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RESOLUTION OF THE CABINET OF MINISTERS OF THE REPUBLIC OF UZBEKISTAN

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

According to article 12 of the Law of the Republic of Uzbekistan "About allowing procedures in the sphere of business activity" and the Resolution of the Cabinet of Ministers of the Republic of Uzbekistan of August 15, 2013 "About measures for implementation of the Law of the Republic of Uzbekistan "About allowing procedures in the sphere of business activity" the Cabinet of Ministers decides No. 225:

1. Approve Regulations on order of registration of medicines and products of medical appointment and issue of the registration certificate according to appendix.

2. To the Ministry of Health of the Republic of Uzbekistan together with the interested ministries and departments to bring departmental regulatory legal acts into accord with this resolution in a month.

3. To impose control of execution of this resolution on the deputy prime minister of the Republic of Uzbekistan A. I. Ikramov.

Prime Minister of the Republic of Uzbekistan

Sh. Mirziyoev

Appendix

to the Resolution of the Cabinet of Ministers of the Republic of Uzbekistan of December 22, 2014 No. 352

Regulations on order of registration of medicines and products of medical appointment and issue of the registration certificate

I. General provisions

1. This Provision is developed according to the laws of the Republic of Uzbekistan "About medicines and pharmaceutical activities" and "About allowing procedures in the sphere of business activity" and determines order of registration and issues of the registration certificate of medicine and product of medical appointment.

2. Registration of medicine and product of medical appointment and issue of the registration certificate are performed by Head department on quality control of medicines and medical equipment of the Ministry of Health of the Republic of Uzbekistan (further - Head department) according to the scheme according to appendix 1 to this Provision.

3. Registration of medicine and product of medical appointment provides issue to the subjects of entrepreneurship who are legal entities (further - subjects of entrepreneurship), the registration certificate of medicine and product of medical appointment (further - the registration certificate).

4. The registration certificate is the basis for use of medicine and product of medical appointment in medical practice according to the procedure, established by legal acts.

5. The registration certificate is issued for a period of 5 years.

6. In case of change of the data provided in registration documents of medicine and product of medical appointment during action of the registration certificate based on provided by the subject of entrepreneurship to Head department of the statement and the documents concerning changes in registration documents of medicine and product of medical appointment corresponding changes and additions are made.

7. Registration and issue of the registration certificate for foreign medicine and product of medical appointment are performed according to this Provision.

II. Allowing requirements and conditions

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

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

submission during action of the registration certificate to Head department the owner of the registration certificate of exhaustive information on changes and amendments in registration documents, with statement of complete data on the reason of modification, their influence on efficiency, safety and indicators of quality of medicine and product of medical appointment, including the obligatory regular notification of Head department about new data concerning pharmacological efficiency and safety of medicine;

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

timely remedial action, specified by experts, and also representation of samples of medicines and products of medical appointment and other materials in terms, stipulated in Item 16 these Provisions.

III. Documents and samples necessary for receipt of the registration certificate

9. For receipt of the registration certificate the subject of entrepreneurship (or the authorized representative acting from his name) represents to Head department:

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

b) copy of the certificate on state registration of the subject of entrepreneurship;

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