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RESOLUTION OF THE CABINET OF MINISTERS OF THE REPUBLIC OF UZBEKISTAN

of October 24, 2018 No. 862

About approval of the Regulations on procedure for recognition of results of the registration of medicines performed outside the Republic of Uzbekistan

According to the resolution of the President of the Republic of Uzbekistan of September 24, 2018 "About additional measures for enhancement of procedure for state registration and circulation of medicines" the Cabinet of Ministers decides No. PP-3948:

1. Approve Regulations on procedure for recognition of results of the registration of medicines performed outside the Republic of Uzbekistan according to appendix No. 1.

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

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

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 October 24, 2018 No. 862

Regulations on procedure for recognition of results of the registration of medicines performed outside the Republic of Uzbekistan

Chapter 1. General provisions

1. This Provision determines procedure for recognition of results of the registration of medicines performed outside the Republic of Uzbekistan.

2. Requirements of this provision extend to the medicines imported to the Republic of Uzbekistan which were registered by the countries and the international organizations specified in the List of the countries and the international organizations which results of registration of medicines are recognized the Republic of Uzbekistan, No. PP-3948 approved by the resolution of the President of the Republic of Uzbekistan of September 24, 2018 "About additional measures for enhancement of procedure for state registration and circulation of medicines" (further - the List).

3. 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;

the medicines - dosed, the packed medicines ready to application;

the regulating document of medicine - the document containing list of indicators of quality, regulations and methods of quality control of medicines, descriptions of physical and chemical, physical, biological, biochemical, microbiological and other methods of quality control of these medicines;

the instruction on medical application of medicine - the document including pharmacological properties, indications to application, contraindications, features of application, data on overdose, interaction with other medicines, storage conditions, release forms and also the information about the producer and medicine other information;

the applicant - the manufacturing organization of medicines, the holder of the registration certificate or their authorized representatives, authorized to submit the application, documents and materials for recognition of results of the registration of medicines performed outside the Republic of Uzbekistan (further - recognition).

4. Recognition is performed by 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) by studying of the submitted documents and inclusion of record about recognition in the State register of the medicines, products of medical appointment and medical equipment allowed for use in medical practice (further - the State register).

5. Recognition provides inclusion of results of state registration and record about recognition in the State register and issue to applicants at will of the statement from this register.

6. Results of recognition join in the form of record in the State register for a period of five years.

After the term of the first recognition according to the statement of the applicant results of recognition can be included in the State register without restriction of term of their action.

7. Are subject to recognition:

medicines;

new combinations of the medicines registered in the Republic of Uzbekistan;

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