ORDER OF THE GOVERNMENT OF THE KYRGYZ REPUBLIC

of July 5, 2018 No. 312

About approval of the Procedure for evaluating quality of medicines

For the purpose of implementation of article 14 of the Law of the Kyrgyz Republic "About drug circulation", 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 evaluating quality of medicines according to appendix.

2. Bring in Resolution of the Government of the Kyrgyz Republic "About approval of the Technical regulation "About Safety of Medicines for Medical Application" of April 6, 2011 No. 137 the following changes:

- the second offer of Item 3 to exclude;

in the Technical regulation "About Safety of Medicines for Medical Application" approved by the above-stated Resolution:

- the paragraph third Item 279, Items 431-433 of Chapter 14 to recognize invalid;

- appendices 20, of 21, 23 and 24 to recognize invalid.

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

- bring the decisions into accord with this Resolution;

- take the necessary measures following from this Resolution;

- make in accordance with the established procedure offers on modification of the Unified register (list) of the state services rendered by state bodies, their structural divisions and subordinated organizations, No. 85 approved by the order of the Government of the Kyrgyz Republic of February 10, 2012.

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 six months from the date of official publication.

Appendix

Approved by the Order of the Government of the Kyrgyz Republic of July 5, 2018, No. 312

Procedure for evaluating quality of medicines

Chapter 1. General provisions

1. This Procedure for evaluating quality of medicines (further - the Procedure) establishes procedures of evaluating quality of medicines, criteria of release of medicines from poseriyny control, the refusal basis in issue of the conclusion about quality of medicine.

2. Medicines, including the pharmaceutical substances imported on the territory of the Kyrgyz Republic or made in the territory of the Kyrgyz Republic, except for the medicines provided by part 2 of article 14 of the Law of the Kyrgyz Republic "About drug circulation" are subject to quality evaluation.

3. In this Procedure the following concepts are used:

- the applicant - the legal entity who addressed with the request for evaluating quality of medicine;

- the conclusion about quality of medicine - the document issued by results of the carried-out quality evaluation of medicines, certifying that products conform to the established requirements of the regulating document for quality;

- EEU - the Eurasian Economic Union;

- identification of batch - establishment of compliance of batch of medicines to shipping documents;

- proper production practice - part of quality management which guarantees that medicines are constantly made and controlled on the quality standards corresponding to their appointment and also according to requirements of the registration file, the protocol of clinical trials and specifications on medicines;

- the regulating document on quality - the document developed by the producer and establishing requirements to medicine quality control (the specification and the description of analytical techniques and testing or the reference to them, and also the corresponding eligibility criterions for the specified quality indicators) based on the carried-out expertize which is approved by authorized state body of the Kyrgyz Republic in the field of health care in case of registration and is intended for quality control during the post-registration period;

- sample - the medicine unit which is selected from controlled series (batch);

- batch - the series or part of series of medicine which arrived from one sender according to one transport document;

- the proper production practice recognized by the Kyrgyz Republic - the proper production practice used by the countries of the region of the International council on harmonization of technical requirements to registration of medicines for medical application (ICH);

- series - the certain amount of initial raw materials, packaging materials or products subjected to processing in one or in a number of consecutive engineering procedures so that to expect uniformity of products;

- the countries of the region of the International council on harmonization of technical requirements to registration of medicines for medical application (further - the countries of the region of ICH) - the states in the territory of which requirements to registration of medicines are regulated by the authorized body which became the founder or the permanent member of the International council on harmonization of technical requirements to medicines for medical application.

Chapter 2. Procedure for evaluating quality of medicines

4. The quality evaluation of medicines is performed by the subordinated organization regulating drug circulation and products of medical appointment, authorized state body of the Kyrgyz Republic in the field of health care (further - authorized body) for the purpose of establishment of compliance of quality of specific series (batches) of the medicines imported into the country or made in the country, to requirements of the regulating document for quality.

5. In case of quality evaluation of pharmaceutical substances as the regulating document on quality monographs of pharmacopeias or specifications (standards) of producers are used.

6. The quality evaluation of medicines includes carrying out the following procedures:

- giving by the applicant in authorized body of the request for evaluating quality of medicines and check on completeness of the filed documents;

- identification of batch of medicines;

- sampling of medicines;

- information analysis in the submitted documents, and also markings and packagings of medicines on compliance to the regulating document on quality;

- decision making and issue of the conclusion about quality of medicine.

7. The applicant for evaluating quality of medicines submits the application to authorized body in form according to appendix 1 to this Procedure in paper and in electronic form with use of information systems with appendix of the following documents:

- the copy of the license for pharmaceutical activities (it is represented once with inclusion in the database on license effective period);

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