On October 4, 2024, the Cabinet of Ministers of the Republic of Uzbekistan adopted Resolution No. 628, titled “On the approval of the Regulation on the Procedure for Conducting Post-marketing Surveillance of Pharmaceutical Products” (the “Regulation No. 628“), which came into effect on October 5, 2024.

According to Regulation No. 628, post-marketing surveillance is conducted by the Pharmaceutical Product Safety Center under the Ministry of Health of the Republic of Uzbekistan (the “Center”) without interfering in the financial and economic activities of business entities.”

Procedure for introducing pharmaceutical products into circulation

Pursuant to Regulation No. 628, medicines, medical purpose devices, and medical equipment (“MPDs, and ME“) manufactured by enterprises that do not possess a valid certificate of conformity may be placed into circulation only after the authorized representative of the enterprise enters information regarding the relevant batch, name, pharmaceutical form, international nonproprietary name (INN), quantity, prices, and production date into a special electronic system maintained by the Center, or in paper form. The responsibility for the accuracy of the provided information rests with the manufacturer.

Grounds and procedures for conducting post-marketing surveillance

The grounds for conducting post-marketing surveillance include:

    • A post-marketing surveillance plan approved monthly by the head of the Center,
    • Receipt of information and complaints from individuals and legal entities, including governmental bodies and organizations, concerning the quality, safety, illegal circulation, and side effects of pharmaceutical products,
    • Information from mass media and the results of public opinion surveys utilizing information and communication technologies.

The Center develops the post-marketing surveillance plan based on a protocol with respect to identified samples once a month. This plan is approved by an order of the head of the Center by the 25th of each month.

If information regarding the quality, safety, illicit trafficking, or adverse effects of pharmaceutical products is received from individuals, legal entities, government bodies and organizations, mass media, and information and communication technologies, the head of the Center shall within one business day issue an order for the implementation of post-marketing surveillance.

To carry out post-marketing surveillance, the Center procures medicines and/or MPDs . Notably, acquiring ME and MPDs not included in the pharmacy assortment is not mandatory for conducting post-marketing surveillance.

The acquired samples must be submitted to testing laboratories within two business days for laboratory testing to assess compliance with regulatory requirements.

Testing laboratories shall conduct tests on samples within five business days. Following the testing, they shall prepare reports that include a statement regarding the conformity or non-conformity of the samples.

For pharmaceutical products requiring testing timeframes exceeding five days, including those requiring sterility, testing shall be conducted within a period of fifteen business days.

Based on Regulation No. 628, should the findings indicate non-conformance of samples of medicines, MPDs, and ME with regulatory requirements, the Center shall take the following measures within three days:

    • To prevent adverse effects from pharmaceutical products, the Center shall decide to suspend their use in medical practice, withdraw them from circulation, implement destruction procedures, and issue directives to enterprises specifying compliance deadlines,
    • The Center shall require businesses to conduct temporary mandatory certification for the first ten batches of pharmaceutical products manufactured after identifying non-conformance.
    • The Center shall submit a mandatory compliance request to the relevant organizations to conduct an unscheduled inspection on the compliance of entities involved in the circulation of nonconforming medicines with the requirements of Good Practices (GxP) and assess manufacturers of MPDs and ME for compliance with ISO 13485,
    • If post-market surveillance indicates regular (twice or more within one year) nonconformance in one or several products from a single enterprise, the Center shall decide to implement temporary mandatory certifications for all products of that organization for one year,
    • The Center shall take actions to suspend the validity of the registration certificate for medicines, as well as licenses for pharmaceutical activities, and proceed with their annulment per the legislation of the Republic of Uzbekistan,
    • Based on the causes and consequences of recognizing samples as non-conforming, the Center shall send conclusions to the relevant state authorities for legal assessment,
    • The Center shall undertake additional measures as per the legislation of the Republic of Uzbekistan.

It is important to note that the Center purchases samples using its extrabudgetary funds to conduct post-marketing surveillance. However, if the samples acquired are found to be non-compliant with regulatory requirements, all expenses, including laboratory research costs, shall be borne by the manufacturing enterprises or organizations engaged in the wholesale trade of pharmaceutical products.

The results of post-marketing surveillance will be regularly published on the official website of the Center.

Implementation of post-marketing surveillance of pharmaceutical products will begin on January 1, 2025.

The Regulation on the reimbursement program for the compensation of medicine expenses in the treatment of diseases in outpatient settings.

On October 2, 2024, the Cabinet of Ministers of the Republic of Uzbekistan adopted Resolution No. 619, titled “On the approval of the Regulation on the Reimbursement Program for the Compensation of Expenditures for Pharmaceutical Products in the Treatment of Diseases in Outpatient Conditions” No. 619 (“Regulation No. 619“), which came into effect on October 5, 2024.

General information

Medications included in the state-guaranteed volume of medical services and medicines are provided to patients free of charge within the reimbursement program, which is predicated on an electronic prescription issued by a physician.

Еxpenses incurred by pharmacies for the medications dispensed within the reimbursement program are compensated by the state budget via the State Medical Insurance Fund (“Fund“). А direct contract is concluded between the Fund and the pharmacies, and reimbursements are made by the treasury authorities at least once a month.

The Center shall continuously monitor the availability of medicinal products provided within the reimbursement program in the retail sector and must report the monitoring to the Fund by the 5th day of each month.

The Ministry of Health of the Republic of Uzbekistan determines the list of diseases included in the reimbursement program and the medicines dispensed for their treatment. The procedure for establishing the maximum reimbursement amount and effectuating payments is approved by the Supervisory Board of the Fund.

The maximum reimbursement amount, INN, forms, and dosages of medicines provided within the reimbursement program are determined by a commission established within the Fund.

The budget for the reimbursement program is set at up to ten percent of the value of the contract executed between the Fund and the relevant medical facility.

Participation of pharmacies in the reimbursement program

Pursuant to the Regulation No. 619, medicines dispensed within the reimbursement program shall be provided to a patient free of charge via electronic prescription through the pharmacies that have entered into agreements with the Fund and are connected to the electronic information system.

Participating pharmacies are responsible for ensuring the continuous availability of medicines dispensed within this program and maintaining their uninterrupted supply. Pharmacies must notify the Fund within seven days of any disruptions in medicine supply.

The Regulation No. 619 establishes the procedure whereby an electronic prescription issued by a physician is forwarded to participating pharmacies, and a patient (or their legal representative or assigned visiting nurse) receives an SMS notification containing the number and date of the electronic prescription. Upon visiting the pharmacy, the patient provides the number of the electronic prescription, and the pharmacy staff dispenses the medicine by requesting a special code sent via SMS. Following the entry of this code into the information system, the patient is supplied with the medicines available at the lowest cost of reimbursement under the program, while the pharmacy staff confirms the dispensing and closes the electronic prescription.

If pharmacies charge patients for medicines provided within the reimbursement program or breach the established requirements, the Fund will take the following actions: for the first violation, the pharmacy will receive a warning; for repeated violations, the Fund reserves the right to exclude the pharmacy from the reimbursement program, thereby unilaterally terminating the agreement.

 

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