Pharmacovigilance in Uzbekistan

Pharmacovigilance

The competent authority carrying out pharmacovigilance activities in the territory of 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".

The competent authority monitoring the safety of medicines is the Ministry of Health of the Republic of Uzbekistan.

Article 13 of the Law of the Republic of Uzbekistan "On Medicines and Pharmaceutical Activities" establishes that medical and prophylactic institutions, pharmacies and organizations that produce, sell and use medicines are obliged to inform the Ministry of Health of the Republic of Uzbekistan in writing about all cases of adverse reactions during the use of medicines.

Requirements for the procedure for informing and the form of communication and undesirable adverse reactions are approved by the Order of the Ministry of Health of the Republic of Uzbekistan dated 16.04.2018 No. 3000 "On Approval of the Regulations on the Procedure for Informing Identified Adverse Reactions when Using Medicines".

The Ministry of Health of the Republic of Uzbekistan assesses the identified adverse reactions in the use of medicines, during which the cause-and-effect relationships between the clinical manifestations of the adverse reaction and the use of the drug are determined, as well as the ratio of the expected benefit to the possible risk of using drugs.

When establishing evidence of non-compliance of a medicinal product when it is used with the established requirements for the safety and efficacy of the medicinal product, the Ministry of Health of the Republic of Uzbekistan shall consider the issue of withdrawing from circulation or suspending the use of such a medicinal product.
The requirements for the creation and maintenance of a pharmacovigilance system in Uzbekistan are not described in any single legislative act. At the same time, in the instructions for medical use, it is necessary to enter the name and address of the organization receiving claims (proposals) on the quality of medicines in the territory of the Republic of Uzbekistan.

Also, when submitting an Application for state registration of a medicinal product, the Applicant submits as part of the registration dossier:

Description of the pharmacological safety control system and the risk management system (RMS - corresponds to the SDM);
Master File Pharmacovigilance System (PSMF);
PSUR.

Ensuring the pharmacovigilance system

To ensure the pharmacovigilance system, the Applicant carries out the following activities:

• Receiving operational information from the Ministry of Health of Uzbekistan regarding all serious side effects (hereinafter referred to as PJ) of a medicinal product (disability, death and other serious PJ). This information may lead to the initiation of measures to minimize the identified risk (for example, amendments to the instructions for medical use), therefore, in accordance with international law, should be distributed to 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 drugs in other countries;

• Providing operational information to the competent authority of Uzbekistan regarding all serious OR of the medicinal product that have been recorded in Uzbekistan (for example, information from medical representatives, direct appeals of doctors and patients, information on PJ from other sources);

• Providing operational information to the competent authority of Uzbekistan regarding all serious PNs that have led to the death or threat to the life of patients in the territory of other countries;

• Providing operational information to the competent authority of Uzbekistan regarding the lack of effectiveness of the drug in the treatment of life-threatening conditions, emergencies and conditions in which the lack of effect may threaten the patient's life;

• Provision of operational summary information (including detailed information, methods of correction of PJ) on all side effects and / or on 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 state of safety of medical use of the medicinal product in Uzbekistan for re-registration;

• Participation in other aspects of cooperation with the competent authority of Uzbekistan and all other subjects of pharmacovigilance;

• Submission of the Risk Management System (RMS), when registering / re-registering drugs, in case of changes requiring new registration, in case of emergence / identification of new risks, at the request of the regulatory authority.

We will professionally perform work on the creation and maintenance of the pharmacovigilance system in Uzbekistan. We know the national legislation and language, have the necessary experience and resources to perform the work.

Pharmacovigilance in Uzbekistan

Pharmacovigilance

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