The competent authority responsible for pharmacovigilance activities in the Republic of Uzbekistan is the Ministry of Health. The legal basis for pharmacovigilance is approved by the Law of the Republic of Uzbekistan “On Medicines and Pharmaceutical Activities”.

According to the Article 13 of the Law of the Republic of Uzbekistan “On Medicines and Pharmaceutical Activities” healthcare institutions, pharmacies and organizations producing, selling and using medicinal products must inform the Ministry of Health of the Republic of Uzbekistan in writing of all cases of adverse reactions to medicinal products.

The requirements for the procedure for informing and the form of a report on undesirable adverse reactions are approved by Order of the Ministry of Health of the Republic of Uzbekistan No. 3000 dated April 16, 2018 “On approval of the regulation on the procedure for informing identified adverse reactions when using medicinal products.”

The Ministry of Health of the Republic of Uzbekistan carries out an assessment of the identified adverse reactions to medicinal products, during which the causal relationship between the clinical manifestations of the adverse reaction and the use of the medicinal product is determined, as well as the ratio of the expected benefit to the possible risk of using medicinal products. 

When establishing evidence of non-compliance of a medicinal product during its use with the established requirements for the safety and efficacy of a medicinal product, the Ministry of Health of the Republic of Uzbekistan considers the issue of withdrawal from circulation or suspension of the use of such a medicinal product.

The requirements for the establishment and maintenance of a pharmacovigilance system in Uzbekistan are not described. At the same time, the name and address of the organization accepting claims (proposals) on the quality of medicinal products on the territory of the Republic of Uzbekistan must be included in the instructions for use (leaflet).

Application for registration should include the following data: 

1. Description of the pharmacological safety control system and risk management system (RMS – corresponds to the RMP);
2. Pharmacovigilance System Master File (PSMF);
3. PSUR.

To maintain the pharmacovigilance system in Uzbekistan, the Applicant (MAH) carries out the following activities:

• Obtaining up-to-date information from the Ministry of Health of Uzbekistan regarding all serious adverse events (hereinafter referred to as AEs) of the medicinal product (disability, death, and other serious AEs). This information can lead to the initiation of measures to minimize the identified risk (for example, amending the instructions for human use), therefore, in accordance with international law, it should be distributed among the regulatory authorities of other countries;
• Obtaining retrospective information from the competent authority of Uzbekistan for the formation of a registration dossier for registration/re-registration of the medicinal product in other countries;
• Providing up-to-date information to the competent authority of Uzbekistan regarding all serious AEs of the medicinal product that have been reported in Uzbekistan (for example, information from medical representatives, direct reports from doctors and patients, information about AEs from other sources);
• Providing up-to-date information to the competent authority of Uzbekistan regarding all serious AEs that have led to death or threatened the life of patients in other countries;
• Providing up-to-date information to the competent authority of Uzbekistan regarding the lack of efficacy of the medicinal product in the treatment of life-threatening conditions, emergency conditions and conditions in which the lack of effect can threaten the life of the patient; 
• Providing up-to-date summary information (including detailed information, methods for correcting AEs) about all side effects and/or about all cases of lack of efficacy of the medicinal product at the request of the competent authority of Uzbekistan;
• Preparation and submission of consolidated information on the safety of human use of the medicinal product in Uzbekistan for renewal procedure;
• Participation in other aspects of cooperation with the competent authority of Uzbekistan and all other pharmacovigilance entities;
• Submission of the Risk Management System (RMS), when conducting registration/re-registration of the medicinal product, in case of changes requiring a new registration, in case of emergency/identification of new risks, at the request of the regulatory body.

Cratia provides professional services of the establishment and maintenance of the pharmacovigilance system in Uzbekistan. We have an excellent knowledge of national legislation, necessary experience and resources.

To start cooperation or get advice, please contact us by phone: +38 068 064-78-31, +38 044 223-61-67, by e-mail: info@cratia.ua, or visit our office.