RESOLUTION OF THE CABINET OF MINISTERS OF THE REPUBLIC OF UZBEKISTAN

of May 13, 2010 No. 91

About measures for further enhancement of procedure for licensing of pharmaceutical activities

In pursuance of the resolution of the President of the Republic of Uzbekistan of April 7, 2010 "About measures for streamlining of licensing of pharmaceutical and medical activities" the Cabinet of Ministers decides No. PP-1319:

1. Approve Regulations on procedure for licensing of pharmaceutical activities according to appendix.

2. Determine that earlier granted licenses for the right of implementation of pharmaceutical activities are effective within 5 years from the date of entry into force of this resolution.

3. To the Ministry of Health of the Republic of Uzbekistan together with the interested ministries and departments in a month:

approve Regulations on procedure for carrying out certification and assignment of qualification categories to health and pharmaceutical workers;

provide reduction of departmental regulatory legal acts in compliance with this resolution.

4. Recognize invalid:

the paragraph third Item 1 of the resolution of the Cabinet of Ministers of October 31, 2003 No. 477 (the joint venture of the Republic of Uzbekistan, 2003, No. 10, the Art. 106) and the appendix N 2 to it;

Item 28 of appendix to the resolution of the Cabinet of Ministers of May 22, 2006 No. 92 (the joint venture of the Republic of Uzbekistan, 2006, No. 5, the Art. 34).

5. To impose control of execution of this resolution on the deputy prime minister of the Republic of Uzbekistan A. N. Aripov.

Appendix

to the Resolution of the Cabinet of Ministers of the Republic of Uzbekistan of May 13, 2010 No. 91

Regulations on procedure for licensing of pharmaceutical activities

I. General provisions

1. This Provision determines procedure for licensing of pharmaceutical activities.

2. Licensing of pharmaceutical activities is performed by the Ministry of Health of the Republic of Uzbekistan (further - the licensing body).

For consideration of documents on issue of licenses, prolongation of their term, preparation of the conclusions on them in the licensing body the commission of experts is created. The structure and regulations on commission of experts affirms the licensing body. At the same time commission of experts specialists of the corresponding profile and specialists of bodies of sanitary and epidemiological surveillance without fail are included.

Meetings of commission of experts are held at least two times a month.

3. The pharmaceutical activities which are subject to licensing according to this Provision include the following types of activity:

a) production of medicines and products of medical appointment;

b) production of medicines and products of medical appointment;

c) research work on creation of medicines and products of medical appointment;

d) quality control of medicines and products of medical appointment;

e) retail sale of medicines and products of medical appointment;

e) wholesale of medicines and products of medical appointment;

g) cultivation, collection, procurement, packing and wholesale of medicinal raw materials of vegetable, animal and mineral origin.

4. Licenses for the right of implementation of the types (parts of type) of pharmaceutical activities specified in subitems "an" - "e" Item 3 this provision, are issued only to legal entities, at the same time pharmaceutical institutions licenses only for types (parts of type) of activities specified in subitems "b" and "d" are granted.

Receipt of the license for the types of pharmaceutical activities specified in subitems "an" and "b" of Item 3 this provision grants to licensees the right to implementation of wholesale and retail sale of the medicines made and made by them and products of medical appointment, at the same time retail sale of medicines and products of medical appointment is performed only only through pharmaceutical institutions.

5. On implementation of pharmaceutical activities standard (simple) licenses are granted.

6. The license is granted to legal entities and physical persons for a period of five years. The license can be granted for the term of less than five years only according to the statement of the license applicant.

7. Pharmaceutical activities can be performed by legal entity or physical person only by the type (part of type of activity) determined in the license.

When licensing for the right of implementation of several types (parts of type) of pharmaceutical activities in the license each of these types (parts of type) is specified.

In the presence at the licensee of branches (territorially separate divisions and objects) used for implementation of the licensed activities along with the license are issued certified by the licensing body of its copy on number of the specified branches (territorially separate divisions and objects) with indication of the location of each of them.

7-1. The licensing body creates the register of addresses and the register of employees of pharmaceutical institutions which license was terminated owing to the revealed violations of the law (further - the register of addresses and the register of workers), including for gross violation of procedure for pricing of medicines and products of medical appointment.

The data entered in the register of addresses and the register of workers are excluded from them after three years from the moment of their introduction

II. Licensed requirements and conditions

8. When implementing pharmaceutical activities the licensee shall:

observe the legislation on pharmaceutical activities, including established procedure of state regulation of the prices of medicines and products of medical appointment;

create personnel of the faces which are not included in the register of workers;

perform activities within specified in the license, and also to the address (addresses) according to the license agreement, except for the addresses included in the register of addresses;

have intended for accomplishment of the licensed activities of the room, belonging to it on the property right or other legal cause and meeting health regulations and standards;

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