Wholesale of Medicines and Medical Devices

The pharmaceutical industry is a key component of the healthcare system, ensuring the population’s access to high-quality and safe medicinal products. Effective organization of the wholesale distribution of medicines and medical devices is of paramount importance for maintaining the stability of pharmaceutical supply and ensuring compliance with the principles of pharmaceutical safety. In Uzbekistan, the legal framework for this activity is established by the Resolution of the Cabinet of Ministers No. 185 dated April 6, 2017, adopted pursuant to the Law “On Medicinal Products and Pharmaceutical Activities.”

The Resolution No. 185 approved the Regulation on the Procedure for Wholesale Distribution of Medicines and Medical Devices, which governs the operations of manufacturers and wholesale trading organizations. According to this regulation, the right to carry out wholesale distribution is granted only to entities holding a license for pharmaceutical activities. Manufacturers may distribute only their own products unless they hold a separate license for wholesale trading.

Principles of Wholesale Distribution

Wholesale distribution must comply with the following requirements:

• national quality standards;
• sanitary and hygienic norms;
• occupational safety, fire safety, and industrial safety rules.

Organizations are required to ensure conditions that preserve the quality and safety of medicines at all stages — from transportation to storage.

Economic Aspects of Pricing

To regulate prices for pharmaceutical products, a system of maximum trade markups is applied:

• no more than 15% of the purchase cost — for wholesale distribution;
• for imported medicines, the regulated price base is determined using the formula:

C = Kₛ + T + Dr, where Kₛ — contract price, T — customs duties, Dr — other related expenses.

For domestic manufacturers, the ex-factory price is formed in accordance with accounting rules for production costs and serves as the basis for regulated domestic pricing.

Storage Conditions and Infrastructure

Wholesale organizations must maintain specially equipped warehouses that comply with sanitary and technical standards, including:

• ventilation, water supply, heating, and lighting;
• designated zones for receiving, storing, and dispensing products;
• refrigeration equipment for thermolabile products;
• safes for storage of accounting documentation and certain categories of medicines.

Storage conditions must ensure protection from light, moisture, temperature fluctuations, and cross-contamination.
It is prohibited to store products directly on the floor without pallets or in unauthorized premises.

Quality Control and Safety

Wholesale distributors are obliged to:

• sell only registered and certified medicines;
• prevent circulation of substandard, falsified, or counterfeit products;
• maintain records of shelf life, storage temperature, and humidity;
• promptly inform the Ministry of Health about any identified adverse reactions.

Supervision of compliance with these requirements is assigned to the Agency for the Development of the Pharmaceutical Industry under the Ministry of Health.

Liability of Entities

Violation of the rules for wholesale distribution entails administrative and, where consequences arise, criminal liability.
Liability arises for:

• distribution of falsified or unregistered medicines;
• non-compliance with storage conditions;
• violation of pricing regulations;
• absence of a license or quality certificates.

Wholesale distribution of medicines and medical devices is a vital link in the pharmaceutical supply chain, ensuring balance between production and the end consumer. The established procedure in Uzbekistan aims to ensure transparency, safety, and quality in pharmaceutical circulation. Resolution No. 185 provides the legal foundation for the sustainable development of the pharmaceutical market, integrating economic, sanitary, and organizational requirements into a unified system of state control.

Algorithm of Wholesale Distribution of Medicines and Medical Devices

№	Stage	Description	Key Regulatory Requirements	Responsible Entities
1	Obtaining a License	Obtaining a license to conduct pharmaceutical activities	In accordance with the Law “On Licensing Certain Types of Activities”	Manufacturer or wholesale organization
2	Procurement of Products	Purchase of medicines from manufacturers, other wholesalers, or foreign suppliers	Only registered and certified medicines may be procured	Wholesale organization
3	Pricing Formation	Determining the base (purchase) cost using the formula: C = Kₛ + T + Dr	Maximum wholesale trade markup — no more than 15% of the purchase price	Manufacturer or importer
4	Storage of Products	Ensuring preservation of product quality and safety in warehouses	Availability of receiving and storage zones, refrigeration, temperature and humidity control	Wholesale organization
5	Transportation	Transporting products while ensuring integrity and stability of quality	Protection from sunlight, moisture, and temperature fluctuations	Carrier / warehouse
6	Accounting and Labeling	Record-keeping of shelf life and storage parameters (journals, electronic databases)	Storage on the floor without pallets is prohibited; labeling and certification are mandatory	Warehouse department
7	Product Sales	Selling medicines only to entities licensed for pharmaceutical activities	Sale of substandard, falsified, or unregistered products is prohibited	Wholesale organizations
8	Information Obligation	Notifying the Ministry of Health about all detected adverse reactions	Written notification in the prescribed manner	Wholesaler / manufacturer
9	Quality Control and Inspection	Internal and state control over compliance with sanitary, technical, and licensing standards	Control exercised by the Agency for the Development of the Pharmaceutical Industry under the Ministry of Health	State authorities
10	Liability	Application of measures for violations	Breach of the Regulation entails liability under applicable law	All entities in the pharmaceutical sector