Consultant plus tests to order 647 n. Good Pharmacy Practice

On March 1, 2017, the Order of the Ministry of Health of Russia No. 647n dated August 31, 2016 "On Approval of the Rules of Good Pharmacy Practice" comes into force medicines for medical use."

You can download the order of the Ministry of Health of Russia No. 647n from the site:

Order of the Ministry of Health of Russia No. 647n "On Approval of the Rules for Good Pharmacy Practice of Medicinal Products for Medical Use"(1.2 MiB, 5,789 hits)

Good Pharmacy Practice Rules for Medicinal Products for Medical Use

I. General provisions

1. These Rules of Good Pharmacy Practice of Medicinal Products for Medical Use (hereinafter, respectively, the Rules, Medicinal Products) establish the requirements for the retail trade by pharmacy organizations, individual entrepreneurs licensed for pharmaceutical activities, medical organizations licensed for pharmaceutical activities, and their separate subdivisions (outpatient clinics, feldsher and feldsher-obstetric stations, centers (departments) of general medical (family) practice) located in rural settlements in which there are no pharmacy organizations (hereinafter referred to as retail trade entities), as well as pharmacy organizations and medical organizations or their separate subdivisions located in rural settlements and areas remote from settlements in which there are no pharmacy organizations, if pharmacy organizations have, medical organizations, their separate divisions of the license provided for by law Russian Federation on licensing certain types of activities dispensing narcotic medicinal products and psychotropic medicinal products individuals.

2. These Rules are aimed at providing the population with high-quality, effective and safe medicines, medical devices, as well as disinfectants, personal hygiene items and means, utensils for medical purposes, items and means intended for caring for the sick, newborns and children under three years of age, spectacle optics and care products, mineral waters, products of medical, children's and dietary nutrition, biologically active additives, perfumery and cosmetics, medical and health education publications intended for propaganda healthy lifestyle life (hereinafter - goods pharmacy assortment).

II. Quality control

3. Retail trade in pharmacy products is carried out through the implementation of a set of measures aimed at complying with the requirements of these Rules and including, among other things (hereinafter referred to as the quality system):

a) determining the processes that affect the quality of services provided by the retailer and aimed at meeting the demand of customers in the pharmacy assortment, obtaining information on the rules for the storage and use of medicinal products, on the availability and price of the medicinal product, including obtaining in the first place the procedure for information on the availability of medicines of the lower price segment (hereinafter - pharmaceutical services);

b) establishing the sequence and interaction of the processes necessary to ensure the quality system, depending on their impact on the safety, efficacy and rationality of the use of medicinal products
drugs;

c) determination of criteria and methods that reflect the achievement of results, both in the implementation of the processes necessary to ensure the quality system, and in their management, taking into account the requirements of the legislation of the Russian Federation on the circulation of medicines;

d) determination of quantitative and qualitative parameters, including material, financial, informational, labor, necessary to maintain the processes of the quality system and their monitoring;

e) providing the population with high-quality, safe, effective pharmacy products;

f) taking measures necessary to achieve the planned results and continuously improve the quality of customer service and increase the personal responsibility of employees.

4. Documentation of the quality system is maintained by employees authorized by the head of the retail trade entity on paper and (or) electronic media and includes, among other things:

a) a document on the policy and objectives of the activities of the retailer, which defines ways to ensure customer demand for pharmacy products, minimizing the risks of low-quality, counterfeit and counterfeit medicines entering the civil circulation, medical devices and biologically active additives;

b) a quality manual that determines the directions for the development of a retail trade entity, including for a certain period of time, and contains references to legislative and other regulatory legal acts regulating the procedure for carrying out pharmaceutical activities;

c) documents describing the procedure for the provision of pharmaceutical services by a retail trade entity (hereinafter referred to as standard operating procedures);

d) orders and instructions of the head of the retail trade entity for the main activity;

e) personal cards of employees of a retail trade entity;

f) license for the right to carry out pharmaceutical activities and annexes to it;

g) documents related to the suspension (resumption) of the sale of pharmacy products, recall (withdrawal) of medicines from circulation, identification of cases of circulation of unregistered medical devices;

h) acts of inspections of a retail trade entity officials bodies state control(supervision), municipal control bodies and internal audits;

i) documents on effective planning of activities, implementation of processes for ensuring the quality system and their management.

5. Documents on the effective planning of activities, the implementation of processes for ensuring the quality system and their management, depending on the functions implemented by the retailer, include:

a) organizational structure;

b) internal labor regulations;

c) a register of registered prices for medicines included in the list of vital and essential medicines;

G) job descriptions with a mark on familiarization of employees holding relevant positions;

e) register of introductory briefing on labor protection;

f) the log of the briefing at the workplace;

g) register of fire safety briefings;

h) electrical safety briefing registration log;

i) a register of orders (instructions) for a retail trade entity;

j) a log of daily registration of temperature and humidity parameters in the premises for the storage of medicines, medical devices and dietary supplements;

k) a log of periodic registration of temperature inside the refrigeration equipment;

l) register of transactions related to circulation medicines, included in the list of medicines subject to subject-quantitative accounting (if any);

m) a register of inspections of a legal entity, an individual entrepreneur, carried out by state control (supervision) bodies, municipal control bodies (if any);

o) a journal on the provision of medicines included in the minimum range of medicines required to provide medical care(hereinafter - the minimum range), but absent at the time of the buyer's request;

o) logbook of incorrectly written prescriptions;

p) register of medicines with a limited expiration date;

c) defect log book;

r) laboratory packing journal;

s) register of transactions related to the circulation of narcotic drugs, psychotropic substances and their precursors (if any);

t) a log of registration of the results of acceptance control;

u) register of receipt and consumption of vaccines (if available);

v) register of prescriptions that were (are) on deferred maintenance (if any);

w) a journal of information work with medical organizations on the procedure for providing certain categories of citizens with medicines and medical devices free of charge, selling medicines and medical devices at a discount.

The head of the retail trade entity has the right to approve other types and forms of magazines.

6. The head of the retail trade entity shall appoint persons responsible for maintaining and storing the documents listed in paragraphs 4 and 5 of these Rules, providing access to them and, if necessary, restoring them. The period of storage of these documents is determined in accordance with the requirements of the legislation of the Russian Federation on archiving.

III. Head of a retail entity

7. The head of the retail trade entity ensures:

a) bringing to the attention of employees these Rules and their observance, bringing to the attention of employees their rights and obligations determined by job descriptions, professional standards;

b) determination of the policy and goals of activities aimed at meeting the demand of buyers for pharmacy products, minimizing the risks of low-quality, counterfeit and counterfeit medicines, medical devices and biologically active additives entering the civil circulation, as well as effective interaction between a medical worker, a pharmaceutical worker and a buyer ;

c) reduction of production losses, optimization of activities, increase in turnover, increase in the level of knowledge and qualifications of pharmaceutical workers;

d) analysis of compliance with the policy and goals of activities, acts of internal audits and external audits in order to improve the provided pharmaceutical services;

e) necessary resources for the functioning of all work processes of a retail entity in order to comply with licensing requirements, sanitary and epidemiological requirements, labor protection and safety regulations, fire regulations and other requirements established by the legislation of the Russian Federation;

f) development of measures aimed at stimulating and motivating the activities of employees;

g) approval of standard operating procedures;

h) establishing an internal procedure for the exchange of information, including information related to the functioning of the quality system, including through the use of a written form (familiarization sheet), stands for announcements in public places, holding information meetings with a certain frequency, electronic distribution of information to the address Email;

i) availability of information systems that allow carrying out operations related to the distribution of goods and the identification of counterfeit, counterfeit and substandard medicines.

8. The head of the retail trade entity, in order to ensure the uninterrupted supply of pharmacy products to customers, organizes:

a) ensuring a procurement system that prevents the distribution of counterfeit, low-quality, counterfeit pharmacy products;

b) equipping the premises with equipment that ensures the proper circulation of pharmacy products, including their storage, accounting, sale and dispensing;

c) access to information on the procedure for the use or use of pharmacy products, including the rules for dispensing, methods of administration, dosing regimens, therapeutic effects, contraindications, interactions of drugs while taking them together and (or) with food, rules for their storage at home (hereinafter referred to as pharmaceutical consulting);

d) informing customers about the availability of goods, including medicines of the lower price segment.

9. The head of the retail trade entity shall bring to the attention of employees the following information:

a) on changes in the legislation of the Russian Federation governing legal relations arising from the circulation of pharmacy products, including changes in the rules for dispensing medicines;

b) the results of internal and external audits;

c) on the necessary preventive and corrective actions to eliminate (preclude) violations of license requirements;

d) on the results of consideration of complaints and proposals of buyers.

10. The head of the retail trade subject, taking into account the requirements of labor legislation and other regulatory legal acts containing labor law norms, shall appoint a person responsible for the implementation and maintenance of the quality system (hereinafter referred to as the responsible person).

11. The head of the retail trade entity analyzes the quality system in accordance with the schedule approved by him. The analysis includes an assessment of the possibility of improvements and the need for changes in the organization of the quality system, including in the policy and objectives of the activity, and is carried out by considering the results of internal audits (checks), a book of reviews and suggestions, questionnaires, verbal wishes of buyers (feedback from the buyer ), modern achievements of science and technology, articles, reviews and other data.

Based on the results of the analysis of the quality system, the head of the retail trade entity can decide on the need and (or) expediency of improving the effectiveness of the quality system and its processes, improving the quality of pharmaceutical services, changes in the need for resources (material, financial, labor and other), necessary investments to improve customer service, employee motivation system, additional training(instruction) of employees and other solutions.

IV. Staff

12. In order to comply with the requirements established by these Rules, a retail trade entity, taking into account the volume of pharmaceutical services it provides, must have the necessary personnel. The head of the retail trade entity approves the staffing list, which contains a list of structural units, job titles, specialties, professions indicating qualifications, information on the number of staff units and the wage fund.

Each employee must be familiarized under signature with their rights and obligations contained in job descriptions, professional standards.

13. Employees performing work that affects product quality must have the necessary qualifications and work experience to comply with the requirements established by these Rules.

14. For newly hired employees, in accordance with the local acts of the retail trade entity, an adaptation program is being introduced and the qualifications, knowledge, and experience of such employees are regularly checked.

The adaptation program includes:

a) introductory briefing upon employment;

b) training (briefing) at the workplace (primary and repeated);

c) updating knowledge: the legislation of the Russian Federation in the field of circulation of medicines and the protection of the health of citizens, the protection of consumer rights; rules of personal hygiene; on the procedure for the provision of pharmaceutical services, including pharmaceutical consulting and the use of medical devices at home;

d) development of communication skills and conflict prevention;

e) briefing on safety and labor protection.

15. The main functions of pharmaceutical workers include:

a) sale of pharmacy goods of proper quality;

b) providing reliable information about the products of the pharmacy
assortment, their cost, pharmaceutical consulting;

c) informing about the rational use of drugs in
responsible self-medication;

d) production of medicinal products according to prescriptions for medicinal products;
drug and requirements-consignment notes of medical organizations;

e) registration of accounting documentation;

f) observance of professional ethics.

16. Requirements for the qualifications and work experience of the head of a retail trade entity and his pharmaceutical workers are established by the Regulations on Licensing Pharmaceutical Activities.

17. The head of the retail trade entity ensures that, according to the schedule approved by him, primary and subsequent training (instruction) of employees on the following issues:

a) rules for dispensing medicinal products for medical use;

b) rules for the release of narcotic drugs and psychotropic substances,
registered as medicines, medicines
preparations containing narcotic drugs and psychotropic substances;

c) rules for dispensing medicinal products subject to subject-
quantitative accounting, rules for keeping a register of medicines,
subject to subject-quantitative accounting;

d) rules for dispensing medicinal products containing small quantities
drugs;

e) the procedure for storing prescriptions;

e) compliance with the requirements for the availability of a minimum assortment;

g) compliance with the requirements of good storage and transportation practices
medicines;

h) application of the established maximum retail markups to the actual ex-works prices of manufacturers for medicinal products included in the list of vital and essential medicinal products, the procedure for setting prices for such medicinal products;

i) compliance with the requirements for working with counterfeit
low-quality, counterfeit goods of the pharmacy assortment;

j) compliance with the restrictions imposed on pharmaceutical workers in the exercise by them professional activity.

k) improving knowledge about medicines, including generic medicines, interchangeable medicines, the ability to present comparative information on medicines and prices, including medicines of the lower price segment, about new medicines, dosage forms medicines, indications for the use of medicines;

l) methods of processing data received from customers on the use of medicinal products identified in the course of use, side effects, bringing this information to the interested persons;

m) compliance with labor protection requirements.

V. Infrastructure

18. The head of the retail trade entity provides and maintains the infrastructure necessary to fulfill the licensing requirements for the implementation of pharmaceutical activities, which, among other things, includes:

a) buildings, working space and related means of work;
b) equipment for processes (hardware and software);
c) support services (transport, communications and Information Systems).

19. Premises and equipment must be located, equipped and operated in such a way that they correspond to the functions performed. Their layout and design should minimize the risk of errors and allow for effective cleaning and maintenance to avoid the accumulation of dust or dirt and any factors that could adversely affect the quality of the pharmacy product range.

20. All premises of a retail trade entity must be located in a building (structure) and functionally combined, isolated from other organizations and ensure that unauthorized persons do not enter the premises. It is allowed to enter (exit) the territory of a retail trade entity through the premises of another organization.

21. A retail trade entity must provide for the possibility of arranging unhindered entry and exit for persons with handicapped in accordance with the requirements of legislation on the protection
disabled people.

In the event that the design feature of the building does not allow the arrangement of entry and exit for persons with disabilities, the retailer must organize the possibility of calling a pharmaceutical worker to serve these persons.

22. A retailer must have a sign indicating:

a) the type of pharmacy organization in Russian and national languages: “Pharmacy” or “Pharmacy point” or “Pharmacy kiosk”;
b) full and (if available) abbreviated name, including
company name, and organizational and legal form of the retail entity
trade;
c) mode of operation.

A retailer selling pharmacy products at night must have an illuminated sign with information about working at night.
When placing a retail trade entity inside the building, the sign must be located on the outer wall of the building, if this is not possible, it is allowed to install a sign, the requirements for which are similar to those for a sign.

23. Premises must comply with sanitary and hygienic standards and requirements and provide the possibility of performing the basic functions of a retail entity in compliance with the requirements approved by these Rules.

24. The area of the premises used by the retailer must be divided into zones designed to perform the following functions:

a) trade in pharmacy assortment goods with provision of storage places,not allowing free access of buyers to goods sold, includingprescription number;
b) acceptance of goods of the pharmacy assortment, quarantine storage area, inincluding separately for medicines;
c) separate storage of workers' clothing.

If the retailer is located in the building together with other organizations, it is allowed to share the bathroom.

25. The presence of other zones and (or) premises as part of the premises of a retail trade entity is determined by the head of the retail trade entity, depending on the volume of work performed, services rendered.

26. The premises of a retail trade entity must be equipped with heating and air conditioning systems (if any), natural or forced-air ventilation (if any), ensuring working conditions in accordance with the labor legislation of the Russian Federation, as well as compliance with the requirements of good practice for the storage and transportation of medicinal products. drugs.

27. Materials used in the decoration and (or) repair of premises (zones) must comply with the fire safety requirements established by the legislation of the Russian Federation.
The premises of a retailer must be designed and equipped in such a way as to provide protection against the entry of insects, rodents or other animals.

In the premises of a retail entity intended for the manufacture of medicinal products, the surfaces of walls and ceilings must be smooth, without violating the integrity of the coating (waterproof paints, enamels or glazed glazed tiles in light colors), finished with materials that allow wet cleaning with the use of disinfectants (unglazed ceramic tiles, linoleum with mandatory welding of seams or other materials).
The places where the walls adjoin the ceiling and floor should not have recesses, protrusions and cornices.

28. The premises of a retailer may have both natural and artificial lighting. General artificial lighting should be provided in all rooms, for individual workplaces, if necessary, local artificial lighting is provided.

29. A retail trade entity must have equipment and inventory that ensures the preservation of the quality, efficiency and safety of pharmacy products.

30. Premises for the storage of medicines should be equipped with equipment to ensure their storage, taking into account the requirements of good practice for the storage and transportation of medicines.

Premises, as well as equipment used by a retail trade entity in carrying out activities, must meet the sanitary requirements for fire safety, as well as safety in accordance with the legislation of the Russian Federation.

31. Installation of equipment must be carried out at a distance of at least 0.5 meters from walls or other equipment in order to have access for cleaning, disinfection, repair, Maintenance, verification and (or) calibration of equipment, provide access to the pharmacy range of goods, free passage of workers. Equipment must not obstruct natural or artificial light sources or obstruct walkways.

32. Only persons authorized by the head of the retail trade entity should have access to the premises (zones). Access of unauthorized persons to these premises is excluded.

33. The equipment used by the retailer must have technical passports kept during the entire period of operation of the equipment. Equipment used by a retailer and related to measuring instruments, prior to commissioning, as well as after repair and (or) maintenance, is subject to initial verification and (or) calibration, and during operation - periodic verification and (or) calibration in accordance with with the requirements of the legislation of the Russian Federation on ensuring the uniformity of measurements.

34. The trading premises and (or) area must be equipped with showcases, racks (gondolas) - with an open display of goods, providing an opportunity to review the pharmacy range of goods allowed for sale, as well as provide convenience for employees of a retail trade entity. Open display of over-the-counter drugs and other pharmacy products is allowed.

35. Information about over-the-counter medicines can be placed on the shelf in the form of a poster, wobbler and other information carriers in order to provide the buyer with the opportunity to make an informed choice of a pharmacy assortment product, to obtain information about the manufacturer, how it is used and in order to save appearance goods. Also, in a place convenient for viewing, a price tag should be placed indicating the name, dosage, number of doses in the package, country of manufacture, expiration date (if any).

36. Non-prescription drugs are placed on showcases, taking into account the storage conditions provided for in the instructions for medical use and/or on the packaging. Medicinal products dispensed by prescription for a medicinal product may be stored in showcases, in glass and open cabinets, provided that buyers do not have access to them.

Prescription drugs are placed separately from non-prescription drugs in closed cabinets with a mark “by prescription for a drug” on the shelf or cabinet in which such drugs are placed.

VI. Processes of activity of the subject of retail trade in goods of the pharmacy assortment

37. All processes of activity of a retail trade entity that affect the quality, efficiency and safety of pharmacy products are carried out in accordance with approved standard operating procedures.

38. The head of a pharmacy organization, an individual entrepreneur with a license for pharmaceutical activities, ensures the availability of a minimum assortment.

39. The head of a retail trade entity must control the quantitative and qualitative parameters of the purchased pharmacy goods, as well as the timing of their delivery in accordance with contracts concluded in accordance with the requirements of the legislation of the Russian Federation.

40. The head of a retail trade entity must approve the procedure for selecting and evaluating suppliers of pharmacy products, taking into account, among other things, the following criteria:

a) compliance of the supplier with the requirements of the current legislation of the Russian Federation on licensing certain types of activities;

b) the business reputation of the supplier in the pharmaceutical market, based on the presence of facts of recall of counterfeit, poor-quality, counterfeit goods of the pharmacy assortment, failure to fulfill the contractual obligations assumed by him, instructions of the authorized state control bodies on the facts of violation of the requirements of the legislation of the Russian Federation;

c) the demand for pharmacy products offered by the supplier for further sale, the compliance of the quality of pharmacy products with the requirements of the legislation of the Russian Federation;

d) compliance by the supplier with the requirements established by these Rules for the preparation of documentation, the availability of a document with a list of declarations of conformity of products to established requirements, a protocol
agreeing on prices for medicines included in the list of vital and essential medicines;

e) compliance by the supplier with the temperature regime during the transportation of thermolabile medicinal products, including immunobiological medicinal products;

f) the provision by the supplier of a quality guarantee for the supplied goods of the pharmacy assortment;

g) the competitiveness of the terms of the contract offered by the supplier;

h) economic feasibility of the terms of delivery of goods offered by the supplier (multiplicity of delivered packages, minimum amount of delivery);

i) the possibility of supplying a wide range;

j) compliance of the delivery time with the working time of the retailer.

41. The retail trade entity and the supplier conclude an agreement subject to the requirements of the legislation on the fundamentals of state regulation of trading activities in the Russian Federation, as well as taking into account the requirements of civil law, which provide for the deadlines for the supplier to accept a claim for product quality, as well as the possibility of returning falsified low-quality, counterfeit pharmacy goods assortment to the supplier, if information about this was received after the acceptance of the goods and execution of the relevant documents.

42. With regard to pharmacy assortment goods (with the exception of medical devices), a retail trade entity is allowed to provide services to a supplier on a reimbursable basis, the subject of which is the performance of actions that are economically beneficial to the supplier and contribute to an increase in sales of pharmacy assortment goods (with the exception of medical devices) and customer loyalty. The supplier independently decides whether it is necessary for him to purchase such services and imposing such services on the supplier by a retail trade entity is not allowed.

43. The purchase of pharmacy assortment goods by a retail trade entity established in the form of a state and municipal unitary enterprise is carried out in accordance with the requirements of the legislation of the Russian Federation on the contract system in the field of procurement of goods, works, services to meet state and municipal needs.

44. In the process of accepting pharmacy products, including those requiring special storage conditions and security measures, the conformity of the goods received with the shipping documentation in terms of assortment, quantity and quality, compliance with special storage conditions (if such a requirement exists), as well as checking for damage is carried out. transport container.

The competence of the retailer to check the quality of the supplied pharmacy goods is limited to a visual inspection of the appearance, verification of compliance with the accompanying documents, the completeness of the set of accompanying documents, including the register of documents confirming the quality of the pharmacy goods. The retail trade entity needs to take into account the features of acceptance and pre-sale inspection of pharmacy products.

45. Acceptance of goods of the pharmacy range is carried out by a financially responsible person. If the goods of the pharmacy range are in the shipping container without damage, then acceptance can be carried out by the number of places or by the number of trade units and markings on the container. If verification of the actual availability of pharmacy assortment goods in containers is not carried out, then it is necessary to make a note about this in the accompanying document.

46. If the quantity and quality of the goods of the pharmacy range correspond to those indicated in the accompanying documents, then the acceptance stamp is affixed to the accompanying documents (waybill, invoice, waybill, register of quality documents and other documents certifying the quantity or quality of the goods received), confirming the fact that the accepted goods of the pharmacy range comply with the data specified in the accompanying documents. The financially responsible person who accepts the goods of the pharmacy assortment puts his signature on the accompanying documents and certifies it with the seal of the retailer (if any).

47. In case of non-compliance of the pharmacy goods supplied to the retailer with the terms of the contract, the data of the accompanying documents, the commission of the retailer, in accordance with the approved standard operating procedure, draws up an act that is the basis for filing claims with the supplier (drawing up an act unilaterally by a materially responsible person is possible if consent of the supplier or absence of his representative).

The retailer, in agreement with the supplier, may approve another method of notifying the supplier of the non-compliance of the supplied pharmacy goods with the accompanying documents.

48. Medicines, regardless of the source of their receipt, are subject to acceptance control in order to prevent counterfeit, low-quality, counterfeit medicines from entering the market.

Acceptance control consists in checking incoming medicinal products by evaluating:

a) appearance, color, smell;
b) the integrity of the package;
c) compliance of the labeling of medicinal products with the requirements,established by the legislation on the circulation of medicines;
d) correct execution of accompanying documents;
e) availability of a register of declarations confirming the quality of medicinal
funds in accordance with applicable regulations.

49. To conduct acceptance control, by order of the head of the retail trade entity, a selection committee is created. Members of the commission must be familiar with all legislative and other regulatory legal acts of the Russian Federation that determine the basic requirements for pharmacy products, the execution of accompanying documents, and their completeness.

50. Pharmaceutical assortment products must undergo pre-sale preparation before being delivered to the trading zone, which includes unpacking, sorting and inspection, checking the quality of the goods (by external signs) and the availability of the necessary information about the product and its supplier.

51. Medicinal, baby and dietary food products, biologically active additives are food products that must be freed from packaging, wrapping and strapping materials, metal clips before they are served in a trading area or other place of trade. The retail trade entity must also check the quality of medical, baby and dietary food products, dietary supplements by external signs, check the availability of the necessary documentation and information, carry out rejection and sorting.

Trade in products of medical, baby and dietary food, biologically active additives is prohibited if the integrity of the package is violated. The quality of this group of goods is confirmed by a certificate of state registration, which indicates the scope and use and a document of the manufacturer and (or) supplier confirming the safety of the product - a declaration of conformity of quality or a register of declarations.

In case of violation of the integrity of the package, the absence of a complete package of documents, medical, baby and dietary foods, biologically active additives must be returned to the supplier.

52. Disinfectants, prior to their delivery to the trading area, placement at the point of sale, must undergo pre-sale preparation, which includes the release of transport containers, sorting, checking the integrity of the package (including the functioning of the aerosol package) and the quality of the goods by external signs, the availability of the necessary information about disinfectants and their manufacturer, instructions for use.

Perfumes and cosmetics supplied to the trade area must comply with the requirements defined by the Decision of the Commission of the Customs Union dated September 23, 2011 No. 799 “On the adoption of the technical regulation of the Customs Union “On the safety of perfumes and cosmetics”.

VII. Sale of pharmaceutical products

53. Retail trade in pharmacy goods includes sales, dispensing, pharmaceutical consulting. For the provision of pharmaceutical consulting services, it is allowed to allocate a special area, including for waiting for consumers, with the installation or designation of special restraints, and the organization of seats.

54. When selling medicinal products, a pharmaceutical worker is not entitled to hide from the buyer information about the availability of other medicinal products that have the same international generic name and their prices are relative to the requested.

55. In the shopping area in a convenient place for viewing are placed:

a) a copy of the license for pharmaceutical activities;

b) a copy of the license for the circulation of narcotic drugs, psychotropic substances and their precursors, the cultivation of narcotic plants (if any);

c) information about the impossibility of returning and exchanging pharmacy goods of proper quality;

d) other documents and information that must be brought to the attention of buyers.

56. At the request of the buyer, the pharmaceutical worker must familiarize him with the accompanying documentation for the goods, containing for each item of goods information on the mandatory confirmation of conformity in accordance with the legislation of the Russian Federation on technical regulation (certificate of conformity, its number, its validity period, the authority that issued the certificate, or information about the declaration of conformity, including its registration number, its validity period, the name of the person who accepted the declaration, and the body that registered it). These documents must be certified by the signature and seal (if any) of the supplier or seller, indicating the address of its location and contact phone number.

57. Retail trade in pharmacy products that are not related to medicinal products may be carried out by employees who do not have a pharmaceutical education or additional vocational education in terms of retail trade in medicines in the case of their work in separate subdivisions (outpatient clinics, feldsher and feldsher-obstetric stations, centers (departments) of general medical (family) practice) of medical organizations licensed to carry out pharmaceutical activities and located in rural areas, where there are no pharmacies.

58. Each retailer must have a book of reviews and suggestions, which is provided to the buyer at his request.

VIII. Performance evaluation

59. The head of the retail entity conducts an assessment of activities in order to verify the completeness of the fulfillment of the requirements established by these Rules and determine corrective actions.

60. Issues related to personnel, premises, equipment, documentation, compliance with the rules for trading in pharmacy products, measures to work with customer reviews and suggestions, work to identify counterfeit, substandard, counterfeit pharmacy products, as well as internal audit activities, should be analyzed by the head of the retail trade entity in accordance with the approved schedule.

61. Internal audit should be carried out independently and thoroughly by persons specially appointed by the head of the retailer who are on the staff of the retailer and (or) involved in
contractual basis.

By decision of the head of the retailer, an independent audit may be conducted, including by experts from third-party retailers.
62. The results of the internal audit are documented.
Documents drawn up as a result of the audit should include all
information received and proposals for necessary corrective actions.
Measures taken based on the results of an internal audit are also documented.
63. An internal audit is also carried out in order to identify deficiencies in meeting the requirements of the legislation of the Russian Federation and make recommendations for corrective and preventive actions.

64. The internal audit program should take into account the results of the previous internal audit, inspections of regulatory bodies.

65. The person responsible for the area being audited by the retailer should ensure that corrective and preventive actions are taken immediately. Further actions should include an audit (verification) of the corrective and preventive actions taken and a report on the results of the actions taken and their effectiveness.

66. The head of a retail trade entity must ensure the identification of pharmacy products that do not meet the requirements of regulatory documentation in order to prevent their unintentional use or sale. Counterfeit, substandard, counterfeit pharmacy products must be identified and isolated from other pharmacy products in accordance with standard operating procedures.

The marking, place and methods of allocating a quarantine zone, as well as the person responsible for working with the indicated pharmacy assortment products, are established by order of the head of the retail trade entity.

67. The head of the retailer should constantly improve the effectiveness of the quality system, using, among other things, the results of internal audit, data analysis, corrective and preventive actions.

68. Standard operating procedures should describe the procedures for:

a) analysis of complaints and suggestions of buyers and making decisions on them;
b) establishing the reasons for the violation of the requirements of these Rules and other requirements of regulatory legal acts regulating the circulation of pharmacy goods;
c) assessing the need and feasibility of adopting appropriate ones in order to avoid the recurrence of a similar violation;
d) determination and implementation of the necessary actions in order to prevent the ingress of counterfeit, low-quality, counterfeit goods of the pharmacy assortment to the buyer;
e) analyzing the effectiveness of the preventive and corrective actions taken.

Acceptance control in a pharmacy is regulated by Order 647 n of August 31, 2016 of the Ministry of Health of the Russian Federation. Let's figure out what you need to pay attention to.

Order 647 n concerns not only acceptance control, but also general rules retail sale of medicines in a pharmacy:

quality management;
pharmacy manager and staff;
infrastructure organizations;
activity processes;
sale of goods;
performance evaluation.

As a whole, Order of the Ministry of Health 647 n defines the rules of good pharmacy practice for medicinal products for medical use.

Organization of acceptance control

Acceptance of goods in a pharmacy is carried out according to:

assortment;
quantity;
quality;
storage conditions;
safety of the transport container.

Important! It is necessary to distinguish the acceptance of goods of the pharmacy assortment from the acceptance control.

Acceptance control is carried out in order to prevent the sale of counterfeit, counterfeit or substandard medicines. A commission is appointed to conduct acceptance control, and it is mandatory on the basis of a written order signed by the head.

In the process of acceptance control in a pharmacy, members of the commission evaluate:

appearance of drugs;
color;
smell;
conformity of marking;
package integrity;
availability and correctness of execution of accompanying documents and quality declarations of medicines.

Therefore, members of the commission must be familiar with all the necessary information, requirements and rules for processing documentation in advance.

In case of non-compliance with the requirements of the tested medicinal products or their packaging, the commission draws up an act to file claims against the supplier. In the act, it is necessary to indicate the shortcomings discovered during the acceptance control and refer to the regulations that reflect these requirements.

Verification of dietary supplements and products for children, dietary and medical nutrition should be carried out as part of the acceptance of goods, and not acceptance control, as they relate to food products. Their quality is checked by external features, the integrity of the packaging and accompanying documents, especially declarations of conformity to quality.

If substandard, counterfeit or counterfeit medicines were found after the acceptance control and signing of the act, they should be isolated from the rest of the pharmacy assortment until the dispute with the supplier is settled.

"On approval of the rules of good pharmacy practice of medicinal products for medical use"

Edition of 08/31/2016 - Valid from 03/01/2017

MINISTRY OF HEALTH OF THE RUSSIAN FEDERATION

ORDER
dated August 31, 2016 N 647n

ON APPROVAL OF THE RULES OF GOOD PHARMACY PRACTICE FOR MEDICINES FOR MEDICAL USE

1. Approve the attached Rules of Good Pharmacy Practice for Medicinal Products for Medical Use.

Acting Minister
I.N. KAGRAMANYAN

APPROVED
order of the Ministry of Health
Russian Federation
dated August 31, 2016 N 647н

RULES OF GOOD PHARMACY PRACTICE FOR MEDICINES FOR MEDICAL USE

I. General provisions

1. These Rules of Good Pharmacy Practice of Medicinal Products for Medical Use (hereinafter, respectively, the Rules, Medicinal Products) establish the requirements for the retail trade by pharmacy organizations, individual entrepreneurs licensed for pharmaceutical activities, medical organizations licensed for pharmaceutical activities, and their separate subdivisions (outpatient clinics, feldsher and feldsher-obstetric stations, centers (departments) of general medical (family) practice) located in rural settlements in which there are no pharmacy organizations (hereinafter referred to as retail trade entities), as well as pharmacy organizations and medical organizations or their separate subdivisions located in rural settlements and areas remote from settlements in which there are no pharmacy organizations, if pharmacy organizations have medical organizations, and x separate divisions of the license provided for by the legislation of the Russian Federation on licensing certain types of activities that sell narcotic medicinal products and psychotropic medicinal products to individuals.

II. Quality control

b) establishing the sequence and interaction of the processes necessary to ensure the quality system, depending on their impact on the safety, efficacy and rationality of the use of drugs;

d) determination of quantitative and qualitative parameters, including material, financial, informational, labor, necessary to maintain the processes of the quality system and their monitoring;

e) providing the population with high-quality, safe, effective pharmacy products;

f) taking measures necessary to achieve the planned results and continuously improve the quality of customer service and increase the personal responsibility of employees.

4. Documentation of the quality system is maintained by employees authorized by the head of the retail trade entity on paper and (or) electronic media and includes, among other things:

a) a document on the policy and objectives of the activity of the retailer, which defines ways to ensure customer demand for pharmacy products, minimizing the risks of low-quality, falsified and counterfeit medicines, medical devices and dietary supplements getting into civil circulation;

c) documents describing the procedure for the provision of pharmaceutical services by a retail trade entity (hereinafter referred to as standard operating procedures);

d) orders and instructions of the head of the retail trade entity for the main activity;

e) personal cards of employees of a retail trade entity;

f) license for the right to carry out pharmaceutical activities and annexes to it;

h) acts of inspections of a retail trade entity by officials of state control (supervision) bodies, municipal control bodies and internal audits;

i) documents on effective planning of activities, implementation of processes for ensuring the quality system and their management.

a) organizational structure;

b) internal labor regulations;

c) a register of registered prices for medicines included in the list of vital and essential medicines;

d) job descriptions with a mark on familiarization of employees holding relevant positions;

e) register of introductory briefing on labor protection;

f) the log of the briefing at the workplace;

g) register of fire safety briefings;

h) electrical safety briefing registration log;

i) a register of orders (instructions) for a retail trade entity;

j) a log of daily registration of temperature and humidity parameters in the premises for the storage of medicines, medical devices and dietary supplements;

k) a log of periodic registration of temperature inside the refrigeration equipment;

l) register of transactions related to the circulation of medicinal products included in the list of medicinal products subject to subject-quantitative accounting (if any);

m) a register of inspections of a legal entity, an individual entrepreneur, carried out by state control (supervision) bodies, municipal control bodies (if any);

o) a magazine for the provision of medicines included in the minimum range of medicines required for the provision of medical care (hereinafter referred to as the minimum range), but not available at the time of the buyer's request;

o) logbook of incorrectly written prescriptions;

p) register of medicines with a limited expiration date;

c) defect log book;

r) laboratory packing journal;

s) register of transactions related to the circulation of narcotic drugs, psychotropic substances and their precursors (if any);

t) a log of registration of the results of acceptance control;

u) register of receipt and consumption of vaccines (if available);

v) register of prescriptions that were (are) on deferred maintenance (if any);

The head of the retail trade entity has the right to approve other types and forms of magazines.

The period of storage of these documents is determined in accordance with the requirements of the legislation of the Russian Federation on archiving.

III. Head of a retail entity

7. The head of the retail trade entity ensures:

a) bringing to the attention of employees these Rules and their observance, bringing to the attention of employees their rights and obligations determined by job descriptions, professional standards;

c) reduction of production losses, optimization of activities, increase in turnover, increase in the level of knowledge and qualifications of pharmaceutical workers;

d) analysis of compliance with the policy and goals of activities, acts of internal audits and external audits in order to improve the provided pharmaceutical services;

e) the necessary resources for the functioning of all the processes of the retail trade entity in order to comply with licensing requirements, sanitary and epidemiological requirements, labor protection and safety regulations, fire regulations and other requirements established by the legislation of the Russian Federation;

f) development of measures aimed at stimulating and motivating the activities of employees;

g) approval of standard operating procedures;

i) availability of information systems that allow carrying out operations related to the distribution of goods and the identification of counterfeit, counterfeit and substandard medicines.

8. The head of the retail trade entity, in order to ensure the uninterrupted supply of pharmacy products to customers, organizes:

a) ensuring a procurement system that prevents the distribution of counterfeit, low-quality, counterfeit pharmacy products;

b) equipping the premises with equipment that ensures the proper circulation of pharmacy products, including their storage, accounting, sale and dispensing;

d) informing customers about the availability of goods, including medicines of the lower price segment.

9. The head of the retail trade entity shall bring to the attention of employees the following information:

a) on changes in the legislation of the Russian Federation governing legal relations arising from the circulation of pharmacy products, including changes in the rules for dispensing medicines;

b) the results of internal and external audits;

c) on the necessary preventive and corrective actions to eliminate (preclude) violations of license requirements;

d) on the results of consideration of complaints and proposals of buyers.

11. The head of the retail trade entity analyzes the quality system in accordance with the schedule approved by him.

The analysis includes an assessment of the possibility of improvements and the need for changes in the organization of the quality system, including in the policy and objectives of the activity, and is carried out by considering the results of internal audits (checks), a book of reviews and suggestions, questionnaires, verbal wishes of buyers (feedback from the buyer ), modern achievements of science and technology, articles, reviews and other data.

IV. Staff

The head of the retail trade entity approves the staffing list, which contains a list of structural units, job titles, specialties, professions indicating qualifications, information on the number of staff units and the wage fund.

Each employee must be familiarized under signature with their rights and obligations contained in job descriptions, professional standards.

13. Employees performing work that affects product quality must have the necessary qualifications and work experience to comply with the requirements established by these Rules.

The adaptation program includes:

a) introductory briefing upon employment;

b) training (briefing) at the workplace (primary and repeated);

c) updating knowledge:

the legislation of the Russian Federation in the field of circulation of medicines and the protection of the health of citizens, the protection of consumer rights;

rules of personal hygiene;

on the procedure for the provision of pharmaceutical services, including pharmaceutical consulting and the use of medical devices at home;

d) development of communication skills and conflict prevention;

e) briefing on safety and labor protection.

15. The main functions of pharmaceutical workers include:

a) sale of pharmacy goods of proper quality;

b) provision of reliable information about the products of the pharmacy assortment, their cost, pharmaceutical consulting;

c) informing about the rational use of drugs for the purpose of responsible self-treatment;

d) manufacture of medicinal products according to prescriptions for medicinal products and invoices of medical organizations;

e) registration of accounting documentation;

f) observance of professional ethics.

16. The requirements for the qualifications and work experience of the head of a retail trade entity and his pharmaceutical workers are established by the Regulations on Licensing Pharmaceutical Activities<1>.

<1>Decree of the Government of the Russian Federation of December 22, 2011 N 1081 "On licensing pharmaceutical activities" (Collected Legislation 2012, N 1, Art. 126; 2012, N 37, Art. 5002; 2013, N 16, Art. 1970; 2016, No. 40, item 5738).

17. The head of the retail trade entity ensures that, according to the schedule approved by him, primary and subsequent training (instruction) of employees on the following issues:

a) rules for dispensing medicinal products for medical use;

b) rules for the release of narcotic drugs and psychotropic substances registered as medicinal products, medicinal products containing narcotic drugs and psychotropic substances;

c) rules for the dispensing of medicinal products subject to subject-quantitative accounting, rules for maintaining a register of medicinal products subject to subject-quantitative accounting;

d) rules for dispensing medicinal products containing small amounts of narcotic drugs;

e) the procedure for storing prescriptions;

e) compliance with the requirements for the availability of a minimum assortment;

g) compliance with the requirements of good practice for the storage and transportation of medicinal products;

i) compliance with the requirements of working with falsified low-quality, counterfeit goods of the pharmacy range;

j) compliance with the restrictions imposed on pharmaceutical workers in the exercise of their professional activities;

l) methods of processing data received from buyers on the use of medicinal products, identified during the use, side effects, bringing this information to interested parties;

m) compliance with labor protection requirements.

V. Infrastructure

a) buildings, working space and related means of work;

b) equipment for processes (hardware and software);

c) support services (transport, communications and information systems).

21. The retailer must provide for the possibility of arranging unhindered entry and exit for persons with disabilities in accordance with the requirements of the legislation on the protection of persons with disabilities.

22. A retailer must have a sign indicating:

a) type of pharmacy organization in Russian and national languages: "Pharmacy" or "Pharmacy point" or "Pharmacy kiosk";

b) full and (if any) abbreviated name, including company name, and organizational and legal form of the retail trade entity;

c) mode of operation.

A retailer selling pharmacy products at night must have an illuminated sign with information about working at night.

When placing a retail trade entity inside the building, the sign must be located on the outer wall of the building, if this is not possible, it is allowed to install a sign, the requirements for which are similar to those for a sign.

24. The area of the premises used by the retailer must be divided into zones designed to perform the following functions:

a) trade in pharmacy goods with provision of storage places that do not allow free access of buyers to goods dispensed, including prescription ones;

b) acceptance of pharmacy assortment goods, quarantine storage area, including separately for medicines;

c) separate storage of workers' clothing.

If the retailer is located in the building together with other organizations, it is allowed to share the bathroom.

27. Materials used in the decoration and (or) repair of premises (zones) must comply with the fire safety requirements established by the legislation of the Russian Federation.

The premises of a retailer must be designed and equipped in such a way as to provide protection against the entry of insects, rodents or other animals.

The places where the walls adjoin the ceiling and floor should not have recesses, protrusions and cornices.

29. A retail trade entity must have equipment and inventory that ensures the preservation of the quality, efficiency and safety of pharmacy products.

31. Installation of equipment must be carried out at a distance of at least 0.5 meters from walls or other equipment in order to have access for cleaning, disinfection, repair, maintenance, verification and (or) calibration of equipment, provide access to pharmacy products, free passage workers.

Equipment must not obstruct natural or artificial light sources or obstruct walkways.

32. Only persons authorized by the head of the retail trade entity should have access to the premises (zones). Access of unauthorized persons to these premises is excluded.

33. The equipment used by the retailer must have technical passports kept during the entire period of operation of the equipment.

Equipment used by a retailer and related to measuring instruments, prior to commissioning, as well as after repair and (or) maintenance, is subject to initial verification and (or) calibration, and during operation - periodic verification and (or) calibration in accordance with with the requirements of the legislation of the Russian Federation on ensuring the uniformity of measurements.

Open display of over-the-counter drugs and other pharmacy products is allowed.

35. Information about over-the-counter medicines can be placed on the shelf in the form of a poster, wobbler and other information carriers in order to provide the buyer with the opportunity to make an informed choice of a pharmacy assortment product, to obtain information about the manufacturer, how it is used and in order to preserve the external type of goods. Also, in a place convenient for viewing, a price tag should be placed indicating the name, dosage, number of doses in the package, country of manufacture, expiration date (if any).

36. Non-prescription drugs are placed on showcases, taking into account the storage conditions provided for in the instructions for medical use, and (or) on the packaging.

Medicinal products dispensed by prescription for a medicinal product may be stored in showcases, in glass and open cabinets, provided that buyers do not have access to them.

Prescription drugs are placed separately from non-prescription drugs in closed cabinets marked "prescription for a drug" on the shelf or cabinet in which such drugs are placed.

VI. Processes of activity of the subject of retail trade in goods of the pharmacy assortment

37. All processes of activity of a retail trade entity that affect the quality, efficiency and safety of pharmacy products are carried out in accordance with approved standard operating procedures.

38. The head of a pharmacy organization, an individual entrepreneur with a license for pharmaceutical activities, ensures the availability of a minimum assortment.

40. The head of a retail trade entity must approve the procedure for selecting and evaluating suppliers of pharmacy products, taking into account, among other things, the following criteria:

a) compliance of the supplier with the requirements of the current legislation of the Russian Federation on licensing certain types of activities;

c) the demand for pharmacy products offered by the supplier for further sale, the compliance of the quality of pharmacy products with the requirements of the legislation of the Russian Federation;

d) compliance by the supplier with the requirements established by these Rules for the preparation of documentation, the availability of a document with a list of declarations of conformity of products to established requirements, a protocol for agreeing prices for medicines included in the list of vital and essential medicines;

e) compliance by the supplier with the temperature regime during the transportation of thermolabile medicinal products, including immunobiological medicinal products;

f) the provision by the supplier of a quality guarantee for the supplied goods of the pharmacy assortment;

g) the competitiveness of the terms of the contract offered by the supplier;

h) economic feasibility of the terms of delivery of goods offered by the supplier (multiplicity of delivered packages, minimum amount of delivery);

i) the possibility of supplying a wide range;

j) compliance of the delivery time with the working time of the retailer.

The supplier independently decides whether it is necessary for him to purchase such services, and imposing such services on the supplier by a retail trade entity is not allowed.

The retailer, in agreement with the supplier, may approve another method of notifying the supplier of the non-compliance of the supplied pharmacy goods with the accompanying documents.

48. Medicines, regardless of the source of their receipt, are subject to acceptance control in order to prevent counterfeit, low-quality, counterfeit medicines from entering the market.

Acceptance control consists in checking incoming medicinal products by evaluating:

a) appearance, color, smell;

b) the integrity of the package;

c) compliance of the labeling of medicinal products with the requirements established by the legislation on the circulation of medicinal products;

d) correct execution of accompanying documents;

e) availability of a register of declarations confirming the quality of medicines in accordance with the current regulatory documents.

Trade in products of medical, baby and dietary food, biologically active additives is prohibited if the integrity of the package is violated. The quality of this group of goods is confirmed by a certificate of state registration, which indicates the scope and use, and a document from the manufacturer and (or) supplier confirming the safety of the product - a declaration of quality conformity or a register of declarations.

In case of violation of the integrity of the package, the absence of a complete package of documents, medical, baby and dietary foods, biologically active additives must be returned to the supplier.

Perfumery and cosmetic products supplied to the trade area must comply with the requirements determined by the Decision of the Commission of the Customs Union of September 23, 2011 N 799 "On the adoption of the technical regulation of the Customs Union "On the safety of perfumery and cosmetic products".

VII. Sale of pharmaceutical products

53. Retail trade in pharmacy goods includes sales, dispensing, pharmaceutical consulting.

For the provision of pharmaceutical consulting services, it is allowed to allocate a special area, including for waiting for consumers, with the installation or designation of special restraints, and the organization of seats.

54. When selling medicines, a pharmaceutical worker is not entitled to hide from the buyer information about the availability of other medicines that have the same international non-proprietary name and their prices relative to the requested one.

55. In the shopping area in a convenient place for viewing are placed:

a) a copy of the license for pharmaceutical activities;

b) a copy of the license for the circulation of narcotic drugs, psychotropic substances and their precursors, the cultivation of narcotic plants (if any);

c) information about the impossibility of returning and exchanging pharmacy goods of proper quality;

d) other documents and information that must be brought to the attention of buyers.

57. Retail trade in pharmacy products that are not related to medicinal products may be carried out by employees who do not have a pharmaceutical education or additional professional education in the retail trade in medicinal products in the case of their work in separate subdivisions (departments) of general medical (family) practice) of medical organizations licensed to carry out pharmaceutical activities and located in rural areas where there are no pharmacy organizations.

58. Each retailer must have a book of reviews and suggestions, which is provided to the buyer at his request.

VIII. Performance evaluation

61. Internal audit should be carried out independently and carefully by persons specially appointed by the head of the retailer, who are on the staff of the retailer and (or) involved on a contractual basis.

By decision of the head of the retailer, an independent audit may be conducted, including by experts from third-party retailers.

62. The results of the internal audit are documented.

Documents drawn up as a result of the audit should include all the information received and proposals for the necessary corrective actions.

Measures taken based on the results of an internal audit are also documented.

63. An internal audit is also carried out in order to identify deficiencies in meeting the requirements of the legislation of the Russian Federation and make recommendations for corrective and preventive actions.

64. The internal audit program should take into account the results of the previous internal audit, inspections of regulatory bodies.

65. The person responsible for the area being audited by the retailer should ensure that corrective and preventive actions are taken immediately.

Further actions should include an audit (verification) of the corrective and preventive actions taken and a report on the results of the actions taken and their effectiveness.

Counterfeit, substandard, counterfeit pharmacy products must be identified and isolated from other pharmacy products in accordance with standard operating procedures.

68. Standard operating procedures should describe the procedures for:

a) analysis of complaints and suggestions of buyers and making decisions on them;

b) establishing the reasons for the violation of the requirements of these Rules and other requirements of regulatory legal acts regulating the circulation of pharmacy goods;

c) assessing the need and feasibility of adopting appropriate ones in order to avoid the recurrence of a similar violation;

d) determination and implementation of the necessary actions in order to prevent the ingress of counterfeit, low-quality, counterfeit goods of the pharmacy assortment to the buyer;

e) analyzing the effectiveness of the preventive and corrective actions taken.

According to Art. 55 of the Federal Law No. 61-FZ “On the Circulation of Medicines”, retail trade in medicines is carried out in accordance with the rules of good pharmacy practice (hereinafter referred to as GAP), approved by the authorized federal executive body.
Let us consider in more detail the rules of the NAP on the following points:

1. What normative documentation approved the rules of the NAP?
On March 1, 2017, the Order of the Ministry of Health of the Russian Federation dated August 31, 2017 No. 647n “On Approval of the Rules for Good Pharmacy Practice of Medicinal Products for Medical Use” came into force.

2. What are the requirements set by the NAP rules?
These rules establish requirements for retail trade by pharmacies, individual entrepreneurs (IEs) licensed for pharmaceutical activities, medical organizations licensed for pharmaceutical activities, and their separate subdivisions (outpatient clinics, feldsher and feldsher-obstetric stations, centers (departments) general medical (family) practice) located in rural settlements where there are no pharmacy organizations, pharmacy organizations and medical organizations or their separate subdivisions, if pharmacy organizations, medical organizations, their separate subdivisions have a license provided for by the legislation of the Russian Federation on licensing certain types of activities dispensing narcotic and psychotropic medicinal products to individuals.

3. What are the requirements of the NAP rules aimed at?
These Rules are aimed at providing the population with high-quality, effective and safe medicines, medical devices, as well as disinfectants, personal hygiene items and means, utensils for medical purposes, items and means intended for caring for the sick, newborns and children under the age of three years, spectacle optics and care products, mineral waters, medical, baby and diet food, biologically active supplements, perfumes and cosmetics, medical and health education publications intended to promote a healthy lifestyle.

4. What is the responsibility for violating the NAP rules?
According to Article 5 of the Federal Law No. 61-FZ “On the Circulation of Medicines”, the powers of the federal executive authorities (in this case, the Federal Service for Surveillance in Healthcare (Roszdravnadzor) and its territorial bodies) include the organization and (or) inspecting the subjects of medicines circulation for compliance with the rules of good pharmacy practice.
Violation of the requirements of the NAP rules refers to an administrative offense, responsibility for which is provided for in Part 1 of Art. 14.4.2 of the Code of Administrative Offenses of the Russian Federation and entails the imposition of an administrative fine: on an official - from five thousand to ten thousand rubles, on a legal entity - from twenty thousand to thirty thousand rubles.

In general, the rules of the NAP can be divided into five main areas, which will be further considered:
I. Officials of the pharmacy organization (what requirements are provided for the head of the entity and staff in accordance with the requirements of the NAP);
II. Mandatory documentation (internal orders of the pharmacy organization, license, etc.);
III. Organization infrastructure requirements;
IV. Basic business processes (SOPs);
V. Internal audit (optimization of the organization's work and preparation for possible inspections by regulatory authorities).

I. Requirements for officials of the pharmacy organization.
In order to ensure uninterrupted supply of pharmacy goods to customers, the head of a retail trade entity organizes:
a) ensuring a procurement system that prevents the distribution of counterfeit, low-quality, counterfeit pharmacy products;
b) equipping the premises with equipment that ensures the proper circulation of pharmacy products, including their storage, accounting, sale and dispensing;
c) access to information on the procedure for the use or use of pharmacy products, including the rules for dispensing, methods of administration, dosing regimens, therapeutic effects, contraindications, interactions of drugs while taking them together and (or) with food, rules for their storage at home (hereinafter referred to as pharmaceutical counseling);
d) informing customers about the availability of goods, including drugs of the lower price segment.
The head of the retail entity also ensures:
a) reduction of production losses, optimization of activities, increase in turnover, increase in the level of knowledge and qualifications of pharmaceutical workers;
b) the necessary resources for the functioning of all processes of the retail trade entity in order to comply with licensing requirements, sanitary and epidemiological requirements, labor protection and safety regulations, fire regulations and other requirements established by the legislation of the Russian Federation;
c) the availability of information systems that allow carrying out operations related to the distribution of goods and the identification of counterfeit, counterfeit and substandard medicines.

The head of the retail entity provides and maintains the infrastructure necessary to fulfill the licensing requirements for the implementation of pharmaceutical activities, which, among other things, includes:

The head of the retailer also ensures that employees are informed of:
a) the current rules of the NAP and their observance;
b) rights and obligations defined by job descriptions and professional standards;
c) information on changes in the legislation of the Russian Federation governing legal relations arising from the circulation of pharmacy products, including changes in the rules for dispensing medicinal products;
d) information on the results of internal and external audits;
e) information on the necessary preventive and corrective actions to eliminate (preclude) violations of license requirements;
f) information on the results of consideration of complaints and suggestions of buyers.

The head of the retail trade entity analyzes the quality system in accordance with the schedule approved by him.
The analysis includes an assessment of the possibility of improvements and the need for changes in the organization of the quality system, including in the policy and objectives of the activity, and is carried out by considering the results of internal audits (checks), a book of reviews and suggestions, questionnaires, verbal wishes of buyers (feedback from the buyer ), modern achievements of science and technology, articles, reviews and other data
Based on the results of the analysis of the quality system, the head of the retail trade entity can decide on the need and (or) expediency of improving the effectiveness of the quality system and its processes, improving the quality of pharmaceutical services, changes in the need for resources (material, financial, labor and other), necessary investments to improve customer service, employee motivation system, additional training (instruction) of employees and other solutions.
Also, the head of the retail entity ensures the analysis of compliance with the policy and goals of activities, acts of internal audits and external audits in order to improve the provided pharmaceutical services.

Questions regarding:
- personnel,
- premises,
- equipment,
- documentation,
- compliance with the rules of trade in pharmacy products,
- measures to work with customer reviews and suggestions,
- work to identify counterfeit, low-quality, counterfeit goods of the pharmacy assortment, as well as
- internal audit activities should be analyzed by the head of the retail entity in accordance with the approved schedule.

The NAP rules state that in order to comply with the established requirements, the retail trade entity, taking into account the volume of pharmaceutical services provided by it, must have the necessary personnel.
The requirements for the qualifications and work experience of the head of a retail trade entity and his pharmaceutical workers are established by the Regulations on Licensing Pharmaceutical Activities (currently - Decree of the Government of the Russian Federation of December 22, 2011 N 1081 "On Licensing Pharmaceutical Activities").
Also, a new clause appears in the NAP rules (clause 57), according to which retail trade in pharmacy products that are not related to medicinal products can be carried out by employees who do not have pharmaceutical education or additional professional education in terms of retail trade in medicinal products if they work in separate subdivisions (outpatient clinics, feldsher and feldsher-obstetric stations, centers (departments) of general medical (family) practice) of medical organizations licensed to carry out pharmaceutical activities and located in rural settlements where there are no pharmacy organizations.

It should be noted that in this case we are talking about pharmacy products that are not related to drugs. The sale of medicines by employees who do not have a pharmaceutical education or additional professional education in the retail trade in medicines will be considered a violation and will entail administrative liability!
With regard to the direct requirements for the personnel of the pharmacy organization, each employee must be familiarized with his signature with his rights and obligations contained in job descriptions, professional standards.
Also, an employee performing work that affects product quality must have the necessary qualifications and work experience to comply with the requirements established by the NAP rules.

Also, the rules of the NAP spell out the main functions of pharmaceutical workers:
a) sale of pharmacy goods of proper quality;
b) provision of reliable information about the products of the pharmacy assortment, their cost, pharmaceutical consulting;
c) informing about the rational use of drugs for the purpose of responsible self-treatment;
d) manufacture of drugs according to prescriptions and invoices of medical organizations;
e) registration of accounting documentation;
f) observance of professional ethics.

II. Mandatory Documentation.
All mandatory documentation of a pharmacy organization can be conditionally divided into 9 main blocks:
- documentation relating to pharmacy staff;
- license to carry out pharmaceutical activities;
- documents confirming the quality of pharmacy products;
- acts of inspections;
- registers;
- journals that must be kept in accordance with the rules of the NAP;
- equipment documentation;
- SOPs (documents on standard operating procedures);
- internal orders.

Documentation relating to pharmacy personnel.
Documentation of the quality system is maintained by employees authorized by the head of the retail trade entity on paper and (or) electronic media and includes, among other things, personal cards of employees of the retail trade entity;
a) organizational structure;
b) internal labor regulations;
c) job descriptions with a mark on familiarization of employees holding relevant positions;
d) staffing.
For newly hired employees, in accordance with the local acts of the retail entity, an adaptation program is being introduced and the qualifications, knowledge, and experience of such employees are regularly checked.
The adaptation program includes:
a) introductory briefing upon employment;
b) training (briefing) at the workplace (primary and repeated);
c) updating knowledge:
- legislation of the Russian Federation in the field of circulation of medicines and the protection of the health of citizens, the protection of consumer rights;
- rules of personal hygiene;
- on the procedure for the provision of pharmaceutical services, including pharmaceutical consulting and the use of medical devices at home;
- development of communication skills and conflict prevention;
- briefing on safety and labor protection.

The head of the retail trade entity ensures that, according to the schedule approved by him, primary and subsequent training (instruction) of employees on the following issues:
a) rules for dispensing medicinal products for medical use;
b) rules for the release of narcotic drugs and psychotropic substances (NS and PS) registered as medicines, drugs containing NS and PS;
c) rules for dispensing medicinal products subject to subject-quantitative accounting (PKU), rules for maintaining a register of medicinal products subject to PKU;
d) rules for dispensing preparations containing small amounts of narcotic drugs (NA);
e) the procedure for storing prescriptions;
e) compliance with the requirements for the availability of a minimum assortment;
g) compliance with the requirements of good practice for the storage and transportation of medicinal products;
h) application of the established limiting retail mark-ups to the actual ex-works prices of manufacturers for drugs included in the list of vital and essential drugs, the procedure for setting prices for such medicines;
i) compliance with the requirements of working with falsified low-quality, counterfeit goods of the pharmacy range;
j) compliance with the restrictions imposed on pharmaceutical workers in the exercise of their professional activities;
k) improving knowledge about drugs, including generic, interchangeable drugs, the ability to provide comparative information on drugs and prices, including drugs in the lower price segment, on new drugs, dosage forms, indications for use;
l) methods of processing data received from buyers on the use of drugs, identified during the use, side effects, bringing this information to interested parties;
m) compliance with labor protection requirements.

Thus, the schedule for the initial and subsequent briefing of the employee must necessarily include all of the above items.

License to carry out pharmaceutical activities.
The documentation of the quality system is maintained by employees authorized by the head of the retail trade entity on paper and (or) electronic media and includes, among other things, a license for the right to carry out pharmaceutical activities and annexes to it.

Documents confirming the quality of pharmacy products.
The documentation of the quality system is maintained by employees authorized by the head of the retail trade entity on paper and (or) electronic media and includes, among other things, documents related to the suspension (resumption) of the sale of pharmacy products, recall (withdrawal) of medicines from circulation, and detection of cases of circulation of unregistered medical devices.
It should be noted that the maintenance of this documentation must be organized by a specially authorized employee; it is also necessary to monitor information received from the Roszdravnadzor authorities on the suspension (resumption) of the sale of pharmacy products, the recall (withdrawal) of medicines from circulation, and the identification of cases of circulation of unregistered medical devices.

Acts of inspections.
The quality system documentation is maintained by employees authorized by the head of the retail trade entity on paper and (or) electronic media and includes, among other things, acts of inspections of the retail trade entity by officials of state control (supervision) bodies, municipal control bodies and internal audits.

Registers.
Documents on the effective planning of activities, the implementation of processes for ensuring the quality system and their management, depending on the functions implemented by the retailer, include a register of registered prices for medicines included in the list of Vital and Essential Drugs.
This information (maximum retail prices for Vital and Essential Drugs), according to Federal Law No. 61-FZ “On the Circulation of Medicines”, must be brought to the attention of visitors to the pharmacy organization.

Logs that must be kept in accordance with the rules of the NAP.
Documents on effective planning of activities, implementation of processes for ensuring the quality system and their management, depending on the functions implemented by the retailer, include:
e) register of introductory briefing on labor protection;
f) the log of the briefing at the workplace;
g) register of fire safety briefings;
h) electrical safety briefing registration log;
i) a register of orders (instructions) for a retail trade entity;
j) a log of daily registration of temperature and humidity parameters in the premises for the storage of medicines, medical devices (MI) and dietary supplements;
k) a log of periodic registration of temperature inside the refrigeration equipment;
l) register of transactions related to the circulation of medicinal products included in the list of drugs subject to CSP (if these drugs are available) - the form of the journal is approved by Order of the Ministry of Health of the Russian Federation dated June 17, 2013 N 378n "On approval of the rules for registering transactions related to the circulation medicinal products for medical use included in the list of medicinal products for medical use subject to subject-quantitative accounting in special registers of transactions related to the circulation of medicinal products for medical use, and the rules for maintaining and storing special registers of transactions related to the circulation of medicinal products means for medical use";
m) a log of inspections of a legal entity, an individual entrepreneur, carried out by state control (supervision) bodies, municipal control bodies (if any) - the form of the log is approved by Federal Law No. implementation of state control (supervision) and municipal control";
n) a magazine for the provision of medicines included in the minimum assortment of medicinal products necessary for the provision of medical care, but not available at the time of the buyer's request;
o) logbook of incorrectly written prescriptions;
p) a register of medicines with a limited shelf life;
c) defect log book;
r) laboratory packing journal;
s) a register of transactions related to the circulation of narcotic drugs, psychotropic substances and their precursors (if these drugs are available) - the form of the journals was approved by Decree of the Government of the Russian Federation of June 9, 2010 N 419 "On the provision of information on activities related to the circulation of narcotic precursors drugs and psychotropic substances, and registration of transactions related to their circulation "and Decree of the Government of the Russian Federation of November 4, 2006 N 644 "On the procedure for submitting information on activities related to the circulation of narcotic drugs and psychotropic substances, and registration of transactions related to the circulation narcotic drugs and psychotropic substances;
t) a log of registration of the results of acceptance control;
u) a register of receipt and consumption of vaccines (if these drugs are available);
v) register of prescriptions that were (are) on deferred service (in the presence of preferential medicines);
h) a journal of information work with medical organizations on the procedure for providing certain categories of citizens with drugs and medical devices (MI) free of charge, selling medicines and MI at a discount.

Equipment documentation.
Equipment used by a retailer and related to measuring instruments, prior to commissioning, as well as after repair and (or) maintenance, is subject to initial verification and (or) calibration, and during operation is subject to periodic verification and (or) calibration in accordance with with the requirements of the legislation of the Russian Federation on ensuring the uniformity of measurements.
Accordingly, documents confirming the verification of the specified equipment must be available (in the case of an audit in relation to the pharmacy organization by the regulatory authority).

SOPs (documents on standard operating procedures).
The quality system documentation includes, among other things, documents describing the procedure for the provision of pharmaceutical services by a retail trade entity (hereinafter referred to as standard operating procedures - SOPs).
It should be noted that standard operating procedures include the specific order of actions of employees and their responsibility for a certain procedure (responsible for receiving drugs, his procedure, responsible for pre-sales, his actions, etc.)
The head of the retailer ensures the approval of standard operating procedures (this is an internal order, which will be discussed later).
All processes of activity of a retail entity that affect the quality, efficiency and safety of pharmacy products are carried out in accordance with approved standard operating procedures ( approx. in the section “Processes of activity of a retail trade entity pharmacy range goods” mentions the processes of purchase, acceptance, pre-sales preparation).

In summary, SOPs in a pharmacy organization should be developed for the following processes:
- purchase of pharmaceutical products;
- their acceptance;
- storage;
- pre-sale preparation;
- realization of goods of chemist's assortment;
- quality control.

In case of non-compliance of the pharmacy assortment goods delivered to the retailer with the terms of the contract, the data of the accompanying documents, the commission of the retailer, in accordance with the approved standard operating procedure, draws up an act that is the basis for filing claims with the supplier (drawing up an act unilaterally by a materially responsible person is possible with the consent of the supplier or absence of his representative).
Thus, SOPs should also be developed for the procedures for drawing up a claim act to the supplier and for the identification and isolation of falsified, poor-quality, counterfeit goods of the pharmacy assortment.

The standard operating procedures should describe the procedures for:
a) analysis of complaints and suggestions of buyers and making decisions on them;
b) establishing the reasons for the violation of the requirements of the NAP rules and other requirements of regulatory legal acts regulating the circulation of pharmacy goods;
c) assessing the need and feasibility of taking appropriate measures to avoid the recurrence of a similar violation;
d) determination and implementation of the necessary actions in order to prevent the ingress of counterfeit, low-quality, counterfeit goods of the pharmacy assortment to the buyer;
e) analyzing the effectiveness of the preventive and corrective actions taken.
Thus, the NAP rules do not establish a clearly defined form of standard operating procedures (description of actions in detail or briefly, with references to regulatory documentation or without them).

Each pharmacy organization has the opportunity to write down its standard operating procedures for itself, but the above orders must be included in the SOPs of the pharmacy organization. If there is a need for new SOPs to improve efficiency and optimize their activities, the pharmacy organization has every right to introduce a new SOP by its internal order.

internal orders.
Documentation of the quality system is maintained by employees authorized by the head of the retail trade entity on paper and (or) electronic media and includes, among other things, orders and orders of the head of the retail trade entity for the main activity.
Next, the indicative names of these internal orders will be given (they can be modified by the organization itself, but without losing the main meaning) and the paragraph of the NAP rules that defines the requirements for these orders.

"On the implementation of a set of measures aimed at compliance with the requirements of these Rules of Good Pharmacy Practice for Medicinal Products for Medical Use"

item 3. Retail trade in pharmacy assortment goods is carried out through the implementation of a set of measures aimed at complying with the requirements of these Rules and including, among other things (hereinafter referred to as the quality system):
a) determining the processes that affect the quality of services provided by the retailer and aimed at meeting the demand of customers in the pharmacy range of goods, obtaining information:
- about the rules of storage and use of medicines,
- on the availability and price of medicines, including obtaining, as a matter of priority, information on the availability of medicines in the lower price segment;
b) establishing the sequence and interaction of processes necessary to ensure the quality system, depending on their impact on the safety, efficacy and rationality of the use of drugs.
c) determination of criteria and methods that reflect the achievement of results, both in the implementation of the processes necessary to ensure the quality system, and in their management, taking into account the requirements of the legislation of the Russian Federation on the circulation of medicines;
d) determination of quantitative and qualitative parameters, including material, financial, informational, labor, necessary to maintain the processes of the quality system and their monitoring;
e) providing the population with high-quality, safe, effective pharmacy products;
f) taking measures necessary to achieve the planned results and continuously improve the quality of customer service and increase the personal responsibility of employees.

"On the person responsible for the implementation and maintenance of the quality system"

item 10. Taking into account the requirements of labor legislation and other regulatory legal acts containing labor law norms, the head of the retail trade entity shall appoint the person responsible for the implementation and maintenance of the quality system (hereinafter referred to as the responsible person).

"On those authorized to maintain and store documentation of the quality system"

item 4. Documentation of the quality system is maintained by employees authorized by the head of the retail trade entity;
item 6. The head of the retail trade entity shall appoint persons responsible for maintaining and storing the documents listed above, providing access to them and, if necessary, restoring them.

"On the policy and goals of activity"

item 4. The quality system documentation includes, among other things:
a) a document on the policy and objectives of the activity of the retailer, which defines ways to ensure customer demand for pharmacy products, minimizing the risks of low-quality, falsified and counterfeit medicines, medical devices and dietary supplements getting into civil circulation;
clause 7. The head of the retail trade entity ensures:
b) defining the policy and goals of activities aimed at ... effective interaction between the medical worker, the pharmaceutical worker and the buyer;

"On the approval of the quality manual"

"On approval of standard operating procedures"

Clause 4. Documentation of the quality system includes, among other things:
c) documents describing the procedure for the provision of pharmaceutical services by a retail trade entity (hereinafter referred to as standard operating procedures);

g) approval of standard operating procedures;
item 37. All processes of activity of a retail entity that affect the quality, efficiency and safety of pharmacy products are carried out in accordance with approved standard operating procedures.

"On the approval of measures aimed at stimulating and motivating the activities of employees"

item 7. The head of the retail entity provides:
f) development of measures aimed at stimulating and motivating the activities of employees;

"On the establishment of an internal procedure for the exchange of information"

item 7. The head of the retail entity provides:
h) establishing an internal procedure for the exchange of information, including information related to the functioning of the quality system, including through the use of a written form (familiarization sheet), stands for announcements in public places, holding information meetings with a certain frequency, electronic distribution of information to an e-mail address ;

"On approval of the schedule for the analysis of the quality system"

item 11. The head of the retail trade entity analyzes the quality system in accordance with the schedule approved by him.
The analysis includes an assessment of the possibility of improvements and the need for changes in the organization of the quality system, including in the policy and objectives of the activity, and is carried out by considering the results of internal audits (checks), a book of reviews and suggestions, questionnaires, verbal wishes of buyers (feedback from the buyer ), modern achievements of science and technology, articles, reviews and other data.

"On Approval of Journal Forms"

item 5. The head of a retail trade entity has the right to approve other types and forms of magazines (this paragraph applies to forms of magazines that are not approved by regulatory documentation).

"On the approval of the staffing table"

item 12. The head of the retail entity approves the staff list, which contains:
- list of structural units,
- job titles,
- specialties,
- professions with qualifications,
- information about the number of staff units
- and wage fund.
It should be noted that this internal order in the paragraph of the list and names of positions must comply with the Order of the Ministry of Health of the Russian Federation of December 20, 2012 N 1183n "On approval of the Nomenclature of positions of medical workers and pharmaceutical workers."

"On approval of the adaptation program for newly hired workers"

For newly hired employees, in accordance with the local acts of the retail entity, an adaptation program is being introduced and the qualifications, knowledge, and experience of such employees are regularly checked.
The adaptation program includes:
a) introductory briefing upon employment;
b) training (briefing) at the workplace (primary and repeated);
c) updating knowledge:
- legislation of the Russian Federation in the field of circulation of medicines and the protection of the health of citizens, the protection of consumer rights;
- rules of personal hygiene;
- on the procedure for the provision of pharmaceutical services, including pharmaceutical consulting and the use of medical devices at home;
d) development of communication skills and conflict prevention;
e) briefing on safety and labor protection.

"On approval of the schedule of primary and subsequent training (instruction) of employees"

item 17. The head of the retail trade entity ensures that, according to the schedule approved by him, primary and subsequent training (instruction) of employees on the following issues:
a) rules for dispensing medicinal products for medical use;
b) rules for the release of NS and PV registered as medicinal products (MP), MD containing NS and PV;
c) the rules for the release of medicines subject to PKU, the rules for maintaining a register of medicines subject to PKU;
d) rules for the release of medicinal products containing small amounts of NA;
e) the procedure for storing prescriptions;
e) compliance with the requirements for the availability of a minimum assortment;
g) compliance with the requirements of good practice for the storage and transportation of medicines;
h) application of the established maximum retail mark-ups to the actual selling prices of manufacturers for medicines included in the list of Vital and Essential Drugs, the procedure for setting prices for such medicines;
i) compliance with the requirements of working with falsified low-quality, counterfeit goods of the pharmacy assortment;
j) compliance with the restrictions imposed on pharmaceutical workers in the exercise of their professional activities;
k) improving knowledge about medicines, including generic medicines, interchangeable medicines, the ability to present comparative information on medicines and prices, including medicines of the lower price segment, about new medicines, dosage forms of medicines, indications for the use of medicines;
l) methods of processing data received from customers on the use of the medicinal product, identified in the process of use, side effects, bringing this information to the interested parties;
m) compliance with labor protection requirements.

"On Approval of Zones and Premises Used by a Retail Trade Entity"

item 25. The presence of other zones and (or) premises as part of the premises of a retail trade entity is determined by the head of the retail trade entity, depending on the volume of work performed, services rendered (all zones/premises present in the retail trade entity, but not in Order 647n are indicated).

“On access to premises (zones) used by a retail trade entity”

item 32. Only persons authorized by the head of the retail trade entity should have access to the premises (zones). Access of unauthorized persons to these premises is excluded (a list of persons having access to the premises of a retail trade entity is indicated).

"On approval of the procedure for the selection and evaluation of suppliers of pharmaceutical products"

item 40. The head of the retail trade entity must approve the procedure for selecting and evaluating suppliers of pharmacy products (indicates how work is carried out with suppliers of pharmacy products, etc.)

"On financially responsible persons carrying out the acceptance of goods of the pharmacy assortment"

item 45. Acceptance of goods of the pharmacy assortment is carried out by a financially responsible person.

"On the establishment of a claim commission"

item 47. In case of non-compliance of the pharmacy assortment goods delivered to the retailer with the terms of the contract, the data of the accompanying documents, the commission of the retailer, in accordance with the approved standard operating procedure, draws up an act that is the basis for filing claims with the supplier

"On the Creation of the Admissions Committee"

item 49. To conduct acceptance control, an acceptance committee is created by order of the head of the retail trade entity.
“On the approval of the schedule for the analysis of issues related to personnel, premises, equipment, documentation, compliance with the rules for trading in pharmacy products, measures to work with customer reviews and suggestions, work to identify counterfeit, poor-quality, counterfeit pharmacy products, as well as activities for internal audit"
item 60. Issues related to personnel, premises, equipment, documentation, compliance with the rules for trading in pharmacy products, measures to work with customer reviews and suggestions, work to identify counterfeit, poor-quality, counterfeit pharmacy products, as well as internal audit activities, should be analyzed by the head retail trade entity in accordance with the approved schedule.

"On the labeling of pharmacy products that do not meet the requirements of regulatory documentation, the place and method of allocating a quarantine zone" and
"On the person responsible for working with pharmacy products that do not meet the requirements of regulatory documentation"

item 66. The marking, place and methods of allocating a quarantine zone, as well as the person responsible for working with the indicated pharmacy assortment products, are established by order of the head of the retail trade entity.

III. Organization infrastructure requirements.
The basic requirements for the infrastructure of a pharmacy organization can be divided into 4 main blocks:
- General requirements;
- planning;
- finishing;
-equipment.

General requirements.
The infrastructure necessary to fulfill the licensing requirements for the implementation of pharmaceutical activities includes, among other things:
a) buildings, working space and related means of work;
b) equipment for processes (hardware and software);
c) support services (transport, communications and information systems).
Premises and equipment must be located, equipped and operated in such a way that they correspond to the functions performed (personal preparations of employees or food, etc. should not be stored in the drug storage area).

Layout.
The layout and design of facilities and equipment should minimize the risk of error and allow for effective cleaning and maintenance to avoid the accumulation of dust or dirt and any factors that could adversely affect the quality of the pharmacy product range.
All premises of a retail trade entity must be located in a building (structure) and
functionally integrated, isolated from other organizations and ensure that unauthorized persons do not enter the premises.
It is allowed to enter (exit) the territory of a retail trade entity through the premises of another organization.
The area of the premises used by the retailer should be divided into zones designed to perform the following functions:
a) trade in pharmacy goods with provision of storage places that do not allow free access of buyers to goods dispensed, including prescription ones;
b) acceptance of pharmacy assortment goods, quarantine storage area, including separately for medicines;
c) separate storage of workers' clothing.
If the retailer is located in the building together with other organizations, it is allowed to share the bathroom.
The premises of a retailer must be designed and equipped in such a way as to provide protection against the entry of insects, rodents or other animals.

Finishing.
The premises must comply with sanitary and hygienic standards and requirements and provide the possibility of performing the basic functions of a retail entity in compliance with the requirements approved by the rules of the NAP.
The premises of a retail trade entity must be equipped with heating and air conditioning systems (if any), natural or forced-air ventilation (if any), ensuring working conditions in accordance with the labor legislation of the Russian Federation, as well as compliance with the requirements of good practice for the storage and transportation of medicines.
The premises of a retailer may have both natural and artificial lighting.
General artificial lighting should be provided in all rooms, for individual workplaces, if necessary, local artificial lighting is provided.
The materials used in the decoration and (or) repair of premises (zones) must comply with the fire safety requirements established by the legislation of the Russian Federation.
In the premises of a retail entity intended for the manufacture of medicinal products, the surfaces of walls and ceilings must be smooth, without violating the integrity of the coating (waterproof paints, enamels or glazed tiles in light colors), finished with materials that allow wet cleaning with the use of disinfectants (unglazed ceramic tiles , linoleum with mandatory welding of seams or other materials).
The places where the walls adjoin the ceiling and floor should not have recesses, protrusions and cornices.
The retailer must provide for the possibility of arranging unimpeded entry and exit for persons with disabilities in accordance with the requirements of legislation on the protection of persons with disabilities.
In the event that the design feature of the building does not allow the arrangement of entry and exit for persons with disabilities, the retailer must organize the possibility of calling a pharmaceutical worker to serve these persons.
The retailer must have a sign indicating:
a) type of pharmacy organization in Russian and national languages: "Pharmacy" or "Pharmacy point" or "Pharmacy kiosk";
b) full and (if any) abbreviated name, including company name, and organizational and legal form of the retail trade entity;
c) mode of operation.
A retailer selling pharmacy products at night must have an illuminated sign with information about working at night.
When placing a retail trade entity inside the building, the sign must be located on the outer wall of the building, if this is not possible, it is allowed to install a sign, the requirements for which are similar to those for a sign.

Equipment.
The retail trade entity must have equipment and inventory that ensures the preservation of the quality, efficiency and safety of pharmacy products.
Premises for the storage of medicinal products should be equipped with equipment to ensure their storage, taking into account the requirements of good practice for the storage and transportation of medicinal products.
The equipment used by the retailer must have technical data sheets kept during the entire period of operation of the equipment.
Premises, as well as equipment used by a retail trade entity in carrying out activities, must meet sanitary requirements, fire safety, and safety in accordance with the legislation of the Russian Federation.
Installation of equipment should be carried out at a distance of at least 0.5 meters from walls or other equipment in order to have access for cleaning, disinfection, repair, maintenance, verification and (or) calibration of equipment, provide access to pharmacy products, free passage of workers ( in this case, if it is not possible to maintain the specified distance of 0.5 meters, the main attention should be paid to the essence of this paragraph: there must be access for cleaning, disinfection, repair, free passage of workers, etc.).
Equipment must not obstruct natural or artificial light sources and
block up the aisles.
The trading premises and (or) area must be equipped with showcases, racks (gondolas) - when displaying goods openly, providing an opportunity to review the pharmacy assortment products that are allowed for sale, as well as provide convenience for employees of the retail trade entity.

IV. Basic business processes (SOPs).
The main processes of the pharmacy organization are divided into 7 blocks:
- General requirements;
- Purchase;
- acceptance;
- Pre-sale preparation;
- Storage;
- Implementation;
- Quality control.

General requirements.
All processes of activity of a retail entity that affect the quality, efficiency and safety of pharmacy products are carried out in accordance with approved standard operating procedures.

Purchase.
The head of a retail trade entity must approve the procedure for selecting and evaluating suppliers of pharmacy products, taking into account, among other things, the following criteria:
a) compliance of the supplier with the requirements of the current legislation of the Russian Federation on licensing certain types of activities;
b) the business reputation of the supplier in the pharmaceutical market, based on the presence of facts of recall of counterfeit, poor-quality, counterfeit goods of the pharmacy assortment, failure to fulfill the contractual obligations assumed by him, instructions of the authorized state control bodies on the facts of violation of the requirements of the legislation of the Russian Federation;
c) the demand for pharmacy products offered by the supplier for further sale, the compliance of the quality of pharmacy products with the requirements of the legislation of the Russian Federation;
d) compliance by the supplier with the requirements established by the rules of the NAP for the preparation of documentation, the availability of a document with a list of declarations of conformity of products to established requirements, a protocol for agreeing prices for medicines included in the list of Vital and Essential Drugs;
e) compliance by the supplier with the temperature regime during the transportation of thermolabile medicinal products, including immunobiological medicinal products;
f) the provision by the supplier of a quality guarantee for the supplied goods of the pharmacy assortment;
g) the competitiveness of the terms of the contract offered by the supplier;
h) economic feasibility of the terms of delivery of goods offered by the supplier (multiplicity of delivered packages, minimum amount of delivery);
i) the possibility of supplying a wide range;
j) compliance of the delivery time with the working time of the retailer.
The retail trade entity and the supplier conclude an agreement subject to the requirements of the legislation on the fundamentals of state regulation of trading activities in the Russian Federation, as well as taking into account the requirements of civil law, which provide for the deadlines for the supplier to accept a claim for product quality, as well as the possibility of returning falsified low-quality, counterfeit goods of the pharmacy range to the supplier, if information about this was received after the acceptance of the goods and the execution of the relevant documents.
With regard to pharmacy assortment goods (except for medical devices), a retail trade entity is allowed to provide services to a supplier on a reimbursable basis, the subject of which is the performance of actions that are economically beneficial to the supplier and contribute to an increase in sales of pharmacy assortment goods (with the exception of medical devices) and customer loyalty.
The supplier independently decides whether it is necessary for him to purchase such services, and imposing such services on the supplier by a retail trade entity is not allowed.
The purchase of pharmacy assortment goods by a retail trade entity established in the form of a state and municipal unitary enterprise is carried out in accordance with the requirements of the legislation of the Russian Federation on the contract system in the field of procurement of goods, works, services to meet state and municipal needs.

acceptance.
Acceptance of goods of the pharmacy range is carried out by a financially responsible person (there must be an internal order on the appointment of this person).
In the process of acceptance of pharmacy assortment goods, including those requiring special storage conditions and security measures, an assessment is made of the conformity of the received goods with shipping documentation in terms of assortment, quantity and quality, compliance with special storage conditions (if such a requirement exists), checking for damage to the shipping container.
The competence of the retailer to check the quality of the supplied pharmacy goods is limited to a visual inspection of the appearance, verification of compliance with the accompanying documents, the completeness of the set of accompanying documents, including the register of documents confirming the quality of the pharmacy goods.
The retailer must take into account the specifics of the acceptance and pre-sale inspection of pharmacy products (for example, if the product requires storage at a temperature of 2-8 ° C, it is necessary to immediately ensure that this requirement is met and move the specified product to the refrigerator). In this case, it should be noted that the term "pharmaceutical assortment products" refers to both drugs and non-drug assortment.
If the goods of the pharmacy range are in the shipping container without damage, then acceptance can be carried out by the number of places or by the number of trade units and markings on the container.
If the quantity and quality of the goods of the pharmacy assortment correspond to those specified in the accompanying documents, then the acceptance stamp confirming the fact compliance of the accepted goods of the pharmacy assortment with the data specified in the accompanying documents.

A frequently asked question - is it necessary to have an acceptance stamp in a pharmacy? NAP rules imply the presence of such a stamp.
The financially responsible person who accepts the goods of the pharmacy assortment puts his signature on the accompanying documents and certifies it with the seal of the retailer (if any).
If verification of the actual availability of pharmacy assortment goods in containers is not carried out, then it is necessary to make a note about this in the accompanying document.
In case of non-compliance of the goods of the pharmacy assortment supplied to the retailer under the terms of the contract, the data of the accompanying documents, the commission of the retailer, in accordance with the approved standard operating procedure, draws up an act that is the basis for filing claims with the supplier (drawing up an act unilaterally by a materially responsible person is possible with the consent of the supplier or his absence representative).
The act is drawn up unilaterally only if the supplier agrees with the identified discrepancy, or there is no representative of the supplier.
The retailer, in agreement with the supplier, may approve another method of notifying the supplier of the non-compliance of the supplied pharmacy goods with the accompanying documents.
This notification option must also be approved by the internal order of the organization and included in the standard operating procedures.

Previously, it was in general about the goods of the pharmacy assortment. As for specific drugs, regardless of the source of their receipt, they are subject to acceptance control in order to prevent counterfeit, low-quality, counterfeit drugs from entering the market.
Acceptance control consists in checking incoming medicinal products by evaluating:
a) appearance, color, smell;
b) the integrity of the package;
c) compliance of the labeling of medicinal products with the requirements established by the legislation on the circulation of medicinal products;
d) correct execution of accompanying documents;
e) availability of a register of declarations confirming the quality of medicines in accordance with the current regulatory documents.
It should be noted that in order to conduct acceptance control, an internal order of the head of the retail trade entity creates a selection committee.
Members of the commission should be familiar with all legislative and other regulatory legal acts of the Russian Federation that determine the basic requirements for pharmacy products, the execution of accompanying documents, and their completeness.
Information on acceptance control is reflected in the journal, which is kept in free form and can be both in print and in electronic form.
Maintaining any other document confirming the conduct of acceptance control, according to the rules of the NAP, is not required.

Pre-sale preparation.
Goods of the pharmacy assortment must undergo pre-sale preparation before being supplied to the trading area, which includes:
- unpacking,
- sorting
- inspection,
- checking the quality of goods (by external signs),
- checking the availability of the necessary information about the product and its supplier.
Medicinal, baby and dietary food products, biologically active additives are food products that must be freed from containers, wrapping and binding materials, metal clips before they are served in a trading area or other place of trade.
The retail trade entity must also check the quality of medical, baby and dietary food products, dietary supplements by external signs, check the availability of the necessary documentation and information, carry out rejection and sorting.
Trade in products of medical, baby and dietary food, biologically active additives is prohibited if the integrity of the package is violated.
The quality of this group of goods is confirmed by a certificate of state registration, which indicates the scope and use, and a document from the manufacturer and (or) supplier confirming the safety of the product, a declaration of quality conformity or a register of declarations.
In case of violation of the integrity of the package, the absence of a complete package of documents, medical, baby and dietary foods, biologically active additives must be returned to the supplier.
Disinfectants must undergo pre-sale preparation, which includes:
- exemption from transport packaging,
- sorting,
- checking the integrity of the package (including the functioning of the aerosol package),
- checking the quality of goods by external signs,
- checking the availability of the necessary information about disinfectants and their manufacturer,
- checking instructions for use.
Perfumery and cosmetic products supplied to the trade area must comply with the requirements determined by the Decision of the Commission of the Customs Union of September 23, 2011 N 799 "On the adoption of the technical regulation of the Customs Union "On the safety of perfumery and cosmetic products".

Storage.
The main information regarding storage is spelled out in GF XIII, Order 706n and Order 646n. However, the NAP rules also state some storage rules that you should pay attention to.
According to the rules of the NAP, open display of over-the-counter drugs and other pharmacy products is allowed (accordingly, open display does not apply to prescription drugs).
Non-prescription drugs are placed on showcases, taking into account the storage conditions provided for in the instructions for medical use, and (or) on the packaging.
Medicinal products dispensed by prescription for a medicinal product may be stored in showcases, in glass and open cabinets, provided that buyers do not have access to them.
Prescription drugs are placed separately from non-prescription drugs in closed cabinets marked "prescription for a drug" on the shelf or cabinet in which such drugs are placed.

Implementation.
The retail trade of pharmacy products includes selling, dispensing and pharmaceutical consulting.
For the provision of pharmaceutical consulting services, it is allowed to allocate a special area, including for waiting for consumers, with the installation or designation of special restraints, and the organization of seats.
The head of the pharmacy organization, individual entrepreneur, ensures the presence of a minimum assortment.
In the shopping area in a convenient place for viewing are located:
a) a copy of the license for pharmaceutical activities;
b) a copy of the license for the circulation of narcotic drugs, psychotropic substances and their precursors, the cultivation of narcotic plants (if any);
c) information about the impossibility of returning and exchanging pharmacy goods of proper quality;
d) other documents and information that must be brought to the attention of buyers.

Each retailer must have a book of reviews and suggestions, which is provided to the buyer at his request (which does not imply its mandatory placement on the stand).
Information about over-the-counter medicines can be placed on the shelf in the form of a poster, wobbler and other information carriers in order to provide the buyer with the opportunity to make an informed choice of a pharmacy assortment product, to obtain information about the manufacturer, how it is used and in order to preserve the appearance of the product .
Also, in a place convenient for viewing, a price tag should be placed indicating:
- names,
- dosages,
- the number of doses in the package,
- country of origin,
- expiration date (if any).
(The main requirements for price tags are also set out in Decree of the Government of the Russian Federation of January 19, 1998 N55 "On approval of the Rules for the sale of certain types of goods, a list of durable goods that are not subject to the buyer's requirement to provide him free of charge for the period of repair or replacement of a similar product, and a list non-food products of good quality, not subject to return or exchange for a similar product of other size, shape, size, style, color or configuration").
When selling medicines, a pharmaceutical worker is not entitled to hide from the buyer information about the availability of other medicines that have the same international non-proprietary name and prices for them relative to the requested one.

Retail trade in pharmacy products that are not related to medicinal products may be carried out by employees who do not have pharmaceutical education or additional professional education in the retail trade in medicinal products if they work in separate divisions (outpatient clinics, feldsher and feldsher-obstetric stations, centers ) general medical (family) practice) medical organizations licensed to carry out pharmaceutical activities and located in rural areas where there are no pharmacy organizations.
At the request of the buyer, the pharmaceutical worker must familiarize him with the accompanying documentation for the goods, containing for each item of goods information on the mandatory confirmation of conformity in accordance with the legislation of the Russian Federation on technical regulation
- certificate of conformity,
- his number,
- its duration
- the issuing authority, or
- information about the declaration of conformity,
- including its registration number,
- its duration,
- the name of the person who accepted the declaration, and
- the body that registered it.
These documents must be certified by the signature and seal (if any) of the supplier or seller, indicating the address of its location and contact phone number.

Quality control.
The head of the retail trade entity must control the quantitative and qualitative parameters of the purchased pharmacy goods, as well as the timing of their delivery in accordance with the contracts concluded in accordance with the requirements of the legislation of the Russian Federation.
The head of a retail trade entity must ensure the identification of pharmacy products that do not meet the requirements of regulatory documentation in order to prevent their unintentional use or sale.
Counterfeit, substandard, counterfeit pharmacy products must be identified and isolated from other pharmacy products in accordance with standard operating procedures.
The marking, place and methods of allocating a quarantine zone, as well as the person responsible for working with the indicated pharmacy assortment products, are established by order of the head of the retail trade entity.
The head of the retail trade entity conducts an assessment of activities in order to verify the completeness of the fulfillment of the requirements established by these Rules and determine corrective actions.

V. Internal audit (will help to properly organize your work without violations and prevent mistakes)
An internal audit is carried out in order to identify shortcomings in meeting the requirements of the legislation of the Russian Federation and make recommendations for corrective and preventive actions.
The internal audit program should take into account the results of the previous internal audit, inspections of regulatory bodies.
An internal audit should be conducted independently and carefully by persons specially appointed by the head of the retail trade entity who are on the staff of the retail trade entity and (or) engaged on a contractual basis (which is also fixed by an internal order).
By decision of the head of the retailer, an independent audit may be conducted, including by experts from third-party retailers.
The results of the internal audit are documented. Documents drawn up as a result of the audit should include all the information received and proposals for the necessary corrective actions. Measures taken based on the results of an internal audit are also documented.
Thus, the main information that should be contained in documents on internal audit includes the following items:
- who conducts the audit;
- when the audit is carried out;
- audit program;
- what is revealed within the framework of internal audit;
- measures taken based on the results of the internal audit.

The person responsible for the area being audited by the retailer must ensure that corrective and preventive action is taken immediately.
Further actions should include an audit (verification) of the corrective and preventive actions taken and a report on the results of the actions taken and their effectiveness.
The head of the retailer must constantly improve the effectiveness of the quality system, using, among other things, the results of internal audit, data analysis, corrective and preventive actions.

Order 647n on the approval of the rules of good pharmacy practice provides pharmacies with new opportunities in serving customers, and also provides for new responsibilities of the head of the pharmacy. What are these rules and how to apply them in practice - we will tell you in detail

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Order 647n on approval of good pharmacy practice: new rules

Order 647n on the approval of new rules for good pharmacy practice (GNA) entered into force on March 1, 2017. These rules apply to all products from the range of pharmacies intended for medical use.

Order 647n of 2017 contains a list of requirements that the retail trade in medicines must comply with.

The purpose of their implementation is to provide the population of the country with the highest quality and safe medicines and medical products.

What areas of work are regulated by order 647n for pharmacies:

The composition of mandatory documentation for the organization of an effective quality system. These include various accounting journals, and pharmacy managers are entitled to introduce additional forms and types of such journals into their work.

A specialist appointed by the head of the pharmacy is responsible for maintaining them in the pharmacy. Record books should be kept within the time limits established by the Federal Law “On Archiving”.

Order 647n of the Ministry of Health of the Russian Federation gives the head of a retail pharmacy trade entity various powers in the implementation of good pharmacy practice. The head of the pharmacy appoints those responsible for the implementation of the internal quality system.
As part of good pharmacy practice, the head of the pharmacy conducts an analysis of the current quality system based on the schedule. Such an analysis allows him to understand which areas of work need to be improved and which need to be revised.

What pharmacy sales tools generate additional profit

Since the rules of good pharmacy practice 647n are mandatory for the execution of the document, the quality system must also be established.

For the first time, order 647n on the approval of the rules of pharmacy practice specifies the status of employees of pharmacy organizations. This is due to the fact that it is the pharmacy workers who directly serve customers and affect the quality of the services provided. Therefore, pharmacy employees must have special education and experience in pharmaceutical activities.

The rules of good pharmacy practice, order of the Ministry of Health 647n, specify the status of pharmaceutical workers as follows:

the level of knowledge and experience of employees should be regularly checked in the pharmacy itself. New employees with no work experience must undergo in-house training;
the functions of pharmacy employees are defined - selling medicines, providing customers with reliable and up-to-date information about the pharmacy range, advising visitors on the choice of medicines and medical devices, informing about the price of goods, etc.

Order 647n on the approval of good pharmacy practice contains generalized requirements for the infrastructure of pharmacies, in particular, for pharmacy premises, for zoning visits, signage, etc.

Here are some of the new requirements:

medicines dispensed freely, as well as other goods, can be placed in the form of an open display;
prescription medicines are stored in cabinets and glass display cases, while buyers should be able to get them from a pharmacist upon request and upon presentation of a prescription;
Prescription and over-the-counter drugs should be stored separately, and the prescription drug shelf should show “by prescription”.

The rules of good pharmacy practice for medicinal products contain requirements for the purchase, acceptance and preparation of a pharmacy assortment for sale. Regardless of the source from which the medicines came, an internal audit is necessary - all medicines are subject to acceptance control. The acceptance committee appointed by the leaders is engaged in acceptance.
One of the new duties of pharmacy employees, which is introduced by order 647 n, is to provide customers with truthful information about the availability of certain drugs in pharmacies, their cheaper counterparts, and inform about the prices of these drugs.

Thus, pharmacists cannot hide from customers the presence of drugs in the pharmacy that can replace a more expensive drug.

The sale of pharmacy products that do not belong to medicines and medical devices can be carried out by employees who do not have a special unit. This rule applies if they work in separate structures of medical institutions located in villages without pharmacies.

4 key rules of good pharmacy practice within the framework of order 647n

Order 647n on the approval of the rules in question identifies 4 basic principles:

The rules of good pharmacy practice are based on international standards in the field of quality management, as well as on the legislation of the Russian Federation.
In accordance with the rules, each pharmacy manager is required to implement a system of independent and internal audit in the organization, as well as develop standard operating procedures.
Pharmacists should offer buyers first of all cheap drugs, pharmaceutical consulting is returning.
The head of the pharmacy is responsible for the timely additional education of their employees, for the adaptation of new employees and the introduction of personal motivation systems.

Adaptation of employees: 3 questions and 4 blocks of the adaptation program

SOPs in the requirements of order 647n

Order 647, which can be downloaded in the appendix to the material, obliges the management of pharmacies to create and implement SOPs (standard operating procedures) in the daily activities of their employees, which allow them to formalize work procedures and help employees resolve any situations with customers.

Good Pharmacy Practice requires pharmacy managers to develop SOPs, or Standard Operating Procedures. In the magazine New pharmacy, we will show ready-made SOPs that help manage quality in a pharmacy organization

Standard operating procedures include descriptions of:

analysis of requests from pharmacy customers;
the procedure for making decisions on appeals;
the process of determining the causes of violations of the rules of good pharmacy practice (order 647n of the Ministry of Health of the Russian Federation);
the procedure for the formation of measures to prevent repeated violations;
what measures to take to exclude counterfeit and low-quality medical goods, and drugs, etc.

On the one hand, the obligation to implement standard operating procedures significantly increases the powers of the head of the pharmacy, but at the same time increases the level of his personal responsibility for the implementation of the rules.

Pharmacy practice internal audits

When carrying out pharmaceutical activities, pharmacies can conduct internal audits, which ensure the safety of the organization's customers.

The head of the pharmacy appoints the person responsible for internal audit. This can be either a third-party contract specialist or a full-time pharmacy employee.

The process of such an audit should take into account violations identified during past inspections, including visits to the pharmacy by supervisory authorities.

Order 647n on approval of the rules of pharmacy practice and others regulations The Russian Federation provides for the written registration of the results of internal audits, as well as the implementation of a set of measures to eliminate identified violations.

The person responsible for conducting internal audit must provide the head of the pharmacy with a detailed report on the results of the control, as well as provide his own recommendations for the prevention of violations. In the future, work to eliminate violations is also analyzed.

Internal audits will help identify problems and risks, improve pharmacy performance, and prepare for external audits. Regular internal audit will help the manager to identify shortcomings in advance, avoid or reduce the amount of fines.

Motivation, adaptation and training of personnel

Order 647n on the approval of good pharmacy practice pays great attention to working with pharmacy staff.

One of the sections of such work is the training of new employees.

Adaptation is carried out according to the program, which includes:

conducting primary, introductory and secondary instruction during employment;
conducting briefings on labor protection and safety;
checking the pharmacy employee's knowledge of the requirements of the current legislation in the field of drug circulation;
checking the practical skills of the employee, the availability of additional training;
knowledge of the rights and obligations of buyers;
advice on personal hygiene, dress code;
work to develop the employee's communication skills, as well as the ability to prevent and resolve conflicts.

How make an employee a master of complex sales, see the magazine "New Pharmacy".

Order 647n of 2017 introduces the definition of a pharmaceutical service for the first time. According to it, the pharmacy organization must provide the buyer not only with the goods, but also with information on its use.

The obligation of pharmacists to first of all recommend to buyers goods from more accessible product groups has been introduced.

Purchasing, sales, assortment

Order 647 establishes the right of pharmacies to provide paid services to suppliers, the subject of which may be various services that stimulate the sale of medicines (with the exception of medical devices).

At the same time, the supplier independently offers marketing contracts to pharmacies, and pharmacies themselves cannot impose such services on suppliers.

Order 647n on the approval of the rules of pharmacy trade obliges pharmacy employees to check the quality of children's, medical and dietary food, dietary supplements. In doing so, one should focus on external signs and accompanying documents.

In practice, it looks like this. Upon acceptance of the goods, the pharmacy employee checks the tightness and integrity of jars with food, milk mixtures, etc. He also studies the accompanying documents for products, checks their expiration dates.

How to write an SOP for expiration dates

look step by step instructions on compiling an SOP for a pharmacy on the expiration date in the New Pharmacy magazine.

New requirements have been established for the retail trade of non-drug assortment in pharmacies in terms of additional education of sellers. For example, medical devices and other non-drug products in a pharmacy can be dispensed by any employee who does not have a pharmaceutical education. And in FAP pharmacies, a paramedic should not receive additional education in order to sell medical products.

Trading floor and entrance to the pharmacy

Order 647n on approval of the rules of pharmacy practice Special attention they pay to the design of the trading floors of pharmacies and the entrance group to the building.

Let's take a look at some of the new rules:

When laying out goods on display cases, pharmacists must take into account the conditions and terms of storage of drugs.
Separately, you should lay out over-the-counter drugs and drugs sold without a prescription.
In pharmacies, a special area can be allocated in which pharmacists will provide pharmaceutical consulting services to customers. It can accommodate seating, restraints, etc.
For pharmaceutical consulting, the pharmacy management must allocate one employee with a pharmaceutical education to work in a special area.
The entrance of the pharmacy must be equipped in a special way so that people with disabilities can freely enter it. It's about the ramp.
If it is impossible to install a ramp at the entrance group due to the design features of the premises, the pharmacy management should install a call button for a pharmacy employee who services the disabled.