Unofficial translation
In accordance with subclause 20) of article 10 of the Code of the Republic of Kazakhstan dated July 7, 2020 "On Public Health and Healthcare System" I HEREBY ORDER:
1. To approve the attached Rules for selection from the market, including in medical organizations, of pharmaceuticals and medical devices subject to quality control taking into account a risk-based approach.
2. Medical and pharmaceutical control Committee of the Ministry of Health of the Republic of Kazakhstan, in accordance with the procedure established by the legislation of the Republic of Kazakhstan, shall ensure:
1) state registration of this order with the Ministry of Justice of the Republic of Kazakhstan;
2) placement of this order on the Internet resource of the Ministry of Healthcare of the Republic of Kazakhstan after its official publication;
3) within ten working days after the state registration of this order with the Ministry of Justice of the Republic of Kazakhstan, submission to the Legal Department of the Ministry of Healthcare of the Republic of Kazakhstan of information about execution of measures stipulated by subclauses об 1) and 2) of this clause.
3. Control over the execution of this order shall be entrusted to the supervising Vice-Minister of Healthcare of the Republic of Kazakhstan.
4. This order shall come into force upon expiry of ten calendar days after the date of its first official publication.
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Acting Minister of Healthcare of the Republic of Kazakhstan |
M. Shoranov |
| Appendix to the order of the Acting Minister of Healthcare of the Republic of Kazakhstan dated December 24, 2020 no. ҚР ДСМ-323/2020 |
Rules for selection from the market, including in medical organizations, of pharmaceuticals and medical devices subject to quality control taking into account a risk-based approach
Chapter 1. General Provisions
1. These rules for selection from the market, including in medical organizations, of pharmaceuticals and medical devices subject to quality control taking into account a risk-based approach (hereinafter referred to as the Rules) have been developed in accordance with subclause 20) of article 10 of the Code of the Republic of Kazakhstan dated July 7, 2020 "On Public Health and Healthcare System" (hereinafter referred to as the Code) and establish the procedure for the selection from the market, including in medical organizations, of pharmaceuticals and medical devices subject to quality control taking into account a risk-based approach (hereinafter referred to as the selection of samples).
2. The following terms and definitions are used for the purposes of these Rules:
1) an authorized body in the field of healthcare (hereinafter referred to as the authorized body) – a central executive body, carrying out management and cross-sectoral coordination in the field of health protection of citizens of the Republic of Kazakhstan, medical and pharmaceutical science, medical and pharmaceutical education, sanitary and epidemiological well-being of the population, circulation of pharmaceuticals and medical devices, quality of provision of medical services (assistance);
2) a state body in the field of circulation of pharmaceuticals and medical devices (hereinafter referred to as the state body) – a state body carrying out management in the field of circulation of pharmaceuticals and medical devices, quality of medical services, control over circulation of pharmaceuticals and medical devices;
3) a state expert organization in the field of circulation of pharmaceuticals and medical devices (hereinafter referred to as the expert organization) – a state monopoly entity carrying out production and economic activities in the field of health care to ensure the safety, efficiency and quality of pharmaceuticals and medical devices;
4) production – pharmaceuticals and medical devices, registered in accordance with the procedure, established by clause 3 of article 23 of the Code and approved for medical use in the Republic of Kazakhstan.
3. Selection of samples is carried out by specialists of expert organization performing the assessment of quality of pharmaceuticals and medical devices in accordance with the procedure, stipulated by clause 1 of article 241 of the Code.
4. The expert organization annually, by December 10, forms a plan of selection of samples to assess the quality of pharmaceuticals and medical devices in circulation in the Republic of Kazakhstan and sends it for approval to manufacturers (holders of pharmaceutical registration certificate, authorized representatives of a medical device manufacturer) or their trusted persons (hereinafter referred to as the manufacturer). In the absence of agreement by the manufacturer within 30 calendar days from the date of receipt of the request from the expert organization, the expert organization within 10 calendar days sends a notification (in any form) to the state body on the adoption of appropriate measures.
Revision or amendments to the plan of selection of samples are carried out by an expert organization on a quarterly basis depending on newly registered pharmaceuticals and medical devices, as well as the lack of pharmaceuticals and medical devices on the market included in the plan of selection of samples.
5. The following shall be subject to inclusion to the plan of selection of samples:
1) pharmaceuticals, requiring special storage conditions;
2) pharmaceuticals, purchased within the guaranteed volume of free medical care and the Mandatory Social Health Insurance;
3) pharmaceuticals, registered on the territory of the Republic of Kazakhstan for the first time;
4) pharmaceutical of parenteral administration;
5) sterile pharmaceuticals and medical devices, as well as medical devices that are personal protective equipment designed by the manufacturer to protect patients or medical personnel and used for medical purposes for personal protection, with the exception of implantable and medical devices for in vitro diagnostics, as well as medical equipment.
Chapter 2. Procedure for selection from the market, including in medical organizations, of pharmaceuticals and medical devices subject to quality control taking into account a risk-based approach
6. Selection of samples is carried out in organizations manufacturing pharmaceuticals and medical devices, organizations engaged in the wholesale and retail sale of pharmaceuticals and medical devices (pharmacies, including those selling via the Internet, pharmacies in health care organizations, pharmacies, distribution warehouses, temporary warehouses for pharmaceuticals, medical products, optical stores, medical product stores), and also in healthcare organizations in the presence of a manufacturer's representative.
7. Selection of samples is carried out in the amount required for one-time laboratory tests.
When selecting samples, a product-sampling certificate is drawn up in the form according to the appendix to these Rules.
8. Simultaneously with the product sampling for testing, control sampling shall be carried out in the amounts equal to the amount of the selected samples.
9. Finished pharmaceuticals in consumer packaging are subject to selection of samples.
10. When sampling, precautions are taken to take into account the toxicity, explosion hazards, flammability, hygroscopicity of pharmaceuticals, and to keep them from contamination.
Selection of samples is carried out subject to the conditions that exclude deterioration in the quality of pharmaceuticals.
Methods of selection of samples ensure that the chemical composition of the product remains unchanged between collection and analysis.
Samples shall be taken among intact packaging units, which are sealed and packed in accordance with regulatory documentation.
11. To perform the test pharmaceuticals for compliance with the requirements of the regulatory document, a multistage selection of samples shall be carried out. Samples in each stage are taken at random in proportional amounts from units taken in the previous stage. The type of packaging shall determine the number of stages.
The first stage: selection of packaging units (boxes, boxes, bags, bottles, drums);
The second stage: selection of packaging units in packaging containers (boxes, vials, cans);
The third stage: selection of products in primary packaging (ampoules, tubes, blister packs).
The calculation of the amount of selected products at each stage is carried out according to the formula 0.4
In case of insufficient number of samples for testing, samples shall be re-selected as described above.
From the packaging units selected at the last stage, after control in appearance, a sample is taken in the amount necessary for laboratory tests in accordance with the requirements of regulatory documents (taking into account tests for microbiological purity, sterility).
For solid dosage pharmaceuticals, the calculation of the number of units required for microbiological control is carried out by dividing the required amount of sample in grams (50 g) by the average weight of the tablet (dragee, capsule, suppository). Samples of pharmaceuticals for injection and eye drops are selected based on testing for particulate matter.
12. Selected samples are isolated from the principal product, packed, sealed off at the place of selection.
Selected samples of pharmaceuticals are sent for control in packaging provided by the regulatory document and ensuring its safety.
13. Finished medical devices in consumer packaging are subject to selection of samples.
14. Before sampling, an external examination of the package is performed, its quality, integrity, as well as the compliance of the container and packaging with the requirements of regulatory documents is determined. At the same time, the temperature conditions of storage of medical devices (temperature regime, humidity) are checked as applicable.
15. Selection of samples shall be carried out subject to the conditions that exclude deterioration of the quality of medical devices.
Samples are taken among intact packaging units, in accordance with regulatory documentation.
16. In the process of sampling medical devices, in general, the following shall be considered:
1) batch homogeneity;
2) representativeness of the sample by composition;
3) representativeness of the sample by amount;
4) compliance of samples with product identification characteristics.
17. The selected samples in terms of design, composition and manufacturing technology correspond to the products intended for sale.
18. The sampling according to the composition of samples reflects the entire set of homogeneous products, which are the object of quality assessment, taking into account the differences in the properties of individual types (brands, sizes, types, models) of such a set.
19. When taking samples of medical devices of a standard-size range of homogeneous products or a medical device included in a kit or set, the sampling shall include samples from different series, which are distributed for testing according to various quality indicators in accordance with the regulatory document on the quality of a medical device.
Product-sampling certificate
From "___" _________ 20___ no. ____________
Name of organization:
__________________________________________________________________________
Place of selection:
__________________________________________________________________________
(address) Selection was performed by: __________________________________________
Surname, name, patronymic (if any) of the person, carried out selection of samples
Act was made by:
__________________________________________________________________________
Surname, name, patronymic (if any) representative of the expert organization, involving:
__________________________________________________________________________
Surname, name, patronymic (if any) of manufacturer or his/her representative
Samples of presented products were selected in accordance with
__________________________________________________________________________
(name of the regulatory document)
_________________________ for testing for the purposes of quality assessment of the products
Products were received according to:
__________________________________________________________________________
(consignment note; receipts no.,
__________________________________________________________________________
under the contract no., date; agreement no., date)
Manufacturer:
__________________________________________________________________________
(country, organization and address)
Supplier:
__________________________________________________________________________
(country, organization and address)
The inspection established:
__________________________________________________________________________
Storage conditions:
__________________________________________________________________________
Appearance and condition of containers, packaging, vessels:
__________________________________________________________________________
Inscriptions on the packaging and labels:
__________________________________________________________________________
Samples taken from products presented under the name:
Name of samples of presented products | Measuring unit | Batch no. | Batch size | Manufacturing date | Shelf life | Number of selected product samples |
1 | 2 | 3 | 4 | 5 | 6 | 7 |
Control samples in quantities equal to the number of samples taken are selected, sealed and stored in appropriate conditions during the validity period of the certificate of conformity of products from an entity in the field of circulation of pharmaceuticals and medical devices.
Representative of the expert organization:
_________________ ________________________________________
signature Surname, name, patronymic (if any)
Manufacturer
(Manufacturer’s representative):
_________________ ________________________________________
signature Surname, name, patronymic (if any)