Decree No. 102/2016/ND-CP dated July 01, 2016 of the Government on drug business requirements

DECREE

Prescribing conditions for drug business[1]

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

Pursuant to the June 14, 2005 Pharmacy Law;

Pursuant to the November 26, 2014 Law on Investment;

At the proposal of the Minister of Health;

The Government promulgates the Decree prescribing conditions for drug business.

Chapter I

GENERAL PROVISIONS

Article 1. Scope of regulation and subjects of application

1. This Decree provides conditions for drug business.

2. This Decree applies to domestic and foreign agencies, organizations and individuals that operate in the field of pharmacy in Vietnam.

Article 2. Interpretation of terms

In this Decree, the terms below are construed as follows:

1. Lawful pharmaceutical establishment means an establishment operating in the field of pharmacy and established in accordance with law. Lawful pharmaceutical establishments include:

a/ Drug business establishments;

b/ Pharmacy departments of medical examination and treatment establishments;

c/ Institutions providing training in pharmacy;

d/ Pharmaceutical research institutes and drug quality control institutes and centers;

dd/ State management agencies in charge of pharmacy;

e/ Representative offices of foreign traders operating in the field of pharmacy in Vietnam;

g/ Other pharmaceutical establishments as prescribed by law.

2. Combination drug containing a habit-forming ingredient is a finished drug fully meeting the following conditions:

a/ Containing active ingredients other than habit-forming ingredients, psychotropic ingredients and pre-substances used as drugs;

b/ Containing habit-forming ingredients, or containing habit-forming ingredients combined with psychotropic ingredients, or containing habit-forming ingredients combined with drug precursors, or containing habit-forming ingredients combined with psychotropic ingredients and drug precursors;

c/ The concentrations and contents of habit-forming ingredients, psychotropic ingredients and drug precursors are smaller than or equal to the concentrations and contents of such ingredients and drug precursors prescribed in the list issued by the Minister of Health.

3. Combination drug containing psychotropic ingredients is a finished drug fully meeting the following conditions:

a/ Containing active ingredients other than habit-forming ingredients, psychotropic ingredients and drug precursors;

b/ Containing psychotropic ingredients or containing psychotropic ingredients combined with drug precursors;

c/ The concentrations and contents of psychotropic ingredients and drug precursors are smaller than or equal to the concentrations and contents of such ingredients and drug precursors as drugs prescribed in the list issued by the Minister of Health.

4. Combination drug containing drug precursors is a finished drug fully meeting the following conditions:

a/ Containing active ingredients other than habit-forming ingredients, psychotropic ingredients and drug precursors;

b/ Containing drug precursors with a concentration and content smaller than or equal to the concentration and content of such drug precursors prescribed in the list issued by the Minister of Health.

5. Pharmachemical drug means a drug containing active ingredients with determined compositions, formulas and purity.

6. Medicinal materials are drug materials which are of plant, animal or mineral origin and qualified for use as drugs.

Medicinal materials do not include semi-finished drugs produced from medicinal materials.

7. Semi-finished drugs produced from medicinal materials are drug materials which are produced from medicinal materials in the form of ointment, granule, powder, extract or essential oil and are used in the manufacture of drugs from medicinal materials.

8. Medicinal raw materials are materials of natural origin from plants, animals or minerals which may be used as drugs but have not yet been preliminarily processed or processed.

9. Traditional medicaments are medicinal materials which are prepared according to traditional medicine theories and methods and used to manufacture traditional drugs or to prevent and treat diseases.

10. Preliminary processing means checking and classifying medicinal raw materials, removing impurities, soaking, fermenting, washing, sun-drying, heat-drying, cleaning, cutting or grinding.

11. Processing means the process of qualitatively and quantitatively changing medicinal raw materials or preliminarily processed medicinal materials into traditional medicaments according to traditional medicine theories and methods.

Article 3. Forms of organization of drug business

1. Drug manufacturing establishments include:

a/ Drug manufacturing enterprises;

b/ Cooperatives and business households manufacturing medicinal materials, traditional drugs and drugs from medicinal materials.

2. Drug wholesale establishments include:

a/ Drug wholesale enterprises;

b/ Cooperatives and business households wholesaling medicinal materials, traditional drugs and drugs from medicinal materials;

c/ Vaccine and medical bio-product wholesale agents.

3. Drug retail establishments include those doing business in the form prescribed in Clause 1, Article 24 of the Law on Pharmacy; and establishments retailing traditional drugs and drugs from medicinal materials as prescribed at Point dd, Clause 1, Article 26 of the Law on Pharmacy.

4. Drug import and export enterprises.

5. Enterprises providing drug storage services.

6. Enterprises providing drug testing services.

7. Establishments conducting clinical trial of drugs.

Chapter II

DRUG BUSINESS

Section 1

CONDITIONS FOR GRANT OF CERTIFICATES OF ELIGIBILITY FOR DRUG BUSINESS

Article 4. Subjects entitled to be granted certificates of eligibility for drug business

1. Certificates of eligibility for drug business shall be granted to drug business establishments that meet the conditions prescribed for each form of drug business in this Chapter.

2. Drug business establishments may only operate in the locations and within the scope of business stated in their certificates of eligibility for drug business.

Article 5. Conditions for grant of a certificate of eligibility for drug business to a drug manufacturing establishment

1. The person in charge of pharmaceutical operations of a drug manufacturing establishment must possess a pharmacy practice certificate relevant to the form of organization of business of the establishment;

2. A drug manufacturing establishment must meet the following conditions:

a/ Having sufficient employees who possess qualifications and are assessed to be suitable to their assigned tasks;

b/ Having workshops, auxiliary facilities and equipment which are equipped, designed, manufactured, tested, appraised, used and maintained according to their use purposes;

c/ Having an area for quality inspection which meets quality inspection requirements in conformity with the scope of manufacture of the establishment;

d/ Having a storage area which meets storage conditions and storage activities in conformity with the scope of manufacture of the establishment;

dd/ Having a quality control system and records based on standards, formulas, instructions and general processes for all activities carried out by the establishment.

Article 6. Conditions for grant of a certificate of eligibility for drug business to a drug wholesale establishment

1. The person in charge of pharmaceutical operations of a drug wholesale establishment must possess a pharmacy practice certificate relevant to the form of organization of business of the establishment.

2. A drug wholesale establishment must meet the following conditions:

a/ Having sufficient employees who possess qualifications and are assessed to be suitable to their assigned tasks;

b/ Having storehouses and auxiliary facilities which are designed, built, used and maintained according to their use purposes and scope so as to ensure that drugs are stored strictly under the conditions stated on their labels; having separate areas for storing products of different types in an orderly manner; having a drug receipt and delivery area capable of protecting drugs against unfavorable weather conditions; and having related storage areas with suitable and conspicuous signboards;

c/ Having storage and transportation equipment which are arranged, designed, tested, appraised, used and maintained according to their use purposes, thus meeting storage conditions and facilitating storage activities;

d/ Having refrigerated storehouses which are equipped with standby generators;

dd/ Having vehicles for drug transportation meeting preservation conditions and security and safety requirements for drugs traded by the establishment;

e/ Having a quality control system, records, instructions and general processes for all activities carried out by the establishment.

Article 7. Conditions for grant of certificates of eligibility for drug business to a drug retail establishment

1. The owner of a drug retail establishment must possess a pharmacy practice certificate relevant to the form of organization of business of the establishment.

2. A drug retail establishment, except those retailing medicinal materials, must meet the following conditions:

a/ Having a fixed, separate location in a safe, well-ventilated, high and dry place far from polluting sources, and with a signboard according to regulations;

b/ Having firmly built retail stores with anti-dust ceilings and easy-to-clean walls and floors and sufficient lighting to avoid direct exposure to sunlight for drugs and ensure the storage conditions stated on their labels;

c/ Having an area suitable to the scope of business with places for drug display and storage and for customers to share drug use-related information with salespersons;

d/ Having an additional area for other activities: Preparing drugs by prescriptions if providing such service; dividing drugs that no longer have primary packages for direct retail to customers; installing hand-washing bowls for drug salespersons and customers; providing private counseling for patients and placing customer waiting chairs;

dd/ Having drug cabinets, stands and racks meeting drug storage conditions as well as drug security and safety requirements;

e/ In case the establishment also trades in cosmetics, functional food or medical devices, it must have a separate space for such articles so that they do not affect drugs.

Article 8. Conditions for grant of a certificate of eligibility to a drug import and export enterprise

1. The person in charge of pharmaceutical operations of a drug import and export establishment must possess a pharmacy practice certificate relevant to the form of organization of business of the establishment.

2. A drug import and export establishment must meet the following conditions:

a/ Having sufficient employees who possess qualifications and are assessed to be suitable to their assigned tasks;

b/ Having storehouses and auxiliary facilities which are designed, built, used and maintained according to their use purposes and scope;

c/ Having storage and transportation equipment which are arranged, designed, tested, appraised, used and maintained according to their use purposes, thus meeting storage conditions and facilitating storage activities;

d/  Having a quality control system, records, instructions and general processes for all activities carried out by the establishment.

3. The enterprise must possess a certificate of eligibility for drug business in the form of drug wholesale.

Article 9. Conditions for grant of a certificate of eligibility for drug business to an enterprise providing drug storage service 

1. The person in charge of pharmaceutical operations of an enterprise providing drug storage service must possess a pharmacy practice certificate relevant to the form of the enterprise.

2. An enterprise providing drug storage service must meet the conditions prescribed in Clause 2 of Article 8, and at Point d, Clause 1, Article 19, of this Decree and shall ensure responsibilities to service users for the quality, quantity and value of drugs and that service users shall take responsibility for the drugs consigned to the enterprise for storage.

Article 10. Conditions for grant of a certificate of eligibility for drug business to an enterprise providing drug testing service

1. The person in charge of pharmaceutical operations of an enterprise providing drug testing service must possess a pharmacy practice certificate relevant to the form of the enterprise.

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

a/ Having sufficient employees who possess qualifications and are assessed to be suitable to their assigned tasks;

b/ Having testing laboratories which are appropriately arranged and designed and large enough for carrying out different testing activities in separate areas and for placing technical equipment and records and arranging working space for staff members;

c/ Having equipment, machinery and devices suitable to testing methods and purposes, sample taking and analysis, calibration and date processing;

d/ Having sufficient chemicals, reagents, standard substances and technical materials meeting testing purposes;

dd/ Having a quality control system, records, instructions and general processes for all activities carried out by the enterprise.

Article 11. Conditions for grant of business eligibility certificates to drug clinical trial service establishments

1. The person in charge of pharmaceutical operations of a drug clinical trial service establishment must possess a pharmacy practice certificate relevant to the form of the establishment, specifically:

a/ The person in charge of pharmaceutical operations of an enterprise providing drug clinical trial service must possess a university diploma in pharmacy or general medicine and have practiced at a suitable pharmaceutical establishment, hospital or institute engaged in in-patient treatment, except the case prescribed at Point b of this Clause;

b/ The person in charge of pharmaceutical operations of an enterprise providing  clinical trial service for drugs from medicinal materials must possess a university degree in pharmacy, general medicine, traditional medicine or traditional pharmacy and have practiced at a suitable pharmaceutical establishment, hospital or institute engaged in in-patient treatment.

2. A drug clinical trial service establishment must meet the following conditions:

a/ Having sufficient employees who possess professional qualifications relevant to their assigned tasks;

b/ Having clinical research labs, testing labs and physical-chemical testing devices which are designed or built on an area suitable to the clinical trial of drugs;

 c/ Having a quality control system and records based on standards, formulas, instructions and processes for drug clinical trial activities

Section 2

CONDITIONS FOR MEDICINAL MATERIAL BUSINESS

Article 12. General conditions for medicinal material import, export, wholesale and retail establishments and medicinal material storage service establishments

1. Medicinal material import, export, wholesale and retail establishments and medicinal material storage service establishments must possess a certificate of eligibility for drug business covering the medicinal material business.

2. Conditions for grant of a certificate of eligibility for drug business covering the medicinal material business   

a/ The person in charge of professional operations of the establishment must possess a pharmacy practice certificate, except the case prescribed in Clause 2, Article 17 of this Decree;

b/ Meeting the conditions applicable to each form of business prescribed in Articles 13, 14, 15 and 16 of this Decree.

Article 13. Import and export of medicinal materials

1. A medicinal material import establishment must meet the following conditions:

a/ Possessing a certificate of eligibility for drug business covering wholesale of medicinal materials;

b/ Meeting Good Storage Practices principles and standards applicable to medicinal materials;

c/ In case the establishment still fails to meet the conditions for direct import of medicinal materials, it shall sign an import entrustment contract with an establishment meeting the prescribed import conditions and the name of the entrusted establishment must be stated in the order for imported goods.

2. Enterprises that possess a certificate of eligibility for drug business covering manufacture of drugs from medicinal materials and a certificate of satisfaction of Good Manufacture Practice standards may import medicinal materials to meet their own needs and for sale to other drug manufacturing establishments and medical examination and treatment establishments in accordance with law.

3. An establishment that exports medicinal materials must meet the following conditions:

a/ The conditions prescribed at Point a, Clause 1 of this Article;

b/ The conditions set by importing countries (if any).

Article 14. Conditions for medicinal material wholesale establishments

They must meeting Good Storage Practices principles and standards and Good Distribution Practices principles and standards applicable to medicinal materials prescribed at Points g and h, Clause 1, Article 19 of this Decree.

Article 15. Conditions for medicinal material retail establishments

1. Physical foundations:

a/ Having a fixed and separate location with an area suitable to the scope of business in a well-ventilated high and dry place far from polluting sources, ensuring fire and explosion prevention and fighting; and having areas for display and storage of medicinal materials;

b/ Having equipment to protect drugs from adverse effects of sunlight, heat, humidity, pollution or insect penetration, including cabinets, stands and racks which must be firm, smooth, easy-to-clean and convenient for drug display and storage; thermometers, hygrometers, air conditioners and dehumidifiers which will help control temperature and humidity at the establishment; and lighting systems and air ventilators. Having storage equipment meeting storage requirements printed on labels. The room temperature shall be kept at 30 degree Celsius at most and humidity level at 75% at most.

2. Employees:

a/ Having employees who possess qualifications suitable to their assigned tasks, including at least 1 person possessing a collegial or higher degree in pharmacy;

b/ Persons directly selling medicinal materials must be regularly trained in professional knowledge and updated with new regulations on storage and management of medicinal materials.

3. Retail establishments may only sell medicinal materials which are purchased from qualified medicinal material traders, have a clear origin and are packed and labeled in accordance with the Minister of Health’s regulations on drug labeling; may not sell unprocessed toxic medicinal materials on the list of toxic medicinal materials usable as drugs in Vietnam issued by the Minister of Health.

Article 16. Conditions for enterprises providing medicinal material storage service

1. The person in charge of pharmaceutical operations of an enterprise providing medicinal material storage service must possess a pharmacy practice certificate relevant to the form of the enterprise.

2. An enterprise providing medicinal material storage service must meet the following conditions:

a/ Having sufficient employees who possess qualifications and are assessed to be suitable to their assigned tasks;

b/ Having storehouses and auxiliary facilities which are designed, built, used and maintained according to their use purposes;

c/ Having storage and transportation equipment which are arranged, designed, tested, appraised, used and maintained according to their use purposes, thus meeting storage conditions and facilitating storage activities;

d/ Having a quality control system, records, instructions and general processes for all activities carried out by the enterprise.

Article 17. Medicinal material business at traditional medicinal material business villages and streets 

1. The import, export and wholesale of medicinal materials and provision of medicinal material storage service at traditional medicinal material business villages and streets must comply with the relevant conditions prescribed in Article 13, 14, 15 and 16 of this Decree.

2.  The retail of medicinal materials at traditional medicinal material business villages and streets must comply with Article 15 of this Decree. The person in charge of professional operations or the owner of a medical material retail establishment at traditional medicinal material business villages and streets must possess one of the diplomas or certificates prescribed at Point c, Clause 3, Article 15 of the Government’s Decree No. 79/2006/ND-CP detailing a number of articles of the Law on Pharmacy, or a certificate of training in traditional medicine or pharmacy granted by a training institution.

Article 18. Conditions for a medicinal material processing establishment

1. Possessing a certificate of eligibility for drug business covering the medicinal material business.

2. The person in charge of professional operations of a medicinal material processing establishment must possess a university degree in pharmacy or traditional medicine and have practiced for at least 2 years at a lawful pharmaceutical establishment.

 3. Persons directly processing medicinal materials must be regularly trained and updated with professional knowledge on medicinal material processing.

4. Workshops and equipment must be designed, built, repaired and maintained in conformity with the processing steps and the scope of processing of the establishment, specifically:

a/ The area for storage of input medicinal materials must meet the conditions on storage location and design according to the Good Storage Practices principles and standards applicable to medicinal materials;

b/ Processing areas:

Depending on the scope of processing activities, the arrangement of medicinal material processing areas must facilitate the transport of materials in the course of processing, which include two areas for preliminary processing and intensive processing.

 The areas for preliminary processing and intensive processing of medicinal materials must have sufficient space for processing activities, be well ventilated, easy to clean and ensure safety and convenience for processing workers and be equipped with clean water supply systems to serve the processing of medicinal materials;

c/ Product quality inspection area

The area for inspection of quality of materials and finished products must be separated from the processing areas and be designed in a way suitable to inspection activities;

d/ The area for storage of processed medicinal materials must comply with Good Storage Practices principles and standards applicable to medicinal materials.

5. Auxiliary facilities:

a/ Air treatment system:

The establishment shall install a separate air treatment or air conditioning system for each area;

b/ Depending on each method of medicinal material processing, water used for processing must at least reach the national technical regulation on residential water;

c/ Wastewater and exhaust treatment and solid waste disposal systems:

The establishment shall take appropriate measures to treat wastewater and exhaust gas and dispose of solid waste generated in the course of processing, ensuring safety and sanitation;

d/ Fight prevention and fighting system:

The establishment shall equip sufficient fight prevention and fight devices as prescribed by the law on fire and explosion prevention and fighting.

6. The establishment must have sufficient equipment and devices for processing medicinal materials. These devices and equipment must ensure safety during operation, be easy to clean and maintain to prevent cross-contamination, dust accumulation and adverse impacts on product quality. The establishment shall develop and implement instructions for operation and cleaning of equipment.

7. The quality inspection area must be equipped with machines, equipment and instruments to serve the sample taking, analysis, calibration and data processing. Analysis equipment must suit testing methods and meet quality inspection requirements of the establishment.

8. At least 30 days before starting the processing of medicinal materials, the establishment shall send a notice thereof to the Ministry of Health. The Ministry of Health shall inspect whether establishments are eligible for medicinal material processing once every three years or on an irregular basis.

Article 19. Conditions on application of Good Practices principles and standards 

1. In addition to the conditions prescribed in Articles 5, 6, 7, 8, 9, 10, 11, 14 and 16, and in Clause 1, Article 13, of this Decree, drug business establishments must satisfy minimum Good Practices principles and standards of the World Health Organization, which are updated on the portal of the Ministry of Health and applied depending on the  form and scope of business as follow:

a/ Good Manufacturing Practices (GMP) principles and standards, for drug manufacturing establishments;

b/ Good Distribution Practices (GDP) principles and standards, for drug wholesale establishments;

c/ Good Pharmacy Practices (GPP) principles and standards, for drug retail establishments;

d/ Good Storage Practices (GSP) principles and standards, for drug storage service establishments and drug import establishments;

dd/ Good Laboratory Practices (GLP) principles and standards, for drug testing service establishments;

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

g/ Good Storage Practices (GSP) principles and standards applicable to medicinal materials, for medicinal material storage service establishments and medicinal material import establishments;

h/ Good Distribution Practices (GMP) principles and standards applicable to medicinal materials, for medicinal material wholesale establishments;

2. Dossiers and procedures for grant of a certificate of good practices prescribed in Clause 1 of this Article must comply with the Government’s Decree No. 79/2006/ND-CP of August 9, 2006, detailing a number of articles of the Pharmacy Law, and the Government’s Decree No. 89/2012/ND-CP of October 24, 2012, amending and supplementing a number of articles of Decree No. 79/2006/ND-CP.

Section 3

CONDITIONS FOR TRADING IN HABIT-FORMING DRUGS, PSYCHOTROPIC DRUGS, DRUG PRECURSORS, AND COMBINATION DRUGS CONTAINING HABIT-FORMING OR PSYCHOTROPIC INGREDIENTS OR DRUG PRECURSORS

Article 20. Conditions for manufacture establishments

1. An establishment manufacturing habit-forming drugs, psychotropic drugs or drug precursors must comply with Article 5 of this Decree and the following provisions:

a/ The establishment has applied GMP principles and standards relevant to each type of processing for at least 2 years;

b/ The keeper of the habit-forming drug storehouse must possess a university degree in pharmacy and has practiced for at least 2 years at a drug manufacturing establishment;

c/ The keeper of the storehouse of psychotropic drugs or drug precursors must possess an intermediate or higher degree in pharmacy and is authorized in writing by the head of the establishment (each authorization must be valid for at most 12 months);

c/ The staff member in charge of keeping records and making reports must possess a university degree in pharmacy and has practiced for at least 2 years at a drug manufacturing establishment;

dd/ Dossiers: The establishment shall compile and records the following books: book for monitoring the preparation of habit-forming drugs, psychotropic drugs and drug precursors, book for monitoring the receipt and delivery of habit-forming drugs, psychotropic drugs and drug precursors, book for monitoring the delivery and receipt of semi-finished and finished products in the course of manufacture, and stock book for habit-forming drug, psychotropic drug and pre-substance storehouses according to the Minister of Health’s regulations.

2. An establishment manufacturing combination drugs containing habit-forming ingredients, combination drugs containing psychotropic ingredients or combination drugs containing drug precursors must meet the following conditions:

a/ The establishment has applied GMP principles and standards relevant to each type of processing for at least 2 years;

b/ The keeper of the storehouse of materials and semi-finished products containing habit-forming ingredients must possess a university degree in pharmacy and has practiced for at least 2 years at a drug manufacturing establishment;

c/ The keeper of the storehouse of materials and semi-finished products containing psychotropic ingredients or drug precursors must possess an intermediate or higher degree in pharmacy and is authorized in writing by the head of the establishment (each authorization must be valid for at most 12 months);

d/ The staff member in charge of keeping records and making reports must possess a university degree in pharmacy and have practiced for at least 2 years at a drug manufacturing establishment;

dd/ Dossiers: The establishment manufacturing combination drugs containing habit-forming ingredients, combination drugs containing psychotropic ingredients or combination drugs containing drug precursors shall fully record the receipt and delivery of these drugs in a monitoring book according to the Minister of Health’s regulations.

Article 21. Conditions for import and export establishments

1. An establishment that imports or exports habit-forming drugs, psychotropic drugs or drug precursors must meet the conditions prescribed in Article 8 of this Decree and the following conditions:

a/ The establishment must have at least 5 years’ experience in drug import and export;

b/ Within 5 years prior to the date of applying for addition of the business of import and export of habit-forming drugs, psychotropic drugs or drug precursors, none of the drugs the establishment has traded in is concluded by state management agencies in charge of drug quality as committing serious violations of drug quality regulations, and the establishment has not committed any acts of forging or tampering with legal dossiers or documents of relevant Vietnamese or foreign agencies; has neither used fake seals nor forged signatures or seals of import establishments, manufacture establishments or other related establishments in its drug import and export dossiers;

c/ The establishment must have separate storehouses meeting GSP principles and standards to store habit-forming drugs, psychotropic drugs and drug precursors in conformity with the scope of its business activities, which must have an area of at least 100 m², a space of at least 300 m³, firm doors with secure locks and other measures to ensure safety and prevent loss;

d/ The establishment must have at least 3 business locations meeting GDP principles and standards in the northern, central and southern regions;

dd/ The establishment must have a software system to monitor and manage habit-forming drugs, psychotropic drugs and drug precursors and apply security and safety measures to prevent loss;

e/ Employees: Storekeepers, persons in charge of making reports and persons in charge of professional operations must possess a university degree in pharmacy and have practiced for at least 2 years at a drug manufacturing or trading establishment.

Employees engaged in import and export business activities must possess certificates of training in legal documents concerning management of habit-forming drugs, psychotropic drugs and drug precursors granted by training institutions designated by the Ministry of Health;

g/ Dossiers: The enterprise shall make and record the following dossiers: book for monitoring the receipt and delivery of habit-forming drugs, psychotropic drugs and drug precursors; delivery notes of habit-forming drugs, psychotropic drugs and drug precursors, which must comply with the Minister of Health’s regulations; and documents related to the import, export and trading of habit-forming drugs, psychotropic drugs and drug precursors.

2. Establishments that meet the conditions for drug business prescribed in Chapter II of the Pharmacy Law and this Decree may import and export combination drugs containing habit-forming ingredients, combination drugs containing psychotropic ingredients and combination drugs containing drug precursors, and shall make and record the following dossiers:

a/ Book for monitoring the import and export of combination drugs containing habit-forming ingredients, combination drugs containing psychotropic ingredients and combination drugs containing drug precursors, which must comply with the Minister of Health’s regulations;

b/ Documents related to the import, export and trading of combination drugs containing habit-forming ingredients, combination drugs containing psychotropic ingredients and combination drugs containing drug precursors.

Article 22. Conditions for wholesale establishments

1. Pharmaceutical enterprises of provinces and centrally run cities (including enterprises which have not yet been equitized and equitized enterprises) may purchase and sell finished habit-forming drugs, finished psychotropic drugs and finished pre-substance drugs if meeting the conditions prescribed in Article 6 of this Decree and the following conditions:

a/ Having storehouses meeting GSP principles and standards, of which storehouses of finished habit-forming drugs, finished psychotropic drugs and finished pre-substance drugs must be equipped with secure locks and have security measures to prevent loss. If it is impossible to arrange separate storehouses for finished habit-forming drugs, finished psychotropic drugs and finished pre-substance drugs, such drugs shall be stored in separate areas meeting GSP principles and standards;

b/ Employees: Storekeepers must possess a university degree in pharmacy and have practiced for at least 2 years at a dug business establishment;

c/ Dossiers: Books for monitoring the receipt and delivery of habit-forming drugs, psychotropic drugs and drug precursors; delivery notes of habit-forming drugs, psychotropic drugs and drug precursors, which must comply with the Minister of Health’s regulations; and documents related to the import, export and trading of habit-forming drugs, psychotropic drugs and drug precursors.

2. Establishments that meet the drug business conditions prescribed in Chapter II of the Pharmacy Law and this Decree may sell and purchase combination drugs containing habit-forming ingredients, combination drugs containing psychotropic ingredients and combination drugs containing drug precursors; and shall compile the following dossiers:

a/ Book for monitoring the receipt and delivery of combination drugs containing habit-forming ingredients, combination drugs containing psychotropic ingredients and combination drugs containing drug precursors, which must comply with the Minister of Health’s regulations;

b/ Documents related to the sale and purchase of combination drugs containing habit-forming ingredients, combination drugs containing psychotropic ingredients and combination drugs containing drug precursors.

Article 23. Conditions for retail establishments

1. An establishment which retails finished habit-forming drugs, finished psychotropic drugs and finished pre-substance drugs must meet the conditions prescribed in Article 7 of this Decree and the following conditions:

a/ Being a pharmacy meeting the GPP principles and standards;

b/ Having registered with the provincial-level Health Department;

c/ The owner or person in charge of professional operations must directly manage and retail finished habit-forming drugs;

d/ The person in charge of management and retail of finished psychotropic drugs and finished pre-substance drugs must possess an intermediate or higher degree in pharmacy;

d/ The establishment must compile, record and archive the following dossiers according to the Minister of Health’s regulations: book for monitoring the receipt and delivery of habit-forming drugs, psychotropic drugs and pre-substance drugs, book for monitoring customers information; delivery notes of habit-forming drugs, psychotropic drugs and pre-substance drugs issued by suppliers; prescriptions of habit-forming drugs and psychotropic drugs; written records of receipt of finished habit-forming drugs handed by patients’ relatives.

2. An establishment that retails combination drugs containing habit-forming ingredients, combination drugs containing psychotropic ingredients and combination drugs containing drug precursors must meet the conditions prescribed in Article 7 of this Decree and the following conditions:

a/ Being a pharmacy meeting GPP standards;

b/ Having a book for monitoring the receipt and delivery and inventory and making biannual and annual reports on the receipt and delivery and inventory of drugs and addresses of customers according to the Minister of Heath’s regulations.

Section 4

CONDITIONS FOR RADIOACTIVE DRUG BUSINESS

Article 24. Conditions for radioactive drug business

In addition to the conditions for drug business prescribed in Chapter II of the Pharmacy Law and Section 1, Chapter II of this Decree, establishments that do business in radioactive drugs must meet the following conditions:

1. Possessing a certificate of radiation safety granted by the Ministry of Science and Technology.

2. The person in charge of radiation safety must have been trained in radiation safety and possess a certificate of training in radiation safety issued by an institution licensed by the Ministry of Science and Technology.

Article 25. Preparation and use of radioactive drugs

1. The preparation and use of radioactive drugs may be carried out only at nuclear medicine establishments which possess a radiation safety certificate issued by the Ministry of Science and Technology.

2.  Licensed nuclear medicine establishments that wish to use radioactive drugs shall make a tentative list of to-be-used drugs according to a set form and send it to the Ministry of Health for approval and to the Ministry of Science and Technology for monitoring.

Chapter III

IMPLEMENTATION PROVISIONS

Article 26. Transitional provisions

1. For persons who possess pharmacy practice certificates of a 5-year validity duration, when their certificates expire, they shall carry out procedures for re-grant of pharmacy practice certificates at competent state agencies.

2. For establishments which possess certificates of eligibility for drug business of a 5-year validity duration, when their certificates expire, they shall carry out procedures for re-grant of pharmacy practice certificates at competent state agencies.

3. Establishments that are currently engaged in the manufacture, import, export, wholesale or retail of habit-forming drugs, psychotropic drugs, drug precursors, combination drugs containing habit-forming ingredients, combination drugs  containing psychotropic ingredients and combination drugs containing drug precursors, may continue operating and shall comply with the 2016 Law on Pharmacy when it takes effect.

Article 27. Effect

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

2. Articles 20, 21, 22, 23, 24, 25, 26 and 27, Section 2 of Chapter IV and Chapter V of the Government’s Decree No. No. 79/2006/ND-CP detailing a number of articles of the Law on Pharmacy cease to be effective on the effective date of this Decree.

Article 28. Implementation responsibility

1. The Minister of Health shall guide and organize the implementation of this Decree.

2. Ministers, heads of minis trial-level agencies, heads of government-attached agencies, chairpersons of provincial-level People’s Committees, and related agencies, organizations and individuals shall implement this Decree.-

On behalf of the Government
Prime Minister
NGUYEN XUAN PHUC