Uzbekistan GVP National Standard O’z MSt 339:2024: Pharmacovigilance Framework Explained

1. Key takeaways

The national standard O’z MSt 339:2024 on Good Pharmacovigilance Practices (GVP) entered into force on November 1, 2024. It was developed by the Center for Drug Safety together with the specialized standardization institute under Presidential Decree No. PF-20 (January 23, 2024). The standard provides the national framework for safety controls, for the timely identification of changes in the benefit-risk balance, and for the implementation of risk management measures, and it also serves as the methodological basis for the PSUR and the risk management system required under registration No. 3752. In practical terms, the GVP standard defines what a working vigilance system must look like inside a company, while registration No. 3752 defines what must be reported to the authority and when. For companies entering the market in 2026, the standard is therefore the reference to read first, because the procedural regulation assumes its vocabulary and its system requirements.

2. Legal basis

3. Expert insights

Insight 1: The standard came into force before the procedural regulation, which shows the system was built methodology first. The national GVP standard entered into force on November 1, 2024, while registration No. 3752 completed Ministry of Justice registration only on January 12, 2026. This sequencing shows that the authority established the methodological framework first and then landed the operational requirements through a procedural regulation. For companies this is good news: the two documents are consistent in methodology, so there is no need to build and maintain two separate systems for the standard and the reporting regulation. For companies, the practical effect is stability: the methodological baseline will not shift underneath the reporting obligations that were built on it.

Insight 2: Uzbekistan is not a member of the EAEU, and national rules take precedence. Because the country is not an EAEU member, the union pharmacovigilance rules do not apply automatically. National regulations, the Uzbekistan GVP standard, the conditions of the marketing authorization, and the formal decisions of the Center take precedence. This is the same logic that applies on the registration side, where EAEU certificates have no automatic effect, now expressed in the pharmacovigilance domain: processes imported from the union level cannot simply be transplanted into the Uzbekistan market without checking them against the national framework. In practice this means a vigilance procedure validated against EAEU rules must be re-checked point by point against the national texts before it is declared applicable in Uzbekistan.

Insight 3: The GVP standard is a system requirement, not a form requirement. The GVP standard requires companies to maintain an operating vigilance system: documented roles, procedures, training, quality control, record retention, and inspection readiness. The individual case reports, the quarterly aggregations, and the PSURs required under registration No. 3752 are the outputs of that system. A company that produces the outputs without building the underlying system will be exposed the moment an inspection examines how the outputs were generated, by whom, and on the basis of which procedures. The system evidence also determines the outcome of an inspection more than the reports themselves, because a report without a procedure behind it is treated as an unmanaged output.

Insight 4: GxP assessment can extend into the post-market surveillance track. Resolution No. 628 provides that when the Center finds a nonconformity, it may request an interim GxP conformity inspection of the organizations concerned. Since the GVP standard is a component of the GxP family, the state of the vigilance system can therefore be drawn into the scope of such an inspection. A failed sample in the market can thus become the entry point for a review of pharmacovigilance documentation, training records, and procedural discipline. Companies can therefore use one inspection-readiness file to cover both the quality system and the vigilance system, provided the GVP elements are explicitly addressed.

4. Practical recommendations

1. Build a documented vigilance system according to the national GVP standard, covering roles, procedures, training, quality control, record retention, and inspection readiness.
2. Design individual case reporting, quarterly aggregation, and the PSUR as natural outputs of the system, rather than as one-off tasks performed for each submission.
3. Apply the principle of national rules taking precedence: do not copy EAEU or European Union vigilance processes directly, but defer to the national regulations and the GVP standard.
4. Retain evidence of system operation, including training records, quality control records, and CAPA documentation, ready for inspection at any time; evidence retention periods should follow the national requirements rather than internal habits.
5. Track revisions of the GVP standard and update internal procedures in step whenever the standard is amended.

5. Verification checklist

• □ A documented vigilance system has been built according to the national GVP standard, covering roles, procedures, training, quality control, and records
• □ Individual case reporting, quarterly aggregation, and the PSUR are managed as outputs of the system
• □ It has been confirmed that national rules take precedence, with no direct application of EAEU or European Union processes
• □ Evidence of system operation has been retained, covering training, quality control, and CAPA
• □ A mechanism for tracking GVP standard revisions and updating internal procedures is in place
• □ It has been confirmed that the GVP system can be drawn into the scope of GxP inspections under Resolution No. 628

Regulatory information verified as of October 29, 2026.

GRZAN provides regulatory support to manufacturers, importers, and authorized representatives seeking medical device registration and post-market compliance in Uzbekistan, including dossier preparation, authorized representative arrangements, vigilance setup, and surveillance readiness. For inquiries, contact info@grzanglobal.com.