Circular No. 02/2000/TT-BYT guiding the business of medicines for disease prevention and treatment in humans

CIRCULAR

Guidelines for the Business of Medicines for Disease Prevention and Treatment in Humans

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Pursuant to the Law on Health Care for the People dated July 11, 1989,

Pursuant to the Ordinance on Private Practice of Medicine and Pharmacy dated October 13, 1993; Decree No. 06/CP dated January 29, 1994 of the Government detailing certain provisions of the Ordinance on Private Practice of Medicine and Pharmacy,

Pursuant to Decree No. 11/1999/NĐ-CP dated March 3, 1999 on Prohibited Commodities and Services, Restricted Commodities and Services, and Commodities and Services Subject to Conditional Business,

The Ministry of Health guides standards, business conditions, procedures, and authority to issue certificates of eligibility for the business of medicines for disease prevention and treatment in humans as follows:

PART I

GENERAL PROVISIONS

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

- Medicines for disease prevention and treatment in humans (hereinafter referred to as medicines) include finished products and raw materials used to produce medicines (raw materials include: active ingredients, excipients, auxiliaries, direct contact packaging with medicines).

- Business of medicines includes activities such as wholesale and retail.

- Wholesale of medicines: selling in large quantities to traders and organizations permitted to buy and sell medicines.

- Retail of medicines: selling directly to end-users.

Article 2. Businesses engaged in the business of medicines under various economic sectors, if they wish to organize wholesale and retail establishments, must have a Certificate of Eligibility for Wholesale and Retail of Medicines and must comply with the provisions of this Circular:

1. Types allowed to engage in wholesale and retail:

a. State-owned enterprises producing and trading in medicines.

b. Limited Liability Companies (LLCs), Joint Stock Companies (JSCs), and private enterprises (hereinafter collectively referred to as enterprises) with the function of trading in medicines that have been issued a Certificate of Eligibility for Establishment of Pharmaceutical Practice Facilities by the Ministry of Health according to the laws on private practice of medicine and pharmacy.

c. Foreign-invested pharmaceutical production enterprises are only allowed to trade in medicines produced by their own units in Vietnam.

2. Types allowed to engage in retail only:

- Private pharmacies.

- Medicine sales agents.

Article 3. Medicines permitted to be traded include:

1. Medicines registered for circulation by the Ministry of Health:

- Imported medicines that have been registered.

- Domestic medicines that have been registered.

2. Imported medicines not yet registered in Vietnam but imported under the permit of the Ministry of Health.

3. Raw materials used to produce medicines may only be supplied to units that have been registered by the Ministry of Health, and may not be sold to other entities without the function of producing medicines.

4. Trading in narcotic drugs shall be carried out in accordance with the Narcotic Drug Management Regulation promulgated together with Decision No. 2033/1999/QD-BYT dated July 9, 1999 of the Minister of Health.

5. Trading in psychotropic substances and precursors shall be carried out in accordance with the Psychotropic Substance Management Regulation promulgated together with Decision No. 2330/1997/QD-BYT dated November 8, 1997 of the Minister of Health.

Article 4. Each wholesale and retail establishment of medicines may only:

- Conduct business at the location registered after being inspected and certified by the competent authority.

- Conduct business within the scope specified in the Certificate of Eligibility for the Business of Medicines for Disease Prevention and Treatment in Humans and comply with all relevant regulations and professional guidelines of the Ministry of Health.

- When changing locations, approval from the local competent authority where the business is currently conducted and the destination must be obtained.

Chapter II

STANDARDS, CONDITIONS, AND SCOPE OF RETAIL BUSINESS FOR MEDICINE ESTABLISHMENTS

Article 5. Standards and conditions for retail drug establishments:

1. Must be a trader with a Business Registration Certificate, clearly stating the business activity of selling drugs (modern drugs, traditional medicine drugs). If it is a private pharmacy establishment, it must also have a certificate of qualification and conditions for practicing pharmacy issued by the competent authority according to the law on private pharmacy practice.

2. The person directly managing and operating the business must meet the following standards:

a. At least 18 years old, having full capacity for civil acts.

b. A university-level pharmacist or licensed pharmacist (if selling finished traditional medicine products, medicinal materials). For mountainous areas, islands, remote and far-flung regions where there is no university-level pharmacist, the Director of the Department of Health may allow a secondary-level pharmacist, secondary-level pharmaceutical technician, or pharmacy assistant to manage and operate the business based on specific local circumstances; the duration of permission is one year as specified by the Director of the Department of Health.

c. Years of experience:

- In cities, towns, and townships: must have at least five years of practice at a legal pharmacy establishment.

- In mountainous areas, islands, remote and far-flung regions: if a university-level pharmacist: two years; if a pharmacy assistant or secondary-level pharmaceutical technician: must have at least two years of practice at a legal pharmacy establishment.

d. Must be in good health, not suffering from infectious diseases or mental illnesses.

e. Not currently under disciplinary action in pharmacy practice and not currently being pursued for criminal responsibility.

3. The person assisting in selling drugs must meet the following standards:

a. Must be a person with a pharmaceutical specialty from pharmacy assistant level upwards.

b. Must be in good health, not suffering from infectious diseases.

c. Not currently under disciplinary action in pharmacy practice, not currently being pursued for criminal responsibility.

4. Conditions regarding physical facilities and equipment of retail establishments:

a. Regarding the location for selling drugs:

- Area: The establishment must have sufficient space, a minimum of 10 square meters.

- Location: Separate, stable, if rented, must have a legal lease agreement for at least one year (confirmed by the People's Committee of the commune, ward). It must be a building of grade 3 or higher in cities and grade 4 or higher in rural areas, meeting requirements for purchasing, selling, storing, and ensuring drug quality according to pharmaceutical regulations.

b. Equipment:

- Must have sufficient sturdy counters and cabinets to display drugs and equipment for drug storage according to the storage requirements indicated on the labels of the sold drugs.

- Must have a separate cabinet or compartment for toxic drugs. Drugs arranged on counters and cabinets must be organized by type of drug, by name, or by manufacturer, ensuring they are easily visible, accessible, and avoiding confusion.

- Must have all fire prevention and firefighting equipment.

- Drugs must be stored in a dry, cool place, away from direct sunlight.

Article 6. Scope of business for retail establishments:

1. Only permitted to organize retail sales of drugs after obtaining a Business Registration Certificate for the pharmaceutical business and a Certificate of Qualification and Conditions for Selling Drugs (retail) issued by the competent authority.

2. Retail sales of prescription drugs must comply with the regulations of the Ministry of Health.

3. Retail agency: only permitted to sell finished drugs listed in the drug catalog agreed upon with the enterprise in the agency opening contract. The enterprise opening the agency and the agency owner must sign an agreement when changing the drug catalog.

4. Strictly prohibited for retail establishments:

- Selling wholesale drugs

- Buying and selling raw materials for drugs, chemical reagents for testing.

- Buying and selling addictive drugs (except for establishments belonging to state-owned enterprises specifically designated in the Narcotic Drug Management Regulations issued together with the Decision of the Minister of Health No. 2033/1999/QĐ-BYT dated July 9, 1999).

- Selling the following drugs:

+ Drugs listed in the prohibited import catalog

+ Compounded drugs (except for establishments with the function of compounding according to prescriptions).

+ Donated drugs.

+ Drugs without a registration permit issued by the Ministry of Health.

+ Foreign drugs not registered without an import permit from the Ministry of Health.

+ Expired drugs, drugs that do not meet quality standards.

+ Prescription drugs without a doctor's prescription.

+ Drugs of unknown origin.

+ Veterinary drugs.

Chapter III

STANDARDS, CONDITIONS AND SCOPE OF BUSINESS FOR WHOLESALE DRUG ESTABLISHMENTS

Article 7. Standards and conditions for wholesale pharmaceutical establishments:

1. The trader must be a business entity holding a Business Registration Certificate for Pharmaceutical Products (specifying Western medicine, traditional medicine). If it is a private pharmacy establishment, it must also have a certificate of qualification for operating a private pharmacy issued by the Ministry of Health within its authority.

2. The person directly managing and operating the pharmaceutical business activities must meet the following standards:

a. At least 18 years old, having full capacity for civil acts.

b. Must be a university pharmacist or licensed pharmacist (if wholesaling traditional medicine or medicinal herbs), with at least five years of practice at a legally established pharmaceutical business.

c. Must be in good health, not suffering from infectious diseases.

d. Not currently under disciplinary action for violating professional regulations on pharmacy or not currently being pursued for criminal responsibility.

3. Sales staff:

a. Must be a person with a pharmaceutical specialty from pharmacy assistant level upwards.

b. Must be in good health, not suffering from infectious diseases.

c. Not currently under disciplinary action in pharmacy practice, not currently being pursued for criminal responsibility.

4. Conditions regarding physical facilities and equipment:

a. Sales premises:

- Area: must be appropriate to the scale of business but the transaction area must be at least 20 square meters.².

- A separate and stable location. If rented, there must be a lease agreement for at least one year.

- If additional retail outlets are opened, they must obtain a certificate of qualification for retailing and the retail location must be separate from the wholesale location.

b. Drug warehouse:

- Warehouse manager: must have at least a secondary-level pharmaceutical education. For wholesale establishments dealing in traditional medicine or medicinal herbs, the warehouse manager must be a licensed pharmacist.

- Warehouse staff: must have a level of education suitable for the assigned tasks.

- For wholesale establishments dealing in addictive drugs, psychotropic drugs, and toxic drugs, the warehouse manager and warehouse staff must comply with the provisions set out in the following regulations: Regulation on Management of Addictive Drugs (annexed to Decision No. 2033/1999/QD-BYT dated July 9, 1999 of the Minister of Health), Regulation on Management of Psychotropic Drugs (annexed to Decision No. 2330/QĐ-BYT dated November 8, 1997 of the Minister of Health), Regulation on Management of Toxic Drugs (annexed to Decision No. 2032/QĐ-BYT dated July 9, 1999 of the Minister of Health).

- Warehouse area: sufficient space appropriate to the scale of business, but the total minimum area must be 30 square meters.².

- Warehouse equipment:

+ The warehouse must be dry, clean, and well-ventilated. It must have a ventilation system and temperature control to maintain the overall warehouse temperature below 25°C and appropriate storage equipment for special requirements of certain types of pharmaceutical products.

+ There must be enough shelves, racks, and cabinets to arrange drugs according to their type, name, or manufacturer and ensure the principle of "first in, first out."

+ Storage and preservation of addictive drugs, psychotropic drugs, and toxic drugs must comply with current regulations.

+ Computer systems must be installed to manage drug imports and exports.

+ Safety measures, fire prevention, and firefighting systems must be in place.

5. Quality control department:

a. Must have dedicated personnel responsible for ensuring drug quality.

b. Must have a quality testing facility or a stable contract with an accredited testing facility to ensure the quality of marketed drugs.

Article 8. Scope of Business for Wholesale Pharmaceutical Establishments:

1. Only permitted to organize wholesale pharmaceutical sales after obtaining a Business Registration Certificate for Pharmaceutical Products and a certificate of qualification and conditions for pharmaceutical business (wholesale) issued by the competent authority.

2. Wholesale pharmaceutical establishments wishing to engage in retail must meet the standards and conditions for retail pharmaceutical businesses stipulated in this Circular and must obtain a separate certificate.

3. Wholesale establishments are responsible for ensuring adequate essential medicines as listed.

4. Wholesale establishments may only sell drugs that are still in their original packaging from the manufacturer.

Article 9. It is strictly prohibited for wholesale establishments to sell the following types of drugs:

1. Drugs listed in the import prohibition directory.

2. Drugs purchased for national health programs.

3. Donated drugs.

4. Drugs that have not been granted circulation registration certificates by the Ministry of Health.

5. Foreign drugs that have not been registered and do not have import permits issued by the Ministry of Health.

6. Expired drugs, drugs that do not meet quality standards, and drugs with remaining shelf life under two months.

7. Drugs of unknown origin.

8. Veterinary drugs.

Chapter IV

RIGHTS AND RESPONSIBILITIES OF WHOLESALE AND RETAIL DRUG ESTABLISHMENTS

Article 10. Rights:

1. The right to refuse to sell drugs that do not comply with professional regulations or that may affect users' health.

2. The right to change the business location when necessary, but must obtain approval from the management authority as stipulated in Clause 4 of this Circular.

3. Establishments can hire drug sales assistants. Sales assistants must meet the requirements set forth in Part 3, Article 5 of this Circular.

4. If the establishment owner is absent due to health reasons or other reasons and cannot ensure business operations, the legal heir must notify the Provincial Department of Health where the certificate was issued and must obtain written consent.

Article 11. Responsibilities:

1. The person managing the drug buying and selling activities at the establishment must be present during operating hours and bear legal responsibility for all aspects of the establishment's activities.

2. Those working directly in sales must comply with the following regulations:

- Must wear white coats and clean, neat white hats.

- Must wear name badges measuring 6cm x 10cm (with photos, full names, and positions issued by the Provincial Department of Health) (Annex 1).

- Must check prescriptions before selling drugs and verify the drug name, concentration, dosage, quantity, and usage instructions before handing them over to customers.

- Must record and retain transaction documents according to regulations.

3. All wholesale and retail drug establishments must have:

- Signage (Annex 2)

- Drug purchase and sale records including:

+ Records of toxic drug purchases and sales (in accordance with the "Regulation on Toxic Drug Management" issued with Decision No. 2032/QD-BYT dated July 9, 1999 of the Minister of Health), prescription drug purchase and sale records (in accordance with the "Prescription Writing and Prescription Drug Sale Regulation" issued with Decision No. 488/BYT-QĐ dated April 3, 1995 of the Minister of Health).

+ Purchase and sale invoices and receipts.

+ Wholesale establishments must have inventory cards for each type of drug (Annex 3), purchase and sale records (Annex 4), and drug quality monitoring records (Annex 5).

+ Retail drug establishments must have drug purchase records (Annex 6) and records of adverse drug reactions reported by customers (Annex 7).

- Must have sufficient professional equipment and materials to support their practice.

- Must report to the Ministry of Health (Vietnam Drug Administration) and the Provincial Department of Health any issues related to drug quality, adverse events, and side effects reported by doctors or consumers.

- Must implement decisions to recall drugs made by manufacturers, distributors, and/or regulatory authorities. Report the results of drug recalls to the Vietnam Drug Administration and the Provincial Department of Health as required by the "Quality Management Regulation" issued with Decision No. 2412/1998/QĐ.BYT dated September 15, 1998 of the Minister of Health.

- Must display drug prices and sell at those prices, without suggesting that customers substitute prescribed drugs with more expensive alternatives.

- Must actively cultivate professional ethics.

- Must report periodically or urgently about business activities to the Ministry of Health (Vietnam Drug Administration) and the Provincial Department of Health as required.

4. When transporting drugs, cross-contamination between products must be avoided, packaging must be protected from tearing or breaking. During transportation, drugs must be stored under appropriate temperature, humidity, light conditions as specified in the storage requirements.

5. During drug sales, wholesale establishments must ensure that drug packaging and labels remain intact and must not alter drug packaging, labels, or information registered by the manufacturer at the Vietnam Drug Administration.

Chapter V

PROCEDURES AND REQUIREMENTS FOR ISSUING BUSINESS LICENSES

Article 12: The Director of the Provincial Department of Health (referred to collectively as the province) shall consider issuing business licenses to wholesale and retail drug establishments within their jurisdiction.

Article 13: The Directors of the Provincial Departments of Health shall establish advisory boards to assist the directors in assessing the criteria and conditions for issuing business licenses for drug sales. The board shall be chaired by the Deputy Director responsible for pharmaceutical affairs, with the Head of the Pharmaceutical Management Division as Vice-Chairman, a representative from the Pharmaceutical Association (if the province has such an association), a representative from the Drug Testing Center, and other members. The board shall have a group of experts in specialized knowledge, technology, and business practices to assist the board in evaluating the criteria and conditions for drug sales.

Article 14. The application dossier for obtaining a Business Condition Certificate (for wholesale and retail) to be submitted to the Department of Health includes:

1. An application form for issuing a Business Condition Certificate for pharmaceuticals for disease prevention and treatment issued by the competent authority (Annex 8)

2. A notarized copy of the Business Registration Certificate in the permitted business field of pharmaceuticals (specifying whether it is modern medicine or traditional medicine).

3. Documents related to business standards and conditions (as stipulated in Articles 5 and 7 of this Circular).

Article 15.: Within fifteen days from the date of receiving a complete and valid application dossier, the Department of Health shall decide on issuing or not issuing a Business Condition Certificate for pharmaceuticals based on the results of the assessment according to the standards set forth in this Circular. In case of non-issuance, the reasons must be clearly stated.

Article 16. For traders who are enterprises wishing to open multiple wholesale or retail outlets, each outlet must meet the business standards and conditions as prescribed in this Circular, and each outlet must be granted a separate certificate.

Article 17. For individual traders (private pharmacies, rural retail drug agents), each trader may only operate at one location and will only be granted one Business Condition Certificate for retail operations.

Article 18. Traders who are granted a Business Condition Certificate for meeting the business standards and conditions must pay the fee as prescribed by the Ministry of Finance.

Chapter VI

EFFECTIVE PERIOD OF THE BUSINESS CONDITION CERTIFICATE

MEETING STANDARDS AND CONDITIONS FOR PHARMACEUTICALS BUSINESS

Article 19. The validity period of the Business Condition Certificate meeting standards and conditions for pharmaceuticals business:

The Business Condition Certificate for wholesale and retail pharmaceuticals has a validity period of three years from the date of issuance.

The Business Condition Certificate shall be made in four copies (one copy retained by the Vietnam Drug Administration, one copy retained by the Department of Health, one copy retained by the Pharmaceutical Corporation (if it is a member unit of the Corporation) or the People's Committee of the province (if it is a local management unit), one copy retained by the enterprise).

Article 20. Three months before the expiration date, the trader must submit an application to the Department of Health requesting renewal of the certificate.

Article 21. Procedures for changing the business location:

1. Application for changing the business location for pharmaceuticals.

2. The Department of Health shall assess the new premises according to the standards and conditions stipulated in this Circular and approve in writing. The premises shall be responsible for completing all procedures with relevant authorities as prescribed by law prior to moving to the new location.

Chapter VII

HANDLING VIOLATIONS

Article 22. The Vietnam Drug Administration and the Health Inspection Department of the Ministry of Health shall organize inspections and audits nationwide regarding pharmaceuticals business activities.

Article 23. Provincial health inspectors shall cooperate with the pharmaceutical management departments of the Department of Health to inspect and audit pharmaceuticals business activities within their provincial territories.

Article 24. Traders violating the provisions of this Circular shall be subject to administrative penalties or criminal prosecution depending on the severity of the violation, as prescribed by law.

Point 25. State officials and civil servants who abuse their positions and powers and fail to comply with the provisions of this Circular shall be subject to disciplinary action, administrative penalties, or criminal prosecution depending on the severity of the violation, as prescribed by law.

Chapter VIII

IMPLEMENTING PROVISIONS

Article 26. This Circular shall take effect fifteen days from the date of issuance. All previous regulations that conflict with the provisions of this Circular shall be abolished.

Article 27: The Vietnam Drug Administration and the Departments of Health of provinces and cities have the responsibility to implement this Circular.