Recognition of Foreign Drug Registration in Uzbekistan

The modern pharmaceutical industry is characterized by a high degree of globalization, which necessitates the harmonization of national drug registration procedures with international standards. In this context, the Republic of Uzbekistan has taken steps to optimize the regulation of pharmaceutical circulation, including the simplification of market access for drugs registered in foreign jurisdictions.

By Resolution of the Cabinet of Ministers No. 862 dated October 24, 2018, the Procedure for Recognition of Foreign Drug Registration Results was approved — one of the key stages in pharmaceutical sector reform.

This regulatory act was adopted in accordance with Presidential Decree No. PP-3948 dated September 24, 2018, “On Additional Measures to Improve the Procedure for State Registration and Circulation of Medicinal Products.”

The document defines:

• the authorities empowered to perform recognition;
• the list of countries and international organizations whose registration results are recognized;
• the conditions, documents, and procedures for recognition;
• the grounds for refusal, extension, suspension, and cancellation of recognition.

Thus, this resolution ensures the mutual recognition of drug registration, reducing administrative barriers for foreign manufacturers.

Key Elements of Legal Regulation

1. Subjects and Objects of Recognition

Recognition applies to medicinal products registered by competent authorities of countries included in the approved list or by international organizations (e.g., WHO, EMA, FDA).

The applicant may be:

• the manufacturer of the medicinal product;
• the holder of the registration certificate;
• an authorized representative of the above parties.

2. Authorized Bodies

Recognition is carried out by the State Center for Expertise and Standardization of Medicines, Medical Devices, and Equipment under the Agency for the Development of the Pharmaceutical Industry of the Ministry of Health of the Republic of Uzbekistan. This Center is responsible for entering the recognition record into the State Register of Medicines.

3. Term and Legal Consequences of Recognition

Recognition is granted by the State Register for a period of five years and may subsequently be extended indefinitely upon reapplication by the applicant. An entry in the State Register confirms the legality of the drug’s circulation within Uzbekistan and its authorization for medical use.

Recognition Procedure

Stage	Content of the Procedure	Timeframe
1. Submission of application	Submission of documents and samples to the State Center	—
2. Preliminary review	Registration of the application, verification of completeness	15 working days
3. Payment of fee	Fee equal to 50 times the basic calculation unit	up to 30 days
4. Expert review	Consideration by pharmacopoeial, pharmacological, and narcological committees	up to 12 working days each
5. Decision of the Expert Council	Adoption of a decision on recognition or refusal	1 day
6. Entry into the register and applicant notification	Within 1 working day after the decision	—

The process is strictly regulated and prohibits the demand for any additional documents not specified by the regulation, ensuring administrative transparency.

Grounds for Refusal and Suspension of Recognition

Refusal is allowed only on objective grounds, such as:

• incomplete documentation;
• submission of inaccurate data.

Refusal “for other reasons, including expediency,” is expressly prohibited. Recognition may be suspended in cases of adverse reactions, threats to public health, or withdrawal of the drug in its country of origin.

Importance of Resolution No. 862

Resolution No. 862 plays a strategic role in integrating Uzbekistan into the global pharmaceutical space. It:

• simplifies market entry for high-quality foreign medicines;
• enhances the country’s pharmaceutical safety;
• encourages local manufacturers to comply with international GMP and pharmacovigilance standards;
• ensures transparency and predictability of administrative procedures;
• promotes investment in the pharmaceutical sector.

The adoption of Resolution No. 862 of October 24, 2018, represents a significant milestone in the liberalization of Uzbekistan’s pharmaceutical market. It has established a legal mechanism for recognizing foreign registration procedures, thereby accelerating the entry of safe and effective medicinal products into the market, strengthening international cooperation, and improving the competitiveness of the national pharmaceutical industry.