Manufacturing
Mandatory GMP from 1 January 2027: what changes for manufacturers and importers
What is being introduced
| Requirement | Effective date | Legal basis |
|---|---|---|
| Recognition of stringent regulators' registrations | from 01.10.2025 | Decree UP-137 of 19.08.2025 |
| Mandatory GMP compliance | from 01.01.2027 | Decree UP-137 |
| ISO 13485 for medical devices | from 01.07.2027 | Decree UP-137 |
| New registration procedure for medicines and devices | from 26.02.2026 | Resolution No. 738 of 24.11.2025 |
Who is affected
Importers and authorisation holders
Products imported into Uzbekistan must originate from a manufacturing site that meets GMP requirements. Companies whose sites lack such confirmation have two options: bring the site into compliance, or move production to a certified facility — including a local one.
Local manufacturers
The requirement applies to domestic production as well. Sites without a valid certificate will be outside the market once the deadline arrives, so preparation starts early: certification is not a one-off inspection but a rebuild of the quality system, documentation and personnel training.
Why this creates a capacity squeeze
The arithmetic is simple: the number of sites holding a valid certificate is limited, while demand for them grows as the deadline approaches. Companies that start looking for a manufacturing partner in late 2026 will face booked capacity and a queue for technology transfer, which itself takes months.
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
National GMP certificate No. GMP-08:2024 was issued in April 2024 and is valid until April 2027. Licence No. 15998 for the manufacture of medicines and medical products is valid from 01.04.2022 to 01.04.2027.
Frequently asked questions
- When does GMP become mandatory in Uzbekistan?
- From 1 January 2027, under Presidential Decree UP-137 of 19 August 2025. For medical devices, ISO 13485 becomes mandatory from 1 July 2027.
- What is the recognition procedure and how long does it take?
- It is an accelerated registration route for products authorised by stringent regulatory authorities. It takes 60 days, against 210 days under the general procedure.
- 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?
- Technology transfer and validation batches take months, and the number of certified sites is limited. Closer to the deadline capacity will be taken.