Unofficial translation
In accordance with subparagraph 44) of article 7 of the Code of the Republic of Kazakhstan dated July 7, 2020 "On people’s health and health care system" I HEREBY ORDER:
1. To approve the rules for assessment of the quality of medicines and medical devices registered in the Republic of Kazakhstan in accordance with Appendix 1 to this order.
2. To recognize as invalid some orders of the Ministry of Health of the Republic of Kazakhstan in accordance with Annex 2 to this order.
3. The Committee for medical and pharmaceutical control of the Ministry of Health of the Republic of Kazakhstan, in accordance with the procedure established by the legislation of the Republic of Kazakhstan, to ensure:
1) state registration of this order in the Ministry of Justice of the Republic of Kazakhstan;
2) posting this order on the Internet resource of the Ministry of Health of the Republic of Kazakhstan after its official publication;
3) within ten working days after the state registration of this order in the Ministry of Justice of the Republic of Kazakhstan, submission of information to the Legal Department of the Ministry of Health of the Republic of Kazakhstan on implementation of the measures provided for in subparagraphs 1) and 2) of this paragraph.
4. The supervising vice minister of health of the Republic of Kazakhstan is authorized to control the execution of this order.
5. This order comes into effect upon the expiration of ten calendar days after the day of its first official publication.
|
Minister of health of the Republic of Kazakhstan |
A. Tsoi |
| Appendix 1 to the order of the Minister of health of the Republic of Kazakhstan dated December 20, 2020 № ҚР ДСМ-282/2020 |
Rules for assessment of quality of medicines and medical devices registered in the Republic of Kazakhstan
Chapter 1. General provisions
1. These rules for assessment of the quality of medicines and medical devices registered in the Republic of Kazakhstan (hereinafter - the Rules) are developed in accordance with subparagraph 44) of Article 7 of the Code of the Republic of Kazakhstan dated July 7, 2020 "On people's health and health care system" (hereinafter – the Code) and determine the procedure for assessment of the quality of medicines and medical devices registered in the Republic of Kazakhstan.
2. The following terms and definitions are used in these Rules:
1) assessment of the quality of medicines and medical devices (hereinafter - product quality assessment) - determination of the compliance of the quality of medicines and medical devices with the data of the registration dossier, regulatory documents on quality, on the basis of which they were registered in the Republic of Kazakhstan (hereinafter - product quality assessment);
2) products - medicines and medical devices registered in the manner prescribed by paragraph 3 of Article 23 of the Code and permitted for medical use in the Republic of Kazakhstan;
3) applicant - an individual or legal entity carrying out pharmaceutical activities in the Republic of Kazakhstan, which provides products for quality assessment;
4) a state body in the field of circulation of medicines and medical devices (hereinafter referred to as the state body) - a state body in charge of the circulation of medicines and medical devices, control over the circulation of medicines and medical devices;
5) a state expert organization in the field of circulation of medicines and medical devices (hereinafter referred to as the expert organization) - a subject of a state monopoly that carries out production and economic activities in the field of health care to ensure the safety, effectiveness and quality of medicines and medical devices;
6) registration dossier - a set of documents and materials submitted for examination of a medicine, medical device;
3. Assessment of product quality in accordance with paragraph 2 of Article 241 of the Code refers to a state monopoly and is carried out by an expert organization with the aim of:
1) determining the quality of registered products;
2) determining the quality of products selected from the market taking into account the risk-based approach;
3) preventing the circulation of counterfeit products in the market of the Republic of Kazakhstan.
4. Payment for the services of assessment of the quality of products is made by the applicant to the account of the expert organization in accordance with the prices established by the authorized body in the field of health care in agreement with the antimonopoly body in accordance with paragraph 2 of Article 241 of the Code.
5. Assessment of the quality of products includes examination of documents when declaring products and laboratory testing of product samples selected from the market, taking into account the risk-based approach during the validity period of the product conformity certificate.
6. Quality assessment is carried out for each series (batch) of products manufactured and imported to the Republic of Kazakhstan during the validity period of the registration certificate, including those registered in accordance with the Rules for registration and examination of medicines for medical use, approved by the decision of the Council of the Eurasian Economic Commission dated November 3, 2016 No. 78 and the Rules for registration and examination of the safety, quality and effectiveness of medical devices approved by the decision of the Council of the Eurasian Economic Commission dated February 12, 2016 No. 46.
Chapter 2. Procedure for assessment of quality of products
7. In order to assess the quality of products, the applicant, in accordance with the Civil Code of the Republic of Kazakhstan, shall enter into an agreement with an expert organization to carry out work on assessing the quality of products and shall provide:
1) application for quality assessment of a medicinal product or medical device according to the form according to Annex 1 to these Rules;
2) a copy of the license for carrying out pharmaceutical activities with the corresponding Annex (production, wholesale sale) to the license or notification of the start of activities (wholesale sale) in accordance with the Law of the Republic of Kazakhstan "On permits and notifications" (hereinafter referred to as the Law), for medical devices it shall be allowed to provide a license for medical activities with an Annex to the license in accordance with the Law;
3) for imported medicines - notarized or apostilled in accordance with the requirements of the Hague Convention dated October 5, 1961 "List of states recognizing apostille" (hereinafter referred to as the Hague Convention) a copy of the GMP certificate valid at the time of production - with notarized translation into Kazakh or Russian (if the document is submitted in a foreign language), for medicines manufactured in the territory of the Republic of Kazakhstan - a document confirming the compliance of the production site with the GMP requirements of the Republic of Kazakhstan (if any);
4) for imported medical devices - a copy of ISO 13485, ISO 9001 or GMP certificate notarized or apostilled in accordance with the requirements of the Hague Convention, with the exception of medical devices of class 1 and 2a (non-sterile), valid at the time of production of products with notarized translation into Kazakh or Russian (if the document is presented in a foreign language), for domestic manufacturer - if any;
5) a copy of the document confirming the quality of the batch of products from the manufacturer with translation into Kazakh or Russian (if the document is presented in a foreign language). For immunological medicinal products (immunobiological medicinal products: vaccines, serums, bacteriophages, toxoids, allergens and blood products) imported into the Republic of Kazakhstan, a batch quality certificate issued by the laboratory of the manufacturer's country or another official laboratory authorized by the regulatory authority of the manufacturer's country to conduct quality control in order to release the batch to the market with translation into Kazakh or Russian (if the document is submitted in a foreign language);
6) for imported products - a copy of the document on the origin of the goods certifying the country of origin of the goods and issued by an authorized organization in accordance with the legislation of this state or state of export, if in the state of export, the certificate is issued on the basis of information received from the country of origin of the goods;
7) a copy of the consignment notes, invoice or invoice for imported products. For medicinal products or medical devices manufactured in the territory of the Republic of Kazakhstan, the applicant shall provide a certificate (arbitrary form) on the availability of ready-to-sell medicinal products or medical devices specified in the application;
8) a copy of the customs declaration for products (electronic), with the exception of products provided for by the resolution of the Government of the Republic of Kazakhstan dated July 21, 2018 No. 441 "On approval of the list of goods in respect of which conditional release shall not be allowed." When importing products produced and/or imported from the member states of the Eurasian Economic Union, a document confirming border crossing is provided.
Submission of the application and documents by the applicant shall be carried out in electronic form in the information system of the state expert organization.
Footnote. Paragraph 7 - in the wording of the order of the Minister of Healthcare of the Republic of Kazakhstan dated 08.12.2021 № ҚР ДСМ-127 (shall enter into force upon expiry of ten calendar days after the day of its first official publication).8. In the event of natural or man-made emergencies, organization and implementation of sanitary-anti-epidemic and sanitary-prophylactic measures and related restrictive measures, including quarantine, when applying for product quality assessment, the applicant additionally provides a letter of guarantee (in any form ) on the provision of documents requiring notarization or apostille, as well as copies of documents signed and sealed by the enterprise, within sixty calendar days after the lifting of restrictive measures.
9. Within five working days from the date of receipt of the application and documents, the expert organization shall verify the submitted documents and verify the data indicated in them with the information provided for in the State register of medicines and medical devices.
When organizing and carrying out sanitary-anti-epidemic and sanitary-preventive measures and related restrictive measures, including quarantine, the quality of products is assessed according to an accelerated procedure within no more than three working days from the date of receipt of the application and documents.
If an incomplete package of documents provided for by paragraphs 7, 8 of the Rules is provided, the information in the submitted documents does not comply with the data of the State register of medicines and medical devices, the expert organization shall send a notification to the applicant by the information system of the state expert organization about the need to eliminate the relevant comments within five working days from the date of receipt of the documents. The applicant shall eliminate the relevant comments within ten working days from the date of receipt of the notification, which shall not be included in the general period of the quality assessment of medicines and medical devices.
Footnote. Paragraph 9 - in the wording of the order of the Minister of Healthcare of the Republic of Kazakhstan dated 08.12.2021 № ҚР ДСМ-127 (shall enter into force upon expiry of ten calendar days after the day of its first official publication).10. Based on the results of the examination of documents, in the absence of comments, the expert organization draws up and registers in the information system of the expert organization a product conformity certificate in the form in accordance with Appendix 2 to these Rules.
When specifying a specific product to which the product conformity certificate applies, an appendix to the product conformity certificate is additionally drawn up in the form in accordance with Appendix 3 to these Rules.
11. Issuance of the product conformity certificate is carried out in electronic format through the information system of the expert organization.
12. The validity period of the product conformity certificate shall be set before the expiration date (operation) of the product, while the shelf life (operation) of the product is determined until the last day of the specified month (for medical equipment in accordance with the technical passport or certificate of quality, production or analysis issued by the manufacturer) inclusive.
Footnote. Paragraph 12 - in the wording of the order of the Minister of Healthcare of the Republic of Kazakhstan dated 08.12.2021 № ҚР ДСМ-127 (shall enter into force upon expiry of ten calendar days after the day of its first official publication).13. When an incomplete package of documents specified in paragraph 7 of these Rules is provided, there are inconsistencies in them with the data of the State Register of medicines and medical devices, unreliable information is found, as well as if the applicant does not eliminate comments within the established time frame, the expert organization issues a decision to refuse to issue a product conformity certificate in the form in accordance with Appendix 4 to these Rules.
14. Excluded by the order of the Minister of Healthcare of the Republic of Kazakhstan dated 08.12.2021 № ҚР ДСМ-127 (shall enter into force upon expiry of ten calendar days after the day of its first official publication).15. During the validity period of the product conformity certificate, the expert organization conducts laboratory tests of product samples selected from the market taking into account the risk-oriented approach.
To conduct laboratory tests of product samples in circulation in the territory of the Republic of Kazakhstan, the expert organization annually develops a schedule for selection of product samples and agrees it with the manufacturer or the holder of the registration certificate of the medicinal product (authorized representative of the manufacturer of the medical product) or their proxies (hereinafter - the manufacturer).
16. The selection of product samples in circulation in the territory of the Republic of Kazakhstan is carried out by an expert organization in accordance with the procedure established by subparagraph 20) of Article 10 of the Code.
17. Tests are carried out at the expense of the manufacturer in accordance with the established prices for services sold by the subject of the state monopoly, approved in accordance with subparagraph 20 of paragraph 2 of Article 241 of the Code.
Reimbursement of the cost of product samples selected for testing to the subject from whom they were selected is carried out by the manufacturer in the frequency of the sampling performed, depending on the number of subjects (objects) of the selection sites (by region, by the number of distributors, pharmacies and medical organizations).
18. Tests of product samples are carried out in testing laboratories of an expert organization, accredited in the manner prescribed by paragraph 6 of Article 25 of the Code.
To test selected samples of products from the market and (or) medical organizations, the manufacturer provides standard samples of chemicals, standard samples of biological products, specific reagents, test strains of microorganisms, cell cultures, if necessary and on terms of return, if applicable, consumables used in testing medicines and sterile medical devices, with the exception of medical equipment in quantities sufficient for a single test with a residual shelf life of at least six months.
If it is impossible to reproduce some quality indicators in accordance with the regulatory document, the manufacturer provides a quality certificate or another similar document with the test results for these indicators.
19. The list of indicators for product testing and testing time is determined in accordance with the regulatory document on product quality.
If the test periods are not provided for in the regulatory documents, then the tests are carried out within twenty-five calendar days from the date of receipt of samples for assessment of the quality of products in an accredited laboratory of an expert organization.
20. The test results are documented in a test report in the form in accordance with Appendix 5 to these Rules.
If the test results are positive, the expert organization, within two working days after the day of receipt of the test report, notifies the manufacturer (in any form) of the conformity of the product to the quality regulatory documents.
21. In case of negative test results, the expert organization draws up, within two working days after the day of receipt of the test report, a negative conclusion on the quality of products in the form in accordance with Appendix 6 to these Rules.
22. In the event of a negative conclusion, the expert organization, within up to five working days, sends the relevant information to the state body for making decisions provided for in paragraph 2 of Article 259 of the Code.
In cases of disagreement with the results of the quality assessment, the applicant applies to the court in the manner, established by the legislation of the Republic of Kazakhstan.
23. Product conformity certificates shall be suspended or revoked by an expert organization at the initiative of the state body or the product marketing authorization holder in cases where provided for by the Rules for the suspension, prohibition or withdrawal from circulation or restriction of the use of medicines and medical devices, approved by order of the Acting Minister of Healthcare of the Republic of Kazakhstan dated December 24, 2020 No. ҚR DSM-322/2020 "On approval of the suspension rules, prohibition or withdrawal from circulation or restriction of the use of medicines and medical devices " (registered in the Register of State Registration of Regulatory Legal Acts under No. 21906).
Footnote. Rules as added by the paragraph 23 in accordance with the order of the Minister of Healthcare of the Republic of Kazakhstan dated 08.12.2021 № ҚР ДСМ-127 (shall enter into force upon expiry of ten calendar days after the day of its first official publication).24. The expert organization shall draw up a decision to suspend or revoke the certificate of conformity of products in accordance with Annex 7 to these Rules, and from the moment of receipt of the decision of the state body, within one working day, shall make the relevant entries in the information system of the state expert organization and in the State register of medicines and medical devices.
Footnote. Rules as added by the paragraph 24 in accordance with the order of the Minister of Healthcare of the Republic of Kazakhstan dated 08.12.2021 № ҚР ДСМ-127 (shall enter into force upon expiry of ten calendar days after the day of its first official publication).| Annex 1 to the Rules for conduct of evaluation of the quality of medicinal products and medical devices, registered in the Republic of Kazakhstan |
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| Form |
Footnote. Annex 1 - in the wording of the order of the Minister of Healthcare of the Republic of Kazakhstan dated 08.12.2021 № ҚР ДСМ-127 (shall enter into force upon expiry of ten calendar days after the day of its first official publication).
___________"____" , 20___
(date for application)
__________________________________________________________________________
(name and address of the expert organization)
Application for quality assessment of a medicinal product or medical device
1 | Applicant name | ||||||||
2 | Legal residence of the entity | ||||||||
3 | Address of the activity of the legal entity | ||||||||
4 | Bank details of the applicant | ||||||||
5 | Information on the declared products * | ||||||||
№ | Trade name | Batch number (serial number for medical devices, devices and equipment) | Production date |
Expiry date | Instalment size | Manufacturer | Country - manufacturer | ||
6 |
Applicant, represented by _________________________________________________________________ | ||||||||
7 | Date of completion | ||||||||
8 | Signature, full name (if any) | ||||||||
Note
* The quality assessment of products shall not be carried out on separately imported (manufactured) components that are part of medical devices and are not used as an independent device or device, as well as on consumables for medical devices specially intended by the manufacturer of a medical device for use with medical devices that can function only with these consumables.
| Annex 2 to the Rules for conduct of evaluation of the quality of medicinal products and medical devices, registered in the Republic of Kazakhstan |
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| Form |
Footnote. Annex 2 - in the wording of the order of the Minister of Healthcare of the Republic of Kazakhstan dated 08.12.2021 № ҚР ДСМ-127 (shall enter into force upon expiry of ten calendar days after the day of its first official publication).
__________________________________________________________________
name and address of the expert organization
Certificate of product compliance
__________________"____", ___ 20, No. ____________
Valid until _____________ "____",___ 20
subject to storage conditions
1. This product compliance certificate shall certify that the products
__________________________________________________________________________
__________________________________________________________________________
(name and type of products according to the State register of medicinal products
and medical devices, series (serial number for medical devices,
devices and equipment), shelf life, number of batches) manufactured
_________________________________________________________________________
(country, manufacturer name)
presented ___________________________________________________________
(name, location of the legal entity, address of the exercise
activity of a legal entity) passed a quality assessment by declaring
2. Product compliance certificate issued on the basis of certificates
_________________________________________________________________________
(GMP, No., date of issue, validity or ISO 13485, No., date of issue, validity)
_________________________________________________________________________
(Manufacturer quality certificate No., date of issue)
3. Additional information
_________________________________________________________________________
_________________________________________________________________________
(to be filled in if necessary)
Signatures of authorized persons _____________ ________________________________
signature of full name (if any)
_____________ ___________________________________________________________
signature of full name (if any)
| Annex 3 to the Rules for conduct of evaluation of the quality of medicinal products and medical devices, registered in the Republic of Kazakhstan |
|
| Form |
Footnote. Annex 3 - in the wording of the order of the Minister of Healthcare of the Republic of Kazakhstan dated 08.12.2021 № ҚР ДСМ-127 (shall enter into force upon expiry of ten calendar days after the day of its first official publication).
__________________________________________________________________________
Name and address of the expert organization
| Annex to certificate of product compliance №______ |
List of specific products covered by the certificate of product compliance
Name of products in accordance with the State register of medicines and medical equipment, name of manufacturer, country of manufacture |
Batch (serial number for medical devices, devices and equipment), shelf life, lot size | Certificate for conformity of validity period |
Signatures of authorized persons: _____________ ________________________________
signature of full name (if any)
_____________ ____________________________________________________________
signature of full name (if any)
| Annex 4 to the Rules for conduct of evaluation of the quality of medicinal products and medical devices, registered in the Republic of Kazakhstan |
|
| Form |
Footnote. Annex 4 - in the wording of the order of the Minister of Healthcare of the Republic of Kazakhstan dated 08.12.2021 № ҚР ДСМ-127 (shall enter into force upon expiry of ten calendar days after the day of its first official publication).
___________________________________________________
Name and address of the expert organization
Decision on refusal to issue a product conformity certificate on implementation address
of activities of a legal entity
1. General information
2. Grounds for failure (mark the required)
| provision of an incomplete package of documents according to the list provided for by paragraph 7 of the Rules for assessing the quality of medicines and medical devices registered in the Republic of Kazakhstan |
| provision of false information |
| inconsistency of the information in the submitted documents with the data of the State register of medicines and medical devices of the Republic of Kazakhstan |
| not elimination of comments made by the expert organization within the established time frame |
Signatures of authorized persons:
___________________ _______________________________________________
signature of full name (if any), position
___________________ _______________________________________________
signature of full name (if any), position
| Appendix 5 to the Rules for assessment of quality of medicines and medical devices, registered in the Republic of Kazakhstan |
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| Form |
Place of application of
Sign and (or) number of the Accreditation certificate
_____________________________________________________________________
name and address of the expert organization
_____________________________________________________________________
Testing laboratory accreditation certificate (No., validity period)
____________________________________________________________________
Address, telephone number of the expert organization (testing laboratory)
Test report
№ ________ dated "____" ____________ Page ____ Number of sheets __
Subject (name address):
___________________________________________________________________
Name of products:
___________________________________________________________________
Test type:
___________________________________________________________________
Grounds:
____________________________________________________________________
Manufacturer, country:
____________________________________________________________________
Series, batch: _________ Date of manufacture: ________ Shelf life: ________
Number of samples:
___________________________________________________________________
Start date and end date of tests:
____________________________________________________________________
Designation of a product regulatory document:
___________________________________________________________________
Designation of a regulatory document for test methods:
___________________________________________________________________
Test results
Name of indicators | Requirements of the product regulatory document | t0С and moisture (%) | Actual results obtained | Brief description of compliance (non-compliance) |
1 | 2 | 3 | 4 | 5 |
Conclusion: Samples shown meet (don't meet) the requirements of regulatory documents (underline the necessary).
Signatures of the authorized persons:
______________ _______________ ______________________________
(position) (signature) full name (if any)
______________ ______________ _______________________________
(position) (signature) full name (if any)
______________ _____________ _______________________________
(position) (signature) full name (if any)
* The test report applies only to samples that have been tested. Full or partial reprint of the test report without the written permission of the expert organization is prohibited.
| Appendix 6 to the Rules for assessment of quality of medicines and medical devices, registered in the Republic of Kazakhstan |
|
| Form |
_____________________________________________________________________
name and address of the expert organization
"____" _______ 20 __ .
__________________________________________________________________________
Name, full name (if any) of subject
__________________________________________________________________________
position, full name (if any) of the head
__________________________________________________________________________
Location of legal entity, legal entity’s business address
Negative conclusion on product quality
Laboratory tests were held:
_______________________________________________________________________
name of products,
1. _____________________________________________________________________
batch number, expiration date, batch size, name of company - manufacturer, country
_______________________________________________________________________
2. According to the test report №
________________________________________________________________________
dated "_____" _________________ 20___, the selected products do not meet the requirements
________________________________________________________________________
name and designation of regulatory document for declared products
________________________________________________________________________
Signatures of the authorized persons:
_____________ ____________________________________
signature full name (if any)
_____________ ____________________________________
signature full name (if any)
| Annex 7 to the Rules for conduct of evaluation of the quality of medicinal products and medical devices, registered in the Republic of Kazakhstan |
Footnote. The Rules as added by the Annex 7 in accordance with the order of the Minister of Healthcare of the Republic of Kazakhstan dated 08.12.2021 № ҚР ДСМ-127 (shall enter into force upon expiry of ten calendar days after the day of its first official publication).
Ministry of Healthcare of the Republic of Kazakhstan
_________________________________________________________________
Name and address of the expert organization
Decision to suspend or revoke a certificate of product compliance
from ___________ "____", 20__ № ____________
Validity of the certificate of product compliance
_________________________________________________________________________
_________________________________________________________________________
(Certificate No., date of issue) suspended, revoked (specify the required)
in accordance with
________________________________________________________________________
(to specify documents, basis)
with _____________"______", _____ 20.
Signatures of authorized persons
__________ ____________________________________
signature of full name (if any)
__________ ____________________________________
signature of full name (if any)
| Annex 2 to the order |
List of some orders of the Ministry of Health of the Republic of Kazakhstan that have become invalid
1. Order of the Minister of Health and Social Development of the Republic of Kazakhstan dated November 26, 2014 No. 269 "On approval of the Rules for assessment of the safety and quality of medicines and medical devices registered in the Republic of Kazakhstan" (registered in the Register of state registration of regulatory legal acts under No. 10003, published on January 8, 2015 in the information and legal system "Adilet");
2. Order of the Minister of Health and Social Development of the Republic of Kazakhstan dated June 28, 2016 No. 569 "On amendments to the order of the Minister of Health and Social Development of the Republic of Kazakhstan dated November 26, 2014 No. 269 "On approval of the Rules for assessment of the safety and quality of medicines and products of medical purpose, registered in the Republic of Kazakhstan" (registered in the Register of state registration of regulatory legal acts under No. 13881, published on August 9, 2016 in the information and legal system "Adilet");
3. Order of the Minister of Health of the Republic of Kazakhstan dated May 17, 2019 No. ҚР ДСМ -82 "On amendments to the order of the Minister of Health and Social Development of the Republic of Kazakhstan dated November 26, 2014 No. 269 "On approval of the Rules for assessment of the safety and quality of medicines and products of medical purpose, registered in the Republic of Kazakhstan" (registered in the Register of state registration of regulatory legal acts under No. 18699, published on May 27, 2019 in the Reference Control Bank of regulatory legal acts of the Republic of Kazakhstan);
4. Order of the Minister of Health of the Republic of Kazakhstan dated July 6, 2020 No. ҚР ДСМ -79/202 "On amendments to the order of the Minister of Health and Social Development of the Republic of Kazakhstan dated November 26, 2014 No. 269 "On approval of the Rules for assessment of the safety and quality of medicines and medical devices, registered in the Republic of Kazakhstan" (registered in the Register of state registration of regulatory legal acts under No. 20937, published on July 6, 2020 in the Reference Control Bank of regulatory legal acts of the Republic of Kazakhstan).
