RESOLUTION OF THE CABINET OF MINISTERS OF THE KYRGYZ REPUBLIC

of September 19, 2024 No. 575

About approval of the Procedure for evaluating quality of medicines and releases from evaluating quality of medicines

For the purpose of implementation of article 22 of the Law of the Kyrgyz Republic "About drug circulation", according to articles 13, of the 17th constitutional Law of the Kyrgyz Republic "About the Cabinet of Ministers of the Kyrgyz Republic" the Cabinet of Ministers of the Kyrgyz Republic decides:

1. Approve the Procedure for evaluating quality of medicines and release from evaluating quality of medicines according to appendix.

2. Recognize invalid:

1) the order of the Government of the Kyrgyz Republic "About approval of the Procedure for evaluating quality of medicines" of July 5, 2018 No. 312;

2) Item 6 of the resolution of the Cabinet of Ministers of the Kyrgyz Republic "About implementation of system of traceability of medicines in the Kyrgyz Republic" of February 9, 2023 No. 53.

3. This resolution becomes effective after thirty days from the date of official publication.

Appendix

to the Resolution of the Cabinet of Ministers of the Kyrgyz Republic of September 19, 2024 No. 575

Procedure for evaluating quality of medicines and release from evaluating quality of medicines

Chapter 1. General provisions

1. This Procedure for evaluating quality of medicines and release from quality evaluation of medicines (further - the Procedure) establishes procedures of evaluating quality of medicines and release from evaluating quality of medicines, and also criteria of release of medicines from poseriyny control.

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 medicines the stipulated in Article 23 Laws of the Kyrgyz Republic "About drug circulation" are subject to quality evaluation.

3. In this Procedure the following concepts are used:

1) active pharmaceutical substance (pharmaceutical substance) - the medicine intended for production and production of medicines;

2) the conclusion about quality of medicine - the electronic 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 from the producer;

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

4) quarantine zone of warehouse - isolated physically or otherwise the storage location of initial raw materials, packaging materials, intermediate, bulk or finished goods, before decision making about their realization, rejection or conversions;

5) identifications of batch - establishment of compliance of batch of medicines with the data specified in the request and documents attached to the request;

6) proper production practice (GMP) - 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;

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

8) 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, EEU);

9) series (batch) - 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;

10) the country of the region of the International council on harmonization of technical requirements to registration of medicines for medical application (International Council on Harmonisation, ICH) - the state, requirements to registration of medicines in the territory of which are regulated by the authorized body which became the founder or the member of the International council on harmonization of technical requirements to medicines for medical application;

11) authorized body - subordinated division of authorized state body in health sector on regulation of the sphere of drug circulation and medical products;

12) bulk products - the pharmaceutical products intended for production of finished pharmaceutical products, which passed all stages of production process except packing, final packaging and marking at other producer;

13) the regulating document on quality - the document developed by the producer, 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) which in case of registration based on the carried-out expertize is approved with authorized state body in health sector, and intended for quality control of medicine in the post-registration period;

14) pharmacopeia - the collection of the fundamental standards of quality applied in the pharmakopeyny analysis, production, production and quality control of medicines.

Chapter 2. Procedure for evaluating quality of medicines

4. The quality evaluation of medicines is performed by 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 pharmacopeias are used. If pharmaceutical substance is not included in pharmacopeias, specifications (standards) of producers of pharmaceutical substances, on condition of availability at producer of pharmaceutical substance of the existing certificate on compliance to requirements of proper production practice are used (further - the certificate of GMP).

6. Documents acceptance for evaluating quality of medicines is performed in electronic form by electronic transfer of documents and information between the applicant and authorized body by means of information system of authorized body.

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

1) giving by the applicant in authorized body of the request for evaluating quality of medicines, and check on availability of the filed documents;

2) identification of batch of medicines;

3) sampling of medicines;

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