of September 14, 2015 No. 713
About approval of Rules of wholesale and retail sale of medicines and medical products
According to article 69 of the Code of the Republic of Kazakhstan of September 18, 2009 "About health of the people and health care system" I ORDER:
1. Approve the enclosed Rules of wholesale and retail sale of medicines, products of medical appointment and medical equipment (further - Rules).
2. To provide to committee of control of medical and pharmaceutical activities of the Ministry of health and social development 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 after state registration of this order in the Ministry of Justice of the Republic of Kazakhstan the direction on official publication in periodic printing editions and information system of law of Ad_let;
3) placement of this order on Internet resource of the Ministry of health and social development of the Republic of Kazakhstan;
4) within ten working days after state registration of this order in the Ministry of Justice of the Republic of Kazakhstan submission to Department of legal service of the Ministry of health and social development 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 vice-Minister of health and social development of the Republic of Kazakhstan Tsoi A. V.
4. This order becomes effective after ten calendar days from the date of its first official publication, except for Item 5 of Rules which becomes effective since January 1, 2018.
Minister of health and social development of the Republic of Kazakhstan
T. Duysenova
Approved by the Order of the Minister of health and social development of the Republic of Kazakhstan of September 14, 2015 No. 713
1. These rules of wholesale and retail sale of medicines and medical products (further - Rules) are developed according to article 69 of the Code of the Republic of Kazakhstan of September 18, 2009 "About health of the people and health care system" (further - the Code) and determine procedure for wholesale and retail sale of medicines and medical products.
2. In these rules the following concepts are used:
1) retail sale of medicines and medical products - the pharmaceutical activities connected with acquisition (except import), storage, distribution, realization (except export) to the final consumer, destruction of medicines and medical products, performed according to Rules;
2) wholesale of medicines and medical products (distribution) - the pharmaceutical activities connected with purchase (acquisition), storage, import (import), export (export), realization (except for realization to the population) without restriction of amounts, transportation and destruction of medicines and medical products, performed according to Rules;
3) drug circulation - the activities including processes of development, preclinical (not clinical) researches, testing, clinical trials, examinations, registration, pharmakonadzor, quality control, production, production, storage, transportation, import and export, leave, realization, transfer, application, destruction of medicines;
4) the address of medical products - designing, development, creation of prototypes, carrying out technical testing, researches (testing) of assessment of biological effect of medical products, clinical trials, examinations of safety, quality and efficiency of medical products, registration, production (production), storage, transportation, realization, installation, adjustment, application (operation), maintenance, repair and utilization of medical products;
5) subjects in the field of drug circulation and medical products - the physical persons or legal entities performing pharmaceutical activities;
6) objects of wholesale of medicines, medical products - pharmaceutical (distributor) warehouse, warehouse of medical products;
7) objects of retail sale of medicines, medical products - drugstore, pharmaceutical Item in the organizations of health care rendering primary medical and sanitary and (or) consulting and diagnostic help, the mobile pharmaceutical unit for the remote rural zones organized from drugstore, shop of optics, shop of medical products.
3. Wholesale of medicines and medical products is performed by the subjects in the field of drug circulation and medical products who obtained the corresponding license for wholesale in pharmaceutical warehouses or notified on the beginning of activities through warehouse of medical products according to the procedure established by the Law of the Republic of Kazakhstan of May 16, 2014 "About permissions and notifications" (further - the Law on permissions and notifications).
4. Retail sale of medicines and medical products is performed by the subjects in the field of drug circulation and medical products who obtained the corresponding license for retail sale in drugstores, pharmaceutical Items, mobile pharmaceutical units or notified on the beginning of activities through shops of optics and medical products according to the procedure established by the Law on permissions and notifications.
5. No. KR DSM-17/2020 is excluded according to the Order of the Minister of Health of the Republic of Kazakhstan of 16.03.2020
6. The subjects in the field of drug circulation and medical products enabling wholesale of medicines observe requirements of proper distributor practice (GDP).
7. The subjects in the field of drug circulation and medical products enabling retail sale of medicines observe requirements of proper pharmaceutical practice (GPP).
8. With subjects of wholesale and retail sale it is provided:
1) sign availability with indication of the name of the subject of pharmaceutical activities, its form of business and operating mode in the state and Russian languages;
2) placement in the place, convenient for acquaintance:
copies of the license for pharmaceutical activities and appendices to it or the document (including the printed-out copy of the electronic document) informing on the beginning or the termination of implementation of activities or certain actions;
information on phone number and addresses of territorial subdivision of state body in the field of drug circulation and medical products;
visitors books;
information on phone numbers of service pharmaceutical desk;
3) systematic personnel training, is at least once in five years advanced training and retraining of pharmaceutical (medical) personnel.
9. Wholesale and retail sale of medicines and medical products in the cases determined by item 4 of article 69 of the Code is not allowed.
10. In settlements, remote from the district center, where there are no drugstores, physical persons and legal entities through pharmaceutical Items in the organizations of health care giving primary medical and sanitary, consulting and diagnostic help, and mobile pharmaceutical units can perform realization of medicines and medical products. In the absence of pharmaceutical Items retail sale of medicines and medical products can be performed through the organizations of health care giving primary medical and sanitary, consulting and diagnostic help. In case of absence of specialists with pharmaceutical education for implementation of retail sale of medicines and medical products the specialists with medical education who were trained for their realization are allowed.
11. The medicines and medical products which are not corresponding to accompanying documents, the expired, not taken place state registration, assessment of safety and quality in the Republic of Kazakhstan falsified which are not conforming to requirements of the legislation of the Republic of Kazakhstan are stored on objects of wholesale and retail sale separately from other medicines and medical products and supplied with the "Realization before Acceptance of Adequate Measures Is Not Subject" label.
12. Treat objects of wholesale of medicines and medical products:
the pharmaceutical warehouse enabling wholesale of medicines and medical products;
the warehouse of medical products enabling wholesale of medical products.
13. Wholesale of medicines and medical products is performed with observance of the following requirements:
1) medicines and medical products are bought only from the producers or subjects having licenses for pharmaceutical activities and appendix to the license for wholesale of medicines, or who notified on the beginning of activities according to the procedure established by the Law on permissions and notifications;
2) medicines and medical products are implemented to the subjects having the license for pharmaceutical or medical activities or which notified on the beginning of activities according to the procedure established by the Law on permissions and notifications;
3) the medicines which are subject to leave without recipe of the doctor are implemented to the subjects in the field of veterinary science which notified on the beginning of the activities, according to the procedure, established by the Law on permissions and notifications;
4) medicines and medical products are implemented after receipt of the conclusion about safety and quality according to the Rules of evaluating safety and quality of the medicines and medical products registered in the Republic of Kazakhstan", approved by the order of the Minister of health and social development of the Republic of Kazakhstan of November 26, 2014 No. 269 (it is registered in the Register of state registration of regulatory legal acts for No. 10003) (further - Rules of assessment of safety and quality);
5) medical products, relating according to the Law of the Republic of Kazakhstan of June 7, 2000 "About ensuring unity of measurements" (further - the Law on ensuring unity of measurements) to gages, is implemented in the presence of the certificate on approval like measuring instruments or the certificate on metrological certification of medical products according to the legislation of the Republic of Kazakhstan on technical regulation;
6) the room, squares and the equipment conform to Qualification requirements, shown to pharmaceutical activities, approved the Minister of health and social development of the Republic of Kazakhstan of April 1, 2015 No. 27 (it is registered in the Register of state registration of regulatory legal acts for No. 10600);
7) medicines and medical products are stored and transported in the conditions providing preserving their safety, efficiency and quality, according to the Storage precautions and transportations of medicines and medical products approved by the order of the Minister of health and social development of the Republic of Kazakhstan of April 24, 2015 No. 262 (it is registered in the Register of state registration of regulatory legal acts at No. 11191) (further - Storage precautions and transportations);
8) availability and functioning of system of documentation allowing to trace the operations performed concerning any are provided to the received and shipped series (batch) of products from the supplier to the buyer and to establish the location of medicine, medical products, specified in Item 9 of these rules;
9) documentary fixing of the facts of detection of medicines and medical products, specified in Item 9 of these rules, the notification about them, withdrawals from the market and informing authorized body or its territorial subdivisions are provided.
14. Realization of medicines and medical products from pharmaceutical (distributor) warehouse, warehouse of medical products is followed by shipping documents according to Item 3 of article 443 of the Code of the Republic of Kazakhstan "About taxes and other obligatory payments in the budget (Tax code)" of December 25, 2017, certified by the signature of the head or person authorized by it, chief accountant, and also the signature of person who allotted medicines and medical products.
In the shipping document are specified each name, batch (series) of products:
name;
dosage (for medicine);
packing;
quantity, unit price;
amount;
series;
expiration date;
number and effective period of the conclusion about safety and quality (for medicine or medical product).
Corrections, additions, blots in shipping documents are not allowed.
15. According to the address of the subject the copy of the conclusion about safety and product quality in the form established by Rules of assessment of safety and quality is provided.
The conclusions about safety and quality of medicines and medical products issued according to Rules of assessment of safety and quality are stored during the term of its action plus one year and are available to consumers and (or) the state monitoring bodies.
16. Wholesale of medicinal substances is enabled to the drugstores having the license for pharmaceutical activities with the production right and also the organizations for production of medicines having the license for pharmaceutical activities with the right of production of medicines according to the Law on permissions and notifications.
17. Treat objects of retail sale of medicines and medical products:
1) drugstore;
2) pharmaceutical Item in the organizations of health care rendering primary medical and sanitary and (or) consulting and diagnostic help;
3) the mobile pharmaceutical unit in the remote rural zones organized from drugstore;
18. For correction of sight, correction glasses, and also joint products on their leaving and repair treat objects of retail sale of medical products, including-point optics:
1) shop of optics;
2) shop of medical products.
19. Objects of retail sale on the place, visible to visitors, have information of the following nature:
"Medicines are not subject to return and exchange",
"Medicines to children are not provided";
"Nonprescription realization of the medicines intended for leave according to the recipe of the doctor is forbidden";
"Storage durations of the medicines produced in drugstore" (for drugstores with the production right).
20. The objects of retail sale performing the state service in providing the population with medicines and medical products within the guaranteed amount of free medical care (further - GOBMP) provide access of the population to information on the list of medicines for free ensuring separate categories of citizens with certain diseases at the out-patient level.
21. The medicines which are subject to leave according to recipes of the doctor are not subject to nonprescription realization.
22. In case of retail sale of medicines and medical products their delivery on the location of the consumer (customer) is allowed.
Delivery to the consumer of medicines and medical products is performed by the method which is not allowing change of their properties in the course of transportation according to Storage precautions and transportations.
23. Retail sale of medicines and medical products is performed with observance of the following requirements:
1) availability of the respective rooms, equipment;
2) storage and transportation of medicines and medical products in the conditions providing preserving their safety, efficiency and quality according to Storage precautions and transportations;
3) the acquisition of the registered medicines and medical products, the safety which passed assessment and qualities according to the procedure established by Rules of assessment of safety and quality at the subjects having the license for pharmaceutical activities, or which notified on the beginning of activities according to the procedure established by the Law on permissions and notifications;
4) realization of the registered medicines and the medical products which passed assessment of safety and quality according to the procedure, established by Rules of assessment of safety and quality, to the populations, and also the physical persons practising private medicine, having the license for medical activities or which notified on the beginning of activities according to the procedure established by the Law on permissions and notifications and also medicines of non-prescription dispensing and medical products to third parties;
5) realization of the medical products relating according to the Law on ensuring unity of measurements to gages, in the presence at them the certificate on approval like measuring instruments or the certificate on metrological certification of medical products according to the legislation of the Republic of Kazakhstan on technical regulation;
6) implementation of interaction with subjects of health care on the questions relating to pharmacotherapy, strengthening of health, prevention of diseases of the population and pharmakonadzor;
7) participation in promotion of rational prescription of medicines;
8) provision by specialists of reliable information relatively:
correct and rational application or use;
possible side effects and contraindications;
interactions with other medicines, precautionary measures in case of their application or use;
expiration dates and storage precautions in house conditions;
service regulations, completeness of medical products;
9) rendering in case of emergency emergency medical service to the population.
24. For the purpose of the prevention of intake of medicines and medical products, specified in Item 9 of these rules and non-admissions of decrease in their quality in case of storage and realization it is provided:
1) quality control in case of acceptance and realization;
2) observance of rules and storage durations of medicines, accounting of medicines with limited expiration date;
3) operability and accuracy of weight measuring devices;
4) check of correctness of the written-out recipe, the term of its action, compliance of the registered doses to age of the patient, compatibility of ingredients, regulations of one-time leave;
5) accounting of effective periods of the conclusions of assessment of safety and quality;
6) in drugstores with the right of production of medicines are in addition provided:
all types of intra pharmaceutical control;
observance of manufacturing techniques of dosage forms.
25. Medicines and medical products before their realization are subject to unpacking, sorting, external survey, if necessary - cleaning, completeness check, assembly, adjustment.
26. Acceptance of medicines and medical products by quantity and quality is performed by specialists of objects of retail sale based on accompanying documents of the supplier.
27. In case of acceptance of medicines and medical products it is checked:
1) quantity compliance, completeness, integrity of container, compliance of packaging, marking to regulating documents, availability of the instruction on medical application of medicine and medical products in the state and Russian languages; availability of the operational document on medical products;
2) compliance specified in accompanying documents of the name, dosage, packing, quantity, batch (series) of products;
3) availability in accompanying documents of the conclusion about safety and quality or references to it in delivery note on goods issue.
28. Realization of medicines with violation of integrity of consumer (secondary) packaging, except for the blister (primary) packaging, on condition of providing the consumer with the instruction on medical application (the copy of the instruction) is allowed.
29. In trade floor of drugstore, in zone of servicing of the population of pharmaceutical Item on show-window the medicines realized without recipe of the doctor are exposed.
30. Medicines according to recipes of veterinarians are not subject to retail sale.
31. Retail sale to the population of medicines within GOMBP, is performed according to the recipe which is written out on prescription forms for free leave which are valid within republic administrative and territorial unit (the area the city, the area) within 3 months from the date of their writing out according to the Rules of writing out, accounting and storage of recipes approved by the order of the Minister of health and social development of the Republic of Kazakhstan of May 22, 2015 No. 373 (it is registered in the Register of state registration of regulatory legal acts at No. 11465) (further - Rules of writing out and storage of recipes).
32. Retail sale to the population of the medicines containing the drugs and psychotropic substances which are subject to control is performed according to the legislation of the Republic of Kazakhstan on the drugs, psychotropic substances, their analogs and precursors which are subject to control in the Republic of Kazakhstan.
33. In case of writing out of medicine in the dose exceeding the highest one-time the doctor in the recipe designates medicine dose copy-book and exclamation mark. In case of non-compliance with this requirement by the doctor, the pharmaceutical worker releases the registered medicine in half, the established highest one-time dose.
34. In case of lack of the medicine which is written out by the doctor, the specialist of object of retail sale offers the patient without approval of the doctor the medicine synonyms under the international unlicensed name which are available in assortment since medicine at the smallest price, or performs its replacement with pharmacological analog in coordination with the attending physician.
At the same time on the back of the recipe it is necessary to specify the trade name of the released medicine, to append the signature and date of leave.
35. The recipe which is not meeting the requirements of its registration and (or) containing incompatible components for individual production of medicine is considered invalid and is left in drugstore, pharmaceutical Item.
At the same time the specialist of object of retail sale releases to the patient the written-out medicine, except for medicine of the individual production containing incompatible components.
36. Invalid recipes are settled by stamp "The recipe is invalid", are registered in the Register of incorrectly written out recipes in form according to appendix to these rules numbered, which is strung together and ratified the head and seal (in the presence) of drugstore, pharmaceutical Item.
Information on incorrectly written out recipes is transferred for data to the head of the relevant medical organization and (or) to the relevant local authorities of public administration by health care.
37. Storage durations in drugstore, pharmaceutical Items of recipes are observed according to Rules of writing out and storage of recipes.
38. After storage duration recipes are liable to destruction.
39. For destruction of recipes the commission as a part of the head and responsible persons of drugstore, pharmaceutical Item is created.
The commission draws up the statement of destruction in which the period and the number of the destroyed recipes in cursive script are specified.
40. Objects of retail sale are equipped with the first-aid kit for first aid which structure is approved by the order of the Minister of health and social development of the Republic of Kazakhstan of May 22, 2015 No. 380 (it is registered in the Register of state registration of regulatory legal acts at No. 11421).
41. Realization of medicines and medical products in settlements, remote from the district center, where there are no drugstores, is performed according to Item 6 of article 69 of the Code.
to Rules of wholesale and retail sale of medicines and medical products
See Appendix (3Kb In original language)
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The document ceased to be valid since October 3, 2020 according to Item 2 of the Order of the Minister of Health of the Republic of Kazakhstan of September 17, 2020 No. KR DSM-104/2020