CIRCULAR

PROMULGATING PRINCIPLES, STANDARDS “GOOD PHARMACY PRACTICE”

Pursuant to the Pharmacy Law No.34/2005-QH-11 dated June 14, 2005;

Pursuant to the Decree No.188/2007/ND-CP dated December 27, 2007 of the Government regulating functions, duties, powers and organizational structure of Ministry of Health;

Pursuant to the Decree No.79/2006/ND-CP dated August 09, 2006 of the Government detailing the implementation of some Articles of the Pharmacy Law,

The Ministry of Health issues principle and standard of "good pharmacy practice" as follows:

Article 1. Scope of governing

Principle and standard of "Good Pharmacy Practice" issued with this Circular are the drug trading conditions for the drug retail establishments according to the schedule stipulated in Circular No.43/2010/TT-BYT dated December 15, 2010 of the Ministry of Health defining the schedule to implement the principle and standard of "good pharmacy practice" GPP; location and scope of operation of the drug retail establishments.

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1. An application for registration for inspection of drug retailing conditions by the principles, standards of "good pharmacy practice" (Form No.1/GPP);

2. A list of material facilities and equipment, list of personnel;

3. A GPP self-check list (Checklist) in Appendix II of this Circular.

Article 3. Dossier of registration for re-inspection of drug retailing conditions by the principles, standards of "good pharmacy practice"

An application for registration for re-inspection of drug retailing conditions by the principles, standards of "good pharmacy practice" (Form No.2/GPP).

 After the establishments filed dossiers for re-registration, they are still allowed to trade drug according to the extent specified in the issued certificates of "good pharmacy practice" and qualified certificates of trading drug (still valid).

Article 4. Competence to inspect, component of the inspection team

1. Competence to inspect and issue certificates

Health Departments of the provinces and centrally-run cities (referred to as the Health Departments) are responsible for receiving dossiers, appraising dossiers and establishing the inspection teams and granting certificates of the establishments achieved standard, "good pharmacy practice".

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a) The heads of inspection teams must have a degree of pharmaceutical university, have experienced in the management of drug for 2 years or more.

b) Members of the inspection teams must have a university degree or higher.

3. Component of the inspection teams shall be decided by the Directors of Health Departments.

Article 5. The order of inspecting drug retailing conditions by the principles, standards of "good pharmacy practice"

1. The Health Departments issuing the process and complying with process of granting certificates of "Good Pharmacy Practice" must ensure the principles:

a) Within 20 days after receipt of application for accreditation of the drug retail establishments meeting the principle and standard of "good pharmacy practice", the Departments of Health establish the inspection teams and carry out to inspect at the establishments.

b) The Health Departments issue the certificates of qualification of "good pharmacy practice" for the establishments within 05 working days from the date of ending the inspection; or within 10 working days from the date the Departments of Health receive the reports of overcoming the shortcomings mentioned in the inspection records.

c) In case of re-inspection, within 10 working days after receiving the report of remedy and application for inspection of the establishments, the Departments of Health must conduct the inspection.

2. Inspection records accompanying Checklist must be signed to certify by the professional manager and head of the inspection team and is made into 02 copies: 01 copy is stored at the establishment, 01 copy is stored at the Health Department of province, centrally-run city where the establishment operates. (Form No.3/GPP).

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Qualified certificates of "good pharmacy practice" have a valid term of 3 years from the signing date (Form No.4/GPP). The certificates which have been issued previously with a valid term of 02 years may continue to extend the operating time for 01 year from the expiry date. The Departments of Health shall issue the Decisions of extending together with the list of the establishments to be extended the certificates’ validity of "good pharmacy practice".

Article 7. Effect

This Circular takes effect from February 05, 2012 and replaces the Decision No.11/2007/QD-BYT dated 24/01/2007 on promulgating the principle and standard of "good pharmacy practice" and the contents related to "good pharmacy practice" in the Decision No.29/2007/QD-BYT dated 11/05/2007 on amending and supplementing some Articles of Decision No.11/2007/QD- BYT.

During the implementation process, if any difficulty arises, the units should promptly reflect to the Drug Administration of Vietnam - Ministry of Health for studying to amend and supplement properly./.

FOR MINISTER
DEPUTY MINISTER




Cao Minh Quang

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“GOOD PHARMACY PRACTICE”
(Issued together the Circular No.46/2011/TT-BYT dated December 21, 2011 of Minister of Health)

Chapter I

I. PRINCIPLES OF "GOOD PHARMACY PRACTICE"

Assurance of use of drugs rationally, safely, and effectively is one of two basic objectives of the National Drug Policy of Vietnam. All imported, domestically produced drug sources distributed to the users are most directly through the activities of the drug retail establishments.

"Good pharmacy practice" (Good Pharmacy Practice, abbreviated as: GPP) is a document offering the principles and basic standards in occupational practice of pharmacists in the pharmacies and pharmaceutical personnel on a basis of voluntary, compliance with ethical and professional standards at higher level higher than the minimum legal requirements.

"Good pharmacy practice" must ensure to implement the following principles:

1. Putting the interests of patients and the public health first.

2. Providing drug required to ensure quality together with information of drugs; advise properly for users and supervision of the drug use.

3. Participating in self-treatment activities, including drug supply and consultancy of drugs use, self-treatment of symptoms of the simple diseases.

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II. Interpretation of terms

In this document, the following terms are construed as follows:

1. Retail establishments meeting the principles and standards of GPP mean the establishments meeting the principles, the standards specified in this Rules.

2. Retailers mean pharmacists graduated from university and those who are trained in drugs, operate in the drug retail establishments, including secondary pharmacists, prescription clerk, physician keeping drugs chests of the health stations and retailers of finished oriental drugs or finished drugs from medicinal herbs.

3. The pharmacy staffs mean pharmacist -pharmacy owner or professional manager and staffs with pharmaceutical qualifications operating in the pharmacy.

4. Drugs-selling means the professional activities of the pharmacy including the supply of drugs together with advice and guidance of using safe and effective drugs for users.

Chapter II

THE STANDARDS

I. PERSONNEL

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2. Retail establishments have the appropriate human resources (number, qualifications, and professional experience) to meet the scale of operation.

3. Employees directly involved in selling drugs, delivery, preservation of drugs, drug quality control, preparation of drugs must meet the following conditions:

a) Having pharmaceutical qualifications and a period of professional practice in accordance with assigned works;

b) Having enough health, not being infected with contagious diseases;

c) Not being in the disciplined period from warning or more related to drug.

II. MATERIAL FACILITIES, TECHNIQUE OF DRUG RETAIL ESTABLISHMENTS

1. Construction and Design

a) Fixed, separate location; located in the safe, high and dry places and away from pollution sources;

b) Building firmly, with anti-dust ceiling, walls, and floors required to be easy to clean, enough light but not letting drugs directly affected by sunlight.

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a) The area must be in accordance with the business scale but at least must be 10m², required to have the areas for display and storage of drugs and area for drug users to contact and exchange information on the use of drugs with the retailers;

b) It must allocate more space for other activities such as:

- Preparation room according to prescription if there is organization to prepare according to prescription;

- The retailing room of drugs that have no longer packaging in directly contact with drugs for retailing directly to patients;

- Place where retailers and drugs buyers wash their hands;

- Private storage of drugs (if needed);

- Private consultancy room or area for patients and chairs for drug buyers in the waiting time.

c) In case of trading more cosmetics, functional foods, medical devices, there must be separate areas, not displaying along with drugs and not causing influence to drugs;

d) The pharmacy with drugs preparation by prescription or with retailing room of drugs that have no longer packaging in directly contact with drugs.

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- Having place for hand-washing, washing the preparation tools;

- Arranging seats for drug purchasers outside of preparation room.

3. Drugs storage devices at the drugs retail establishments

a) There are sufficient storage facilities for drugs to avoid the adverse effects of light, temperature, humidity, pollution, the entry of insects, including:

- Firm, smooth cabinets, counters, shelves, easy to clean, convenient for the sale, storage of drugs and aesthetic assurance;

- Thermometer, hygrometer to control temperature, humidity in the drug retail establishments. There is system of lighting, ventilation fan.

b) Equipment for preserving drugs must be consistent with preservation requirements on drug labels. Storage condition at room temperature is maintained at temperatures below 30 ° C, humidity not exceeding 75%.

c) There are tools for retailing and the packaging for retailing consistent with drug storage conditions, including:

- In case of retailing drugs that are no longer packaging in direct contact with drugs, it must use tight packaging, it is encouraged the use of hard packaging, closed for children not directly contacting with drugs. It is better to use manufacturer's original packaging. It can re-use the packaging after they have been treated according to the proper packaging handling process;

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- Drugs used out of the prescription/narcotics, psychotropic drugs should be packed in distinctive packaging;

- Drugs prepared following prescription should be contained in pharmaceutical packaging for not affecting the drug quality and easy to compare with products which are not drugs - such as soft drink/food/ household products.

d) Record of drugs labels:

- In the case retailing drugs are not contained in their original packaging, it should clearly state: name of drugs: dosage forms; concentration, content of drugs; in case of having no prescription enclosed, it must be stated dose, number of use times and way to use;

- Drugs prepared following prescription: in addition to the complete record of the above provisions, it must write additionally date of preparation; expiration date, name of patient, name and address of the establishment preparing drugs; the safety warning for children (if any).

đ) The pharmacy preparing drugs by prescriptions must have chemicals, equipment for preparing, equipment for sterilizing tools (drier, autoclaves), table for preparation must be easy for preparation, cleaning.

4. Records, books and professional materials of the drugs retail establishments

a) Having documentation for drug use, the current pharmaceutical regulations for the retailers able to look up and use as needed.

b) The records and books related to drug-dealing activities, including:

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- Documents or records to store data related to patients (patients with prescriptions or other special cases) are put in the guaranteed places to look up timely when needed;

- Recording books, records and regularly recording activities of buying and selling drugs, storage of drugs for narcotic and psychotropic drugs and precursor substance in accordance with the provisions of the Regulations on management of narcotic drugs and Regulations on management of psychotropic drugs, book for preparing drugs in case of organizing the preparation of drugs following prescription;

- Records and books must be kept for at least a year since the expiration date of drug.

c) Development and implementation following the standard procedures, manipulation under form of text for all professional activities for all employees to apply, at least must have the following procedures:

- The process of buying drugs and quality control;

- The process of selling prescription drugs;

- The process of selling non-prescription drugs;

- The process of preservation and quality monitoring;

- The process for handling in case drugs to be complained or revoked;

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- The other related processes.

III. MAJOR ACTIVITIES OF DRUG RETAIL ESTABLISHMENTS

1. Drugs purchase

a) Drugs are purchased at the lawful drug trading establishments.

b) Having records for monitoring, selecting suppliers who are prestigious and ensure drugs quality in the business process;

c) Only buying drugs permitted for circulation (drugs having registration number or drugs without registration number but permitted for import according to demand of treatment). Drugs must be intact and have full manufacturer's packaging, proper labels according to provisions under the current regulations. There are enough valid invoices, vouchers of the purchase of drugs;

d) When buying drugs, the retailers check its expiration date, check the label information following the labeling regulations, check quality (by sense organs, especially for drugs that are easy to change their quality) and control during storage;

đ) The pharmacy must have enough drugs of the list of essential drugs used for level C in the list of essential drugs in Vietnam defined by the local Health Department.

2. Drugs selling

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- The retailers ask the buyers the questions related to the disease, to drugs at request of the buyers;

- The retailers advise the buyers on drugs selection, drug usage, guide drug usage verbally. Where there is no accompanied prescription, retailers must guide additionally use of drugs by handwriting or typing, printing and attached to the packaging.

- Retailers provide appropriate drugs, inspect, cross-check sold drugs on the label of the drug, by sense organs on quality, quantity and type of drugs.

b) The provisions of advising buyers, including:

- The drug buyers should be got proper advice to ensure effective and appropriate treatment to the needs and aspirations;

- The retailers must clearly identify the circumstances required consultation of persons with expertise suitable to provided drugs to advise the buyers information on drugs, price and selection of non-prescription drugs;

- For patients required diagnosis by a physician before they can use drugs, retailers need to advise patients to see the appropriate specialized physicians or treatment doctors;

- For those who buy drugs without necessity for using drugs, drugs sellers should explain clearly for them to understand and self-care, self-monitor their diseases symptoms;

- For poor patients, who cannot afford to pay, the retailers should advise drug selection at reasonable prices, ensure treatment and decreased to the lowest cost;

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c) Sale of prescription drugs:

- Upon the sale of prescription drugs, it must be directly joined by retailers having appropriate professional qualifications and complied with current rules and regulations of the Ministry of Health on sale of prescription drugs.

- The retailers must sell drugs in compliance with the prescription. Where the description is found not being clear on drug name, concentration, content, quantity, or violation of legislation, expertise or affecting patient health, retailers must notify the prescribing persons for knowing.

- The retailers must explain clearly for the buyers and may refuse to sell prescription drugs in case of invalid prescriptions, prescription errors or doubt, invalid prescription not for treatment purpose.

- Retailers who are university pharmacists may substitute drugs with other drugs of the same active substance, dosage form, the same amount as being agreed by the buyers.

- The retailers guide the buyers on the method of drugs use, remind the buyers to use in compliance with prescriptions.

- After selling narcotic drugs, the pharmacy staff must record into the books, archive the original prescription.

3. Drugs preservation

a) The drugs must be preserved as required on drug labels;

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c) The prescription drugs are displayed for sale and preserved in the private sector marked "Prescription drugs" or if it is in the same area, the prescription drugs must place separately. The arrangement must be ensured the convenience, avoid causing confusion.

4. Requirements for retailers in professional practice

a) For the people who work in the drugs retail establishments:

- Having polite, gracious attitude in contact with the drugs buyers, the patients;

- Providing for guidance and explanation, information and proper advice on the drugs usage to the buyers or the patients and the necessary consultation to ensure their safe and effective, rational use;

- Keeping confidential the information of the patients in the practice process as their illness, the information required by patients;

- Wearing white blouse, clean, neat, wearing a tag detailing the name and title;

- Strictly complying with pharmaceutical regulations, voluntarily complying with morality of pharmaceutical practice;

- Participating in the classes of training, updating professional knowledge and law on health;

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- Always be present during the operation period and be responsible before law for all operations of the establishments; in case of absence, they must authorize for employees having equivalent professional qualifications or higher to administer under regulations;

- Directly participate in the sale of prescription drugs, advising the buyers.

- Contact with the doctor who has prescribed in the necessary cases to handle situation occurs.

- Control quality of purchased drugs, drugs preserved at the pharmacy.

- Regularly update professional knowledge, legal documents on pharmaceutical practice and continuously improve the quality of supply service.

- Train and guide staffs at the retail establishments on professional skill and morality of pharmaceutical practice as well as.

- Coordinate with the basis medical facilities and basis health staffs on the residential areas to supply essential drugs, participate in drug education and communication for the community and other activities.

- Monitor and inform the health authorities on the undesirable effects of the drugs.

c) The retail establishments’ activities required to do for drugs to be complained or recalled:

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- It must have the recall notices to customers; inspection and direct recall, special reserves for drugs to be recalled;

- It must have records stating clearly on the complaints and remedies for the buyers on the complaints or drugs recall;

- If it is decided to destroy drugs, then must have records in accordance with the regulations on management of drug quality;

- It must send reports to the levels in accordance with provisions./.

INSTRUCTIONS OF MAIN CONTENTS OF THE STANDARD PROCESSES OF MANIPULATION

1. Purpose: Providing for the way of implementation of standard manipulations in the activities at the retail establishments

2. Scope of application: for a specific activity

3. Mission: objects required to implement

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5. Attached documents

6. Storage form

7. Amendment and supplement

Some basic requirements:

- Page 1: Introduction: Naming the retail establishments; the process name, number of pages; number and date of issuance, names of parts; full name of the editor/examiner/approver.

- Page 2 onwards is the main content of the process

- Required to write by imperative mood, short, easy to understand.

- The process must be inspected and approved by professional manager or owner of a retail establishment.

- The original of the process must be stored in the document. Several copies of each process are sent to the relevant departments and if necessary, it must put a copy in a convenient place for staff’s reference. After the issuance of a new process, it must recover the corresponding former process to store for a period, depending on the regulations of the establishment.

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APENDIX II

CHECKLIST

I. GENERAL GUIDANCES

1. Purpose for developing the list

- For the business establishments to implement GPP; help the establishment to self-evaluate, self-inspect.

- For the pharmaceutical management agency to inspect, evaluate and recognize GPP.

- For unifying on the national implementation of GPP.

2. Principles for scoring

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Standard points are defined from about 0.5 to 2 depending on each criterion (principle of implementing step by step).

The criterion should be noted:

+ Scoring plus points (the incentive points) if the establishments perform higher than the minimum specifications. There are 10 contents applied plus points.

+ Scoring minus points if the establishments perform but there are also many existences. There are 9 contents applied plus points.

Scoring unacceptable points if the establishments fail to perform a number of criterions;

There are 9 unacceptable contents in the list.

The part in italics: additional inspection by interview form.

3. Method of counting points

3.1. Scoring maximum points, not giving intermediate points

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- Having no preparation by prescription, standard point: 95

- Having no storage, standard point: 98

- Having no both preparation by prescription and storage, standard point: 93

3.3. For the establishments that are operating, the inspection, scoring is calculated on actual operations at the establishments.

3.4. For the establishments that have newly been established, not yet operated:

- The criterions that have been deployed in the preparation process: scoring is calculated on actual results.

- The criterions that shall be took place only when operating: points shall be calculated if the criterions were defined in the records, documentation, standard manipulation procedures, and forms... to deploy the activities and was signed for issuance by the competent persons, the employees of the establishments were trained, understand, and correctly practice.

4. The method of conclusion

- The establishments not getting any mistake of the unacceptable point.

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- From 80% to 89% of points: The establishments should overcome and send a written report within 30 days for the inspection team to review the application for grant of certificate of qualification of GPP. If a period of 30 days is over but the establishments have not overcome and still want to practice, they should apply for re-inspection.

- Less than 80% of points: The establishments should overcome for re-inspection.

- The establishment getting the mistakes of the unacceptable point: The establishments should overcome for re-inspection.

II. CHECKLIST OF GOOD PHARMACY PRACTICE (CHECKLIST)

No.

Contents

1

Name of the establishment:

Address:

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2

Name of owner of the establishment/manager of professional operation

Certificate of qualification for drug trade:

3

Type of business registration:

- Private household:

- Retail place of enterprise

- Retail place of the establishment of medical examination, treatment

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Reference

Standard points

Plus points

Minus points

Achieved points

Note

1

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3

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5

6

7

I

Personnel: 19 points

1.1

Professional manager

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1.1.1

To be present when the retail establishment operates or to authorize in accordance with provisions

III.4b

2

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1.1.2

Directly participate in selling prescription drugs

III.4b

2

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1.1.3

Participated in quality control of drugs upon purchasing and during the process of storage at the pharmacy

III.4b

1

Check SOP and interview the role of pharmacist in control of drugs quality  

1.1.4

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III.4b

2

Interview pharmacist. 

1.1.5

Trained, guided staffs the Regulations, professional knowledge

III.4b

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(interview staffs, check records of staffs training)

1.1.6

Guided staffs to supervise unexpected effects and report to the health authorities  

III.4b

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1.1.7

Coordinated with basic health authorities  

III.4b

0,5

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1.2

Retailers

1.2.1

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I.2

1

The establishments with from 2 pharmacists graduated from university or more

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1.2.2

Qualifications in accordance with assigned work

I.1.3

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Question for valuation

The staffs is enough health to undertake the work, there is no employee who is infected with contagious diseases

0,5

Actual observation

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Wearing Blouse and name tags stating clearly titles

III.4a

1

1.2.4

Trained, updated professional knowledge and law on health

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2

(Check knowledge of staffs)

All staffs to be trained to understand and perform the right principle of GPP

2

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1

Check knowledge of staffs. Subtract points if they do not know 

1.2.5

With gracious, polite attitude as contacting with customers

III.4a

0,5

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1.2.6

Keep secret the information of patients

III.4a

0,5

Defined in SOP or internal rules

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Material facilities: 15 points

2.1

Construction and Design:
location is separate, fixed, the area of display,  storage is separate, ensures to control the environment of drug storage:

II.1

2

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The pharmacy’s completely separate environment

0,5

With close partition and separate aisle

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0,5

Anti-dust ceiling

0,5

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Wall and the floor  must be flat, smooth, easy to clean, wash

0,5

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2.2

Area and arrangement:

Total area of the establishment:

II.2a

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1

2.3

Storage, display area is at least 10m2

II.2a

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unacceptable Points

If the area is from 10m2 or less,  then it is unacceptable Points

2.4

Storage, display area is 20m2 - 29 m2

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Storage, display area is 30m2 or more

2

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2.5

There is area for drug buyers to contact and exchange information

II.2a

1

2.6

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II.2b, 2d

0,5

Not required to place in the entrance 

2.7

Other activities:
If there is organization for making up prescriptions, it must have separate room for preparation, have the place for washing the preparation tools

II.2b

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unacceptable Points

It must have separate retailing area

0,5

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It may consider the approval  if setting up private room or box/partition for retailing drugs 

The retail area is isolated from display, storage areas

0,5

If there are the storages, the storages must meet the requirements on drugs storage.

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2

unacceptable Points

There is a consultancy area (Consultancy area must ensure privacy)

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There is separate consultancy area or room (Inside the area of pharmacy and convenience for customers)

0,5

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Cosmetics, functional food, medical devices are placed in the private area, not affecting drugs

II.2c

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III

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3.1

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3.1.1

Drugs preservation equipment:

II.3a, 3b

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- There are enough cabinets, counters for drug preservation 

- Cabinets, counters, shelves are easy to clean, ensured sense

1

Having thermometer, hygrometer (calibrated) monitor and recorded for monitoring

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1

Place where drugs are sold is enough light to ensure the manipulation shall happen smoothly and without confusion

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sunlight does not shine directly into the place of display, storage of drugs

1,5

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The establishments had storage facilities to meet the storage requirements recorded on labels

II.3a, 3b

2

unacceptable Points

Example: drugs required for cold or cool storage, it is  required to have refrigerator or dedicated box of storage VD: 

Place where drugs are sold is maintained at a temperature below 30 ° C, humidity at or below 75% and satisfactory the storage conditions of drugs    

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2

unacceptable Points

Using the humidity, temperature control device, (air conditioners, fans, dehumidifiers…)

3.2

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3.2.1

Having packaging for retailing drugs

II.3c

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3.2.2

Having tight packaging for drugs that are no longer packaging in direct contact

II.3c

1

3.2.3

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II.3c

1

3.2.4

Retailing drugs not contained in the packaging naming other drugs or containing ads content of another drug

II.3c

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3.2.5

Prepared drugs by prescription contained in pharmaceutical packaging

II.3c

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3.2.6

Drugs preparing, retailing tools according to prescriptions are suitable, easy to clean and keep clean

II.3đ

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3.2.7

Having sterilizer, instruments preparing drugs by prescriptions  

II.3đ

1

IV

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Retailed drugs having no longer their packaging is attached to the following information:
- Drug name, dosage forms
- Concentration, content
If necessary (ie, having no prescriptions, manuals if sold with a little amount), it is required to get more information:
- Method of use
- Dosage
- Number of use times

II.3d

1

Drugs prepared according to prescription, other than those specified as section 4.1, with the following information:
- Date of preparation
- Date of expiry
- Name of patient
- Name and address where the preparation is made
- Security warnings for children (if any)

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1

Records, books and professional materials: 17 points

5.1

Legal documents:

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5.1.1

The legal documents such as business registration certificates, certificate of practice of pharmacists in charge of professional knowledge, certificates of drugs business registration (for the establishments that are operating)

I.1

2

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unacceptable points

5.1.2

Having employee records.
(A dossier comprises: a labor contract, health certificate, qualifications, resume, training certificates)

I.3

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5.2

Materials guiding  drugs usage:

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Having materials guiding  drugs usage

II.4a

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5.2.2

Having the current professional pharmaceutical regulations

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1

5.2.3

Having Internet to search information

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5.3

Records, books related to drug-dealing activities:

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5.3.1

Monitoring the number of lots, expiry of drugs and related issues:
- Monitoring by computer
- Monitoring by number
- Monitoring the preparation by prescriptions (if any). Having preparation books

II.4b

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1

Plus 1 point if records are adequate or monitored sufficiently on the computer

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1

5.3.2

Having data monitoring related to patients: prescriptions or patient prescriptions should be noted
(Subscribe by computer or by book   

(Monitoring by computers or by books)

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1

• Records, books that can look up promptly when necessary

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5.4

Development and implementation of standard manipulation procedures:

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5.4.2

Having all the basic processes at the request (Content of procedures is proper and suitable to the operation of pharmacies):

II4.c

The process of buying drugs and quality control

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1

The process of selling prescription drugs

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The process of selling non-prescription drugs

1

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1

The process of settlement for drugs to be complained and revoked

1

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5.4.3

Having other processes (specify)

II.4c

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5.4.4

The processes of standard manipulation of the establishment approved and signed for issuance by the competent authority

Appendix 2

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Drugs selling staffs’ application, implementation of full  procedures

II.4c

2

Check the knowledge and manipulations of process execution

VI

Source of drugs: 3 points

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6.1

Having records of prestigious drug suppliers, including
- Copies of certificates of qualification for drug trading
- Having a list of supply items

III.1a

1

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