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Approved by the Order of the Center for the state supervision of pharmaceutical and medical activities (with the right of service) the Republic of Tajikistan of June 22, 2007 No. 20

Regulations on certification of medicines

I. General provision

II. Basic concepts and determinations

2. The basic concepts applied in the present provision:

Certification of medicines - activities for confirmation of conformity of medicines, the established requirements.

Certification of quality systems (production) of medicines - the procedure of confirmation of conformity of quality systems (production) of medicines to qualifying standards containing in rules to production organization of medicines.

Obligatory certification of medicines - confirmation of conformity of medicines to the requirements of regulating documents approved in accordance with the established procedure, carried out without fail.

Voluntary certification of medicines - the certification which is carried out in this system at the initiative of applicants on terms of the contract between it and certification body.

Certification body (OS) - the authorized body which is carrying out works on certification of medicines or quality systems (production).

Test laboratory (the test center) - the body accredited in accordance with the established procedure performing testing of specific types of products or specific types of testing for the purposes of certification of medicines.

Accreditation of test laboratory - the procedure by means of which the possibility of carrying out by test laboratory of works on testing of medicines in the declared area of accreditation with issue of protocols of the analysis for the purposes of certification is officially acknowledged.

Area of accreditation - types of activity of accredited laboratory (with indication of the list of transactions, procedures, control methods) which can and have the right to carry out accredited laboratory.

The test report of medicine - the document issued by the accredited laboratory which is carrying out medicine testing.

The certificate of conformity of quality systems (production) the document certifying what quality systems (production) declared (declared) producer medicines conforms to the established requirements.

The certificate of conformity of medicines - the document issued by rules of system of certification for confirmation of conformity of medicines to requirements of regulations.

The holder of the certificate of conformity - legal entities irrespective of organizational legal form, entrepreneurs without formation of legal entity and physical persons on whose name the certificate is issued.

Inspection check-up for the certified produktsiyeykontrolny assessment of conformity of medicines to regulating documents performed for the purpose of establishment of compliance of products to the set requirements confirmed in case of certification.

3. The system of certification of medicines provides:

- certification of medicines (obligatory, voluntary);

- certification of the quality system (production) (voluntary).

4. Medicines are subject to obligatory certification:

- issued by the manufacturing companies of medicines in the territory of the Republic of Tajikistan;

- imported on the territory of the Republic of Tajikistan according to the procedure, established by the current legislation.

Advertizing of medicines subject to obligatory certification, in the absence of the certificate of conformity is forbidden.

5. Certification of medicines is carried out - the Center based on the test reports issued by national laboratory and other accredited test laboratories.

6. In case of certification of medicines the existing schemes of certification, products in the Republic of Tajikistan are applied.

7. Certification is performed for the purpose of:

protection of consumer interests in products safety issues for life and health, for the environment;

- assistance to consumers in the competent choice of products;

- consumer protection from bad faith of the producer (seller);

- export promotion and increase in product competitiveness;

- confirmation of the indicators of product quality declared by producers;

- ensuring accomplishment of the existing rules of production organization and quality control of medicines in the Republic of Tajikistan.

8. The system of certification of medicines is constantly developing system, the regulatory base of System is periodically staticized.

9. Participants of system shall follow the rules stated in regulatory legal acts of the Republic of Tajikistan.

III. Structure and list of participants of system of certification of medicines

10. The system of certification of medicines includes:

- the participants of System performing certification;

- documentary part of System.

11. Participants of certification:

Certification body of medicines, regional certification bodies, test laboratories, manufacturers (sellers, entrepreneurs) of products, the companies, organizations and the organizations irrespective of patterns of ownership, and also public organizations.

12. Regional certification bodies carry out works on certification within the competence.

13. The test laboratory accredited in accordance with the established procedure carries out:

- testing of medicines for the purposes of certification, draws up and sends to Certification body official protocols by results of testing;

- carries out testing of medicines when carrying out inspection check-up by certification body behind the certified products;

- creates and conducts fund of the regulating documents applied in case of certification.

14. Manufacturers (sellers, entrepreneurs) - being subjects of drug circulation shall sell products only in the presence of the certificate issued or recognized by the representative on that body.

15. Certification body of medicines:

- exercises integrated management in the field of certification of pharmaceutical products, medical equipment, products of medical and sanitary and hygienic appointment, products of treatment-and-prophylactic food and cosmetics;

- performs accreditation of test laboratories and laboratories of health care system;

- coordinates activities of accredited laboratories and regional certification bodies of medicines;

- accepts and considers certification applications of medicines

- interacts with test laboratories and other certification bodies;

- makes selection and identification of medicines;

- issues certificates of conformity of medicines;

- exercises inspection check-up;

- suspends or cancels the issued certificates;

- records the certified medicines;

- determines procedure for utilization of medicines which quality did not prove to be true in case of certification and in case of inspection check-up;

- participates in relations with foreign countries and the international organizations concerning certification of medicines;

- represents the Republic of Tajikistan in the international organizations concerning certification of medicines;

- will organize, creates and conducts fund of the regulating documents necessary for certification of medicines;

- considers appeals concerning certification.

16. The documentary base of System consists of the following document groups:

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