Uzbekistan Regulatory Compliance

General Overview

Resolution No. 149 of the Cabinet of Ministers of the Republic of Uzbekistan dated April 2, 2022 “On the introduction of a system of mandatory digital labeling of medicines and medical devices” was adopted. The document provides for the phased introduction in 2022-2025 of a system of mandatory digital labeling, taking into account groups of medicines (except substances) and medical devices.

 

 

The products that will be labeled are divided into four groups:

 

  • Group 1 medicinal products with secondary (external) packaging (except orphan drugs);
  • Group 2 medicines with primary (inner) packaging (provided there is no secondary (external) packaging) (except orphan drugs);
  • Group 3:

a) medicines and medical devices for orphan diseases (according to the list approved by the Ministry of Health);

b) medicines included in the register of medicines with foreign registrations, the results of which are recognized in Uzbekistan;

  • Group 4 medical products according to the list determined by the Ministry of Health.

 

 

Transitional measures

 

Within 3 years from the date of mandatory labeling for the relevant group – it is allowed to sell medicines and medical devices manufactured before the date of mandatory labeling without labeling;

 

Within 90 days from the date of mandatory labeling for the relevant group – local manufacturers are allowed to certify without mandatory labeling medicines and medical devices manufactured before the mandatory labeling date;

 

Within 180 days from the date of mandatory labeling for the relevant group, foreign manufacturers are allowed to certify and import without mandatory labeling medicines and medical devices manufactured before the mandatory labeling date;

 

Within 12 months from the date of mandatory labeling for the relevant group, foreign manufacturers must either open their representative office in Uzbekistan or conclude an agreement with a local company on the implementation of digital labeling (with the obligatory indication of such a company in the instructions for the medicinal product or medical devices). The functions of the representative office/local company should also include ensuring the payment of fines in case of violation of the mandatory labeling rules.

Timeline

Separate terms are established for four groups:

 

From September 1, 2022 – 1st group;

From November 1, 2022 – 2nd group;

From March 1, 2023 – 3rd group;

From February 1, 2025 – 4th group.

Other features

1.Foreign manufacturers get access to the digital marking system after receiving a local individual taxpayer number (TIN) and an electronic digital signature (EDS);

 

2.Interaction on digital marking with foreign manufacturers may be limited in case of 3-time violation of marking rules within 1 year;

 

3.Until July 1, 2022, the operator of the digital marking system must develop a procedure for recognizing foreign digital markings.

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