ORDER OF THE MINISTER OF HEALTH OF THE REPUBLIC OF KAZAKHSTAN

of May 17, 2019 No. KR DSM-82

About introduction of amendments to the order of the Minister of health and social development of the Republic of Kazakhstan of November 26, 2014 No. 269 "About approval of Rules of evaluating safety and quality of the medicines and products of medical appointment registered in the Republic of Kazakhstan"

According to the subitem 84) of Item 1 of article 7 of the Code of the Republic of Kazakhstan of September 18, 2009 "About health of the people and health care system" I ORDER:

1. Bring in the order of the Minister of health and social development of the Republic of Kazakhstan of November 26, 2014 No. 269 "About approval of Rules of evaluating safety and quality of the medicines and products of medical appointment registered in the Republic of Kazakhstan" (it is registered in the Register of state registration of regulatory legal acts at No. 10003, it is published on January 8, 2015 in information system of law of Ad_let) the following changes:

state heading in the following edition:

"About approval of Rules of evaluating safety and quality of the medicines and medical products registered in the Republic of Kazakhstan";

state Item 1 in the following edition:

"1. Approve the enclosed Rules of evaluating safety and quality of the medicines and medical products registered in the Republic of Kazakhstan";

Rules of evaluating safety and quality of the medicines and products of medical appointment registered in the Republic of Kazakhstan to be reworded as follows according to appendix to this order.

2. To provide to committee of pharmacy of the Ministry of Health of the Republic of Kazakhstan in the procedure established by the legislation of the Republic of Kazakhstan:

1) state registration of this order in the Ministry of Justice of the Republic of Kazakhstan;

2) within ten calendar days from the date of state registration of this order the direction it the copy in paper and electronic type in the Kazakh and Russian languages in the Republican state company on the right of economic maintaining "The republican center of legal information" of the Ministry of Justice of the Republic of Kazakhstan for official publication and inclusion in Reference control bank of regulatory legal acts of the Republic of Kazakhstan;

3) placement of this order on Internet resource of the Ministry of Health of the Republic of Kazakhstan after its official publication;

4) within ten working days after state registration of this order submission to Department of legal service of the Ministry of Health of the Republic of Kazakhstan of data on execution of the actions provided by subitems 1), 2) and 3) of this Item.

3. To impose control of execution of this order on the supervising vice-Minister of Health of the Republic of Kazakhstan.

4. This order becomes effective after ten calendar days after day of its first official publication.

Appendix

to the Order of May 17, 2019 No. KR DSM-82

Approved by the Order of the Minister of health and social development of the Republic of Kazakhstan of November 26, 2014 No. 269

Rules of evaluating safety and quality of the medicines and medical products registered in the Republic of Kazakhstan

Chapter 1. General provisions

1 These rules of evaluating safety and quality of the medicines and medical products (further - products) registered in the Republic of Kazakhstan (further - Rules), determine procedure for evaluating safety and quality of the medicines and medical products registered in the Republic of Kazakhstan and extend to subjects in the field of drug circulation and medical products, state body in the field of drug circulation and medical products (further - state body), the state expert organization in the field of drug circulation and medical products (further - the expert organization).

2. Assessment of safety and product quality according to Item 2 of article 63-1 of the Code of the Republic of Kazakhstan of September 18, 2009 "About health of the people and health care system" (further - the Code) belongs to the state monopoly and is performed by the expert organization - the Republican state company on the right of economic maintaining "The national center of examination of medicines and medical products" of Committee of quality control and safety of goods and services of the Ministry of Health of the Republic of Kazakhstan having the test laboratories accredited according to the procedure established by the paragraph two Items 3 of article 14 of the Code.

3. Assessment of safety and product quality is performed on purpose:

1) confirmations of safety and product quality during the post-registration period;

2) confirmations of the safety and product quality withdrawn from the market by state body in case of the claims brought to product quality;

3) confirmations of the safety and product quality withdrawn from the market by state body taking into account risk - the oriented approach;

4) confirmations of safety and product quality by results of pharmakonadzor of medicines and monitoring of safety, efficiency and quality of medical products;

5) prevention of the address of counterfeited products in the market of the Republic of Kazakhstan.

4. Fee on evaluating safety and product quality is made by the applicant into the account of the expert organization according to the prices established by authorized body in the field of health care in coordination with antimonopoly authority according to Item 2 of article 63-1 of the Code.

Chapter 2. Procedure for evaluating safety and product quality

5. Assessment of safety and product quality is performed on the registered medicines and medical products in the Republic of Kazakhstan before their release into the stream of commerce, and also according to Item 3 of these rules.

6. The medicines and medical products imported into the Republic of Kazakhstan and made in the territory of the Republic of Kazakhstan are exposed to assessment of safety and quality.

7. Assessment of safety and product quality is performed by one of the following methods:

1) serial assessment of safety and quality of the medicines made in conditions, conforming to requirements of the Standard of proper production practice (GMP) (further - GMP) approved according to the subitem 115) of Item 1 of article 7 of the Code and medical products made in the conditions conforming to requirements of the international standard ISO 13485 or GMP;

2) assessment of safety and quality of each series (batch) of products;

3) declaring of safety and quality of the medicines made in conditions, conforming to requirements of the GMP standard of the Republic of Kazakhstan or GMP of the Eurasian Economic Union (further - GMP PK or GMP of EEU) or to requirements of the countries of the region of the International conference on harmonization of technical requirements to registration of medicines for medical application (ICH), being the state which regulatory bodies are part of founders and permanent members of ICH (the country of the European Union, the United States of America, Japan, Switzerland, Canada) (further - GMP ICH), the imported medical products made in the conditions conforming to requirements of the international standard ISO 13485 and/or EN ISO 13485 certificates which are issued by the accredited organization of one of the countries of Organization for Economic Cooperation and Development for foreign producers (further - ISO 13485 OECD, EN ISO 13485), or GMP ICH for domestic manufacturers of the medical products and medical products which are devices, devices, the equipment of the international standard ISO 13485.

8. The applicant independently chooses method of evaluating safety and product quality.

9. Assessment of safety and product quality includes:

1) the conclusion of the contract for work according to safety and product quality between the applicant and the state expert organization according to the Civil code of the Republic of Kazakhstan of December 27, 1994;

2) application for evaluating safety and product quality (further - the request) with application of documents and the materials provided by Items 11, of 12 and 13 these rules;

3) check of completeness of the documents provided in case of application;

4) check of reliability and reconciliation of data in the documents provided in case of application with data in the state register of medicines, medical products of the Republic of Kazakhstan and products, the producer, the manufacturing packer, the holder of the registration certificate, effective period of the registration certificate;

5) testing of product samples for compliance to the regulating document on quality, except for medicines and medical products which pass assessment of safety and quality by declaring.

Application and documents by the applicant is performed in electronic form in information system of the state expert organization.

Paragraph 1. Application process on evaluating safety and quality

10. The applicant by means of information system of the state expert organization submits the request for evaluating safety and product quality in form according to appendix 1 to these rules.

In case of application for carrying out serial assessment of safety and product quality, effective period of the registration certificate constitutes at least six months from the date of application.

11. To the request when carrying out serial assessment of safety and product quality are provided on the electronic medium:

1) the copy of the license for occupation pharmaceutical activities with the corresponding appendix to the license or notifications on the beginning of activities according to the Law of the Republic of Kazakhstan of May 16, 2014 "About permissions and notifications" (further - the Law "About Permissions and Notifications") (once is provided and it is brought in the database of the expert organization);

2) the certificate (any form) of availability of long-term contracts on delivery of products or their permanent deliveries under separate contracts;

3) copy of information on the manufacturing company: the file of the production site taking into account the production sites performing all production phases and quality control for medical products of the file of the production site or the quality manual;

4) for the imported medicines - notarially attested or apostilled according to requirements of the Hague Convention of October 5, 1961 "The list of the states recognizing apostille" (further - the Hague Convention) the copy of the certificate of GMP, for the medicines made in the territory of the Republic of Kazakhstan - notarially attested copy of the document confirming compliance of the production site to requirements of GMP of the Republic of Kazakhstan (once is provided and it is brought in the database of the expert organization, in case of the subsequent address the copy of the document is provided);

5) notarially attested or apostilled according to requirements of the Hague Convention copy of the certificate of ISO 13485 or EN ISO 13485 or GMP for medical products (once is provided and it is brought in the database of the expert organization, in case of the subsequent address the copy of the document is provided).

12. To the request when evaluating safety and quality of each series (batch) of products are provided on the electronic medium:

1) the copy of the license for occupation pharmaceutical activities with the corresponding appendix to the license or notifications on the beginning of activities according to the Law "About Permissions and Notifications" (once is provided and it is brought in the database of the expert organization);

2) the copy of the quality certificate of products from the producer;

3) for medicines: vaccines, serums, bacteriophages, anatoxins, allergens and the medicines of blood imported into the Republic of Kazakhstan the copy of the quality certificate of series issued by the laboratory of the country of the producer or official laboratory authorized by regulatory body the carrying-out quality control for the purpose of release of series on the market in addition is provided;

4) the copy of the certificate of origin for the imported medicines and medical products;

5) waybill copy, invoices or invoice;

6) the copy of the customs declaration on products (electronic), certified by impress of a seal of the applicant, except for the products made and imported from state members of the Eurasian Economic Union;

7) the copy of the contract (contract) for delivery (when importing) medicines and medical products;

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