The key facts

  • The amendments were registered by the Ministry of Justice on 12 November 2026 under number 3430-2
  • Combination medicines containing two or more active substances may become over-the-counter
  • After a refusal to reclassify a medicine as over-the-counter, a re-application is possible without waiting three years

What has changed

In Uzbekistan, amendments have been registered to the regulation on the procedure for classifying medicines as prescription-only or over-the-counter. As reported by the Ministry of Justice, the document was registered on 12 November 2026 under number 3430-2. The changes were covered on 14 November by Zamon.uz, Daryo.uz and Kun.uz.

New criteria for the over-the-counter category

The criteria by which a medicine may be classified as over-the-counter have been clarified. The following are taken into account: the possibility of safe self-use without constant supervision by a healthcare professional; a low risk of misuse, overdose, abuse or dependence; clarity and comprehensibility of the instructions for the consumer; the results of pharmacovigilance and post-registration surveillance; as well as the medicine's classification as over-the-counter by regulatory authorities recognized by the WHO.

Combination medicines and re-application

A fundamental innovation is that the over-the-counter category may now include medicines combining two or more active substances. In doing so, the contribution of each component to the treatment, the benefit-risk ratio of the combination, its clinical justification, interactions between the substances, as well as the risks of overdose and misuse are assessed. Previously, judging by the wording of the sources, the rules referred to medicines without taking such combinations into account.

What this means in practice

If an applicant is refused the reclassification of a medicine from the prescription category to the over-the-counter category, they will be able to apply again without waiting three years, provided that the grounds for the refusal have been eliminated or new data on the medicine's safety and efficacy have emerged. In addition, the authorized body will be able to review a medicine's category based on new safety data, pharmacovigilance results and changes in legislation. No specific lists of medicines affected by the changes were provided in the publications.