The government of Uzbekistan has updated the requirements for medicines that may be sold without a prescription, a regulatory change registered by the Ministry of Justice on 12 November 2026 and due to take effect three months after official publication. The new rules are intended to more clearly define which medicines are safe for self-administration without continuous medical supervision, improve the clarity of patient instructions and reduce risks of misuse, abuse and adverse reactions. The measure affects manufacturers, pharmacies, applicants and patients across the country.
Key Takeaways: The changes were registered by the Ministry of Justice on 12 November 2026 and will enter into force three months after official publication. When granting over-the-counter status, the regulator will consider safety without constant medical supervision, clarity of instructions, abuse potential, post-market safety results and the experience of WHO-recognized foreign regulators. A rejected application may be resubmitted after the reasons for refusal are resolved or new safety and efficacy data emerge, replacing the previous three-year restriction.
The update is significant because it revises how Uzbekistan decides which medicines can move from prescription-only to over-the-counter sale. Under the revised approach, the assessment is broader than a simple review of formal criteria: officials will examine whether a patient can use the product safely and independently, whether the package leaflet is understandable to an ordinary buyer, and whether there is a risk of dependence or improper use. The regulator will also take into account pharmacovigilance and post-marketing control results, along with relevant decisions by foreign regulators recognized by the World Health Organization. These criteria matter most for widely purchased products used for pain, allergies, colds and other common conditions, where patients often choose medicines without a doctor’s consultation.
The updated procedure also allows combination medicines containing two or more active substances to be considered for over-the-counter status. In such cases, specialists must assess the benefit of each component, the efficacy of the combination, possible interactions and the risk of overdose. The rules for repeat applications have changed as well: if a request to reclassify a medicine as over-the-counter is rejected, the applicant may apply again after removing the grounds for refusal or after new safety and efficacy data become available. Previously, a three-year restriction applied to repeat applications. The authorized body may also review a medicine’s category after registration on the basis of new safety or efficacy data, pharmacovigilance and post-marketing control results, or changes in legislation.
Separately, Uzbekistan plans to update rules on the sale, storage and delivery of medicines. A draft prepared by the Ministry of Health provides for online ordering of over-the-counter medicines and certain medical devices, as well as new requirements for pharmacies and courier services. The measures are expected to enter into force three months after official publication, giving pharmacies, manufacturers and applicants time to adjust internal procedures and documentation. How the new criteria affect access to medicines and the quality of pharmacy advice will be closely watched in the coming months.
Source: podrobno.uz