Uzbekistan Approves Updated Registration Procedures for Medicines and Medical Devices

Uzbekistan is strengthening its regulatory framework for medicines and medical devices by approving updated state registration procedures under Resolution No. 738, dated 24 November 2025. The new procedures, formally published on the LexUz national legislation portal, are set to take effect on 26 February 2026.

This legislative reform represents a significant step in modernising the country’s regulatory landscape, aligning administrative processes more closely with international expectations and improving clarity for industry stakeholders.

What the Updated Procedures Cover

The new legal act establishes detailed requirements for:

• The state registration of medicines and the detailed dossier requirements that must be submitted to the authorised body.

• The state registration of medical devices specifies the criteria, required documentation, initial evaluation processes, and timelines for decisions on registration applications.

• Conditions and rules for amendments to registration certificates, including procedures for submitting changes or additions to registered products.

• Protocols for suspension, revocation, and termination of registration certificates if products no longer meet safety, quality, or efficacy requirements.

• The contents of the State Register of Medicines and Medical Devices establish transparency in what products are authorised for use within the healthcare system.

The document provides comprehensive guidance for both manufacturers and authorised representatives on how to prepare and submit registration dossiers, and on regulatory expectations throughout the lifecycle of a registered medicine or device.

Why This Matters to Industry Stakeholders

This updated regulatory act enhances transparency and predictability in Uzbekistan’s registration system. It offers clearer procedural pathways and detailed documentation expectations, which are critical for companies planning market entry or continuing compliance.

Improved Clarity

Having codified procedures helps manufacturers and regulatory teams better understand what is required for registration submissions, reducing ambiguity and administrative burden.

Lifecycle Management

The inclusion of structured processes for changes to registration certificates and criteria for suspension or revocation reinforces product lifecycle oversight, ensuring ongoing safety and quality.

Alignment with Broader Reforms

The new procedures form part of a broader regulatory modernisation initiative in Uzbekistan, which also includes updated classification rules for medical devices and other regulatory legal acts aimed at strengthening the safety and effectiveness of health products.

Preparing for the Transition (Feb 2026)

With the new procedures entering into force on 26 February 2026, organisations operating in the Uzbek market should begin preparing now by:

• Reviewing existing registration dossiers to assess compliance with updated documentation requirements.

• Aligning internal regulatory processes with the new procedural timelines.

• Updating internal systems and workflows to reflect the revised submission criteria and registry expectations.

• Engaging local authorised representatives or regulatory partners to ensure readiness ahead of enforcement.

Looking Ahead

The adoption of these updated registration procedures signals Uzbekistan’s commitment to enhancing regulatory clarity, strengthening product oversight, and raising the overall standard of healthcare regulation. It also provides a foundation for future reforms, including anticipated alignment with international quality standards and risk-based regulatory practices.

For industry participants, proactive engagement with these changes will be crucial in ensuring smooth market access, continued compliance, and uninterrupted supply of safe, effective medicines and medical devices in Uzbekistan.

Source: Decision on Approval of Medicines and Medical Devices Registration Procedures Resolution No. 738 of the Cabinet of Ministers of the Republic of Uzbekistan (24 Nov 2025), on LexUz, effective 26 Feb 2026.