ORDER OF THE GOVERNMENT OF THE KYRGYZ REPUBLIC

of March 15, 2019 No. 120

About approval of the Procedure for inspection in the field of the address of medical products

For the purpose of implementation of article 12 of the Law of the Kyrgyz Republic "About the address of medical products", according to articles 10 and 17 of the constitutional Law of the Kyrgyz Republic "About the Government of the Kyrgyz Republic" the Government of the Kyrgyz Republic decides:

1. Approve the Procedure for inspection in the field of the address of medical products according to appendix.

2. Bring in the order of the Government of the Kyrgyz Republic "About approval of the Technical regulation "About Safety of Products of Medical and Veterinary Prescription for Laboratory Diagnosis in Artificial Conditions (in Vitro)" of April 5, 2013 No. 173 the following change:

in the Technical regulation "About Safety of Products of Medical and Veterinary Prescription for Laboratory Diagnosis in Artificial Conditions (in Vitro)" approved by the above-named resolution:

- to state paragraph two of Item 6 in the following edition:

"in vitro - the medical tests which are carried out in controlled environment out of live organism;".

3. To the Ministry of Health of the Kyrgyz Republic:

- bring the decisions into accord with this resolution;

- take the adequate measures following from this resolution.

4. To impose control of execution of this resolution on department of social development of Government office of the Kyrgyz Republic.

5. This resolution becomes effective after fifteen days from the date of official publication.

Appendix

to the Order of the Government of the Kyrgyz Republic of March 15, 2019 No. 120

Procedure for inspection in the field of the address of medical products

Chapter 1. General provisions

1. This Procedure for inspection in the field of the address of medical products establishes the main requirements to inspection of production of medical products, assessment of quality management system of medical products (further - the Procedure).

2. Inspection of production in case of state registration of medical products is performed by the subordinated organization of authorized state body of the Kyrgyz Republic in the field of health care regulating drug circulation and medical products (further - authorized body) by assessment of conditions of production of medical products and quality management system.

Chapter 2. The determinations used in this Procedure

3. In this Procedure the following concepts are used:

diagnosis of in vitro - the medical tests which are carried out in controlled environment out of live organism;

production inspection - assessment of conditions of production of medical product and quality management system of the producer of medical product on compliance to this Procedure;

corrective action - action taken by the producer of medical product for the purpose of elimination of the reason of the found discrepancy or undesirable event;

the critical supplier - the supplier, products or services of which exert direct impact on safety and (or) efficiency of medical product;

assessment of quality management system of medical product - confirmation of implementation, maintenance and effectiveness of functioning of quality management system of medical products for ensuring compliance of the released medical products to General requirements of safety and efficiency of medical products, requirements to their marking, technical and operational documentation, applicable to them, on them approved by the Decision of Council of the Eurasian economic commission of February 12, 2016 No. 27 (further - General requirements of safety and efficiency), except for Item 63 of the specified General requirements of safety and efficiency of medical products, requirements to their marking and operational documentation on them;

post-sale monitoring - system of collection and data analysis of the producer of medical products about use of medical products, tracking and identification of side effects of medical products in the course of their operation;

the warning action - action taken for the purpose of elimination of the reason of potential discrepancy or potentially undesirable situation;

the production site - territorially isolated complex intended for accomplishment of all production process of medical product or its certain stages;

quality management system of medical products - organizational structure, functions, the procedures, processes and resources necessary for the coordinated activities for management and management of medical products of the manufacturing organization in relation to quality;

conditions of production of medical products - the infrastructure and the production circle necessary for ensuring compliance of the made medical products to General requirements of safety and efficiency.

Chapter 3. Procedure of inspection of production

4. Inspection of production of medical products is performed in the following cases:

- production of the medical product which is earlier registered in the Kyrgyz Republic was not exposed to production inspection;

- production of medical product is performed on for the first time the declared production site of the applicant;

- lack of possibility of conducting analytical examination owing to the high cost of samples of medical products, impossibility of observance of conditions of transportation of the specified samples and (or) their storage, lack of the special equipment and consumable materials. Technical testing (researches) in this case are carried out in the presence of representatives of authorized body in laboratory of quality control of the producer of medical product or in the contractual laboratory used by the producer;

- lack of possibility of evaluating accuracy of the data about safety, quality and efficiency of medical product according to the documents submitted in the registration file.

5. Inspection of production is performed for the purpose of confirmation:

- opportunities to make the medical products conforming to General requirements of safety and efficiency;

- compliance of the actual data about medical product obtained during inspection of production of medical products, the declared producer of medical product in the registration file.

6. Inspection of production is performed by authorized body in time, not entering aggregate term of conducting examination of safety, quality and efficiency of medical products in case of their registration which shall not exceed in total 90 calendar days from the date of decision making about conducting inspection of production, and includes:

- check of the organization of incoming inspection of raw materials and materials;

- identification and traceability of medical products;

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