Regulatory update: licensing and permit requirements in Uzbekistan in the pharmaceuticals sector

Uzbekistan's pharmaceutical sector has attracted substantial foreign investment over the past several years, and the country's regulatory framework has been evolving to match that ambition. Since late 2025 and into 2026–2027, the authorities responsible for pharmaceutical oversight have introduced a sequence of changes to licensing and permit requirements that materially affect the position of foreign companies seeking to manufacture, distribute, or import medicinal products in the country. For international companies that have established or are considering establishing a presence in Uzbekistan — whether through a subsidiary, a joint venture, or a distribution arrangement — understanding what has changed and what now applies is not an optional exercise.

The central development is a restructuring of which activities require a licence and which require a permit, alongside revised criteria for obtaining each. Under the framework that has taken shape through 2026, the distinction between licensed activities — those requiring affirmative state authorisation before commencement — and notified or permitted activities has been drawn more sharply than under the previous rules.

Manufacturing of pharmaceutical products in Uzbekistan has long required a licence, and this requirement remains in place. What has changed is the set of conditions attached to that licence. The competent authority — the Agency for the Development of the Pharmaceutical Industry (ADFI), operating under the Ministry of Health — has introduced updated Good Manufacturing Practice (GMP) conformity requirements as a precondition for initial licence issuance. For foreign-owned or foreign-controlled manufacturing entities, this means that GMP certification issued by a recognised foreign or international body is no longer automatically accepted as a substitute for domestic GMP compliance assessment. A local conformity inspection is now required in most cases, conducted by ADFI-authorised inspectors. The timeline for completing this inspection, from the submission of a complete application package, typically extends to several months, though the precise duration varies with facility type and the workload of the inspectorate at the relevant period.

Wholesale distribution of medicinal products — a category that affects the majority of foreign companies operating through a local legal entity or through a distribution partner — has also seen its licensing conditions updated. The permitted legal form requirement has been clarified: only a registered legal entity in Uzbekistan (an LLC or JSC) may hold a wholesale distribution licence. A foreign company acting through a representative office alone cannot hold this licence; it must operate through a locally incorporated subsidiary or a licensed local partner. This clarification resolves ambiguity that existed in practice, but it also closes a route that some foreign principals had used to maintain a lighter regulatory footprint.

Retail pharmaceutical activities — including the operation of pharmacies — remain separately licensed, and this category is not addressed further in this update, as it is less directly relevant to foreign manufacturers and wholesale market entrants.

Import of medicinal products into Uzbekistan requires both product registration with the Ministry of Health and, separately, compliance with the import permit regime. The product registration process has been brought closer in structure to the EAEU registration system, even though Uzbekistan is not itself an EAEU member. In practice, this means that companies whose products are already registered within the EAEU may find procedural alignment helpful, but EAEU registration does not substitute for Uzbek registration. A separate registration dossier, in the format prescribed by the Ministry of Health, remains required.

"The progressive tightening of GMP conformity requirements in Uzbekistan reflects a deliberate regulatory convergence strategy — one that rewards early movers who build compliant infrastructure rather than those who seek to enter on the basis of foreign certifications alone." — Nodira Yusupova, Contributing Regional Analyst — Uzbekistan, Vetrov & Partners

The practical impact of these changes differs meaningfully depending on how a foreign company is present or intends to be present in the Uzbekistan pharmaceuticals market.

Foreign manufacturers seeking to establish local production face the most direct impact from the revised GMP inspection requirement. Companies that had factored EAEU GMP certificates or EU GMP certificates into their licensing timeline will need to revise those plans. A domestic inspection adds time and requires preparation of site documentation, translation of technical files, and coordination with the inspectorate. For companies in pre-investment planning, this should be treated as a critical-path item, not a formality to be addressed after construction or equipment installation.

Foreign companies distributing through a local partner: where a foreign principal sells into the Uzbekistan market through a locally incorporated distributor that holds the relevant wholesale licence, the foreign principal is not directly subject to the licensing requirements. However, the regulatory update affects the contractual and compliance framework governing that relationship. The local distributor's licence conditions have changed, and any distribution agreement that references compliance with the previous regulatory framework may require review. If the distributor's licence is subject to renewal or extension in the current period, the new conditions apply — and the foreign principal bears indirect exposure if the distributor's licence lapses or is suspended.

Foreign companies operating through a representative office: a representative office cannot itself hold a wholesale distribution licence under the current framework. Foreign companies that had been informally directing distribution activities through a representative office structure — relying on a formally separate but operationally integrated local partner — should treat this clarification as a compliance signal requiring prompt review.

Joint ventures with Uzbek partners: where a foreign company holds an interest in an Uzbek entity engaged in pharmaceutical manufacturing or wholesale distribution, the licensing conditions apply to the Uzbek entity directly. The foreign shareholder's practical concern is whether the joint venture entity's licences are current, whether the GMP inspection cycle has been completed, and whether the management of the joint venture is prepared to navigate the updated requirements. This is a due diligence item for new joint venture negotiations and a governance item for existing joint ventures.

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For companies already operating in the Uzbekistan pharmaceuticals market, the priority is an audit of the current licensing position of the operating entity — whether held directly or through a local partner — against the updated requirements. Three specific actions are relevant across most structures.

First, confirm that any GMP-dependent licence was obtained or renewed under the current inspection regime, not under transitional provisions that may no longer apply. The risk of operating under a licence obtained under superseded conditions is that renewal or extension will be subject to the current requirements in full, with no grandfathering of the prior conformity determination.

Second, review distribution agreements and local partner arrangements against the current licence conditions applicable to the Uzbek counterparty. Where the agreement contains representations or warranties about regulatory compliance framed by reference to the previous framework, those provisions require updating.

Third, for companies in the planning or negotiation phase, build the GMP inspection timeline into the market entry schedule as a hard constraint. The registration and inspection processes are sequential in material respects — product registration, GMP inspection, and licence issuance each depend on prior steps — and compressing the timeline by treating them as parallel is a common source of delay.

One additional consideration for companies with operations across the CIS region: Uzbekistan's approach to pharmaceutical regulation is developing in a manner that is broadly convergent with international standards, but the specific procedural requirements and the applicable documentation formats differ from those in Russia, Kazakhstan, and other regional markets. Experience with the EAEU regulatory framework is a useful starting point but is not a substitute for Uzbekistan-specific counsel.

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Q: What specifically changed in Uzbekistan's pharmaceutical licensing rules in 2026–2027?

A: The principal change is the introduction of a mandatory domestic GMP conformity inspection as a condition of manufacturing licence issuance. Previously, internationally recognised GMP certificates — including those issued under EAEU or EU frameworks — were accepted in certain circumstances without a separate local inspection. Under the current framework, ADFI conducts its own inspection of manufacturing facilities in most cases. In addition, the licensing conditions for wholesale distribution have been clarified to require a locally incorporated legal entity, excluding representative offices from holding this licence category. Product registration requirements for imported pharmaceuticals have also been brought into closer alignment with international dossier standards, though Uzbek registration remains a separate requirement from any EAEU or other regional registration.

Q: Which foreign companies operating in Uzbekistan's pharmaceutical market are most directly affected?

A: Foreign manufacturers with or seeking Uzbekistan manufacturing licences are most immediately affected, as the GMP inspection requirement directly extends their regulatory timeline and increases the documentation burden. Foreign principals distributing through Uzbek partners are indirectly affected through the compliance obligations of their local counterparties. Companies operating through representative office structures are affected by the clarification that such structures cannot hold wholesale distribution licences. Foreign shareholders in Uzbek pharmaceutical joint ventures are affected as a corporate governance matter — the updated requirements apply to the operating entity and bear on licence renewal timelines and compliance risk within the joint venture.

Q: What should a foreign company do before commencing pharmaceutical market entry in Uzbekistan?

A: The sequence that minimises delay is: first, confirm that the product is eligible for Uzbek registration and identify any formulation or packaging adaptations required by local standards; second, engage qualified local counsel to prepare and submit the registration dossier in the format currently required by the Ministry of Health; third, initiate the GMP inspection process in parallel where manufacturing activities are planned, treating the inspection as a critical-path item; and fourth, select the legal vehicle through which the licensed activities will be conducted, ensuring it is capable of holding the required licences. Companies with regional operations elsewhere in the CIS or EAEU should verify that their existing compliance and registration documentation is structured in a way that supports, rather than substitutes for, the Uzbek-specific requirements.

• [Market entry and company formation in Uzbekistan for foreign investors](/jurisdictions/uzbekistan/company-formation/)
• [Distribution and franchising arrangements in Uzbekistan: structuring for foreign principals](/jurisdictions/uzbekistan/distribution-franchising/)
• [Regulatory and licensing requirements in Kazakhstan: a comparison for regional market entrants](/jurisdictions/kazakhstan/regulatory-licensing/)

Vetrov & Partners is a Russian boutique law firm established in 2009, recognised by Pravo-300 for eight consecutive years. The firm advises foreign companies on market entry, regulatory compliance, and dispute resolution across Russia and the broader CIS region, working in conjunction with regional contributing analysts and trusted local counsel in Uzbekistan and other CIS jurisdictions.

For matters governed by the law of Uzbekistan or other CIS jurisdictions, the firm collaborates with trusted counsel in the relevant jurisdiction. We are a Russian-qualified law firm and do not hold Uzbek qualification.

Enquiries: info@vetrovpartners.com | WhatsApp / Telegram: +7 (983) 510-38-76 | t.me/vitvetcom

— Nodira Yusupova Contributing Regional Analyst — Uzbekistan, Vetrov & Partners vetrovpartners.com/contributions/

This publication is provided for informational purposes only and does not constitute legal advice under Russian or any other applicable law. The information herein should not be relied upon as a substitute for professional legal counsel tailored to your specific circumstances. Vetrov & Partners is a Russian-qualified law firm. For matters governed by foreign law or requiring local admission in another jurisdiction, we collaborate with trusted counsel in the relevant jurisdiction. For advice regarding your particular situation, please contact info@vetrovpartners.com.