As of 26 February 2026, Resolution of the Cabinet of Ministers of the Republic of Uzbekistan No. 738 dated 24 November 2025 enters into force, approving a new Regulation on the Procedure for State Registration of Medicinal Products and Medical Devices. The Resolution establishes an updated regulatory framework governing the circulation of medicinal products and medical devices, including enhanced mechanisms for compliance with intellectual property rights. The new rules aim to improve legal certainty, ensure higher quality market entry standards, and strengthen the protection of rights holders.
Updated Requirements for State Registration
Resolution No. 738 comprehensively regulates key aspects of state registration, including:
- conditions and requirements for the registration of medicinal products and medical devices;
- the list of mandatory documents and samples;
- examination procedures and decision-making processes.
One of the most significant innovations is the strengthened control over intellectual property compliance. From now on, the state registration process is directly linked to the assessment of the lawful use of intellectual property objects involved in bringing medicinal products to the market.
Opinion of the Competent Authority on Intellectual Property
Under the new rules, obtaining an opinion from the competent authority in the field of intellectual property becomes a mandatory condition for the successful registration of a medicinal product. The competent authority is the Ministry of Justice of the Republic of Uzbekistan. During the review process, the Ministry is entitled to issue an opinion confirming the existence or absence of intellectual property infringement, including the unlawful use of protected objects such as:
- trademarks;
- industrial designs;
- elements used in the trade name, packaging, or design of the medicinal product.
In practice, this means that without the relevant opinion, the state registration procedure cannot be completed.
Updated List of Registration Documents
The Resolution also approves an updated List of Documents required for the state registration of medicinal products. In particular, a new item 1.15 has been introduced in the “General Documents” section, which requires the applicant to submit one of the following: a protection document (certificate or patent, together with its annex) confirming rights to intellectual property objects used in the medicinal product, including trademarks and industrial designs; an agreement governing the use of the relevant intellectual property objects; or an opinion issued by the authorized intellectual property authority regarding the trade name and design of the medicinal product. As a result, applicants must address intellectual property matters at an early stage of the registration process or formally confirm the absence of infringement risks through an official opinion.
Practical Impact of the New Rules
The introduction of a mandatory intellectual property opinion significantly strengthens the protection of intellectual property rights holders, reduces the risk of medicinal products that infringe third-party rights entering the market, and enhances legal certainty for bona fide manufacturers and distributors. At the same time, these changes bring Uzbekistan’s regulatory practice closer to international standards in pharmaceutical regulation and intellectual property compliance, contributing to a more transparent and predictable market environment.
Conclusion
Resolution of the Cabinet of Ministers No. 738 marks an important milestone in the development of state control over the circulation of medicinal products and medical devices in Uzbekistan. The integration of intellectual property protection mechanisms into the state registration procedure creates a more balanced and predictable regulatory environment, supporting the sustainable development of the pharmaceutical market and safeguarding the legitimate interests of all stakeholders.