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RESOLUTION OF THE CABINET OF MINISTERS OF THE REPUBLIC OF UZBEKISTAN

of March 23, 2018 No. 213

About approval of the Regulations on procedure for state registration of medicines, products of medical appointment and medical equipment and issue of the registration certificate

According to the Law of the Republic of Uzbekistan "About medicines and pharmaceutical activities", and also in pursuance of resolutions of the President of the Republic of Uzbekistan of June 12, 2017 No. PP-3052 "About measures for further enhancement of activities of bodies of health care", on January 23, 2018 "About measures for further streamlining of production and import of medicines and products of medical appointment" and on February 14, 2018 No. PP-3532 "About additional measures for the accelerated development of pharmaceutical industry" the Cabinet of Ministers decides No. PP-3489:

1. Approve Regulations on procedure for state registration of medicines, products of medical appointment and medical equipment and issue of the registration certificate according to appendix.

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

3. The resolution of the Cabinet of Ministers of December 22, 2014 No. 352 "About approval of the Regulations on order of registration of medicines and products of medical appointment and issue of the registration certificate" (2014, No. 12, the Art. 126) to declare the joint venture of the Republic of Uzbekistan invalid.

4. To impose control of execution of this resolution on the deputy prime minister of the Republic of Uzbekistan K. V. Akmalov and the Minister of Health of the Republic of Uzbekistan A. K. Shadmanov.

Prime Minister of the Republic of Uzbekistan

Abdullah Aripov

Appendix

to the Resolution of the Cabinet of Ministers of the Republic of Uzbekistan of March 23, 2018 No. 213

Regulations on procedure for state registration of medicines, products of medical appointment and medical equipment and issue of the registration certificate

Chapter 1. General provisions

1. This Provision determines procedure for state registration (further - registration) medicines, products of medical appointment and medical equipment and issue of the registration certificate (further - the certificate).

2. In this Provision the following basic concepts and terms 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;

products of medical appointment - the products allowed for use in medical practice for prevention, diagnostics and treatment of diseases and also for change of condition and functions of human body;

medical equipment - devices, the equipment, devices, tools, devices and complexes allowed for use in medical practice for prevention, diagnostics and treatment of diseases and also for identification and change of condition and functions of human body;

pharmacological means - the substances or mix of substances having certain dosage form, with the pharmacological activity established in preclinical researches and safety, being objects of clinical trial;

The state center of examination and standardization of medicines, products of medical appointment and medical equipment of the Agency on development of pharmaceutical industry under the Ministry of Health of the Republic of Uzbekistan (further - the State center) - the working body of the Agency on development of pharmaceutical industry providing implementation of state registration, quality control, standardization and certification of medicines, products of medical appointment and medical equipment;

the applicant - the subject of entrepreneurship, the legal entity (or the authorized representative acting from his name) who addressed to the State center for state registration of medicine, product of medical appointment and medical equipment and receipt of the certificate;

registration documents - the documents submitted to the State center in case of registration of medicines, products of medical appointment, medical equipment;

medicinal vegetable raw materials - the plants or their parts containing biologically active agents used for production and production of medicines;

the recipe - written specifying of the doctor, to the specialist with pharmaceutical education about production and (or) leave of medicine and method of its application.

3. Registration of medicine, product of medical appointment and medical equipment provides issue to applicants of the certificate.

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