June 1, 2023	By September 1, 2023	By January 5, 2024	By December 1, 2025
5.4	Entering data on all product circulation actions into the NIS "Asl belgisi"	By August 1, 2023	By November 1, 2023	By March 1, 2024	By February 1, 2026

Schedule for phased implementation of the mandatory digital labeling system for medicinal products and medical devices by foreign manufacturers

The labeling implementation schedule for medicinal products by foreign manufacturers is presented in Annex No. 3 to Cabinet of Ministers Resolution No. 149 dated 04/02/2022 "On the introduction of a mandatory digital labeling system for medicinal products and medical devices".

No.	Name of Activities	Implementation Deadlines
No.	Name of Activities	First Group	Second Group	Third Group	Fourth Group
Stage 1. Conducting preparatory work for the transition to the digital labeling system
1.1	Ensuring submission of an application for registration to obtain electronic digital signature key certificates to the tax authority electronically via the official website of the State Tax Committee of the Republic of Uzbekistan	By June 1, 2022	By August 1, 2022	By December 1, 2022	By January 5, 2023
1.2	Registration in the NIS "Asl belgisi" and signing of the respective contract	By July 1, 2022	By September 1, 2022	By January 5, 2023	By January 5, 2024
1.3	Training responsible employees on digital labeling rules and procedures for working in the NIS "Asl belgisi"	By July 15, 2022	By September 15, 2022	By January 15, 2023	By January 15, 2024
1.4	Entering product data into the "Labeled Product Catalog" system	By July 20, 2022	By September 20, 2022	By January 20, 2023	By January 20, 2024
1.5	Implementation of sending orders for digital labeling codes from the NIS "Asl belgisi" Operator	From July 1, 2022	From September 1, 2022	From January 5, 2023	From December 1, 2024
1.6	Import, certification, and release into free circulation in the territory of the Republic of Uzbekistan of medicinal products and medical devices without digital labeling	By June 1, 2023	By August 1, 2023	By December 1, 2024	By November 1, 2025
Stage 2. Introduction of mandatory digital labeling
2.1	Establishing mandatory digital labeling of medicinal products and medical devices by direct application of identification means on the product or by sticker labeling	By September 1, 2022	By November 1, 2022	By March 1, 2023	By February 1, 2025
2.2	Organizing the entry of information about digital labeling of products into the NIS "Asl belgisi"	By September 10, 2022	By November 10, 2022	By March 10, 2023	By February 10, 2025
2.3	Organizing the reflection of the aggregated customs code for batches of imported products with digital labeling in the customs cargo declaration and submission of the corresponding import notification to the NIS "Asl belgisi" Operator	From October 1, 2022	From December 1, 2022	From April 1, 2023	From March 1, 2025
Stage 3. Implementation of the aggregation system
3.1	Studying the procedure and rules of the aggregation system	By December 25, 2022	By March 25, 2022	By July 25, 2023	By July 1, 2025
3.2	Signing contracts for purchasing hardware and software products necessary for system implementation	By January 5, 2023	By April 5, 2023	By August 5, 2023	By July 5, 2025
3.3	Ensuring installation of hardware and software products	By March 1, 2023	By June 1, 2023	By October 1, 2023	By September 1, 2025
3.4	Implementation of the aggregation system for finished products	By May 1, 2023	By August 1, 2023	By December 1, 2023	By November 1, 2025
Stage 4. Sale of unlabeled products, providing product information in the NIS "Asl belgisi"
4.1	Ensuring the sale and/or withdrawal from circulation of remaining unlabeled medicinal products and medical devices	By August 1, 2025	By October 1, 2025	By March 1, 2026	By February 1, 2028
4.2	Ensuring attachment of information about digital labeling codes to electronic invoices	By May 1, 2023	By August 1, 2023	By December 1, 2023	By November 1, 2025
4.3	Entering information about the sale of medicinal products and medical devices to trade entities and medical organizations into the NIS "Asl belgisi"	By June 1, 2023	By September 1, 2023	By January 5, 2024	By December 1, 2025
4.4	Entering data on all product circulation actions into the NIS "Asl belgisi"	By August 1, 2023	By November 1, 2023	By March 1, 2024	By February 1, 2026

Schedule for phased transition of wholesale and retail trade organizations to the mandatory digital labeling system for medicinal products and medical devices

The transition schedule for the wholesale and retail sector to mandatory labeling systems is presented in Annex No. 4 to Cabinet of Ministers Resolution No. 149 dated 04/02/2022 "On the introduction of a mandatory digital labeling system for medicinal products and medical devices".

No.	Name of Activities	Implementation Deadlines
No.		First Group	Second Group	Third Group		Fourth Group
		Retail Trade	Wholesale Trade	Wholesale Trade	Retail Trade	Wholesale Trade	Retail Trade
1	Registration in the NIS "Asl belgisi" and signing of the respective contract	By February 1, 2023	By January 5, 2023	By May 1, 2023	By August 1, 2023	By April 1, 2025	By June 1, 2025
2	Ensuring attachment of information about digital labeling codes to electronic invoices	By May 1, 2023	By August 1, 2023	By December 1, 2023	By December 1, 2023	By November 1, 2025	By November 1, 2025
3	Providing information to the NIS "Asl belgisi" about the sale of medicinal products and medical devices to the end consumer	From July 20, 2023	From September 20, 2023	From January 20, 2024	From February 20, 2024	From December 20, 2025	From January 20, 2026

Within 180 days from the mandatory labeling date for the respective group – foreign holders of registration certificates are allowed to certify and import medicinal products and medical devices produced before the mandatory labeling date without mandatory labeling.

Within 90 days from the mandatory labeling date for the respective group – local manufacturers are allowed to certify medicinal products and medical devices produced before the mandatory labeling date without mandatory labeling.

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