Uzbekistan: New changes proposed to rules governing marketing authorization and distribution of medicines and medical devices | Dentons

A draft Presidential Decree that, once passed, will have a significant impact on the obtaining of marketing authorization as well as the distribution of medicines and medical devices. The Ministry of Health of the Republic of Uzbekistan (the Regulator) has published the full text of the draft decree, which you can access here (in Uzbek only). 

Below, we provide you a brief overview of the key changes.

Are the proposed changes relevant to my business?

Yes, if your business involves the manufacture, import or sales of medicines or medical devices in Uzbekistan.

What are the proposed changes about?

Changes to obtaining marketing authorization—the following has been proposed:

1) From January 3, 2023:

1. clinical trials will be introduced to in order to obtain marketing authorization of medicines that do not have Uzbekistan-recognized authorizations from foreign countries. At the same time, the requirement for clinical trials may be abolished for specific medicines in a separate order (this process must still be developed);
2. for state registration of medicines, on-site examinations of manufacturing facilities will be introduced to verify compliance with “Good Manufacturing Practice– GMP” requirements (except for medicines registered by countries and international organizations—provided the registration results are recognized in Uzbekistan);
3. marketing authorization for medicinal substances will be abolished;
4. the submission of standard samples when recognizing a medicine’s registration test results conducted outside of Uzbekistan will no longer be required.

2) By December 31, 2022:

1. A list will be developed and approved of medicines and medical devices, allowing their use in medical practice until January 1, 2025 without first obtaining marketing authorization; however, they will be subject to the mandatory certification procedure. This exemption will apply to medicines and medical devices that do not have analogues already registered in Uzbekistan. At the same time, any medicines and medical devices that have an analogous medicine/device registered subsequently will be removed from the list within three months from the date of such registration.

Changes to the distribution of medicine—the following has been proposed:

1) From January 1, 2023:

1. The Regulator will no longer approve the list of over-the-counter medicine. In addition, the practice will be implemented to provide prescription and over-the-counter medicine in accordance with the manufacturer’s instructions for use of the medicine;
2. Medicines without a recorded reference price or whose price exceeds the recorded reference price will not be certified.