Decree No. 102/2016/NĐ-CP on Conditions for Drug Business

 

DECREE

REGULATIONS ON CONDITIONS FOR MEDICINE BUSINESS

Pursuant to the Law on Government Organization dated June 19, 2015;

Pursuant to the Medicine Law dated June 14, 2005;

Pursuant to the Investment Law dated November 26, 2014;

At the proposal of the Minister of Health;

The Government promulgates this Decree on conditions for medicine business.

PART I
GENERAL PROVISIONS

Article 1. Scope of Regulation and Applicability

1. This Decree stipulates conditions for medicine business.

2. This Decree applies to agencies, organizations, and individuals both within and outside Vietnam operating in the pharmaceutical field in Vietnam.

Article 2. Interpretation of Terms

2. Self-generated and self-consumed electricity is electricity produced and consumed by an organization or individual to serve their own needs.

1. A legitimate pharmaceutical establishment is an entity operating in the pharmaceutical field established in accordance with the law, including:

a) Medicine retail establishments;

b) Pharmaceutical departments of medical examination and treatment facilities;

c) Schools training pharmaceutical specialties;

d) Pharmaceutical research institutes, testing centers, and institutes;

e) State management agencies for pharmaceuticals;

f) Representative offices of foreign traders operating in the pharmaceutical field in Vietnam;

g) Other pharmaceutical establishments as prescribed by law.

2. Finished combination medicines containing narcotic substances are finished medicines that simultaneously meet the following conditions:

a) Containing non-narcotic substances, non-psychotropic substances, and not precursors used as medicines;

b) Containing narcotic substances, or containing narcotic substances combined with psychotropic substances, or containing narcotic substances combined with precursors used as medicines, or containing narcotic substances combined with psychotropic substances and precursors used as medicines;

c) The concentrations and quantities of narcotic substances, psychotropic substances, and precursors used as medicines are all less than or equal to the concentrations and quantities specified in the list issued by the Minister of Health.

3. Finished combination medicines containing psychotropic substances are finished medicines that simultaneously meet the following conditions:

a) Containing non-narcotic substances, non-psychotropic substances, and not precursors used as medicines;

b) Containing psychotropic substances or containing psychotropic substances combined with precursors used as medicines;

c) The concentrations and quantities of psychotropic substances and precursors used as medicines are all less than or equal to the concentrations and quantities specified in the list issued by the Minister of Health.

4. Finished combination medicines containing precursors are finished medicines that simultaneously meet the following conditions:

a) Containing non-narcotic substances, non-psychotropic substances, and not precursors used as medicines;

b) Containing precursors used as medicines at concentrations and quantities less than or equal to the concentrations and quantities specified in the list issued by the Minister of Health.

5. Chemical medicines are medicines containing active ingredients with defined components, formulas, and purity levels.

6. Herbal medicines are raw materials for medicines derived from natural sources such as plants, animals, minerals, and meeting the standards for medicinal use.

Herbal medicines do not include semi-finished medicines derived from herbal medicines.

7. Semi-finished medicines derived from herbal medicines are raw materials for medicines from herbal medicines in the form of extracts, powders, granules, alcohol, decoctions, essential oils, and used in the production of medicines from herbal medicines.

8. Raw herbal medicines (living herbal medicines) are natural raw materials from plants, animals, minerals that can be used as medicines but have not been processed or refined.

9. Traditional Chinese medicine ingredients are herbal medicines processed according to the theories and methods of traditional medicine used for producing traditional Chinese medicines or for disease prevention and treatment.

10. Processing is the inspection and classification of raw herbal medicines, removal of impurities, soaking, fermenting, washing, drying, cleaning, dehydrating, cutting, or grinding into powder.

11. Refining is the process of changing the quality and quantity of raw herbal medicines or processed herbal medicines into traditional Chinese medicine ingredients according to the theories and methods of traditional medicine.

Article 3. Forms of organizing pharmaceutical business

1. Pharmaceutical production facilities include:

a) Pharmaceutical manufacturing enterprises;

b) Cooperatives and households engaged in the production of medicinal herbs, traditional medicine, and medicines derived from medicinal herbs.

2. Wholesale pharmaceutical facilities include:

a) Pharmaceutical wholesale enterprises;

b) Cooperatives and households engaged in the wholesale of medicinal herbs, traditional medicine, and medicines derived from medicinal herbs;

c) Wholesalers of vaccines and medical products.

3. Retail pharmaceutical facilities include forms of pharmaceutical business organization as stipulated in Clause 1 of Article 24 of the Medicine Law; specialized retail facilities for traditional medicine and medicines derived from medicinal herbs as stipulated in Point d of Clause 1 of Article 26 of the Medicine Law.

4. Enterprises exporting and importing medicines.

5. Enterprises providing pharmaceutical storage services.

6. Enterprises providing pharmaceutical testing services.

7. Facilities providing clinical drug trial services.

Chapter II
PHARMACEUTICAL BUSINESS

Section 1

CONDITIONS FOR ISSUING A LICENSE TO OPERATE A PHARMACEUTICAL BUSINESS

Article 4. Recipients of a License to Operate a Pharmaceutical Business

1. The License to Operate a Pharmaceutical Business shall be issued to pharmaceutical business establishments that meet the conditions specified for each form of pharmaceutical business operation as provided in this Chapter.

2. A pharmaceutical business establishment may only operate at the location and within the scope of business as specified in the License to Operate a Pharmaceutical Business.

Article 5. Conditions for Issuing a License to Operate a Pharmaceutical Business for Production Facilities

1. The professional manager in charge of pharmaceuticals must hold a valid Pharmaceutical Practice Certificate appropriate to the organizational form of the production facility.

2. The pharmaceutical production facility must satisfy the following conditions:

a) Having a sufficient number of staff with appropriate qualifications and assessed as suitable for assigned tasks;

b) The factory premises, auxiliary systems, and equipment must be equipped, arranged, designed, manufactured, evaluated, certified, used, and maintained in accordance with their intended purposes;

c) Having a quality control area that meets the requirements for quality control commensurate with the scale of production;

d) Having a storage area that ensures storage conditions and storage activities appropriate to the scale of production;

đ) Having a quality management system, documentation based on standards, formulas, guidelines, and procedures covering all activities carried out.

Article 6. Conditions for Issuing a License to Operate a Pharmaceutical Business for Wholesale Facilities

1. The professional manager in charge of pharmaceuticals must hold a valid Pharmaceutical Practice Certificate appropriate to the organizational form of the wholesale facility.

2. The pharmaceutical wholesale facility must satisfy the following conditions:

a) Having a sufficient number of staff with appropriate qualifications and assessed as suitable for assigned tasks;

b) Warehouses and auxiliary systems must be designed, constructed, used, and maintained in accordance with their intended purpose of storage and the scale of use, ensuring proper storage conditions as indicated on the drug labels; there must be separate areas for orderly storage of different types of products; receiving and distribution areas must have the capacity to protect drugs from adverse weather conditions; related storage areas must have appropriate and clear signage;

c) Storage and transportation equipment must be equipped, arranged, designed, evaluated, certified, used, and maintained in accordance with their intended purposes, ensuring storage conditions and storage activities;

d) Cold storage warehouses must be equipped with backup power generation systems for warehouse operations;

đ) Having transportation means that ensure storage conditions, security, and safety requirements for drugs as required by the business;

e) Having a quality management system, documentation, guidelines, and procedures covering all activities carried out.

Article 7. Conditions for Issuing a Business Registration Certificate for Retail Drug Sales

1. The owner of a retail drug sales establishment must have a Pharmacy Practice Certificate appropriate to each form of business organization of the retail drug sales establishment.

2. A retail drug sales establishment, except for a retail herbal medicine sales establishment, must meet the following conditions:

a) Must have a fixed, separate location; arranged in a high, airy, safe place, far from sources of pollution, and with signage as prescribed;

b) The retail sales location must be constructed securely, with a dust-proof ceiling, walls and floor that are easy to clean, well-lit but not directly exposed to sunlight, ensuring the storage conditions indicated on the drug label;

c) The area must be suitable for the scale of business operations, having areas for displaying and storing drugs, and areas for customers to interact and exchange information about drug usage with the retailer;

d) Additional space must be provided for other activities: a compounding area if there is compounding according to prescriptions; an unpackaged drug sales area for direct sale to patients; hand washing facilities for retailers and customers; a private consultation area for patients and seating for customers while waiting;

đ) Must have cabinets, shelves for storing drugs that meet the requirements for drug storage conditions and security and safety for drugs;

e) In cases where cosmetics, health foods, medical devices are also sold, they must have separate areas, not displayed together with drugs and not affecting the drugs;

Article 8. Conditions for Issuing a Business Registration Certificate for Wholesale and Import/Export Drug Sales

1. The professional manager in pharmacy must have a Pharmacy Practice Certificate appropriate to each form of business organization of the import/export drug sales establishment.

2. An import drug sales establishment, an export drug sales establishment must meet the following conditions:

a) Having a sufficient number of staff with appropriate qualifications and assessed as suitable for assigned tasks;

b) Warehouses and auxiliary systems must be designed, constructed, used, and maintained appropriately for storage purposes and the scale of use;

c) Storage equipment and transportation equipment must be equipped, arranged, designed, evaluated, certified, used, and maintained appropriately for their intended purpose, ensuring storage conditions and storage activities;

d) Must have a quality management system, documentation, guidelines, and procedures covering all activities carried out;

3. The enterprise must have a Business Registration Certificate for Wholesale Drug Sales.

Article 9. Conditions for Issuing a Business Registration Certificate for Drug Storage Service Enterprises

1. The professional manager in pharmacy must have a Pharmacy Practice Certificate appropriate to the form of drug storage service enterprise;

2. A drug storage service enterprise must meet the conditions stipulated in Clause 2 of Article 8, Point d of Clause 1 of Article 19 of this Decree, and must ensure responsibilities to the service user regarding the quality, quantity, value of drugs, and ensure that the service user fulfills responsibilities for the drugs entrusted for storage;

Article 10. Conditions for Issuing a Business Registration Certificate for Drug Testing Service Enterprises

1. The professional manager in pharmacy must have a Pharmacy Practice Certificate appropriate to the form of drug testing service enterprise;

2. A drug testing service enterprise must meet the following conditions:

a) Must have sufficient personnel with appropriate qualifications and assessed as suitable for assigned tasks;

b) The testing laboratory must be arranged and designed appropriately, spacious enough to separate different testing activities, adequate space for specialized equipment, documentation, and working space for staff;

c) Equipment, machinery, tools must be equipped appropriately for testing methods, testing purposes of the enterprise, and suitable for sampling, analysis, calibration, and data processing;

d) Must be fully equipped with chemicals, reagents, standards, technical documentation to meet testing purposes;

đ) Must have a quality management system, documentation, guidelines, and procedures covering all activities carried out.

Article 11. Conditions for Issuing a Business Registration Certificate for Facilities Providing Clinical Drug Testing Services

1. The professional manager in charge of pharmaceuticals must have a valid pharmaceutical practice certificate appropriate to the form of clinical drug testing service facility, specifically:

a) The professional manager in charge of pharmaceuticals of enterprises providing clinical drug testing services must hold a bachelor's degree in pharmacy or general medicine and have at least three years of specialized practical experience at a suitable pharmaceutical establishment or hospital with beds, except in cases stipulated in point b of this clause;

b) The professional manager in charge of pharmaceuticals of enterprises providing clinical drug testing services for drugs derived from medicinal herbs must hold a bachelor's degree in pharmacy, general medicine, traditional Chinese medicine, or traditional herbal medicine and have at least three years of specialized practical experience at a suitable pharmaceutical establishment or hospital with beds.

2. Facilities providing clinical drug testing services must meet the following conditions:

a) Have sufficient personnel with appropriate professional qualifications for the assigned tasks;

b) Have premises, clinical testing rooms, laboratories, and biochemical testing equipment designed, constructed, and sized appropriately for clinical drug testing activities;

c) Have a quality management system for file documentation based on standards, formulas, guidelines, and procedures for clinical drug testing activities.

Section 2

CONDITIONS FOR PHARMACEUTICAL HERB BUSINESS

Article 12. General Conditions for Exporting, Importing, Wholesale, Retail, and Storage of Pharmaceutical Herbs

1. Facilities exporting, importing, wholesaling, retailing, and storing pharmaceutical herbs must be issued a Business Registration Certificate for Medicines with a scope of business in pharmaceutical herbs.

2. Conditions for issuing a Business Registration Certificate for Medicines with a scope of business in pharmaceutical herbs:

a) The professional manager of the facility must have a valid pharmaceutical practice certificate, except in cases stipulated in Clause 2 of Article 17 of this Decree;

b) Must meet corresponding conditions for each type of business as specified in Articles 13, 14, 15, and 16 of this Decree.

Article 13. Exporting and Importing Pharmaceutical Herbs

1. Enterprises importing pharmaceutical herbs must meet the following conditions:

a) Already been issued a Business Registration Certificate for Medicines with a scope of wholesale pharmaceutical herbs;

b) Comply with the principles and standards of Good Storage Practices for Medicines applicable to pharmaceutical herbs;

c) Enterprises engaged in the business of pharmaceutical herbs that do not meet the direct import conditions must enter into a consignment import agreement with an enterprise that meets the import conditions as prescribed, and the name of the consignee importer must be reflected on the import order.

2. Enterprises holding a Business Registration Certificate for Medicines with a scope of manufacturing medicines from pharmaceutical herbs and having a certificate of compliance with Good Manufacturing Practices (GMP) may import pharmaceutical herbs to meet their own production needs and sell them to other manufacturing enterprises and healthcare facilities in accordance with the law.

3. Enterprises exporting pharmaceutical herbs must meet the following conditions:

a) The conditions stipulated in point a of Clause 1 of this Article;

b) The conditions stipulated by the importing country for pharmaceutical herbs (if any).

Article 14. Conditions for wholesale establishments of medicinal materials

Must comply with the principles and standards of Good Storage Practices for Medicinal Materials and the principles and standards of Good Distribution Practices for Medicinal Materials as stipulated in Point g and Point h Clause 1 Article 19 of this Decree.

Article 15. Conditions for retail establishments of medicinal materials

1. Regarding physical facilities:

a) Have a fixed location with an appropriate area suitable to the scale of business, separate from other areas; located in a dry, airy, safe place, far from sources of pollution, ensuring fire prevention and explosion control; must have display areas and storage areas for medicinal materials;

b) Have equipment to store medicines that can prevent adverse effects of light, heat, humidity, contamination, and insect intrusion, including: sturdy, smooth, easy-to-clean shelves, counters, and racks suitable for displaying and storing medicines; thermometers, hygrometers, air conditioners, dehumidifiers to control temperature and humidity at the retail establishment; lighting systems, exhaust fans. Storage equipment must be suitable for the storage requirements indicated on the label. Room temperature storage conditions should not exceed 30°C, and humidity should not exceed 75%.

2. Regarding personnel:

a) Have staff with qualifications appropriate to the assigned tasks, including at least one person with a qualification level of pharmacist or higher;

b) Personnel directly involved in retailing medicinal materials must regularly undergo specialized training and updates on new legal regulations regarding the storage and management of medicinal materials.

3. Retail establishments may only sell medicinal materials purchased from establishments that meet the conditions for trading in medicinal materials; these materials must have clear origins and packaging labels complying with the guidelines issued by the Minister of Health for drug labeling; they may not sell unprocessed medicinal materials with toxicity listed in the Catalogue of Toxic Medicinal Materials Used as Drugs in Vietnam issued by the Minister of Health.

Article 16. Conditions for enterprises providing medicinal material storage services

1. The professional manager in charge of pharmaceuticals must hold a valid Pharmaceutical Practice Certificate appropriate to the form of enterprise providing medicinal material storage services.

2. Enterprises providing medicinal material storage services must meet the following conditions:

a) Having a sufficient number of staff with appropriate qualifications and assessed as suitable for assigned tasks;

b) Warehouses and auxiliary systems must be designed, constructed, used, and maintained appropriately for storage purposes and the scale of use;

c) Storage equipment and transportation equipment must be equipped, arranged, designed, evaluated, certified, used, and maintained appropriately for their intended purpose, ensuring storage conditions and storage activities;

d) Must have a quality management system, documentation, guidelines, and procedures covering all activities carried out;

Article 17. Trading in medicinal materials in traditional craft villages, traditional villages, and traditional streets for medicinal material trade

1. Forms of export, import, wholesale, and storage service provision for medicinal materials in traditional craft villages, traditional villages, and traditional streets for medicinal material trade must comply with the conditions for corresponding types of business as specified in Articles 13, 14, 15, and 16 of this Decree.

2. Forms of retail trade in medicinal materials in traditional craft villages, traditional villages, and traditional streets for medicinal material trade must comply with the provisions of Article 15 of this Decree. The person responsible for professional management or the owner of the retail establishment in traditional craft villages, traditional villages, and traditional streets for medicinal material trade must hold one of the certificates or diplomas prescribed in Point c Clause 3 Article 15 of Government Decree No. 79/2006/NĐ-CP detailing the implementation of certain provisions of the Medicine Law or a certificate or training certificate in pharmacy or traditional medicine issued by a training institution.

Article 18. Conditions for establishments engaged in medicinal material processing

1. Hold a Certificate of Eligibility for Drug Business with a scope of medicinal material business.

2. The professional manager of the medicinal material processing establishment must have a bachelor's degree in pharmacy or a bachelor's degree in traditional medicine and have at least two years of practical experience at a legitimate pharmaceutical establishment.

3. Personnel directly involved in medicinal material processing must regularly undergo training and updates on specialized knowledge related to medicinal material processing.

4. Factories and equipment must be designed, constructed, repaired, and maintained in accordance with the processes and scale of processing activities of the establishment, specifically as follows:

a) The incoming medicinal material storage area must meet the conditions for warehouse location and design in accordance with the principles and standards of Good Storage Practices for Medicinal Materials.

b) Processing Area:

Depending on the scale of processing, the processing areas for medicinal materials must be arranged to facilitate the movement of raw materials during processing, including two areas: preliminary processing area and complex processing area.

The preliminary processing and complex processing areas for medicinal materials must be spacious, well-ventilated, easy to clean, ensure safety and convenient operation, and have a system of clean water supply for processing medicinal materials.

c) Quality Control Area:

The quality control area for raw materials and finished products must be separated from the processing area. The quality control area must be designed to suit the inspection activities.

d) Post-processing Storage Area:

The post-processing storage area for medicinal materials must meet the principles and standards of Good Storage Practices for Medicinal Materials.

5. Auxiliary Systems:

a) Air Handling System:

The establishment must install separate air handling or air conditioning systems for each area.

b) Water Treatment System:

Depending on the requirements of different processing methods for medicinal materials, the water used for processing purposes must at least meet national technical standards for potable water.

c) Wastewater, Exhaust Gas, and Solid Waste Treatment System:

The establishment must have appropriate measures to treat wastewater, exhaust gas, and solid waste generated during processing, ensuring safety and hygiene.

d) Fire Prevention and Extinguishing System:

The establishment must be equipped with sufficient firefighting tools and equipment according to regulations on fire prevention and extinguishing.

6. The establishment must have all necessary equipment for medicinal material processing. These devices must ensure safety during operation, be easy to clean and maintain, prevent cross-contamination, dust accumulation, and avoid adverse effects that could impact product quality. The establishment must develop and strictly adhere to operational and cleaning guidelines for the equipment.

8. At least thirty days before commencing the processing of medicinal materials, the facility must notify the Ministry of Health. The Ministry of Health shall organize regular inspections every three years or at random to ensure that the facility meets the conditions for processing medicinal materials.

Article 19. Conditions for Applying Good Practice Principles and Standards

1. In addition to meeting the conditions stipulated in Articles 5, 6, 7, 8, 9, 10, 11, 14, 16, and Clause 1 of Article 13 of this Decree, pharmaceutical business establishments must also meet the minimum good practice principles and standards of the World Health Organization, as updated and published on the Ministry of Health's electronic portal, corresponding to each form and scope of business as follows:

a) Good Manufacturing Practices (GMP) principles and standards for pharmaceutical production facilities;

b) Good Distribution Practices (GDP) principles and standards for wholesale pharmaceutical facilities;

c) Good Pharmacy Practices (GPP) principles and standards for retail pharmaceutical facilities;

d) Good Storage Practices (GSP) principles and standards for pharmaceutical storage service facilities and pharmaceutical import-export facilities;

đ) Good Laboratory Practices (GLP) principles and standards for pharmaceutical testing service facilities;

e) Good Clinical Practices (GCP) principles and standards for clinical trial service business establishments;

g) Good Storage Practices (GSP) principles and standards for medicinal materials applicable to medicinal material storage service facilities and medicinal material import-export facilities;

h) Good Distribution Practices (GDP) principles and standards for medicinal materials applicable to wholesale medicinal material facilities.

2. The procedures for issuing certificates of good practices specified in Clause 1 of this Article shall be carried out in accordance with Decree No. 79/2006/ND-CP dated August 9, 2006, of the Government detailing the implementation of certain provisions of the Medicine Law; Decree No. 89/2012/ND-CP dated October 24, 2012, of the Government amending and supplementing certain provisions of Decree No. 79/2006/ND-CP dated August 9, 2006, of the Government detailing the implementation of certain provisions of the Medicine Law, and related legal documents.

Section 3

CONDITIONS FOR THE SALE OF DRUGS CAUSING ADDICTION, PSYCHOTROPIC DRUGS, PRECURSOR CHEMICALS USED IN DRUGS, FINISHED DRUGS CONTAINING ADDICTIVE, PSYCHOTROPIC, OR PRECURSOR CHEMICALS

Article 20. Conditions for Production Facilities

1. Pharmaceutical production facilities producing drugs causing addiction, psychotropic drugs, and precursor chemicals used in drugs must comply with the provisions of Article 5 of this Decree and the following regulations:

a) Must meet Good Manufacturing Practices (GMP) principles and standards suitable for each dosage form for at least two years;

b) The warehouse manager responsible for storing drugs causing addiction must have a bachelor's degree in pharmacy and at least two years of work experience in a pharmaceutical production facility;

c) The warehouse manager responsible for storing psychotropic drugs, precursor chemicals used in drugs must have a bachelor's degree in pharmacy or a diploma in pharmacy and above, authorized in writing by the head of the facility (the authorization period shall not exceed twelve months each time);

d) Key staff members responsible for record-keeping and reporting must have a bachelor's degree in pharmacy and at least two years of work experience in a pharmaceutical production facility;

đ) Documentation and ledgers: Pharmaceutical production facilities producing drugs causing addiction, psychotropic drugs, and precursor chemicals used in drugs must establish and record the following tracking ledgers: ledger for compounding drugs causing addiction, psychotropic drugs, and precursor chemicals used in drugs, ledger for tracking the entry and exit of drugs causing addiction, psychotropic drugs, and precursor chemicals used in drugs, ledger for transferring semi-finished and finished products during production, inventory card for drugs causing addiction, psychotropic drugs, and precursor chemicals used in drugs, all in accordance with the regulations of the Minister of Health.

2. Pharmaceutical production facilities producing finished drugs containing addictive substances, finished drugs containing psychotropic substances, and finished drugs containing precursor chemicals must comply with the following regulations:

a) Must meet Good Manufacturing Practices (GMP) principles and standards suitable for each dosage form for at least two years;

b) The warehouse manager responsible for storing raw materials and semi-finished products containing addictive substances must have a bachelor's degree in pharmacy and at least two years of work experience in a pharmaceutical production facility;

c) The warehouse manager responsible for storing raw materials and semi-finished products containing psychotropic substances, raw materials and semi-finished products containing precursor chemicals must have a bachelor's degree in pharmacy or a diploma in pharmacy and above, authorized in writing by the head of the facility (the authorization period shall not exceed twelve months each time);

d) Key staff members responsible for record-keeping and reporting must have a bachelor's degree in pharmacy and at least two years of work experience in a pharmaceutical production facility;

đ) Documentation and ledgers: Pharmaceutical production facilities producing finished drugs containing addictive substances, finished drugs containing psychotropic substances, and finished drugs containing precursor chemicals must fully record the ledgers for tracking the entry and exit of finished drugs containing addictive substances, finished drugs containing psychotropic substances, and finished drugs containing precursor chemicals in accordance with the regulations of the Minister of Health.

Article 21. Conditions for Export and Import Establishments

1. Export and import establishments dealing with narcotic drugs, psychotropic substances, and precursor chemicals used as drugs must comply with the provisions set forth in Article 8 of this Decree and the following requirements:

a) Having at least five years of experience in exporting and importing drugs;

b) Within the five-year period prior to the date of application for additional export and import activities involving narcotic drugs, psychotropic substances, and precursor chemicals used as drugs, the establishment has not engaged in business with drugs that have been seriously violated in terms of quality as concluded by the competent state agency responsible for drug quality management, nor has it committed acts of forgery or tampering with the files, documents, or legal papers of relevant agencies in Vietnam or abroad; it has not used fake seals or forged signatures or stamps of the importing establishment, the manufacturing establishment, and related establishments in the export and import documents;

c) Having a dedicated warehouse meeting the principles and standards of Good Storage Practices for Narcotic Drugs, Psychotropic Substances, and Precursor Chemicals Used as Drugs, suitable for the scale of business operations but with a minimum area of 100 square meters² and a minimum volume of 300 cubic meters³. The warehouse must have doors, secure locks, safety measures, and prevent loss;

d) Having a minimum of three sales locations meeting the principles and standards of Good Distribution Practices for Narcotic Drugs, Psychotropic Substances, and Precursor Chemicals Used as Drugs in the three regions of North, Central, and South;

đ) Having a software system for tracking and managing narcotic drugs, psychotropic substances, and precursor chemicals used as drugs, along with security measures to prevent loss;

e) Personnel: The warehouse manager, the person responsible for reporting, and the person responsible for specialized matters must hold a bachelor's degree in pharmacy and have at least two years of professional experience in drug manufacturing and trading establishments;

Individuals involved in business and export-import activities must be trained on relevant regulatory documents concerning the management of narcotic drugs, psychotropic substances, and precursor chemicals used as drugs, provided by training institutions assigned tasks by the Ministry of Health;

g) Documents and ledgers: Export and import enterprises dealing with narcotic drugs, psychotropic substances, and precursor chemicals used as drugs must establish and record all types of documents and ledgers as follows: ledger for tracking the import and export of narcotic drugs, psychotropic substances, and precursor chemicals used as drugs; Drug dispatch note for narcotic drugs, psychotropic substances, and precursor chemicals used as drugs implemented according to the regulations of the Minister of Health; documents related to the export, import, purchase, and sale of narcotic drugs, psychotropic substances, and precursor chemicals used as drugs;

2. Establishments meeting the business conditions for drugs as stipulated in Chapter II of the Pharmacy Law and this Decree may export and import finished products containing narcotic drug ingredients, finished products containing psychotropic substance ingredients, and finished products containing precursor chemical ingredients; they must establish and record the following documents:

a) Ledger for tracking the import and export of finished products containing narcotic drug ingredients, finished products containing psychotropic substance ingredients, and finished products containing precursor chemical ingredients, implemented according to the regulations of the Minister of Health;

b) Documents related to the export, import, purchase, and sale of finished products containing narcotic drug ingredients, finished products containing psychotropic substance ingredients, and finished products containing precursor chemical ingredients.

Article 22. Conditions for Wholesale Enterprises

1. Provincial and centrally-administered city pharmaceutical enterprises (including those not yet privatized and those already privatized) may purchase and sell finished narcotic drugs, finished psychotropic drugs, and finished precursor drugs in accordance with the provisions of Article 6 of this Decree and the following requirements:

a) Must have a warehouse that meets the principles and standards of Good Storage Practices for Drugs, including a secure lockable area for storing finished narcotic drugs, finished psychotropic drugs, and finished precursor drugs, with safety measures to prevent loss. If there is no separate warehouse, these drugs must be stored in a designated area within a warehouse that meets the principles and standards of Good Storage Practices for Drugs;

b) Personnel: The warehouse manager must hold a bachelor's degree in pharmacy and have at least two years of experience working in a drug trading company;

c) Documentation and ledgers: Records of the import and export of narcotic drugs, psychotropic drugs, and precursor drugs used as medicines, Narcotic Drug Outbound Warehouse Orders, Psychotropic Drug Outbound Warehouse Orders, and Precursor Drug Outbound Warehouse Orders used as medicines shall be carried out in accordance with the regulations of the Minister of Health; related documents concerning the export, import, purchase, and sale of narcotic drugs, psychotropic drugs, and precursor drugs used as medicines.

2. Entities meeting the conditions for operating drug businesses as stipulated in Chapter II of the Pharmaceutical Law and this Decree may purchase and sell combined finished drugs containing narcotic substances, combined finished drugs containing psychotropic substances, and combined finished drugs containing precursors; they must establish and record the following documents:

a) Records of the import and export of combined finished drugs containing narcotic substances, combined finished drugs containing psychotropic substances, and combined finished drugs containing precursors, carried out in accordance with the regulations of the Minister of Health;

b) Documents related to the purchase and sale of combined finished drugs containing narcotic substances, combined finished drugs containing psychotropic substances, and combined finished drugs containing precursors.

Article 23. Conditions for Retail Establishments

1. Retail establishments selling finished narcotic drugs, finished psychotropic drugs, and finished precursor drugs must comply with the provisions of Article 7 of this Decree and the following requirements:

a) Must be a pharmacy that meets the principles and standards of Good Pharmacy Practice;

b) Must register with the Department of Health in their locality;

c) The pharmacy owner and the professional manager must directly manage and retail finished narcotic drugs;

d) A pharmacist with a secondary education or higher must manage and retail finished psychotropic drugs and finished precursor drugs;

đ) Must establish, record, and retain the following types of documents according to the regulations of the Minister of Health: Records of the import and export of narcotic drugs, psychotropic drugs, and precursor drugs used as medicines, detailed customer information records, Narcotic Drug Outbound Warehouse Orders, Psychotropic Drug Outbound Warehouse Orders, and Precursor Drug Outbound Warehouse Orders used as medicines from the supplier; Narcotic Drug Prescriptions and Psychotropic Drug Prescriptions retained at the establishment after sale; Receipts for narcotic drug finished products returned by family members of patients.

2. Retail establishments selling combined finished drugs containing narcotic substances, combined finished drugs containing psychotropic substances, and combined finished drugs containing precursors must comply with the provisions of Article 7 of this Decree and the following requirements:

a) Must be a pharmacy that meets Good Pharmacy Practice;

b) Must have records, inventory checks, and reports on the quantity purchased, imported, stock, quantity sold, remaining stock, and customer addresses every six months and annually, in accordance with the regulations of the Minister of Health.

Section 4

RADIOPHARMACEUTICAL BUSINESS CONDITIONS

Article 24. Business Conditions

In addition to meeting the pharmaceutical business conditions stipulated in Chapter II of the Pharmacy Law and Section 1 of Chapter II of this Decree, a radiopharmaceutical business entity must also meet the following conditions:

1. Hold a radiation safety assurance permit issued by the Ministry of Science and Technology.

2. The radiation safety officer must be trained in radiation safety knowledge and must hold a radiation safety training certificate issued by a training institution authorized by the Ministry of Science and Technology.

Article 25. Preparation and Use of Radiopharmaceuticals

1. The preparation and use of radiopharmaceuticals can only be carried out in nuclear medical facilities that have been granted a radiation safety assurance permit by the Ministry of Science and Technology.

2. Nuclear medical facilities that require radiopharmaceuticals must prepare a forecast table according to the prescribed model for review by the Ministry of Health, while simultaneously reporting to the Ministry of Science and Technology for monitoring.

Chapter III
IMPLEMENTING PROVISIONS

Article 26. Transitional Provisions

1. For a Pharmaceutical Practice Certificate valid for five years, upon expiration, the individual must reapply for the Pharmaceutical Practice Certificate at the competent state authority.

2. For a Pharmaceutical Business Condition Compliance Certificate valid for five years, upon expiration, the business entity must reapply at the competent state authority.

3. Entities currently engaged in the production, export, import, wholesale, and retail of narcotic drugs, psychotropic drugs, precursor substances used in drug manufacturing, finished drug products containing narcotic active ingredients, finished drug products containing psychotropic active ingredients, and finished drug products containing precursor substances may continue their operations until they comply with the provisions of the Pharmacy Law 2016.

Article 27. Effective Date

1. This Decree takes effect from July 1, 2016.

2. Articles 20, 21, 22, 23, 24, 25, 26, and 27 of Section 2, Chapters IV and V of Decree No. 79/2006/NĐ-CP dated August 9, 2006, detailing the implementation of certain provisions of the Pharmacy Law, shall cease to be effective from the date this Decree comes into force.

Article 28. Responsibility for Implementation

1. The Minister of Health is responsible for guiding and organizing the implementation of this Decree.

2. Ministers, Heads of ministerial-level agencies, Heads of government-affiliated agencies, Chairpersons of provincial People's Committees under central cities, and related agencies, organizations, and individuals are responsible for implementing this Decree.