Unofficial translation
Footnote. It became invalid by Order of the Minister of Health of the Republic of Kazakhstan dated 03.12.2020 No. KR DCM -229/2020 (effective after ten calendar days after the date of its first official publication).In accordance with subparagraph 38) of paragraph 1 of Article 7-1 of the Code of the Republic of Kazakhstan “On Public Health and the Healthcare System” as of September 18, 2009 and subparagraph 5) of Article 6 of the Law of the Republic of Kazakhstan “On Protection of Consumer Rights”, I hereby ORDER:
1. To approve the appended Rules for maintaining the register of products not meeting the requirements of regulatory legal acts in the field of sanitary and epidemiological welfare of the population, hygiene standards and technical regulations.
2. In accordance with the procedure established by the legislation of the Republic of Kazakhstan, the Public Health Protection Committee of the Ministry of Healthcare of the Republic of Kazakhstan shall:
1) ensure state registration of this order with the Ministry of Justice of the Republic of Kazakhstan;
2) within ten calendar days of the state registration of this order, send its copy in Kazakh and Russian in paper-based and electronic forms to the Republican State Enterprise with the Right of Economic Management “Republican Center of Legal Information” of the Ministry of Justice of the Republic of Kazakhstan for its official publication and inclusion into the Reference Control Bank of Regulatory Legal Acts of the Republic of Kazakhstan;
3) within ten calendar days of the state registration of this order, send its copy to print periodicals for official publication;
4) place this order on the website of the Ministry of Healthcare of the Republic of Kazakhstan after its official publication;
5) within ten working days of the state registration of this order, submit information about the implementation of measures, provided for in subparagraphs 1), 2), 3) and 4) of this paragraph, to the Legal Department of the Ministry of Healthcare of the Republic of Kazakhstan;
6) ensure the monthly placement of the register of products not meeting the requirements of regulatory legal acts in the field of sanitary and epidemiological welfare of the population, hygienic standards and technical regulations on the website of the office of the authorized body in the field of healthcare.
3. The control over the execution of this order shall be assigned to the supervising deputy minister of healthcare of the Republic of Kazakhstan.
4. This order shall take effect after the day of its first official publication.
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Minister of Healthcare of the Republic of Kazakhstan |
E.Birtanov |
| Approved by Order № KR-DCM-59 as of May 2, 2019 of the |
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| Minister of Healthcare of the Republic of Kazakhstan |
Rules for maintaining the register of products not meeting the requirements of regulatory
legal acts in the field of sanitary and epidemiological welfare of the population, hygienic
standards and technical regulations
Chapter 1. General provisions
1. These Rules for maintaining the register of products not meeting the requirements of regulatory legal acts in the field of sanitary and epidemiological welfare of the population, hygienic standards and technical regulations (hereinafter referred to as the Rules) are developed in accordance with subparagraph 38) of paragraph 1 of Article 7-1 of the Code of the Republic of Kazakhstan “On Public Health and the Healthcare System” as of September 18, 2009 and subparagraph 5) of Article 6 of the Law of the Republic of Kazakhstan “On Protection of Consumer Rights” and determine the procedure for maintaining the register of products not meeting the requirements of regulatory legal acts in the field of sanitary and epidemiological welfare of the population, hygienic standards and technical regulations.
2. The following terms are used in these Rules:
1) the register of products not meeting the requirements of regulatory legal acts in the field of sanitary and epidemiological welfare of the population, hygienic standards and technical regulations (hereinafter referred to as the Register) - a list of products that do not meet the requirements of regulatory legal acts in the field of sanitary and epidemiological welfare of the population, hygienic standards and technical regulations;
2) product safety monitoring - a system of measures aimed at identifying, preventing and suppressing the import, production, use and sale of products not meeting the requirements of regulatory legal acts in the field of sanitary and epidemiological welfare of the population, hygienic standards and technical regulations;
3) the authorized body in the field of healthcare (hereinafter referred to as the authorized body) - the central executive body that exercises the leadership and intersectoral coordination in the field of public health, medical and pharmaceutical science, medical and pharmaceutical education, sanitary and epidemiological welfare of the population, turnover of medicines and medical products, control over the quality of medical services.
3. The register is maintained to inform consumers about products posing risk to their health and safety, which are identified as a result of product safety monitoring.
4. The information contained in the Register is open and accessible to all interested persons.
Chapter 2. The procedure for maintaining the register of products not meeting the
requirements of regulatory legal acts in the field of sanitary and epidemiological welfare
of the population, hygienic standards and technical regulations
5. The Register’s maintenance shall be understood to mean:
1) timely entry of information on products not meeting the requirements of regulatory legal acts in the field of sanitary and epidemiological welfare of the population, hygienic standards and technical regulations in accordance with paragraph 6 of these Rules, removal of products wrongfully recognized as failing to meet the requirements, and also introduction of alterations and additions pursuant to applicants’ applications, which is conducted in electronic format in Kazakh and Russian;
2) monthly placing and updating of the list of non-conforming products on the website of the office of the authorized body in the field of healthcare (hereinafter referred to as the Office).
6. The register includes the following information on the results of product safety monitoring conducted by the Office’s territorial divisions:
1) types of products in accordance with Appendix 1 to these Rules;
2) the name of a product;
3) the name and location of the manufacturer of a product or the surname, name, patronymic (if any) and location of an individual entrepreneur who is the manufacturer of a product, or the name and location of the person authorized by the manufacturer, the name and location of the importing organization, or the surname, name, patronymic (if any) and location of the importing individual entrepreneur;
4) country of origin;
5) the place of sampling (name of the object, address);
6) date of manufacture, shelf life, storage conditions;
7) batch or series number;
8) research protocol based on the results of the sanitary-epidemiological examination;
9) identified violations of safety and quality indicators (their actual value and permissible standards).
7. The Office’s territorial divisions ensure the timeliness, completeness and reliability of the information provided in the Register in accordance with Appendix 2 to these Rules.
8. Monthly, by the 5th day of the month following the reporting period, the Office’s territorial divisions generate a report on the product safety monitoring indicating the list of products in electronic form.
9. The criteria for recognizing products as not meeting the requirements of regulatory legal acts in the field of sanitary and epidemiological welfare of the population, hygienic standards and technical regulations for the purposes of their subsequent entry into the Register are as follows:
1) the results of the sampling and sanitary-epidemiological examination of products posing threat to life, human health and the environment in cases of violations of the requirements of the legislation of the Republic of Kazakhstan in the field of sanitary-epidemiological welfare of the population, hygienic standards and technical regulations;
2) the results of the sampling and sanitary-epidemiological examination of products, which confirm information from international organizations, member states of the Eurasian Economic Union or third countries on the identification of products controlled by the state sanitary-epidemiological surveillance (control) that do not meet the requirements of technical regulations.
10. The information published in the Register is valid and applies only to products of the series (batch) and the production date that are indicated in the Register.
11. The products are removed from the Register by the Office when the applicant provides the following information and materials:
1) information confirming manufacturers’ compliance with the requirements of regulatory legal acts in the field of sanitary and epidemiological welfare of the population, hygienic standards and technical regulations that guarantee commercial distribution of safe and good-quality products;
2) information on the introduction of the procedure based on the HACCP principles;
3) the results of extensive laboratory control along with additional monitoring of the raw materials used, if necessary.
12. Products included in the Register pursuant to inaccurate information or improper examination shall be removed from the Register within three working days of the establishment of such a fact on the basis of the protocol of the consultative and advisory commission.
Types of products
1. Meat and meat products
2. Poultry and poultry products
3. Fish and fish products
4. Oil and fat products
5. Milk and dairy products
6. Sugar and confectionery
7. Juice products
8. Fruits and vegetables, products of their processing
9. Soft drinks
10. Alcoholic beverages
11. Bottled drinking water, including mineral water
12. Baby food
13. Specialized food products
14. Biologically active additives (BAAs)
15. Flour and flour products
16. Bread and bakery products
17. Cereals
18. Culinary products
19. Tea and coffee
20. Food salt
21. Yeast
22. Spices
23. Other food products
24. Household chemical goods
25. Light industry products
26. Children toys and games
27. Products intended for children and adolescents
28. Personal hygiene products
29. Paints and varnishes
30. Other industrial products
31. Tobacco products
32. Perfume and cosmetic products
33. Personal protective equipment
34. Furniture products
Item № | Type of products | Name of product | Manufacturer | Batch or series number, manufacturing date, expiration date | Place of sampling (object name, address) | |||
product (goods) code | Name by code | Country code | Name of country | Manufacturer (name of legal entity or individual, address) | ||||
Types of violations | ||||
Microbiological indicators, actual value and permissible standards according to RD (examination protocol №, date) | physical-chemical, actual value and permissible standards according to RD (examination protocol №, date) | safety indicators, actual value and permissible standards according to RD (examination protocol №, date) | marking, nature of violations (examination protocol №, date) | Counterfeit products |
Continued
Measures taken | ||||||||||
order issued (№, date, to whom it was sent) | shopping facility | supplier | ||||||||
inspection report, date, №, identification of violation) | measures (fine, article, amount of the fine, who shall pay) | withdrawn from sale, total | Including the amount Returned to the supplier (amount in kg, l) | including Destroyed products, method of destruction (amount in kg, l) | Inspection report, date, №, identified violations) | measures (fine, article, amount of the fine, who shall pay) | withdrawn from sale, total (amount in kg, l) | including the amount Returned to the supplier or manufacturer (amount in kg, l) | including Destroyed products, method of destruction (amount in kg, l) | |
Continued
Measures taken | name of the document confirming the conformity of products (goods) | product (goods) supplier (name, address) | ||||
court order | ||||||
materials submitted to court | under consideration | satisfied (administrative measures, ruling) | dismissed | number | name, date of issue, valid until, issued by | |
