Why is drug registration important?
Drug registration in Uzbekistan is not merely a matter of submitting documents. The process requires preparing a specialized dossier, conducting laboratory tests, communicating with competent authorities, and adhering to strict deadlines. Any error made at any stage of the process may result in the rejection of documents, extended timelines, and additional financial costs.
Primary regulatory framework
The key documents governing the circulation of medicinal products and marketing authorization in Uzbekistan include the Law of the Republic of Uzbekistan "On Medicinal Products and Pharmaceutical Activities" and Resolution No. 213 dated March 23, 2018. These documents define the registration procedure, the composition of materials to be submitted, and the rules for conducting expert evaluation.
Key stages of the registration process
Analysis of the product and selection of the optimal registration pathway
Preparation and review of the registration dossier (CTD format, modules, translations)
Organization of laboratory and other required testing
Monitoring the expert evaluation process and responding to queries
Submission of variations (amendments to the registration dossier)
Deadline control and regular reporting to the client
International recognition opportunities
Since November 1, 2018, Uzbekistan has introduced the recognition of drug registration outcomes from 20 countries. This significantly simplifies the process of bringing products to the Uzbekistan market for foreign manufacturers. Additionally, the State Register of Uzbekistan is regularly updated, with the list of approved medicinal products continuously expanding.
Reliable results with Pharm Way Group
Pharm Way Group provides professional assistance at all stages of drug registration. We cover the full cycle, from the initial analysis of your product through to successful state registration. A clear plan, deadline control, and qualified support at every stage — all of this ensures that your product reaches the market quickly and through the proper channels.
