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RESOLUTION OF THE CABINET OF MINISTERS OF THE REPUBLIC OF UZBEKISTAN

of April 6, 2017 No. 185

About measures for implementation of the Law of the Republic of Uzbekistan of January 4, 2016 No. ZRU-399 "About modification and amendments in the Law of the Republic of Uzbekistan "About medicines and pharmaceutical activities""

(as amended on 16-08-2024)

For the purpose of implementation of the Law of the Republic of Uzbekistan of January 4, 2016 No. ZRU-399 "About modification and amendments in the Law of the Republic of Uzbekistan "About medicines and pharmaceutical activities"", the Cabinet of Ministers decides streamlinings of wholesale and retail sale of medicines and products of medical appointment, and also providing the population with safe, high-quality and effective medicines and products of medical appointment:

1. Approve:

Regulations on procedure for wholesale of medicines and products of medical appointment according to appendix No. 1;

Regulations on procedure for retail sale of medicines and products of medical appointment according to appendix No. 2;

Regulations on procedure for retirement and destruction of the substandard, counterfeited, unregistered medicines in the Republic of Uzbekistan and products of medical appointment, illegal copies of the medicines and also which are in drug circulation registered in the Republic of Uzbekistan and products of medical appointment in cases of identification of the facts confirming their harmful effects on health of the person according to appendix No. 3.

2. Make changes to some decisions of the Government of the Republic of Uzbekistan according to appendix No. 4.

3. Recognize invalid some decisions of the Government of the Republic of Uzbekistan according to appendix No. 5.

4. To the ministries and departments to bring the regulatory legal acts adopted by them into accord with this resolution in a month.

5. This resolution becomes effective since July 1, 2017.

6. To impose control of execution of this resolution on Information analysis department concerning health care, ecology, environmental protections, physical culture and sport of the Cabinet of Ministers of the Republic of Uzbekistan.

Prime Minister of the Republic of Uzbekistan
Abdullah Aripov

Appendix No. 1

to the Resolution of the Cabinet of Ministers of the Republic of Uzbekistan of April 6, 2017 No. 185

Regulations on procedure for wholesale of medicines and products of medical appointment

Chapter 1. General provisions

1. This Provision according to the Law of the Republic of Uzbekistan "About medicines and pharmaceutical activities" determines procedure for wholesale of the medicines allowed for use in medical practice and products of medical appointment as producers and organizations of wholesale of medicines and products of medical appointment.

2. Requirements of this provision are obligatory for producers of medicines and products of medical appointment (further - producers), and also the organizations of wholesale of medicines and products of medical appointment (further - the organizations of wholesale), irrespective of their form of business.

3. Wholesale of medicines and products of medical appointment is performed by the producers and the organizations of wholesale having the corresponding license for implementation of pharmaceutical activities by the rules of wholesale and storage of medicines and products of medical appointment approved by the Ministry of Health of the Republic of Uzbekistan.

4. Producers have the right to wholesale of medicines and products of medical purpose only of own production, except for the producers having the license for wholesale of medicines and products of medical appointment.

5. The organizations of wholesale have the right to buy medicines and products of medical appointment from producers of medicines and products of medical appointment, from other organizations of wholesale of medicines and products of medical appointment, and also from foreign producers and the organizations of wholesale of medicines and products of medical appointment.

Wholesale of the medicines and products of medical appointment imported on import, and also which are purchased from domestic manufacturers is performed using the limiting trade allowances determined irrespective of number of the intermediaries participating in deliveries for wholesale - in sizes no more than 15% from purchase value.

5-1. The purchase value of the imported medicines and products of medical appointment forms base of establishment of regulated price for the imported products.

The purchase (basic) value is determined by the following formula:

With = Ks + T + Other,

where: With - the purchase (basic) value of the imported medicines and products of medical appointment;

Ks - the contractual cost of the imported medicines and products of medical appointment determined proceeding from Central Bank rate for date of filling of the cargo customs declaration;

T - the customs payments calculated in accordance with the established procedure at the Central Bank rate;

Pr - the other expenses connected with purchase of goods, created according to the legislation.

The holiday cost of the medicines and products of medical appointment made in the territory of the republic is created by producers according to Regulations on structure of costs on the production and sales of products (works, services) and procedure for forming of financial results approved by the resolution of the Cabinet of Ministers of February 5, 1999 No. 54.

The holiday cost of domestic manufacturer of medicines and products of medical appointment forms base of establishment of regulated price for production manufactured.

6. The organizations of wholesale have the right to implement medicines and products of medical appointment to the organizations having the license for implementation of pharmaceutical activities, to the medical organizations, and also the organizations using medicines and products of medical appointment for own needs for the purpose of medical application.

7. Realization of the medicines and products of medical appointment registered in the Republic of Uzbekistan in accordance with the established procedure is allowed.

Chapter 2. Basic concepts

8. In this Provision the following basic concepts are applied:

medicines - the means received on the basis of medicinal substances (substances) and excipients, medicinal substances (substances), medicines allowed for use in medical practice for prevention, diagnostics and treatment of diseases and also for change of condition and functions of human body;

medicinal substances (substances) - the substances of natural or synthetic origin having pharmacological, immunological or metabolic activity or used for the diagnostic purposes, allowed for use in medical practice;

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