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Ministry of Justice

Republic of Tajikistan

On June 1, 2006 No. 215

Approved by the Order of the State center of examination of drugs of the Republic of Tajikistan of May 3, 2006 No. 24

Regulations on procedure for accreditation of the pharmaceutical organizations and physical persons occupied with pharmaceutical activities in the Republic of Tajikistan

1. General provisions

1.2. Accreditation of pharmaceutical organizations, companies and physical persons includes determination of compliance of conditions and the place of their activities to the established requirements (standards).

1.3. The purpose of accreditation is ensuring interests of citizens in receipt of necessary amount and quality of the medicinal help and services.

1.4. Pharmaceutical organizations are subject to the state accreditation, including: pharmaceutical organizations and the companies in case of their opening, expansion of work types (production of disinfection, disinsection and deratization means, shops of optics), their change organizationally - legal form and pattern of ownership (further the referred to as organizations), and also the physical persons performing individual or collective pharmaceutical activities (further the referred to as persons).

1.5. For the purpose of providing the high-quality population with medicines, medical goods, treatment-and-prophylactic food, cosmetics, disinfection, disinsection and deratization means of accreditation are exposed:

- the activities of pharmaceutical organizations in general performed by them in the Republic of Tajikistan;

- separate types of pharmaceutical activities;

- realization of medical goods, shops and departments of optics;

- departments, shops of realization of cosmetics, products of treatment-and-prophylactic food, nutritional supplements and disinfection, disinsection and deratization means;

- persons occupied with pharmaceutical activities in system of providing with medical goods.

1.6. Accreditation is carried out by Licensing and Accreditation Commission of the State center of examination of drugs and its accreditation commissions in regional branches.

1.7. Control of activities of Licensing and Accreditation Commission is imposed on the State center of examination of drugs.

2. Procedure for carrying out accreditation

2.1. Accreditation of the pharmaceutical organizations and persons occupied with pharmaceutical activities in the Republic of Tajikistan is carried out without fail before licensing for receipt of accreditation or qualification category according to post.

2.2. For receipt of the accreditation certificate the pharmaceutical organization or the physical person submits Licensing and Accreditation Commission documents according to the list (appendices 1, 2).

2.3. Accreditation is carried out ahead of schedule at the initiative of pharmaceutical organization or person for the purpose of receipt of the certificate on accomplishment of new types of pharmaceutical activities and services, qualification category or in case of address modification of the room, and also upon the demand of the State center of examination of drugs under the Ministry of Health of the Republic of Tajikistan.

2.4. Accreditation of persons which graduated from the highest and average pharmaceutical educational institutions can be carried out each 5 years of occupational work, on pharmaceutical positions in pharmaceutical organizations according to qualification requirements.

2.5. The organizations and persons which underwent accreditation in legislative procedure receive the certificate (appendix 3, 4), confirming degree of compliance of the declared types of pharmaceutical activities and services to the established requirements (standards) in full, with restrictions or reasonable refusal in issue of the certificate.

2.6. Accreditation certificates are issued to pharmaceutical organizations, and also the physical persons performing individual or collective pharmaceutical activities no more than 5 years (according to the amount of effected payment).

For the procedure of issue, prolongation and re-registration of the certificate the amount, according to the approved calculation is levied.

2.7. The procedure of accreditation is determined by the commission and provides studying of the documents submitted by organization (physical person), the decision of the commission and issue of the certificate.

2.8. Accreditation is carried out according to the current legislation and regulating documents of state bodies of pharmaceutical service of the Republic of Tajikistan regulating pharmaceutical activities of pharmaceutical organizations, professional level of the physical persons occupied with pharmaceutical activities and quality requirements of rendering the medicinal help and this Provision.

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