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The document ceased to be valid since   March 26, 2018 according to Item 3 of the Resolution of the Cabinet of Ministers of the Republic of Uzbekistan of March 23, 2018 No. 213

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 the 16th this provision.

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;

c) the registration documents of medicine or product of medical appointment in two identical copies completed according to the procedure, provided in appendices 3 (for medicines) and 3a (for products of medical appointment) to this Provision, the entrepreneurships grouped in parts, page by page numbered in parts respectively, certified by the sign and seal of the head of the subject submitting the application;

d) medicine samples in the quantity necessary for carrying out triple testing in three industrial series (for foreign medicines one series), and products of medical appointment in the quantity necessary for carrying out testing according to regulating documents, standard samples of substances (medicinal substances), foreign impurity and related substances, control materials, specific reactants and quality certificates on them for determination of compliance of medicine and product of medical appointment to requirements of regulating documents.

10. The requirement from the subject of entrepreneurship of submission of documents and samples, not stipulated in Item the 9th this provision is not allowed.

11. The documents and the corresponding samples necessary for receipt of the registration certificate are represented to Head department directly, through means of mail service or electronically with the notification on their obtaining. The documents submitted electronically are confirmed by the digital signature of the subject of entrepreneurship.

At the same time samples are represented directly or through means of mail service.

12. The documents and the corresponding samples provided to Head department for receipt of the registration certificate are accepted according to the inventory which is without delay issued (goes) to the subject of entrepreneurship with mark about date of documents acceptance, and is confirmed specifying of position, surname, name by the signature of person who accepted documents.

13. The confidential information given in the documents submitted for receipt of the registration certificate shall not be disclosed by Head department.

IV. Consideration of the application and decision making about issue of the registration certificate or about refusal in its issue

14. The head department in accordance with the established procedure through the relevant departments carries out work on registration of medicine and product of medical appointment.

15. For consideration of the application of the subject of entrepreneurship about issue of the registration certificate collection in 10-fold size of minimum wage is levied. The amount of collection is credited into the account of the State center of examination and standardization of medicines (further - the State center). In case of refusal the subject of entrepreneurship from the submitted application for issue of the registration certificate the fee paid amount is not subject to return.

The collection amount for consideration of the application of the foreign producer (or the authorized representative acting from his name) about issue of the registration certificate, modification and amendments, issue of the duplicate, prolongation of effective period, renewal of the registration certificate is established by the Ministry of Health of the Republic of Uzbekistan within expense amount of Head department on implementation of the specified procedures.

16. The head department considers the application of the subject of entrepreneurship for issue of the registration certificate in time, not exceeding 180 working days from the date of reception of an application, issues or refuses issue of the registration certificate.

Do not join in the generally established time of registration which is not exceeding 180 working days:

the term which is not exceeding 45 working days, established for remedial action revealed in the course of examination of medicine and product of medical appointment, and submission of the relevant documents by the applicant;

the term which is not exceeding 45 working days, established for submission by the applicant to clinical bases of programs of the clinical testing, samples of medicine and product of medical appointment approved in the appropriate order for carrying out clinical testing;

directly terms of carrying out clinical testing.

17. For issue of the registration certificate collection in double size of minimum wage is levied. The amount of collection is credited into the account of the State center.

18. The head department according to this Provision by results of works on registration of medicine and product of medical appointment no later than 1 working day from acceptance date of the relevant decision shall issue to the subject of entrepreneurship the registration certificate or notify him in writing on refusal in issue of such document.

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