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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

(as amended on 17-08-2019)

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.

Registration of medicine, product of medical appointment and medical equipment and certification are performed by the State center for the scheme according to appendix 1 to this Provision.

4. Are subject to registration:

medicines;

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

the medicines which are earlier registered in the Republic of Uzbekistan, but made in other dosage forms, dosages or other producer;

products of medical appointment;

medical equipment.

5. Registration of medicines with various medicinal substances under the identical trade name, and also registration of medicines of one producer having identical composition of medicinal substances under different trade names is not allowed.

Medicines and the products of medical appointment made in drugstores, and also delivered for research works, performing preclinical, clinical trials, procedures of state registration, to exhibiting at exhibitions, fairs, the international forums are not subject to registration.

6. By results of registration of medicines, products of medical appointment and medical equipment the certificate by effective period for five years is issued.

7. The certificate is the document confirming the fact of state registration and permission of the Ministry of Health of the Republic of Uzbekistan to the right of use of medicine, product of medical appointment and medical equipment in medical practice.

8. Registration and certification for foreign medicine, product of medical appointment and medical equipment are performed according to this Provision.

Chapter 2. Allowing requirements and conditions

9. To allowing requirements and conditions, the mandatory applicant in case of application in medical practice of medicine, product of medical appointment and medical equipment based on the registration certificate, belong:

unconditional observance of legal acts by the applicant who addressed for registration of medicine, product of medical appointment and medical equipment in case of their application in medical practice;

representation by the applicant during action of the certificate in the State center of exhaustive information on changes and amendments in registration documents;

obligatory observance of requirements of regulating documents in the field of technical regulation (further - regulating documents) on medicines, products of medical appointment and medical equipment and the data provided in registration documents;

timely remedial action, specified by the State center, and also representation of samples of medicines, products of medical appointment and medical equipment and other materials in terms, stipulated in Item the 15th this provision.

Chapter 3. Documents and samples necessary for receipt of the certificate

10. For receipt of the certificate the applicant represents to the State center:

a) the statement in form according to appendix 2 (for medicines) and to appendix 2a (for products of medical appointment and medical equipment) to this Provision;

b) the registration documents of medicine or product of medical appointment and medical equipment in two identical copies completed according to the procedure, provided in appendices 3 (for medicines) and 3a (for products of medical appointment and medical equipment) to this Provision, grouped in parts, page by page numbered in parts respectively, certified by the signature of the applicant;

c) medicine samples in the quantity necessary for carrying out triple testing in one industrial series;

d) samples of product of medical appointment or medical equipment in the quantity necessary for carrying out testing according to regulating documents;

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