Manufacturing
GMP in Uzbekistan: registration and conformity certification
What is being introduced
| Requirement | Effective date | Scope |
|---|---|---|
| GMP for registration and renewal | from 01.01.2026 | Subject to exceptions |
| GMP for medicine conformity certification | from 01.01.2027 | Subject to exceptions |
| ISO 13485 for device conformity certification | from 01.07.2027 | Subject to exceptions |
The decree includes exceptions, including recognition and WHO-prequalified products. Review the current rules and product-specific regulatory route with the responsible regulatory specialist.
Who is affected
Importers and authorisation holders
GMP requirements apply to registration and conformity certification under different rules. The applicable route and exceptions must be checked for each medicine before a supply or transfer decision.
Local manufacturers
GMP requirements apply to registration and conformity certification under different rules. The applicable route and exceptions must be checked for each medicine before a supply or transfer decision.
Why this creates a capacity squeeze
Availability must be checked with each site. Allow time for technical assessment, transfer and validation; the schedule depends on the product and agreed scope.
What to do in advance
- Check the status of the sites currently producing for the Uzbek market.
- Assess whether the product qualifies for the recognition procedure — it materially shortens registration.
- If localisation is planned, start with a feasibility assessment at a specific site.
- Budget time for technology transfer and validation batches, not just for registration.
- Review the labelling and packaging requirements applicable in Uzbekistan.
Laxisam site status
The site operates according to GMP principles. Request current quality documentation and its scope for the proposed project from Laxisam.
Frequently asked questions
- When does GMP become mandatory in Uzbekistan?
- GMP requirements apply to registration and renewal from 1 January 2026, and to medicine conformity certification from 1 January 2027. The decree provides exceptions; applicability must be checked for the specific medicine and procedure.
- What is the recognition procedure and how long does it take?
- Resolution No. 738 provides 210 days for the general medicine-registration procedure and 60 days for recognition. These periods do not include all additional steps, such as time to address dossier deficiencies or conduct required studies.
- Which regulation governs registration now?
- Resolution of the Cabinet of Ministers No. 738 of 24 November 2025, in force since 26 February 2026. It replaced the former Resolution No. 213.
- What should an importer do if its site has no GMP confirmation?
- Either bring the manufacturing site into compliance, or move production to a certified facility, including a local one.
- Why not postpone the decision to late 2026?
- Availability must be checked with each site. Allow time for technical assessment, transfer and validation; the schedule depends on the product and agreed scope.