The pharmaceutical market in Uzbekistan was estimated in 2022 to be worth UZS 19.9 trillion (approximately US$1.8 billion), with prescription drugs accounting for 78 percent and over-the-counter medicines making up the remaining 22 percent.¹

Every aspect of a medicine’s lifecycle—from development and manufacturing to distribution, advertising and sales—is subject to Uzbekistan regulations. Below we highlight 10 essential legal considerations for successfully accessing the Uzbek pharmaceutical market:

1. Marketing authorization (MA)

Every medicine exported to Uzbekistan must either undergo:
- Standard state registration with the Ministry of Healthcare (MoH), or
- Recognition of its foreign-issued MA through a simplified procedure available only for MAs issued by 21 countries recognized by Uzbekistan (12 EU countries, Australia, Canada, Israel, Japan, Norway, South Korea, Switzerland, UK, USA) and five organizations (EMA, Japan PMDA, South Korea MFDS, UK MHRA, US FDA).

MAs can be held by both residents and nonresidents of Uzbekistan.

2. Labeling and packaging 

Labeling and packaging of medicines must be cleared with local state authorities. Each unit of packaging (inner pack, outer pack) must have a label that conforms with technical regulations. Instructions for use must be in Uzbek (and optionally in other local languages).

3.Serialization

Medicines are subject to mandatory digital labeling (serialization) through the National Digital Labeling System “Asl belgisi.” Serialization codes are unique codes assigned to each unit of a medicinal product allowing to identify and trace their movement on the market. These codes must be obtained either by the MA holder or its representative office.

4. GMP inspections

The standard procedure for registering medicines in Uzbekistan envisages on-site inspections to ensure compliance with the country’s good manufacturing practice (GMP) standards; this is applicable to both local and international manufacturers. Exceptions exist, including for products undergoing MA recognition through a simplified process. For more information about this process, see our previous alert on the topic here.

5. Price controls

Uzbekistan uses both reference pricing and maximum markup controls.
Maximum markups are established for both wholesale (15 percent) and retail (20 percent) supplies of medicines, regardless of the number of intermediaries in the sales chain.
Under the reference pricing system, the medicine should have a recorded local reference price. This is calculated based on the price in the country of origin, in Uzbekistan and in 10 reference countries. Medicines may not be imported to Uzbekistan if their price exceeds the recorded reference price. You may also find useful our previous alert on reference pricing here.

6. Distribution

The wholesale sale of medicines is a licensed activity. As part of the licensing requirements, distributors must comply with pricing regulations and pharmaceutical regulations including good distribution practice (GDP) and good storage practice (GSP).

7. Advertising

The advertising of medicines is strictly regulated to ensure public safety and informed use of medications. Advertising is prohibited for prescription-only medicines, those containing narcotics or psychotropic substances and products not registered by the MoH. Moreover, advertisements must not feature endorsements by public figures or medical professionals, mislead about a product’s efficacy or safety, or suggest self-treatment without professional consultation.

8. Intellectual Property (IP) protection

Uzbekistan is a signatory to all major international agreements pertaining to IP rights and is modernizing its laws in line with the TRIPS agreement, as preparation for WTO accession. Patents are protected for 20 years and trademarks for 10 years (with the possibility of extension). For the violation of IP rights, Uzbekistan’s legislative framework provides for civil remedies, administrative and criminal penalties, as well as certain customs border enforcement tools. Nevertheless, IP infringements remain a possibility in Uzbekistan, requiring IP holders to take proactive actions to protect their brand.

9. Local presence

To address pharmacovigilance issues, implementation of serialization as well as the proper handling of consumer complaints, medicine manufacturers will need to either have their own local presence or a representative (partner). To fulfill this requirement, manufacturers may choose to set up a representative office within the country or forge a partnership with a local entity.

10. Local partners

As the market is constantly changing, it is prudent to choose your local partner carefully. A number of publicly available sources can be examined to run background checks on potential candidates. Your local partners (distributors) will also be assisting you, so that they can comply with certain local regulations—in particular, local certifications requirements.

We will be happy to delve into more details and to help ensure your compliance with the local regulations.

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1. BMI - Uzbekistan Pharmaceuticals Report (Q3 2023).