THE GOVERNMENT -------	SOCIALIST REPUBLIC OF VIETNAM Independence - Freedom - Happiness ---------------
No. 102/2016/ND-CP	Hanoi, July 01, 2016

 

DECREE

DRUG BUSINESS REQUIREMENTS

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

Pursuant to the Law on Pharmacy June 14, 2005;

Pursuant to the Law on Investment dated November 26, 2014;

At the request of the Minister of Health;

The Government promulgates a Decree on drug business requirements.

Chapter I

GENERAL PROVISIONS

Article 1. Scope and regulated entities

1. This Decree provides for drug business requirements.

2. This Decree applies to Vietnamese and foreign organizations and individuals operating in pharmacy in Vietnam.

Article 2. Definitions

For the purpose of this Decree, the terms below are construed as follows:

1. Lawful pharmaceutical establishment means a pharmaceutical establishment that is lawfully established. It is either a/an:

a) drug-trading establishment;

b) pharmacy department of a health facility;

c) institution providing pharmacy training;

d) pharmaceutical research institution, drug-testing laboratory;

d) pharmacy authority;

e) representative office of a foreign drug trader in Vietnam;

g) any another establishment defined by law.

2. Commercial compounded drug containing addictive ingredients means a commercial drug that satisfies all of the following conditions:

a) It contains active ingredients other than addictive ingredients, psychotropic ingredients and drug precursors;

b) It contains addictive ingredients, or addictive ingredients and psychotropic ingredients, or addictive ingredients and drug precursors, or addictive ingredients and psychotropic ingredients and drug precursors;

c) The concentrations of addictive ingredients, psychotropic ingredients and drug precursors do not exceed the maximum concentrations prescribed by the Minister of Health.

3. Commercial compounded drug containing psychotropic ingredients means a commercial drug that satisfies all of the conditions below:

a) It contains active ingredients other than addictive ingredients, psychotropic ingredients and drug precursors;

b) It contains psychotropic ingredients, or psychotropic ingredients and drug precursors;

c) The concentrations of psychotropic ingredients and drug precursors do not exceed the maximum concentrations prescribed by the Minister of Health.

4. Commercial compounded drug containing precursors means a commercial drug that satisfies all of the following conditions:

a) It contains active ingredients other than addictive ingredients, psychotropic ingredients and drug precursors;

b) The concentrations of drug precursors contained therein do not exceed the maximum concentrations prescribed by the Minister of Health.

5. Modern drug means a drug whose ingredients, formulae and purities thereof are defined.

6. Herbal ingredient means a drug ingredient that is derived from plants, animals, minerals and fit for medicinal purpose.

Herbal ingredients do not include semi-finished herbal drugs.

7. Semi-finished herbal drug means a medicinal ingredient derived from herbal ingredients in the form of glue, granule, powder, alcohol, extract, essential oil and is used for manufacture of herbal drugs.

8. Raw herbal ingredient means a drug ingredient that is derived from plants, animals, minerals and fit for medicinal purpose and has not undergone working or processing.

9. Traditional herbal ingredient means an herbal ingredient manufactured according to traditional methods and used for manufacture of orient drugs or medicinal purpose.

10. Preparation means inspection and classification of raw herbal ingredients, removal of impurities, immersion, incubation, washing, drying, cleaning, division or grinding.

11. Processing means the process that changes the quality and quantity of raw herbal ingredients or prepared herbal ingredients.

Article 3. Type of drug business

1. Drug manufacturers comprised of:

a) Enterprises manufacturing drugs;

b) Cooperatives, household businesses manufacturing herbal ingredients, orient drugs and herbal drugs.

2. Drug wholesalers comprised of:

a) Enterprises wholesaling drugs;

b) Cooperatives, household businesses wholesaling herbal ingredients, orient drugs and herbal drugs;

c) Agents wholesaling vaccines and biologicals.

3. Drug retailers comprised of the organizations specified in Clause 1 Article 24 of the Law on Pharmacy; retailers of orient drugs and herbal drugs specified in Point dd Clause 1 Article 26 of the Law on Pharmacy.

4. Drug exporters and importers.

5. Drug preservation service providers.

6. Drug testing service providers.

7. Clinical trial service providers.

Chapter II

DRUG TRADING

Section 1. CONDITIONS FOR ISSUANCE OF CERTIFICATE OF ELIGIBILITY FOR DRUG BUSINESS

Article 4. Eligible recipients of certificates of eligibility for drug business

1. The certificate of eligibility for drug business shall be granted to a drug-trading establishment that satisfies all conditions for its type of drug business specified in this Chapter.

2. A drug-trading establishment shall adhere to the location and scope of business written on the certificate of eligibility for drug business.

Article 5. Conditions for issuance of certificate of eligibility for drug business to a drug manufacturer

1. The pharmacist in charge has a pharmacy practice certificate suitable for the drug manufacturer’s type of business.

2. The drug manufacturer satisfies all of the following conditions:

a) The personnel is suitable in terms of quantity and qualifications;

b) The factory, auxiliary systems and equipment are designed, manufactured, inspected, used, and maintained suitably for their uses;

c) There is a quality inspection area that satisfies quality inspection conditions and is suitable for its production scale;

dd) There is a storage area that satisfies storage requirements and is suitable for its production scale;

dd) There is a system for quality control and management of documents according to certain standards, formulae, instructions and procedures.

Article 6. Conditions for issuance of certificate of eligibility for drug business to a drug wholesaler

1. The pharmacist in charge has a pharmacy practice certificate suitable for the drug wholesaler’s type of business.

2. The drug wholesaler satisfies all of the following conditions:

a) The personnel is suitable in terms of quantity and qualifications;

b) Its warehouse and auxiliary systems are designed, built, used and maintained suitably for their use and storage conditions written on the package inserts; different products are neatly stored in separate areas; areas where drugs are received or dispensed are able to protect drugs from bad weather; storage areas have suitable and clear signs;

c) Storage and transport equipment are designed, manufactured, inspected, used, and maintained suitably for their uses and storage purpose;

d) The storage has a backup generation system serving the cold storage;

dd) Vehicles for transporting drugs satisfy storage, security and safety requirements;

e) There is a system for quality control and management of documents, instructions and procedures for its activities.

Article 7. Conditions for issuance of certificate of eligibility for drug business to a drug retailer

1. The owner of the drug retailer has a pharmacy practice certificate suitable for its type of business.

2. The drug retailer other than an herbal ingredient retailer satisfies all of the following conditions:

a) The retailing place is fixed, isolated, airy, safe, away from sources of pollution and has a conformable signboard;

b) The retailing place is sturdily built and has an anti-dust ceiling; its walls and floor is easy to clean; lighting is sufficient but drugs are protected from direct sunlight; storage conditions written on package inserts are satisfied;

c) The area is suitable for the business scale; there is an area for display and storage of drug, and an area for buyers to exchange drug use information with the sellers;

d) There are separate areas for other activities: preparation of prescribed drugs (if any); retailing drugs without primary packages; hand washing areas for sellers and buyers; consultation area and waiting chairs;

dd) Drugs are store on shelves that satisfy storage conditions, security and safety requirements;

e) Cosmetics, functional foods and medical equipment (if any) are displayed in a separate area and do not affect drugs.

Article 8. Conditions for issuance of certificate of eligibility for drug business to a drug exporter/importer

1. The pharmacist in charge has a pharmacy practice certificate suitable for the drug importer’s/exporter’s type of business.

2. The drug importer/exporter satisfies all of the following conditions:

a) The personnel is suitable in terms of quantity and qualifications;

b) The warehouse and auxiliary systems are designed, built, used and maintained suitably for their uses and scale of business;

c) Storage and transport equipment are designed, manufactured, inspected, used, and maintained suitably for their uses and storage purpose;

d) There is a system for quality control and management of documents, instructions and procedures for its activities.

3. A certificate of eligibility for drug wholesaling is granted.

Article 9. Conditions for issuance of certificate of eligibility for drug business to a drug preservation service provider

1. The pharmacist in charge has a pharmacy practice certificate suitable for provision of drug preservation services.

2. The conditions specified in Clause 2 Article 8 and Point d Clause 1 Article 19 of this Decree are satisfied; quality, quantity and value of drugs of service buyers are ensured and service buyers are able to fulfill their responsibility for the drugs preserved.

Article 10. Conditions for issuance of certificate of eligibility for drug business to a drug testing service provider

1. The pharmacist in charge has a pharmacy practice certificate suitable for provision of drug testing services.

2. The drug testing service provider satisfies all of the following conditions:

a) The personnel is suitable in terms of quantity and qualifications;

b) The design and size of the testing laboratory is suitable for various testing activities and sufficient for equipment, documents and working space;

c) The equipment is suitable for the testing methods and testing purposes; suitable for sampling, analysis, calibration, and data processing;

d) Chemicals, reagents, reference materials and documents are adequate and suitable for testing purposes;

dd) There is a system for quality control and management of documents, instructions and procedures for its activities.

Article 11. Conditions for issuance of certificate of eligibility for drug business to a clinical trial service provider

1. The pharmacist in charge has a pharmacy practice certificate suitable for provision of clinical trial services. To be specific:

a) The pharmacist in charge shall have a bachelor’s degree in pharmacy or general medicine and have at least 03 years’ internship at a pharmacy establishment, hospital or inpatient institution, except for the case in Point b of this Clause;

b) The pharmacist in charge of a provider of herbal drug clinical trial services shall have a bachelor’s degree in pharmacy, general medicine, traditional medicine or traditional pharmacy and have at least 03 years’ internship at a pharmacy establishment, hospital or inpatient institution.

2. The clinical trial service provider satisfies all of the following conditions:

a) The personnel is suitable in terms of quantity and qualifications;

b) Its location, testing laboratory, testing equipment and area are suitable for provision of clinical trial services;

c) There is a system for quality control and management of documents according to certain standards, formulae, instructions and procedures for clinical trial.

Section 2. CONDITIONS FOR HERBAL INGREDIENT BUSINESS

Article 12. Conditions to be satisfied by exporters, importers, wholesalers, retailers and herbal ingredient preservation service providers

1. Exporters, importers, wholesalers, retailers and herbal ingredient preservation service providers must obtain certificates of eligibility for drug business including herbal ingredient business.

2. Conditions for issuance of certificate of eligibility for drug business including herbal ingredient business:

a) The pharmacist in charge has a pharmacy practice certificate, except for the cases specified in Clause 2 Article 17 of this Decree;

b) Conditions for corresponding type of business specified in Article 13 through 16 of this Decree are satisfied.

Article 13. Export and import of herbal ingredients

1. An herbal ingredient importer has to satisfy the following conditions:

a) The certificate of eligibility for drug business including herbal ingredient business is obtained;

b) Good preservation practice requirements applied to herbal ingredients are fulfilled;

c) An herbal ingredient trader that has not satisfied all conditions for direct import of herbal ingredients shall conclude an import contract with a qualified importer and the import order must bear the name of such importer.

2. A enterprise that has the certificate of eligibility for drug business which permits manufacture of herbal drugs and GMP certificate may import herbal ingredients serving its manufacture and for sale to other manufacturers and health facilities as prescribed by law.

3. An herbal ingredient exporter has to satisfy the following conditions:

a) The conditions specified in Point a Clause 1 of this Article;

b) Other conditions imposed by importing country (if any).

Article 14. Conditions to be satisfied by herbal ingredient wholesalers

Good preservation practice requirements applied to herbal ingredients and good distribution practice requirements applied to herbal ingredients specified in Point g and h Clause 1 Article 19 of this Decree are satisfied.

Article 15. Conditions to be satisfied by herbal ingredient retailers

1. Infrastructure and equipment:

a) The retailing area is fixed and suitable for the business scale, isolated, airy, safe, away from sources of pollution, ensures fire safety; herbal ingredients are displayed and stored in separate areas;

b) Herbal ingredients are protected from adverse effect of light, temperature, humidity, pollution, inspects in shelves, cabinets that are sturdy, easy to clean, convenient for display and preservation of herbal ingredients; thermometers, hygrometers, air conditioners, dehumidifiers for controlling temperature and humidity in the retailing area; lighting system and ventilation fans. Storage equipment is suitable for storage conditions written on the labels. Temperature is maintained at 30°C, humidity not exceeding 75%.

2. Personnel:

a) The employees are qualified for their tasks; at least one of them has a basic degree in pharmacy;

b) The sellers are regularly provided with training in professional knowledge and regulations of law on preservation and management of herbal ingredients.

3. A retailer may only sell herbal ingredients purchased from qualified sellers; herbal ingredients having clear origin, packages and labels as prescribed by the Minister of Health on drug labeling; must not sell unprocessed toxic herbal ingredients on the Vietnam’s List of medicinal toxic herbal ingredients promulgated by the Minister of Health.

Article 16. Conditions to be satisfied by herbal ingredient preservation service providers

1. The pharmacist in charge has a pharmacy practice certificate suitable for provision of herbal ingredient preservation services.

2. An herbal ingredient preservation service provider has to satisfy the following conditions:

a) The personnel is suitable in terms of quantity and qualifications;

b) The warehouse and auxiliary systems are designed, built, used and maintained suitably for their uses and scale of business;

c) Storage and transport equipment are designed, manufactured, inspected, used, and maintained suitably for their uses and storage purpose;

d) There is a system for quality control and management of documents, instructions and procedures for its activities.

Article 17. Herbal ingredient business in trade villages and herbal ingredient streets

1. Export, import, wholesaling of herbal ingredients and provision of preservation services in trade villages and herbal ingredients streets shall comply with provisions of Article 13 through 16 of this Decree.

2. Retailing of herbal ingredients in trade villages and herbal ingredients streets shall comply with provisions of Article 15 of this Decree. The pharmacist in charge or owner of the retailing establishment shall have one of the qualifications specified in Point c Clause 3 Article 15 of the Government's Decree No. the Government's Decree No. 79/2006/ND-CP dated August 09th 2006, specifying the implementation of a number of articles of the Law on Pharmacy or traditional pharmacy or medicine qualification issued by a training institution.

Article 18. Conditions to be satisfied by an herbal ingredient processor

1. A certificate of eligibility for drug business including herbal ingredient business is obtained.

2. The pharmacist in charge of the processor has a bachelor’s degree in pharmacy or traditional medicine and at least 2 years’ apprenticeship in a lawful pharmaceutical establishment.

3. Direct participants in herbal ingredient processing are regularly provided with training in herbal ingredient processing.

4. The workshop and equipment are designed, built, repaired and maintained suitable for processing and the scale of business. To be specific:

a) Location and design of the raw material storage satisfy good preservation practice requirements applied to herbal ingredients;

b) Processing area:

The preliminary processing area and deep processing area must be designed in a manner that is convenient for movement of raw materials.

The processing areas must be spacious enough, airy, easy to clean, safe and convenient, and has clean water supply serving herbal ingredient processing;

c) Quality inspection area:

The area for herbal ingredient and product quality inspection must be separate from the processing area. The quality inspection area shall be designed suitably for inspection activities;

d) The area for preservation of processed herbal ingredients must satisfy good preservation practice requirements applied to herbal ingredients are fulfilled;

5. Auxiliary systems:

a) Air treatment system:

Each area shall have a separate air treatment or air conditioning system;

b) Water treatment system:

Depending on requirements of the processing method, the water source shall satisfy at least National standards for tap water;

c) Sewage, exhaust and solid waste treatment system:

Measures for treatment of sewage, exhaust and solid wastes during the processing must be taken to ensure hygiene and safety;

d) Fire safety system:

Fire safety equipment has to be adequate in accordance with fire safety regulations.

6. Necessary equipment for herbal ingredient processing has to be adequate. The equipment must be safe for use, easy to clean and maintain, prevent cross-contamination, dust accumulation, and avoid adverse effect on product quality. Instructions on operation and hygiene of the equipment must be complied with.

7. The quality inspection area must have equipment for sampling analysis, calibration, and data processing. Analysis equipment must be suitable for the testing method and satisfy quality inspection requirements.

8. A notice must be sent to the Ministry of Health at least 30 days before commencement of herbal ingredient processing. The Ministry of Health shall inspect fulfillment of conditions for herbal ingredient processing every 03 years or without notice.

Article 19. Good practice requirements

1. Apart from the conditions specified in Article 5, 6, 7, 8, 9, 10, 11, 14, 16 and Clause 1 Article 13 of this Decree, a drug-trading establishment shall satisfy corresponding good practice requirements established by WHO and updated on the website of the Ministry of Health. To be specific:

a) Good manufacturing practice (GMP) requirements shall be satisfied by drug manufacturers;

b) Good distribution practice (GDP) requirements shall be satisfied by drug wholesalers;

c) Good pharmacy practice (GPP) requirements shall be satisfied by drug retailers;

d) Good storage practice (GSP) requirements shall be satisfied by drug preservation service providers and drug importers;

dd) Good laboratory practice (GLP) requirements shall be satisfied by drug-testing service providers;

e) Good clinical practice (GCP) requirements shall be satisfied by clinical trial service providers;

g) Good storage practice (GSP) requirements applied to herbal ingredients shall be satisfied by herbal ingredient preservation service providers and herbal ingredient importers;

b) Good distribution practice (GDP) requirements applied to herbal ingredients shall be satisfied by herbal ingredient wholesalers.

2. Procedures for obtainment of Good Practice Certificates are specified in the Government's Decree No. 79/2006/ND-CP dated August 09th 2006, specifying the implementation of a number of articles of the Law on Pharmacy, the Government's Decree No. 89/2012/ND-CP on amendments to Decree No. 79/2006/ND-CP and relevant legislative documents.

Section 3. CONDITIONS FOR TRADING IN NARCOTIC DRUGS, PSYCHOTROPIC DRUGS, DRUG PRECURSORS, COMMERCIAL COMPOUNDED DRUGS CONTAINING ADDICTIVE INGREDIENTS, PSYCHOTROPIC INGREDIENTS OR PRECURSORS

Article 20. Conditions to be satisfied by manufacturers

1. A manufacturer of narcotic drugs, psychotropic drugs or drug precursors shall satisfy requirements in Article 5 of this Decree and the following requirements:

a) GMP requirements suitable for each dosage form are satisfied for at least 02 years;

b) Each warehouse keeper of narcotic drugs has a bachelor’s degree in pharmacy and at least 02 years’ working experience at a drug manufacturer;

c) Each warehouse keeper of psychotropic drugs or drug precursors has a bachelor’s or degree in pharmacy (or an associate degree in pharmacy if authorized in writing by the head of the establishment for up to 12 months);

d) The person in charge of bookkeeping and reporting has a bachelor’s degree in pharmacy and at least 02 years’ working experience at a drug manufacturer;

dd) A manufacturer of narcotic drugs, psychotropic drugs or drug precursors shall maintain the following documents: logbooks of preparation, purchases and sales of narcotic drugs, psychotropic drugs or drug precursors, transfer of semi-finished products and finished products.

2. A manufacturer of commercial compounded drugs containing addictive ingredients, psychotropic ingredients or precursors shall satisfy the following conditions:

a) GMP requirements suitable for each dosage form are satisfied for at least 02 years;

b) Each warehouse keeper of raw materials or semi-finished products containing addictive ingredients has a bachelor’s degree in pharmacy and at least 02 years’ working experience at a drug manufacturer;

c) Each warehouse keeper of raw materials or semi-finished products containing psychotropic ingredients or precursors has a bachelor’s or degree in pharmacy (or an associate degree in pharmacy if authorized in writing by the head of the establishment for up to 12 months);

d) The person in charge of bookkeeping and reporting has a bachelor’s degree in pharmacy and at least 02 years’ working experience at a drug manufacturer;

dd) A manufacturer of commercial compounded drugs containing addictive ingredients, commercial compounded drugs containing psychotropic ingredients or commercial compounded drugs containing precursors shall maintain logbooks of purchases and sales of the drugs as prescribed by the Minister of Health.

Article 21. Conditions to be satisfied by exporters and importers

1. An exporter or import of narcotic drugs, psychotropic drugs or drug precursors shall satisfy requirements in Article 8 of this Decree and the following requirements:

a) The exporter or importer has at least 05 years’ experience of export or import of drugs respectively;

b) Over 5 years before applying for permission for export or import of narcotic drugs, psychotropic drugs or drug precursors, the applicant does not commit serious violations, forge or falsify documents of Vietnamese or foreign regulatory bodies, use fake seals or signatures in the export or import documents;

c) The exporter or importer has a separate warehouse that satisfy GSP requirements to store narcotic drugs, psychotropic drugs or drug precursors suitable for the scope of business. The minimum area of the warehouse is 100 m² and volume 300 m². The warehouse has solid doors and locks and measures are taken to ensure safety and security;

d) There are at least 03 business locations that satisfy GDP requirements in the North, the Central Coast and the South;

dd) There is a software system for management of narcotic drugs, psychotropic drugs and drug precursors as well as measures for ensure safety and security;

e) Personnel: warehouse keepers, bookkeepers and pharmacists have bachelor’s degrees in pharmacy and at least 02 years’ working experience at a drug manufacturer or drug-trading establishment;

Any participant in the trading, export or import must be provided with training in legislative documents on narcotic drugs, psychotropic drugs or drug precursors by training institutions appointed by the Ministry of Health;

g) An exporter or import of narcotic drugs, psychotropic drugs or drug precursors shall maintain logbooks of purchases and sales of narcotic drugs, psychotropic drugs or drug precursors, documents about export, import and trading thereof.

2. An establishment that satisfies all conditions specified in Chapter II of the Law on Pharmacy and this Decree may export or import commercial compounded drugs containing addictive ingredients, commercial compounded drugs containing psychotropic ingredients or commercial compounded drugs containing precursors and is required to:

a) keep a log of the import, export of commercial compounded drugs containing addictive ingredients, commercial compounded drugs containing psychotropic ingredients or commercial compounded drugs containing precursors as prescribed by the Minister of Health;

b) maintain documents about the import, export of commercial compounded drugs containing addictive ingredients, commercial compounded drugs containing psychotropic ingredients or commercial compounded drugs containing precursors.

Article 22. Conditions to be satisfied by wholesalers

1. Provincial pharmaceutical enterprises (including those that are not equitized) may buy and sell commercial addictive drugs, commercial psychotropic drugs and commercial precursor drugs that comply with provisions of Article 6 of this Decree and the provisions below:

a) There are warehouses satisfying GSP requirements; the warehouse where commercial addictive drugs, commercial psychotropic drugs or commercial precursor drugs are stored must have solid locks and measures for ensuring safety and security. If separate warehouses are not available, commercial addictive drugs, commercial psychotropic drugs and commercial precursor drugs must be placed separately in the warehouse according to GSP requirements;

b) Personnel: Warehouse keepers must have bachelor’s degrees in pharmacy and at least 02 years’ working experience at a drug-trading enterprise;

c) Documents monitoring the purchases and sales of narcotic drugs, psychotropic drugs or drug precursors; documents about export, import, purchases and sales of narcotic drugs, psychotropic drugs or drug precursors shall comply with regulations of the Minister of Health.

2. An establishment that satisfies all conditions specified in Chapter II of the Law on Pharmacy and this Decree may trade in commercial compounded drugs containing addictive ingredients, commercial compounded drugs containing psychotropic ingredients and commercial compounded drugs containing precursors and is required to:

a) keep a log of the purchase and sale of commercial compounded drugs containing addictive ingredients, commercial compounded drugs containing psychotropic ingredients and commercial compounded drugs containing precursors as prescribed by the Minister of Health;

b) maintain documents about the purchase and sale of commercial compounded drugs containing addictive ingredients, commercial compounded drugs containing psychotropic ingredients and commercial compounded drugs containing precursors.

Article 23. Conditions to be satisfied by retailers

1. A retailer of commercial addictive drugs, commercial psychotropic drugs or commercial precursor drugs shall satisfy requirements in Article 7 of this Decree and the following requirements:

a) GPP requirements are satisfied;

b) The retailer is registered with the Provincial Department of Health;

c) Commercial addictive drugs are directly retailed by the owner of the drug store or the pharmacist in charge;

d) Commercial psychotropic drugs and commercial precursor drugs are managed and retailed by holders of at least associate degrees in pharmacy;

dd) The following documents shall be maintained: Logbooks of purchase and sale of narcotic drugs, psychotropic drugs and drug precursors; logbooks of customers, delivery notes of narcotic drugs, psychotropic drugs and drug precursors provided by supplies; prescriptions for narcotic drugs, psychotropic drugs and drug precursors retained at the drugstore after sale; notes of receipt of commercial addictive drugs submitted by patients’ family.

2. A retailer of commercial compounded drugs containing addictive ingredients, commercial compounded drugs containing psychotropic ingredients or commercial compounded drugs containing precursors shall satisfy requirements in Article 7 of this Decree and the following requirements:

a) GPP requirements are satisfied;

b) The purchases, sales, inventory and addresses of customers are recorded in logbooks and made into biannual and annual reports as prescribed by the Minister of Health.

Section 4. CONDITIONS FOR RADIOPHARMACEUTICAL BUSINESS

Article 24. Conditions

Apart from conditions specified in Chapter of the Law on Pharmacy and Section 1 Chapter II of this Decree, an establishment trading in radiopharmaceuticals shall satisfy the following conditions:

1. A radiation safety certificate is granted by the Ministry of Science and Technology.

2. The person in charge of radiation safety is trained in radiation safety and has 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 radiopharmaceuticals

1. Radiopharmaceuticals shall only be prepared and used within nuclear medicine establishments that are granted radiation safety certificates by the Ministry of Science and Technology.

2. A licensed nuclear medicine establishment that wishes to use radiopharmaceuticals shall submit a plan to the Ministry of Health for approval and a report to the Ministry of Science and Technology.

Chapter III

IMPLEMENTATION

Article 26. Transition clause

1. Holders of pharmacy practice certificates that expire after 5 years shall apply for reissuance of pharmacy practice certificates at competent authorities.

2. Holders of certificates of eligibility for drug business that expire after 5 years shall apply for reissuance of pharmacy practice certificates at competent authorities.

3. Manufacturers, exporters, importers, wholesalers, retailers of narcotic drugs, psychotropic drugs, drug precursors, commercial compounded drugs containing addictive ingredients, commercial compounded drugs containing psychotropic ingredients and commercial compounded drugs containing precursors may keep operating until the effective date of the Law on Pharmacy 2016.

Article 27. Effect

1. This Decree comes into force from July 01, 2016.

2. Article 20 through 27 of Decree No. 79/2006/ND-CP are abolished from the effective date of this Decree.

Article 28. Responsibility for implementation

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

2. Ministers, Heads of ministerial agencies, Heads of Governmental agencies, Presidents of the People’s Committees of provinces, relevant organizations and individuals are responsible for the implementation of this Decree./.

 

ON BEHALF OF THE GOVERNMENT THE PRIME MINISTER Nguyen Xuan Phuc