Registration of pharmaceutical products — it takes about 1,5 years. The registration fee per product is around 10000 USD. If a clinical test in Uzbekistan of a product will be demanded, then the applicant must conduct a clinical trial in the territory of Uzbekistan, which we can organize.
Inspection of manufacturing unit according to Uzbekistan GMP standards. To register a new product in Uzbekistan, all manufacturing sites must undergo an inspection from Uzbekistan and get the GMP. We can assist our customer factories.
Extension of registration of pharmaceutical products — The registration certificates are granted for 5 years. Before expiring, 3-4 months ago, need to apply to extend the Registration Certificate.
That procedure takes 4-6 months’ time for the extension procedure. After that a new registration certificate can be obtained for next 5 years.
Re-registration or amendments to regulatory documents, drug name, specifications, artworks, inserts, etc. Manufacturing site address or product’s full composition is not possible to change. It will be treated as new registration.
Registration of nutraceuticals, food products and supplements – It will take 1 year time to get a product registered.
For any questions regarding requirements to the manufacturing site, dossier format, costs, time required for completion, distributor search, please contact us.
Population in Uzbekistan is 36.40 million (2024). GDP of Uzbekistan is 115 billion USD. In Uzbekistan, a significant portion of medicines consumed is imported. Several sources report that the percentage of imported medicines is around 78% to 89% of the total market.
While the population in EAEU countries is total 185 million (2024) and the total GDP is 2.5 trillion USD.