Circular No. 09-BYT/TT guiding the implementation of the Ordinance on Private Medical and Pharmaceutical Practice and Decree No. 06/CP dated January 29, 1994 of the Government regarding the detailed provisions of certain articles in the Ordinance on Private Medical and Pharmaceutical Practice in the field of pharmaceuticals.

 

 

 

 

CIRCULAR

OF THE MINISTRY OF HEALTH

GUIDELINES FOR IMPLEMENTING THE PRIVATE PRACTICE OF MEDICINE AND PHARMACY ORDINANCE AND DECREE NO. 06/CP OF JANUARY 29, 1994 OF THE GOVERNMENT ON SPECIFIC PROVISIONS OF CERTAIN ARTICLES IN THE PRIVATE PRACTICE OF MEDICINE AND PHARMACY ORDINANCE IN THE FIELD OF PHARMACY

 

Medicines are special goods related to the health and lives of users. To ensure unified management and bring private pharmacy practices into lawful operation, thereby ensuring public health;

BASED ON THE ORDINANCE ON PRIVATE PRACTICE OF MEDICINE AND PHARMACY ON SEPTEMBER 30, 1993;

BASED ON DECREE NO. 06/CP OF JANUARY 29, 1994 OF THE GOVERNMENT ON SPECIFIC PROVISIONS OF CERTAIN ARTICLES IN THE ORDINANCE ON PRIVATE PRACTICE OF MEDICINE AND PHARMACY;

The Ministry of Health provides specific guidelines for private pharmacy practice;

 

PART I
GENERAL PROVISIONS

Article 1. In this Circular, the following terms are understood as follows:

1- Medicines are products derived from animals, plants, minerals, or biological sources that are formulated for human use with the purpose of preventing disease, treating disease, restoring, adjusting bodily functions, alleviating symptoms, diagnosing disease, restoring or enhancing health, reducing sensations in a part or the whole body, affecting the reproductive process, or changing body shape.

2- Raw materials for medicines include all substances directly involved in the formula of the product, whether they have activity or not, and whether they undergo change or remain unchanged during production.

3- Semi-finished products are products that have undergone one or more production stages and still require one or more additional production stages before becoming finished products.

4- Finished products are forms of medicines that have gone through all production stages including packaging to be delivered to the user.

5- Products are results created, including those that are not yet finished products.

6- Modern medicines include:

Chemical and biological raw materials used in medicines.

Semi-finished chemical and biological products.

Finished chemical and biological products.

7- Traditional ethnic medicines include:

Forms of medicines produced from medicinal herbs processed according to the theory and methods of traditional medicine, used for disease prevention, treatment, and health enhancement for humans.

Article 2. 2. National Treasury units at all levels;

1- Limited liability company, joint-stock company engaged in selling medicines for human use.

2- Private business engaged in selling medicines for human use.

3- Private pharmacy - a pharmacy is a place where medicines for human use are purchased and sold to participate in the direct retail network of medicines to users. A private pharmacy is named by one qualified pharmacist who meets all necessary conditions as stipulated, being the sole owner of the pharmacy.

4- Medicine sales agent for businesses - an agent is a place that sells medicines on behalf of a business engaged in the sale or production of medicines for human use to earn commission, named by a private individual to participate in the direct retail network of medicines to users.

 

PART II
STANDARDS, CONDITIONS, SCOPE
PRIVATE PHARMACY PRACTICE

Article 3. Those holding the following positions shall not name themselves as the owner of a pharmacy or a sales agent for medicines:

a) Director, Deputy Director of the Pharmacy Department.

b) Director, Deputy Director of the Pharmaceutical Inspection Institute.

c) Director, Deputy Director of the Branch Pharmaceutical Inspection Institute.

d) Head, Deputy Head of the professional department of the Pharmaceutical Inspection Institute and Branch Pharmaceutical Inspection Institute.

e) Director, Deputy Director of pharmaceutical inspection centers and stations.

g) Director, Deputy Director of Provincial Health Departments under central cities.

h) Director, Deputy Director of State-owned enterprises engaged in pharmaceuticals and medicinal herbs trade.

i) Chief Inspector, Deputy Chief Inspector, pharmaceutical inspector.

k) Head, Deputy Head of the Professional Department of Provincial Health Departments under central cities.

Article 4. Standards for the Director of a company or private business engaged in selling medicines for human use:

In addition to the standards prescribed in the Company Law, Business Law, Ordinance on Private Practice of Medicine and Pharmacy, and Decree on Specific Provisions of Certain Articles in the Ordinance on Private Practice of Medicine and Pharmacy, the Director of a Company and the Owner of a Private Business engaged in selling medicines must meet the following standards:

1. Specialization, technical skills:

a) For companies selling both modern and traditional ethnic medicines: The Director must hold a bachelor's degree in pharmacy, and the Board of Directors must include someone with a certificate in traditional ethnic medicine issued by the Ministry of Health or Provincial Health Departments under central cities.

b) For companies only selling modern medicines: The Director must hold a bachelor's degree in pharmacy.

c) For companies only selling traditional ethnic medicines: The Director must be a licensed traditional healer, or hold a bachelor's or associate degree in pharmacy with a certificate in traditional ethnic medicine issued by the Ministry of Health or Provincial Health Departments under central cities.

d) For private businesses selling both modern and traditional ethnic medicines: The Owner must hold a bachelor's degree in pharmacy and a certificate in traditional ethnic medicine issued by the Ministry of Health or Provincial Health Departments under central cities.

e) For private businesses only selling modern medicines: The Owner must hold a bachelor's degree in pharmacy.

g) For private businesses only selling traditional ethnic medicines: The Owner must be a licensed traditional healer, or hold a bachelor's or associate degree in pharmacy with a certificate in traditional ethnic medicine issued by the Ministry of Health or Provincial Health Departments under central cities.

2- Experience (tenure) in practice: Must have five years of practice in a legitimate pharmacy institution in accordance with their specialized training.

3- Must be in good health.

4- Not currently subject to professional discipline or criminal prosecution.

Article 5. Personnel working in companies, private businesses engaged in selling medicines, pharmacies, and medicine sales agents must meet the following standards:

a) Must have sufficient professional qualifications to meet the requirements of the assigned work as stipulated in this Circular and the Pharmacy Regulations.

b) Must be in good health.

c) Not currently subject to criminal prosecution.

Article 6. Standards for the Owner of a Pharmacy:

a) Must be a bachelor's degree holder in pharmacy. If working at state medical or pharmaceutical institutions, must obtain written consent from the head of the current workplace and can only engage in practice outside regular working hours.

b) Must have five years of experience practicing pharmacy in a legitimate pharmacy institution.

c) Must be in good health.

d) Must be the actual owner of the pharmacy.

e) Not currently subject to professional discipline or criminal prosecution.

Article 7. Criteria for drug sellers:

a) Must have professional qualifications: university-level pharmacist, secondary-level pharmacist, secondary-level pharmaceutical technician, pharmacy assistant.

b) Must be in good health.

c) Not currently under professional disciplinary action and not being pursued for criminal responsibility.

Article 8. Criteria for drug agency owners:

a) For agencies selling drugs to pharmaceutical manufacturing enterprises; permitted to open agencies in both urban and rural areas, the agency owner must have a university-level pharmacist or secondary-level pharmacist qualification.

b) For agencies selling drugs to pharmaceutical trading enterprises: only permitted to open agencies in rural areas, the agency owner must have a university-level pharmacist or secondary-level pharmacist qualification, or a secondary-level pharmaceutical technician or pharmacy assistant with at least two years of practical experience at a legitimate pharmaceutical facility. If the person applying to open an agency is working at a state health or pharmaceutical facility, they must obtain written consent from the head of their current workplace.

c) Must be in good health.

d) Not currently under professional disciplinary action and not being pursued for criminal responsibility.

Article 9. Conditions for establishing a company or private business engaged in drug trade:

1. Conditions regarding production and trading facilities.

a) Must have sufficient space that is dry, clean, well-drained, suitable for drug production and trading purposes, constructed according to technical standards set by the Ministry of Health, meeting quality assurance requirements for drugs as stipulated in the Pharmaceutical Regulations for each type of drug: modern drugs, traditional ethnic medicines; and for each type of business.

b) Must not be polluted and must not cause pollution to the environment.

c) Must have a system ensuring occupational safety and fire prevention and extinguishing systems in accordance with regulations on occupational safety and fire prevention and extinguishing.

2. Warehouse conditions.

a) Must have appropriate space that is dry, clean, well-ventilated, well-drained, suitable for each type of drug and type of business, constructed according to technical standards set by the Ministry of Health, meeting quality assurance requirements for drugs. Must have shelves and storage systems suitable for the items to be stored and preserved: raw materials, finished products, semi-finished products, and other types as stipulated in the Pharmaceutical Regulations for each type of drug and type of business.

b) Must have separate warehouses or designated areas within the warehouse for raw materials, semi-finished products, finished products, and separate cabinets for toxic drugs and prescription drugs as specified in the Pharmaceutical Regulations.

c) Must have a system ensuring occupational safety and fire prevention and extinguishing systems in accordance with regulations on occupational safety and fire prevention and extinguishing.

d) Must not be polluted and must not cause pollution to the environment.

3. Equipment and layout conditions for business operations.

Must have specialized equipment that meets technical standards, and the layout of such equipment must be suitable for each type of drug and type of business to meet the quality assurance requirements for drugs as stipulated in the Pharmaceutical Regulations.

4. Quality assurance system conditions.

a) Must have staff with appropriate professional qualifications dedicated to drug quality inspection and control work. AT All stages of the business process must be staffed with personnel having the appropriate qualifications to meet the requirements of the assigned tasks as stipulated in the Pharmaceutical Regulations.

b) Must have inspection and control procedures at all stages of the business process in accordance with the provisions of the Pharmaceutical Regulations.

c) Products leaving the factory and those sold out must meet the quality standards registered by the manufacturer. Labels and packaging must comply with the "Labeling and Branding Regulations for Drugs" (for domestically produced drugs), and imported drugs must retain original packaging and labels down to the smallest unit of packaging, as required.

d) Must maintain complete records tracking drug quality and management in accordance with the provisions of the Pharmaceutical Regulations for each type of drug and each type of business.

e) Must have clean water meeting standards.

g) Must have all necessary professional tools, materials, and relevant legal documents for professional practice.

Founders applying to establish a company, or individuals applying to establish a private business engaged in drug trade, must prepare complete documentation regarding professional qualifications, technical aspects, production and trading facilities, warehouses, equipment, production line layout, quality inspection and assurance systems, fire prevention and extinguishing systems, environmental protection conditions, and organizational structure documentation to submit to competent authorities in accordance with current regulations.

Article 10. Conditions for operating pharmacies and drug sales agents for businesses:

a) Having a fixed location that meets the following requirements:

The minimum distance between the selected location to open a pharmacy and the two nearest pharmacies on the same street (counting both sides) must be at least 500 meters.

It must be a separate room, dry, clean, and spacious, meeting the requirements for purchasing, selling, storing, and ensuring the quality of drugs according to pharmaceutical regulations.

b) Having signage as prescribed:

The sign must be rectangular, with its length twice its width, and the width must not be less than 40 cm.

The name of the pharmacy or agent must be written larger than four times the size of other characters.

The red cross symbol must not be painted on the sign.

The name of the pharmacy must not be taken from the name of any agency or unit.

The display of the sign must comply with the prescribed regulations (see Appendix 1-a for pharmacy signs, Appendix 1-b and 1-c for agent signs).

c) Having sufficient sturdy counters and cabinets, and equipment for storing drugs that meet the requirements for purchasing, selling, storing, and ensuring the quality of drugs according to pharmaceutical regulations.

Counters and cabinets must have separate compartments for:

Poisonous drugs.

Drugs sold by prescription as stipulated by the Ministry of Health.

Practice licenses, certificates, invoices, documents, ledgers... necessary for inspection and supervision by competent authorities.

Drugs in counters and cabinets must be arranged by therapeutic groups, within each group they must be arranged by dosage form to avoid confusion and facilitate control.

d) Having all necessary professional equipment and materials for practice.

e) For drug sales agents, they must be accepted by a legitimate pharmaceutical business to enter into a contract to establish an agency.

Article 11. Those directly engaged in professional work in companies, enterprises, pharmacies, and drug sales agents must comply with the following regulations:

a) Wearing white coats and clean, neat white hats.

b) Wearing a plastic badge measuring 6 cm x 10 cm (with a photo and clearly stating their name, position), issued by the Department of Health, worn on the left chest.

c) Checking prescriptions before selling drugs. Before delivering drugs to customers, they must verify the prescription again: drug name, concentration, dosage, quantity, and dosage instructions.

Drugs delivered to customers must be carefully packaged, each type of drug must be separately packaged, and the packaging must clearly state the following information:

Name and address of the seller. Example: Pharmacy A, Company X, house number, street or Medicine Shop Y, village (ward) S, district (city) K, province (city) T.

Drug name, concentration, dosage, quantity.

Dosage instructions, usage method.

d) Updating records of drug purchases and sales in a logbook. Retaining prescriptions for sold drugs according to the Pharmaceutical Regulations.

Article 12. Scope of permitted operations for private pharmaceutical companies:

a) Private pharmaceutical companies dealing in both modern and traditional herbal medicines are allowed to trade in traditional herbal medicine ingredients, except those that are toxic and addictive, and finished products (except addictive ones) that have been approved for production and circulation by the Ministry of Health.

b) Private companies dealing only in modern medicines are allowed to trade in finished modern and biological medicines (except addictive ones) that have been approved for production and circulation by the Ministry of Health or the Department of Health.

c) Companies dealing solely in traditional herbal medicines are allowed to trade in traditional herbal medicine ingredients and finished products (except toxic and addictive ones) that have been approved for production and circulation by the Ministry of Health or the Department of Health.

d) Private companies are not allowed to deal in:

Ingredients for modern and biological medicines.

Addictive drugs.

Article 13. Scope of permitted operations for private pharmacies:

a) Pharmacies are only allowed to sell finished drugs that have been legally approved for production and circulation by the Ministry of Health.

b) Pharmacists who own pharmacies are allowed to compound drugs according to prescriptions from treating doctors at legally established and operational healthcare facilities for patients with valid prescriptions. Pharmacists must strictly adhere to professional regulations in compounding drugs: compounding premises, compounding equipment, compounding formulas, record-keeping, and bear full responsibility for compounded drugs. After compounding, prescriptions must be retained in accordance with prescription management regulations. Pharmacies that compound drugs must register with the local Department of Health where the pharmacy's practice certification was issued.

c) Pharmacies are not allowed to:

Sell drugs wholesale.

Purchase or sell raw materials for modern and traditional medicines. Pharmacies registered for compounding may purchase appropriate quantities of raw materials for compounding purposes. When purchasing raw materials for compounding, pharmacists must submit an order form reviewed by the Department of Health issuing the practice certification.

Purchase or sell testing chemicals.

Purchase or sell addictive drugs.

Purchase or sell veterinary drugs.

Purchase or sell drugs of unknown origin, substandard quality, expired, damaged packaging, or without a registration number issued by the Ministry of Health for production and circulation.

Article 14. Scope of permitted activities for drug sales agents for businesses.

a) Agents for domestic pharmaceutical manufacturing companies can only sell wholesale and retail finished products produced by that company and approved for circulation by the Ministry of Health. The list of drugs sold through agents must be registered with the Department of Health when applying for permission to establish an agency and must be approved in writing by the Department of Health.

b) Agents for pharmaceutical trading companies can only sell retail finished products according to the list approved by the Department of Health.

The company establishing the agency cannot assign the agent to handle drugs outside the approved list when applying for permission to establish an agency, nor can the agent accept such drugs. If there is a need to change the list of agency drugs, the company establishing the agency and the agent must apply for permission from the Department of Health that granted the establishment permission and obtain written approval.

CHAPTER III
RIGHTS AND OBLIGATIONS OF PERSONS
PRIVATE PHARMACY PRACTICE

Article 15. In addition to the responsibilities, powers, and obligations already prescribed in the Law on Enterprises, the Law on Private Business Enterprises, Article 20 and Article 21 of the Ordinance on Private Practice of Medicine and Pharmacy, and other Laws of the Socialist Republic of Vietnam, private practitioners of pharmacy have the following powers and obligations:

1. Rights

a) Equality with other economic sectors in the field of pharmaceutical expertise, they are entitled to participate in activities related to professional, technical, and occupational organizations.

b) The right to refuse to sell prescriptions that do not comply with professional regulations or which they consider harmful to the health of the user.

c) The right to change the location of their drug business when necessary, but such changes must be approved by the relevant management authorities in accordance with this Circular.

d) Companies, private enterprises, and private pharmacies have the right to hire dispensers who meet the standards for dispensers as stipulated in this Circular.

e) Companies have the right to open retail stores for selling drugs, the procedures for opening such stores are similar to those for opening pharmacies, and the store manager must meet the same standards as the pharmacy owner as specified in this Circular.

g) In the event of the death of a pharmacist-owner or due to health reasons preventing them from practicing, the lawful heir must report to the Department of Health where the practice certificate was issued and apply for permission from the Department to have a qualified university-level pharmacist take over for a maximum period of six months to sell off remaining stock. During this time, the substitute pharmacist has the same rights and responsibilities as the original pharmacist-owner.

h) If the agent owner dies or cannot continue operating due to health reasons, the enterprise that established the agency is responsible for resolving the remaining stock of drugs.

2. Obligations.

a) The pharmacist-owner must be present at the pharmacy during its operation and must close the pharmacy when the pharmacist-owner is absent.

b) Strictly adhere to medical policies and national drug policies of the Ministry of Health. Subject to professional and technical supervision by the Ministry of Health and the Department of Health.

c) Must study, understand, and implement all relevant laws, regulations, and professional rules within the scope of their practice.

d) Be responsible under the law and towards consumers for the quality of drugs produced and sold by themselves.

e) Provide information and guidance on the use of drugs in accordance with the "Drug Information for Prevention and Treatment of Diseases" regulation and other regulations of the Ministry of Health.

g) Have the responsibility to inform the Department of Health (Department of Medical and Pharmaceutical Affairs) about issues related to drug quality, adverse reactions, and side effects reported by doctors or users.

h) Maintain and improve professional ethics in the production and sale of drugs.

i) Participate in serving urgent healthcare needs.

k) Report the results of their operations and business to the Department of Health as required.

 

PART IV
PROCEDURES AND AUTHORITY FOR ISSUING CERTIFICATES OF QUALIFICATION AND ESTABLISHMENT REQUIREMENTS
STANDARDS AND CONDITIONS FOR ESTABLISHING A FACILITY
PRIVATE PHARMACY PRACTICE

Article 16. Procedures for registering, examining, and issuing certificates of qualification and establishment requirements for companies and private enterprises engaged in the sale of human-use drugs:

a) The Minister of Health, based on the need for public health care, and upon reviewing the professional, technical, organizational structure, and operational conditions, and considering the proposal of the Department of Health, will issue certificates of qualification and establishment requirements for private pharmacy practices for companies and private enterprises, including foreign-founded companies or companies founded by overseas Vietnamese, and joint ventures with foreign entities operating in Vietnam. For other types of private pharmacy practices, the Ministry of Health delegates the authority to the Provincial Department of Health Chairperson to review and issue certificates of qualification and establishment requirements.

b) The Ministry of Health establishes an Advisory Council to assist the Minister in assessing the qualifications and conditions for issuing certificates. The Council is chaired by the Deputy Minister in charge of pharmaceutical affairs, with the Director of the Pharmaceutical Department as the Vice-Chairman, a representative from the Vietnam Pharmaceutical Association's Executive Board, and other members.

c) The Provincial Department of Health establishes an Advisory Council to assist the Department Director in assessing the qualifications and conditions for issuing certificates. The Council is chaired by the Deputy Director in charge, with the Head of the Medical and Pharmaceutical Affairs Department or the Head of the Testing Station as the Vice-Chairman, a representative from the Provincial Pharmaceutical Association's Executive Board, and other members.

d) The Chairpersons of the Councils at various levels have the authority to establish specialized teams in professional, technical, and operational matters to assist the Councils in evaluating companies, private enterprises, private pharmacies, and drug sales agents within their jurisdiction.

Article 17. The application documents for establishing a company or private enterprise engaged in drug sales include:

a) Application form for establishing a company or enterprise (model form - Appendix 2).

b) Draft charter of the company's operations.

c) Professional, technical, and organizational structure documents of the company or enterprise.

d) Documents of the company's General Manager, company's Board of Directors, or private enterprise owner, including:

Professional certificates, if copies, must be certified by a state notary.

A detailed resume must be confirmed by the managing authority.

Health certificate issued by a general hospital.

Certificate confirming five years of practical experience at a legal pharmaceutical facility.

All documents above should be submitted to the Department of Health where the company or enterprise is headquartered. After reviewing, the Department of Health is responsible for forwarding the "application package" for establishing a company or enterprise and the review document with the Department's comments to the Ministry of Health (Pharmaceutical Department).

Article 18. Documents to be submitted to the Department of Health for applying to open a private pharmacy include:

a) Application form for opening a pharmacy (model form - see Appendix 3).

b) University diploma in pharmacy, if a copy, must be certified by a state notary.

c) Detailed resume must be confirmed by the authority or local government.

d) Health certificate issued by a general hospital.

e) A declaration of the location for opening a pharmacy, if renting a location to sell medicine, must include a commitment letter with the shortest lease term of at least one year between the lessee and lessor, attached with a diagram describing the position of the intended pharmacy location and clearly stating the distance from this location to the two nearest pharmacies on the same street.

g) If the person is a current public servant, they must provide a written consent from the head of the direct supervising agency.

i) A certificate confirming five years of practical experience at a legitimate pharmaceutical establishment.

Article 19. The dossier submitted to the Department of Health to open a drug sales agency for businesses includes:

a) An application form to open a drug sales agency (see Appendix 4).

b) A resume of the agency owner certified by the local authority.

c) A copy of the professional certification confirmed by the supervising agency.

d) An economic contract between the business granting the agency and the agency owner selling drugs for the business.

e) A list of medicines entrusted to the agency owner by the business.

g) A declaration of the location for opening the agency.

i) A certificate confirming two years of practical experience at a legitimate establishment.

Article 20. Regulations on the retention of files for various types of private pharmaceutical practices:

a) Files of pharmaceutical businesses and companies will be retained at the Ministry of Health (Department of Medicine). Even those of businesses and companies that have not been granted a practice qualification certificate.

b) Files of private pharmacies and drug sales agencies for pharmaceutical businesses will be retained at the Department of Health (Medical Affairs Division).

Article 21. Quantity of practice qualification certificates and storage addresses:

a) The practice qualification certificate of a company or business issued by the Ministry of Health shall be made in four copies: one copy sent to the People's Committee of the province or centrally-administered city where the decision to establish was made, one copy sent to the applicant, one copy retained at the Ministry of Health, and one copy retained at the Department of Health where the company or business is headquartered.

b) The practice qualification certificate of a pharmacy shall be made in two copies: one copy retained at the Department of Health (Medical Affairs Division), and one copy sent to the applicant.

c) The practice qualification certificate of a drug sales agency for businesses shall be made in three copies: one copy retained at the Department of Health (Medical Affairs Division), one copy sent to the business where the agency is located, and one copy sent to the applicant.

After obtaining the practice qualification certificate, the procedures for establishing a company or private business, and registering a business, pharmacy, or agency shall be carried out in accordance with the relevant laws.

Article 22. Validity period of the practice qualification certificate:

a) The practice qualification certificate of a company or private business is valid for a period of five years from the date of issuance.

b) The practice qualification certificate of a pharmacy is valid for a period of three years from the date of issuance.

c) The practice qualification certificate of a drug sales agency for businesses is valid for a period of three years from the date of issuance (if the economic contract between the business opening the agency and the agency owner remains effective).

Two months before expiration, companies and private businesses must submit an application to the Ministry of Health; pharmacies and drug sales agencies for businesses must submit an application to the Department of Health to renew their practice qualification certificate.

Article 23. Procedures for changing the business location of a company, business, pharmacy, or drug sales agency for businesses:

a) When a company or private business wishes to change its headquarters, production and business premises, or warehouse, it must follow these steps:

The company or business must submit an application for changing the headquarters, and an application along with technical and professional documents for changing the production and business premises or warehouse to the Department of Health.

The Department of Health will process the review as done when the company or business applied for establishment. The dossier and request letter will be forwarded to the Ministry of Health (Department of Medicine).

Upon receiving written approval from the Ministry of Health, the company or business may move to the new location.

Upon moving to the new location, the company or business is responsible for completing all necessary procedures with relevant authorities as required by law.

b) When a pharmacy owner or drug sales agency owner wishes to change their business location, they must submit an application and follow the procedures for opening a pharmacy or agency and send them to the Department of Health. Only upon receiving written approval from the Department of Health can the pharmacy owner or agency owner move to the new location.

Article 24. When submitting an application for a practice qualification certificate for establishing a company, business, pharmacy, or drug sales agency for businesses, or for transferring a location and renewing a license, the entity or individual must pay a fee as stipulated by the Joint Circular of the Ministry of Finance and the Ministry of Health.

 

CHAPTER V
INSPECTION, AUDIT AND VIOLATION HANDLING

Article 25. Inspection and supervision of private pharmaceutical practices:

a) The Ministry of Health's Inspectorate, in coordination with the Department of Medicine, organizes inspections and supervision of the implementation of pharmaceutical laws by all organizations and individuals engaged in private pharmaceutical practices.

b) Provincial or municipal health inspectorates, in coordination with the Medical Affairs Division of the Department of Health, conduct inspections and supervision of the implementation of pharmaceutical laws by organizations and individuals engaged in private pharmaceutical practices within their jurisdiction.

c) Organizations and individuals engaged in private pharmaceutical practices must comply and facilitate inspections and supervision at their premises.

d) Inspections and supervision of organizations and individuals engaged in private pharmaceutical practices are conducted regularly or at random.

 Article 26. Handling violations: Organizations and individuals engaged in private pharmaceutical practices who violate pharmaceutical professional regulations, policies, and state laws will be subject to disciplinary action or administrative penalties as prescribed in Decree No. 341-HĐBT dated September 22, 1992, issued by the Council of Ministers regarding "Regulations on Administrative Penalties in the Field of Health," or criminal liability as provided by law, depending on the severity and nature of the violation.

 

Chapter VI
FINAL PROVISIONS

Article 27. This Circular takes effect from the date of issuance, and all previous provisions contrary to this Circular are hereby abolished.

In the course of implementation, if new issues arise, localities are requested to report to the Ministry (Department of Medicine) for timely supplementation and amendment.

 

ANNEX 1-A

PROCEDURE FOR DISPLAYING THE SIGN OF PRIVATE PHARMACIES
(From top to bottom)

1. Name of pharmacy: Clearly state the name of the pharmacy as registered with the Department of Health when applying for the pharmacy license.

2. Scope of business: Clearly state that it only sells retail drugs (and if compounding according to prescription, specify accordingly as in example 1).

3. Name of pharmacist - owner of the pharmacy: Fully state surname, middle name, and given name.

4. Pharmacy registration number issued by the Department of Health.

5. Address of the pharmacy: Clearly state house number, street, city (town) or commune (ward), district (city), province (city).

6. Telephone number (if available).

Example 1

 

PHARMACY Á ĐÔNG Specializes in retailing...compounding drugs according to prescriptions Pharmacist - owner of the pharmacy: Nguyễn Văn Anh Registration Number: 1036/SYT-HN 118 Le Duan Street, Hanoi City Telephone: 264418, 262163

 

Example 2

 

PHARMACY HỒNG NHUNG Specializes in retailing Pharmacist - owner of the pharmacy: Lê Hồng Nhung Registration Number: 126/SYT-HT Commune A, District (City) B, Province (City) Telephone: ...

 

ANNEX 1-B, 1-C

PROCEDURE FOR DISPLAYING THE SIGN OF DRUGS AGENT STORE
FOR DRUG PRODUCERS
(In top-down order)

1. Clearly state which drug producer the agent store sells for.

2. Position and name of the agent store owner.

3. Registration number issued by the Department of Health.

4. Agent store address: Commune, District, Province.

5. Telephone number (if available).

Example 1: Display format of the sign of the agent store selling drugs for a drug producing enterprise (1-b).

 

 

Example 2: Display format of the sign of the agent store selling drugs for a drug trading enterprise (1-c)

 

DRUGS AGENT STORE FOR COMPANY DƯỢC PHẨM Y Pharmacy Technician: Phạm Thị B Registration Number: 27/SYT-NH Commune M, District N, Province NH Telephone: 368148 - 368683

 

ANNEX 2

MODEL APPLICATION FOR ESTABLISHING A COMPANY OR PRIVATE BUSINESS
TO OPERATE DRUGS FOR HUMAN USE

SOCIALIST REPUBLIC OF VIETNAM

Independence - Freedom - Happiness

Day... month... year 199...

APPLICATION FOR ESTABLISHING A COMPANY (BUSINESS)
PRIVATE BUSINESS TO OPERATE DRUGS FOR HUMAN USE
(According to Circular guiding number...day... month... year... of the Ministry of Health)

Respectfully submitted to: - People's Committee of the province, centrally governed city or equivalent administrative unit where the headquarters will be located,

- Department of Health,

1. Full name, date of birth, permanent address of the founders requesting to establish the company (or full name, date of birth, permanent address of the business owner).

2. Name of the company (or business).

3. Location of the company's headquarters (or business).

4. Scope of business of the company (or business).

5. Charter capital and method of contribution of the company (or initial investment capital of the business).

6. Environmental protection measures.

7. Company establishment program.

We hereby submit along with this application the following documents:

a) Initial business plan of the company (or business).

b) Draft charter of the company.

c) Professional and technical files of the company (or business).

d) Organizational structure file of the company.

e) Files of the General Director of the company and the founders (or files of the business owner).

 

ANNEX 3

SOCIALIST REPUBLIC OF VIETNAM

Independence - Freedom - Happiness

Day... month... year 199...

APPLICATION FOR ESTABLISHING A PRIVATE PHARMACY
(According to Circular guiding number...day... month... year... of the Ministry of Health).

Respectfully submitted to: Director of the Department of Health of the province (city)

My name is: Born in:

Permanent address:

Professional qualifications:

Year of graduation from university: At school:

I have worked in the pharmaceutical industry from day.. month... year... to day.. month... year 199...

At:

I request to open a pharmacy at: House number...street...

Commune (Ward)...District (City)...Province (City)...

Is:

Owned by my family:

Rented from Mr./Mrs.:

The location of the pharmacy I intend to open is...meters away from the nearest pharmacy on both sides of the same street.

Scope of requested business permit:

Is there a registration for compounding according to prescription?

Initial investment capital:

I hereby submit along with this application the following documents:

 

Copy of the bachelor's degree in pharmacy.

Curriculum vitae

Health certificate

Layout of the pharmacy opening location

Lease agreement (if rented)

Opinion Agreement of the head of the agency where I am currently working to open the pharmacy.

I solemnly pledge to strictly implement the national policy on drugs, pharmaceutical regulations, and related laws, always improving and maintaining medical ethics in drug sales. Adhering strictly to the guidance of the Ministry of Health and the Department of Health regarding the pharmacy.

 

ANNEX 4

SOCIALIST REPUBLIC OF VIETNAM

Independence - Freedom - Happiness

Day... month... year 199...

APPLICATION FOR ESTABLISHING A DRUGS AGENT STORE FOR A BUSINESS
PRODUCING (OR TRADING) DRUGS

(According to Circular guiding number...day... month... year... of the Ministry of Health)

Respectfully submitted to: Director of the Department of Health of the province (city)

My name is:

Born in:

Permanent address:

Professional qualifications:

Year of graduation:

At school:

I request to open a drugs agent store for the business: Clearly state the name of the business (for example: Enterprise DƯỢC PHẨM X or Company DƯỢC PHẨM Y).

At house number, street, city (town) or commune (ward), district (city), province (city).

Is:

Owned by my family:

Rented from Mr./Mrs.:

I hereby submit along with this application the following documents:

Copy of professional qualification certificate.

Curriculum vitae

Health certificate

Report on the location of the agent store selling drugs.

List of drugs requested to sell at the agent store.

Economic contract between the agent store owner and the business opening the agent store.

Opinion Agreement of the head of the agency where I am currently working.

Lease agreement (if rented).

I solemnly pledge to strictly implement the national policy on drugs, pharmaceutical regulations, and related laws, continuously improve and maintain professional ethics in drug sales.