May 17, 2022

Procedure for mandatory labelling of drugs and medical products

1. Legislation

2. Definitions. Deadlines. System

3. Step-by-step instructions for obtaining a marking code

4. Liability for non-performance

1. Legislation.

1. Decree of the Cabinet of Ministers of April 02, 202 No. 149 “On the introduction of a mandatory digital labelling system for drugs and medical products” (“Decree No. 149”).
2. Decree of the Cabinet of Ministers of December 31, 2020 No. 833 “On measures to ensure the gradual introduction of a system of mandatory digital labelling of certain types of goods”.

2. Definitions. Deadlines. System.

Mandatory digital labelling (marking) is introduced for drugs and medical products in the following terms:

Period of implementation	Type of products to be labeled
From September 1, 2022	Drugs produced in secondary (outer) packaging (except for orphan drugs)
From November 1, 2022	Drugs produced in primary (inner) packaging (in the absence of secondary packaging) and medical agricultural products (except for orphan drugs)
From March 1, 2023	Orphan drugs and medical products to treat rare diseases as well as drugs included in registries with foreign registrations whose results are recognized in Uzbekistan and subject to marking
From February 1, 2025	Medical products according to list approved by tax authorities and Ministry of Health

CRPT TURON LLC has been identified as the single operator of digital labelling. With the onset of the above deadlines, the following will be prohibited:

• Production (except for export) of local drugs and medical products without digital labelling, as well as registration for customs treatment when importing medicinal products without specifying the information on the aggregated import code issued by the Operator in the Customs Cargo Declaration;
• Certification of drugs and medical products without digital marking, except for the following cases:
  • Within 90 days, certification of drugs and medical products without digital labelling and produced by residents before the above-mentioned deadlines for the introduction of digital labelling is allowed;
  • Within 180 days, certification and import of drugs and medical products produced by non-residents before the above deadlines for the introduction of digital labelling.

The obligation to digitally label is assigned to the holder of the registration certificate of drugs and medical products (the – “Company”).

For drugs, the maximum selling price of which does not exceed 1% of the basic estimate amount (UZS 270,000 / approximately USD 25), marking codes will be provided free of charge.

3. Step-by-step instructions for obtaining a marking code

Getting access to the electronic marking system

The law provides for 2 ways of using the system. The first one is by filing an application for registration in order to obtain electronic digital signature key certificates to the tax authority and registration of the taxpayer identification number.  The second, by obtaining access to the system through login and password, in case the electronic digital signature cannot be obtained.

Obtaining TIN and EDS in the tax authorities

Non-residents (foreign producers) can register with the tax authorities of Uzbekistan with the assignment of taxpayer identification number to obtain electronic digital signature (EDS), which will allow to use public services on the territory of Uzbekistan on a remote basis.

To obtain EDS and TIN for the purposes of digital labelling of drugs, foreign manufacturers of products are not required to have an actual location in the Republic of Uzbekistan or to have a representative office. However, the law introduces a requirement to open a representative office within 12 months from the date of introduction of mandatory labelling for foreign manufacturers holding registration certificates. This representation or local legal entity has an obligation to:

• order marking codes for the purposes of digital marking of products (only for the representative office of the foreign manufacturer);
• implement an interaction with the relevant government agencies and business associations;
• inform the foreign manufacturer of changes in the rules and requirements in the field of digital labelling
• inform of the responsibility of foreign manufacturers (for resident legal entities) in case a violation of digital labelling rules by a foreign manufacturer is detected and payment of the fine established for violation of the rules.

Documents needed for registration in tax authorities:

1) Registration number of the Company

2) TIN of the Company

3) Application

4) A notarized power of attorney

5) A copy of the passport (authorized person or management)

6) A copy of the foreign passport (if any)

7) Photo 3*4 on a white background as 300 dpi

8) All registration certificates of medicines

As noted earlier, if it is impossible to obtain the EDS and TIN for ordering digital marking codes, the Company can enter the system using a login and password.

To obtain a login and password, the Applicant should contact the Agency for the Development of the Pharmaceutical Industry (hereinafter referred to as the “Regulator“) with the following information:

• a letter indicating the reason for obtaining a login and password;
• non-resident identification number (NIN);
• a copy of the certificate of state registration of the relevant drug;
• information about a legal entity that is a representative or its authorized representative in the Republic of Uzbekistan;
• copies of documents confirming the authority of the owner of the certificate of state registration.

In case of a positive decision, within 15 business days, the Operator will send the Applicant a login and password, through which orders for the preparation of digital marking codes will be placed.

Placing an order for a marking code

The order is sent to the Operator by means of a request in the electronic platform. The information specified in the application must comply with the requirements of the Regulation. If the application meets the requirements, the Operator serializes the required number of marking codes and submits a list to the Company.

At the same time, the Operator has the right to refuse to execute the order in the following cases:

• in case of non-compliance of the order with the requirements stipulated by the rules for digital marking of products in the Republic of Uzbekistan;
• when sending an order by persons who are not manufacturers;
• when providing the Operator with information about the absence (termination, cancellation, termination) of the manufacturer’s license to carry out pharmaceutical activities (During the production of drugs and medical devices on the territory of the Republic of Uzbekistan);
• upon presentation to the Operator of information about the absence (termination, cancellation, termination) of the registration certificate for drugs and medical devices registered on the territory of the Republic of Uzbekistan (with the exception of orphan drugs orphan and medical devices used for the diagnosis and treatment of orphan diseases);
• when providing the Operator with information on non-recognition (termination, cancellation) of the results of registration of drugs carried out outside the Republic of Uzbekistan, and (or) about this in the State Register of drugs, medical devices and medical equipment as part of the procedure for recognizing the results of registration carried out outside the Republic of Uzbekistan.

4. Liability for non-performance

According to Article 166 of the Code of Administrative Responsibility of the Republic of Uzbekistan:

Type of violation	Measure of responsibility
Sale, as well as acquisition for the purpose of sale by economic entities of food and industrial goods without documents certifying their quality and production mark. a fine for citizens from 3-5 basic estimate amount (which is UZS 810,000-1,350,000 / approx. USD 72-120), and for officials – from 5-10 basic estimate amount (UZS 1,350,000-2,700,000, approx. USD 120-241) with confiscation of goods.	a fine for citizens from 3-5 basic estimate amount (which is UZS 810,000-1,350,000 / approx. USD 72-120), and for officials – from 5-10 basic estimate amount (UZS 1,350,000-2,700,000, approx. USD 120-241) with confiscation of goods.
The same offense committed repeatedly within a year after the imposition of an administrative penalty	a fine of 5-10 basic estimate amount for citizens (UZS 1,350,000-2,700,000, approx. USD 120-241), and for officials – 10-15 basic estimate amount (UZS 2,700,000-4,050,000, approx. equal to USD 241-361) with confiscation of goods.

Also, a provision is introduced according to which violation of the rules of mandatory digital marking of goods by means of identification by manufacturers and importers, for which the legislation establishes mandatory digital marking – a fine of 100 basic estimate amount is introduced (UZS 27,000,000, approx. USD 2,406).