We handle the dossier, translations, submission and expert review. You know the timeline upfront and see every step.
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You send the documents as they are. We check them, translate them and arrange them the way the expert review requires.
Product “Example”, 500 mg tablets
Collecting documentsPicture this:your product is already in Tashkent pharmacies,and your team has not spent a single dayin queues or in letters to the expert review.
Three product types, each with its own procedure. Pick a stage to see the work we take off your hands.
Standard registration, or recognition of a registration from a country with a strong regulator under Cabinet Resolution No. 738. You see the time and cost of each route before work starts.
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Risk class I, IIa, IIb or III is set under the classification approved by the Ministry of Health. The class decides the scope of testing, the registration timeline and the document list.
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We prepare the application and documents under Annex 63 to the Unified Regulation (Cabinet Resolution No. 86).
More about the serviceWe handle the whole route to registration, or a single stage if you do the rest yourself.
New medicines, generics and biologics: from dossier to certificate.
Devices of every risk class: technical file, testing, expert review.
Equipment for clinics and laboratories, including service documents.
We renew the registration before the certificate expires.
A new manufacturer, pack, composition or patient leaflet.
Import and production permit, sanitary-epidemiological conclusion.
A specialist studies the product and documents and gives a timeline and price.
Stages, deadlines and every payment, including fees, are visible upfront.
We find gaps before submission, not after a rejection.
We build the dossier to the regulator's rules and translate documents into Uzbek and Russian.
We give you a document checklist for your product
We submit and answer queries ourselves. You do not need to visit any agency.
We answer expert queries and arrange delivery of samples to the laboratory.
We obtain the certificate and hand it over with copies of all documents.
We tell you each time your case moves to a new stage
We warn you before the certificate expires and prepare the renewal.
For manufacturers and importers bringing a product line to Uzbekistan.
Discuss your portfolioOne person answers for every product and deadline.
Documents are kept in a closed system with role-based access.
Status of every product and the next step.
We agree the document and report format with your team.
Uzbek pharmaceutical legislation: laws, resolutions, orders and standards. A document that covers several areas appears in each of them.
“You always know which stage your case is at”
One specialist owns each case. They report every step and answer questions within a business day.
Pharmalex teamRegistration of medicines and medical devices