ORDER OF THE GOVERNMENT OF THE REPUBLIC OF TAJIKISTAN

of October 1, 2008 No. 483

About Service of the state supervision of pharmaceutical activities

According to article 12 of the Constitutional law of the Republic of Tajikistan "About the Government of the Republic of Tajikistan", the Government of the Republic of Tajikistan decides:

1. Approve the Provision, Structure of Central office, the Scheme of management and the List of jurisdictional enterprises of Service of the state supervision of pharmaceutical activities (appendices 1, 2, 3, 4).

2. Establish the extreme number of staff of Service of the state supervision of pharmaceutical activities in number of 98 units (without service personnel), including 44 units of Central office and 54 units in regional structural divisions.

3. Permit Service to have one deputy chief on the state supervision of pharmaceutical activities and to set limit of office cars in number of 6 units, including in number of 2 units for Central office.

4. To perform financing of Central office of Service of the state supervision of pharmaceutical activities at the expense of means of the republican budget and special means in coordination with the Ministry of Finance of the Republic of Tajikistan, including 44 units at the expense of the republican budget and 54 units at the expense of special means.

5. Under Service of the state supervision of pharmaceutical activities function:

- State unitary enterprise "Examination and testing of pharmaceutical and medical products;

- The state unitary enterprise "Examination and testing of pharmaceutical and medical products in Sughd area.

6. Declare invalid the order of the Government of the Republic of Tajikistan of April 3, 2007 No. 183 "About the Center for the state supervision of pharmaceutical and medical activities (with the right of service)".

Appendix 1

Approved by the Order of the Government of the Republic of Tajikistan of October 1, 2008 No. 483

Provision of Service of the state supervision of pharmaceutical activities

I. General provisions

1. The service of the state supervision of pharmaceutical activities (further Service), is authorized body of the state executive authority, the exercising state supervision of pharmaceutical activities in the Republic of Tajikistan.

2. The service is included into the Scheme of management of the Ministry of Health and Social Protection of the Republic of Tajikistan.

3. The service performs the activities in interaction with executive bodies, other organizations and law enforcement agencies in the established sphere.

4. The legal basis of Service are the Constitution of the Republic of Tajikistan, the Law of the Republic of Tajikistan "About medicines and pharmaceutical activities", the laws and other regulatory legal acts of the Republic of Tajikistan, and also the international legal acts recognized by the Republic of Tajikistan and this Provision.

II. Powers

5. Main objectives of Service:

- in interaction with law enforcement agencies and other ministries and departments realizes the development program of the state system of examination, standardization, certification regarding the state providing the population with high-quality medicines, medicinal raw materials, drugs, psychotropic substances and their precursors, medical goods, products of sanitary and hygienic appointment, the cosmetic, mineral waters having treatment-and-prophylactic action, disinfectants, reagents for the analysis and baby food;

- exercises control and supervision of activities of the pharmaceutical organizations, irrespective of their patterns of ownership and departmental accessory, and also legal circulation of medicines, drugs, psychotropic substances and precursors, medical goods, products - sanitary and hygienic appointment, the dietary supplements and cosmetics having treatment-and-prophylactic properties;

- implementation of cross-industry coordination and the state supervision of activities of the pharmaceutical organizations, irrespective of patterns of ownership and departmental accessory, concerning production, production, export, import, quality control, storage, realization and use of the medicines, drugs, psychotropic substances and precursors, medical goods, products of sanitary and hygienic appointment, dietary supplements and cosmetics having treatment-and-prophylactic properties;

- preparation and maintaining the state register of medicines, medicinal raw materials, medical goods and sanitary and hygienic means;

- implementation of works on preparation, registration and representation in the procedure for documents established by the Government of the Republic of Tajikistan on issue of import permits and export of medicines, medical goods, medicinal raw materials, sanitary and hygienic goods and the cosmetic, mineral waters having treatment-and-prophylactic action, disinfectants, reagents for the analysis and baby food in the Republic of Tajikistan;

- implementation of works on preparation, registration and representation in the procedure for documents established by the Government of the Republic of Tajikistan on issue of import permits and export of dietary supplements in the Republic of Tajikistan based on the sanitary and epidemiologic conclusions;

- carrying out state registration of the domestic and foreign medicines, medicinal raw materials, medical goods, products of sanitary and hygienic appointment, dietary supplements and cosmetics having treatment-and-prophylactic properties, and also cancellation of the certificate on their state registration in accordance with the established procedure;

- prohibition of release, realization and withdrawal from circulation of medicines, drugs, psychotropic substances and precursors, medical goods, products of sanitary and hygienic appointment, dietary supplements and the cosmetic, mineral waters having treatment-and-prophylactic action, disinfectants, reagents for the analysis and baby food of the existing standards which are not meeting the requirements in the Republic of Tajikistan;

- development and approval in accordance with the established procedure the regulatory legal acts and documentation regulating industry of pharmaceutical activities;

- supervision of activities of healthcare institutions for the purpose of their certification and recertification on the right of carrying out clinical testing of medicines and medical goods;

- carrying out inspection check-up of the laboratories which are engaged in pharmaceutical activities irrespective of their form of business and patterns of ownership;

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