News and developments
Legislative changes in Pharma and Business Licensing in Uzbekistan
On 22 November 2023, Uzbekistan President signed a Law, "On Amendments and Supplements to Certain Legislative Acts of the Republic of Uzbekistan in connection with the Improvement of Pharmaceutical Activity" No. ZRU – 879 (the “Law No. 879”).
The Law No. 879 amended and supplemented the Law of the Republic of Uzbekistan “On Medicines and Pharmaceutical Activities” No. ZRU-399 dated 4 January 2016 (the “Law on Medicines”) and the Law of the Republic of Uzbekistan “On Blood Donation and its Components" No. 402-II dated 30 August 2002 (the "Law on Blood Donation"). Law No. 879 came into force on 22 November 2023.
As per the amendments and supplements made to the Law on Medicines, healthy individuals can now participate in clinical trials of a pharmacological agent or medicine. Previously, only patients were allowed to participate as subjects in the clinical trials. According to the updated Law on Medicines:
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- Participation of a subject in clinical trial of a pharmacological agent or medicine shall be carried out on a voluntary basis upon his/her written consent,
- The head of the clinical trial is obliged to give the subject a detailed explanation on the significance of the method, nature, and possible risks of the clinical trial,
- The subject of a clinical trial is entitled to refuse to participate at any stage of the clinical trial.
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- Now the same manufacturer can register several medicines having the same composition under different trade name.
- Registration certificates for medicines, medical devices, and medical equipment issued to domestic manufacturers have become valid for indefinite term. Previously, the validity period of registration certificates for domestic manufacturers was 5 (five) years.
- Possessing an appropriate license, the third-party manufacturers are now allowed to manufacture medicines and medical devices based on a contract and in accordance with the purchase order of the customer (manufacturer of medicines and medical devices). The registration certificate is issued to the third-party manufacturer directly manufacturing medicines and medical devices in accordance with the purchase order. Notably, a separate regulatory legal act governing contract manufacturing has not been adopted yet.
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- Implementation of targeted screenings,
- Free provision of necessary medicines to the vulnerable groups of population,
- Early detection of the causes of the development and prevention of allergic and immunological diseases among children, adolescents, and pregnant women,
- Expanding the types of high-tech diagnostics and treatment, as well as introducing methods of molecular diagnostics of allergic diseases in the regions.
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- Conducting mass and selective screenings in areas with high rates of allergic diseases (including seasonal allergies) at least 1 (once) a year,
- Organization of systematic monitoring and individual rehabilitation of identified patients suffering from allergic diseases and diseases of secondary immunodeficiency by allergists,
- Gradual increase from 10 (ten) to 20 (twenty) types of high-tech diagnostics and treatment modalities in the field of allergology and clinical immunology in the regions,
- Full provision of allergen reagents to the laboratories of territorial subdivisions of the Republican Scientific and Specialized Allergological Center at the expense of local budgets in cooperation with the Council of Ministers of the Republic of Karakalpakstan, the khokimiyats (regional government administrations) of the regions and Tashkent city.
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- Prevention, molecular diagnosis, and treatment of allergic and immunological diseases based on fundamental and practical research in the field of molecular allergology and clinical immunology,
- Implementation of screening programs for early detection and elimination of the causes of allergic diseases,
- Implementation of national programs for the prevention, early detection, and management of allergic diseases and secondary immunodeficiency diseases in primary healthcare.
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- Systematic (2 (two) or more times within 1 (one) year) violation by the licensee or the person who received the permit of licensing or permit requirements and conditions,
- A single gross violation by the licensee or a person who has received a permit of licensing or permit requirements and conditions, if these violations resulted in harm to the life and health of citizens, infringement of the rights and legitimate interests of individuals and legal entities, public safety and harm to the environment, damage to the interests of society and the state, creating a threat to peace and security.
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- Medical services,
- Veterinary services,
- Medicines, veterinary medicines, medical and veterinary devices.
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- Medicines, veterinary medicines, medical and veterinary devices,
- Raw materials imported according to the list determined by legislation which are used to produce medicines, veterinary medicines, medical and veterinary devices.
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- Maximum trade mark-ups for wholesale and retail sales of medicines and medical devices,
- Sales of socially significant medicines and medical devices at fixed prices.
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- Order of the MoH “On Approving the Regulation on the Procedure for Registration of Prices for Medicines in the Reference Price Formation System” No. 3242 dated 10 June 2020,
- Decree of the President “On Additional Measures to Deepen Reforms in the Pharmaceutical Industry of the Republic of Uzbekistan” No. PP-4554 dated 30 December 2019 (the “Decree No. 4554”).