Decree No. 79/2006/ND-CP detailing the implementation of certain provisions of the Medicine Law

DECREE

Regulations detailing implementation of certain provisions of the Medicine Law

_______________

THE GOVERNMENT

Pursuant to the Law on Organization of the Government dated December 25, 2001;

Based on the Medicine Law dated June 14, 2005.

Considering the proposal of the Minister of Health,

DECREE

Chapter I

GENERAL PROVISIONS

Article 1. Scope of Regulation and Applicability

1. This Decree stipulates detailed implementation of certain provisions of the Medicine Law regarding:

a) State policy in the field of medicine;

b) State management of drug prices;

c) Conditions for drug business operations;

d) Management of drugs listed in the special control list;

đ) Drug quality standards, state drug testing facilities, and resolution of complaints about drug quality conclusions;

e) State management authority and responsibility in the field of medicine.

2. This Decree applies to agencies, organizations, and individuals, both domestic and foreign, operating in the field of medicine in Vietnam.

Article 2. Interpretation of Terms

In this Decree, the following terms and phrases shall be understood as follows:

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) Training institutions for pharmaceutical staff;

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

đ) State management agency for medicines;

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

g) Other pharmaceutical establishments as prescribed by law.

2. Publicizing drug prices means making drug selling prices public by printing, pasting, writing selling prices on the packaging containing the drugs or outer packaging of the drugs, or publicly announcing on boards, paper, or other forms placed, put, hung, or pasted at drug selling and supply locations as provided for in Article 11 of this Decree.

Article 3. Forms of organizing pharmaceutical business

1. A drug manufacturing facility includes the following business organization forms:

a) Pharmaceutical manufacturing enterprises;

b) Cooperatives, individual business households producing medicinal herbs, traditional medicine, and drugs made from medicinal herbs.

2. A wholesale drug facility includes the following business organization forms:

a) Pharmaceutical wholesale enterprises;

b) Cooperatives, individual business households wholesaling medicinal herbs, traditional medicine, and drugs made from medicinal herbs;

c) Wholesalers of vaccines and medical products.

3. A retail drug facility includes the business organization forms prescribed in Clause 1 of Article 24 of the Medicine Law.

4. Enterprises exporting and importing medicines.

5. Enterprises providing pharmaceutical storage services.

6. Enterprises providing pharmaceutical testing services.

Chapter II

STATE POLICY IN THE FIELD OF MEDICINE

Article 4. Projects in the field of medicine eligible for investment incentives

Projects eligible for investment incentives in capital, land, tax, and other incentives as prescribed by law include:

1. Projects aimed at developing the pharmaceutical industry into a leading economic and technical sector:

a) The project specified in Clause 1 of Article 3 of the Medicine Law;

b) Investment projects to build facilities for bioequivalence testing, drug bioavailability assessment; pharmaceutical facilities meeting good manufacturing practices in production, storage, testing, distribution, clinical trials of drugs, cultivation, harvesting, and processing of medicinal herbs.

2. Projects aimed at developing sources of medicinal herbs and producing drugs from medicinal herbs:

a) Cultivation projects for medicinal herbs, natural extraction of medicinal herbs, preservation and development of medicinal herb genetic resources;

b) Research projects to prove scientific foundations and establish testing standards for traditional medicine formulas; surveys and statistics of types of medicinal herbs used in medicine; collection, inheritance, dissemination, and rational application of traditional medicine formulas; exploration, exploitation, and utilization of new medicinal herbs, export of medicinal herbs..

Article 5. Forms of drug support

1. Subjects under policy benefits, ethnic minority areas, regions with particularly difficult socio-economic conditions, and regions with difficult socio-economic conditions shall enjoy drug prices not higher than those in mountain city markets, be exempted, reduced, or subsidized for drug costs and other drug support policies as prescribed by law.

2. The Ministry of Health shall take the lead and coordinate with the Ministry of Labor, Invalids, and Social Affairs, the National Ethnic Committee, and the Ministry of Finance based on the requirements and support policies for drugs in each period, study and amend,supplement the forms, systems, drug support policies prescribed in Clause 1 of this Article to submit to the Prime Minister for decision.

Article 6. Planning the network for circulation, distribution, and supply of medicines

Based on the tasks of economic and social development of the country during each period, the Ministry of Health shall develop plans for the development of the system for the circulation, distribution, and supply of medicines nationwide, with particular attention to remote areas to ensure sufficient quality medicines at reasonable prices to meet the needs of medicine usage by the people, to be submitted to the Prime Minister for decision; organize implementation after approval by the Prime Minister.

Article 7. Ensuring safe, rational, and effective use of medicines, preventing and combating adverse effects of medicines

1. The Ministry of Health shall be responsible for stipulating the prescription and guidance on the safe, rational, and effective use of medicines; implementing measures to prevent and combat adverse effects of medicines.

2. The Ministry of Health shall coordinate with the Ministry of Culture, Sports and Tourism in providing information, propaganda, and guidance on the safe, rational, and effective use of medicines in the community.

3. People's Committees at all levels shall be responsible for directing, organizing, and supervising the implementation of regulations on information and advertising of medicines; strengthening information and propaganda on the guidance for safe, rational, and effective use of medicines; inspecting and controlling the business of medicines within their jurisdiction.

Chapter III

STATE MANAGEMENT OF MEDICINE PRICES

Article 8. Principles of state management of medicine prices

1. The State manages medicine prices according to the principle that production, export, import, and trading establishments set their own prices, compete on price, and are subject to inspection and supervision by competent state agencies in accordance with laws on pharmaceuticals and other relevant legal documents; using measures to stabilize medicine prices on the market to meet the needs for health care services for the people.

2. Medicines subject to price management under this Decree are finished products permitted for circulation and use in Vietnam by the Ministry of Health.

3. Medicine trading establishments must fully comply with regulations on declaration and display of medicine prices and bear legal responsibility for declared and displayed prices and selling prices in accordance with the Law on Pharmaceuticals., This Decree and other relevant legal documents.

Article 9. Types of medicine prices to be declared and displayed

1. Types of medicine prices include:

a) Import price is the price including the value of the medicine based on the exporting country's price, insurance costs, and transportation fees from the exporting country to Vietnamese ports (referred to as CIF price), and excluding import taxes (if applicable);

b) Wholesale price is the price of medicines sold between trading establishments and between trading establishments and medical examination and treatment facilities;

c) Retail price is the price of medicines sold directly to users at retail outlets;

d) Projected retail price is the price of medicines by manufacturing and importing establishments projected to sell directly to users.

2. Medicine prices declared and displayed shall be in Vietnamese currency and calculated based on the smallest unit of packaging.

Article 10. Declaration of medicine prices

1. When submitting drug registration applications, depending on the form of wholesale or retail business for each product, drug manufacturing establishments must declare wholesale prices, projected retail prices in Vietnam, and import prices (if it is imported drugs). In cases where the manufacturing establishment is not named in the drug registration application, the registering establishment must declare drug prices in accordance with the prescribed regulations.

2. When submitting applications to import drugs without registration numbers, depending on the form of wholesale or retail business for each product, drug importing establishments must declare import prices, wholesale prices, and projected retail prices in Vietnam.

3. During the course of drug business, drug manufacturing establishments and drug importing establishments may not sell at higher prices than those declared. If selling drugs at higher prices than those declared, they must re-declare and explain the reasons to the competent state agency managing drug prices before implementing new prices. If selling drugs at lower prices than those declared, they must comply with the provisions of the law on anti-dumping.

4. Declared and re-declared drug prices at the time of declaration may not be higher than the corresponding prices of similar drugs in countries in the region with similar healthcare and trade conditions at the same time. Countries in the region with similar healthcare and trade conditions to Vietnam are those with the following statistical indicators similar to Vietnam:

a) Annual per capita gross national income;

b) Annual per capita purchasing power parity;

c) Network of preventive healthcare, medical examination and treatment, rehabilitation, and health promotion services and medicine supply for the people.

The Ministry of Health shall take the lead and coordinate with the Ministry of Trade and related ministries and sectors to compile a specific list of countries in the region with similar healthcare and trade conditions to Vietnam.

5. The competent state agency managing drug prices shall be responsible for updating and publicly announcing drug prices declared by trading establishments on the industry's website, specialized magazines, and other mass media as a basis for patients and medical examination and treatment facilities to refer to when purchasing drugs; competent state agencies with authority shall organize inspections and checks on the implementation of regulations on declaring drug prices by manufacturing, registering, and importing establishments in accordance with this Article.

Article 11. Displaying drug prices

1. Production facilities, importers, and wholesale drug sellers must display wholesale prices for each type of drug by publicly announcing them on boards, paper, or other forms placed, hung, or affixed at drug sales locations to facilitate customer observation, oversight by competent state management agencies, and shall not sell at prices higher than those displayed.

2. Retail drug sellers must display retail prices for each type of drug by printing, writing, or affixing retail prices on the packaging containing the drugs or on the outer packaging of the drugs, and shall not sell at prices higher than those displayed.

3. Medical examination and treatment establishments providing supply of drug types listed in the essential drug directory for medical examination and treatment purposes that are not subject to the provisions of Clause 2, Article 12 of this Decree must display supply prices for each type of drug. The supply price of drugs at medical examination and treatment establishments shall not be higher than the prevailing retail price of the same type of drug in the same locality at the same time.

Article 12. Management of drug prices paid by the state budget and health insurance

1. State management agencies for drug prices have the responsibility to announce maximum prices for drug types paid by the state budget and health insurance periodically every six months or in cases of abnormal price fluctuations.

The Ministry of Health, based on economic and social development conditions during each period, ensures sufficient quality drugs with reasonable prices to meet the drug usage needs of the people, coordinates with the Ministry of Finance, the Ministry of Trade, and related agencies to provide specific guidance on determining and announcing maximum prices for drugs stipulated in this clause.

2. Purchasing drugs listed in the essential drug directory for use in public medical examination and treatment establishments and drugs paid for by the state budget must be conducted through bidding in accordance with the law on bidding, ensuring the following principles:

a) Prioritize purchasing domestically produced drugs of the same type, equivalent quality, and not higher in price than imported drugs at the time of bidding;

b) The winning bid price for drugs shall not exceed the current maximum price announced at the nearest time point as stipulated in Clause 1 of this Article.

3. The Minister of Health shall lead and coordinate with the Minister of Planning and Investment and the Minister of Finance to provide specific guidance on bidding for drugs stipulated in Clause 2 of this Article.

Article 13. State management agency for drug prices

The Vietnam Drug Administration under the Ministry of Health is the agency assisting the Minister of Health in performing state management functions over drug prices.

The Minister of Health shall specify the functions and tasks of the Vietnam Drug Administration in managing drug prices.

Chapter IV

CONDITIONS FOR DRUG TRADING

Section 1

 CONDITIONS AND PROCEDURES FOR ISSUING PHARMACEUTICAL PRACTICE LICENSES

Article 14. Pharmaceutical Practice License

1. A pharmaceutical practice license is issued to the professional manager of a drug trading facility suitable for each form of business organization. Individuals receiving a pharmaceutical practice license must meet the conditions specified in Clause 1, Article 13 of the Pharmacy Law and the provisions of this Decree.

2. Each individual may only be issued one pharmaceutical practice license and may only manage one form of drug business organization.

3. The authority to issue pharmaceutical practice licenses is implemented according to the provisions of Clause 3, Article 13 of the Pharmacy Law.

Article 15. Professional certificates, diplomas, and practical experience for obtaining a Pharmaceutical Practice Certificate

1. A person eligible to obtain a Pharmaceutical Practice Certificate must possess one of the following diplomas as required for each form of pharmaceutical business organization:

a) Bachelor's degree in Pharmacy

b) Secondary diploma in Pharmacy

c) Diploma in Pharmacy Technician

d) Secondary diploma in Medicine

đ) Bachelor's degree in Medicine or Bachelor's degree in Biology

e) Bachelor's or secondary degree in Traditional Medicine

g) Certificates in Traditional Medicine Practitioner, Traditional Pharmacy Practitioner, Family Prescriptions Certification, and Traditional Medicine Specialization

The types of certificates specified in point g, Clause 1 of this Article shall be defined by the Minister of Health in accordance with economic and social conditions and healthcare needs at each locality during each period.

2. Requirements for professional certificates and practical experience for the professional management of pharmacy in pharmaceutical production establishments:

a) The professional manager of a pharmaceutical production enterprise must have the certificate specified in point a, Clause 1 of this Article and at least five years of practical experience at a legitimate pharmacy establishment.

b) The professional manager of a vaccine and medical product production enterprise must have one of the certificates specified in points a and đ, Clause 1 of this Article and at least five years of practical experience at a legitimate pharmacy establishment.

c) The professional manager of a cooperative or individual household producing herbal medicines, traditional Chinese medicine, and medicines derived from herbs must have one of the certificates specified in points a, b, e, and g, Clause 1 of this Article and at least two years of practical experience at a legitimate pharmacy establishment.

3. Requirements for professional certificates and practical experience for the professional management of pharmacy in wholesale pharmaceutical establishments:

a) The professional manager of a wholesale pharmaceutical enterprise must have the certificate specified in point a, Clause 1 of this Article and at least three years of practical experience at a legitimate pharmacy establishment.

b) The professional manager of a wholesale vaccine and medical product enterprise must have one of the certificates specified in points a and đ, Clause 1 of this Article and at least three years of practical experience at a legitimate pharmacy establishment.

c) The professional manager of an enterprise, cooperative, or individual household trading in herbal medicines, traditional Chinese medicine, and medicines derived from herbs must have one of the certificates specified in points a, b, e, and g, Clause 1 of this Article and at least two years of practical experience at a legitimate pharmacy establishment.

d) The professional manager of a vaccine and medical product sales agency must have one of the certificates specified in points a, b, d, and đ, Clause 1 of this Article and at least two years of practical experience at a legitimate pharmacy establishment.

4. Requirements for professional certificates and practical experience for the owner of a retail pharmaceutical establishment:

a) The owner of a pharmacy in centrally-administered cities, provincial cities, and provincial towns must have the certificate specified in point a, Clause 1 of this Article and at least five years of practical experience at a legitimate pharmacy establishment; for other areas, they must have the certificate specified in point a, Clause 1 of this Article and at least two years of practical experience at a legitimate pharmacy establishment. A bachelor's graduate in pharmacy through a part-time program may apply for a Pharmaceutical Practice Certificate immediately upon graduation.

b) The owner of a drug counter must have a diploma from a secondary vocational school in pharmacy or higher and at least two years of practical experience at a legitimate pharmacy establishment.

c) The owner of a drug sales agency of an enterprise must have a pharmacy technician certificate or higher and at least two years of practical experience at a legitimate pharmacy establishment.

d) The manager of a medical station pharmacy must have a specialization level of pharmacy technician or higher and at least two years of practical experience in pharmacy at a legitimate pharmacy establishment; if there is no person with a pharmacy technician specialization level or higher, then a person with a medical assistant specialization level or higher must be named.

5. Requirements for professional certificates and practical experience for the professional management of pharmacy in export and import pharmaceutical enterprises:

a) A person eligible to obtain a Pharmaceutical Practice Certificate under the conditions stipulated in Clause 1 of Article 24 of this Decree shall be considered the professional manager of pharmacy in an import pharmaceutical enterprise.

b) A person eligible to obtain a Pharmaceutical Practice Certificate from a pharmaceutical business establishment shall be considered the professional manager of pharmacy in an export pharmaceutical enterprise.

6. Requirements for professional certificates and practical experience for the professional management of pharmacy in pharmaceutical service storage enterprises:

a) The professional manager of a pharmaceutical service storage enterprise must have the certificate specified in point a, Clause 1 of this Article and at least three years of practical experience at a legitimate pharmacy establishment.

b) The professional manager of a vaccine and medical product storage service enterprise must have one of the certificates specified in points a and đ, Clause 1 of this Article and at least three years of practical experience at a legitimate pharmacy establishment.

7. Requirements for professional certificates and practical experience for the professional management of pharmacy in pharmaceutical testing service enterprises:

a) The professional manager of a pharmaceutical testing service enterprise must have the certificate specified in point a, Clause 1 of this Article and at least five years of practical experience at a legitimate pharmacy establishment.

b) The professional manager of a vaccine and medical product testing service enterprise must have one of the certificates specified in points a and đ, Clause 1 of this Article and at least five years of practical experience at a legitimate pharmacy establishment.

Article 16. Documents for Application to Issue, Replace, Extend, or Reissue the Pharmaceutical Practice Certificate

1. Documents for Application to Issue the Pharmaceutical Practice Certificate for Vietnamese citizens include:

a) An application form for issuance of the Pharmaceutical Practice Certificate;

b) Legal copies of relevant academic certificates;

c) A curriculum vitae with confirmation from the Chairman of the People's Committee of the commune, ward, or town where the applicant resides, or from the head of the agency where the applicant works, if they are a civil servant;

d) A health certificate for practicing issued by a medical examination and treatment facility within six months from the date of issuance;

đ) A certificate confirming the period of practical experience at a legitimate pharmaceutical establishment issued by the head of that establishment;

e) A commitment to comply with the provisions of laws and regulations related to pharmaceuticals;

g) A legal copy of the Identity Card with notarization or certification;

h) Two passport-sized photographs measuring 4cm x 6cm.

2. Documents for Application to Issue the Pharmaceutical Practice Certificate for foreign individuals and overseas Vietnamese include:

a) The documents specified in points a, b, d, đ, e, and h of Clause 1 of this Article;

b) A criminal record verified by the competent authority of the country of residence;

c) A work permit or a certificate confirming membership on the Board of Directors or Management Board of a drug business establishment;

d) A legal copy of the passport with notarization or confirmation by the diplomatic representative of the country of which they are a citizen.

Academic certificates related to pharmaceuticals and other documents stipulated in points b, đ of Clause 1 and point b of Clause 2 of this Article issued by foreign agencies or notarized must be apostilled and translated into Vietnamese; the translation must be notarized according to Vietnamese law.

3. Documents for Application to Replace the Pharmaceutical Practice Certificate due to damage or wear and tear; or change of permanent residence address of the individual registered for pharmaceutical practice, include:

a) An application form for replacement of the Pharmaceutical Practice Certificate;

b) A legal copy of the document approving the change of permanent residence address issued by the competent authority for cases involving changes in the permanent residence address of the individual registered for pharmaceutical practice;

c) The original Pharmaceutical Practice Certificate already issued;

d) Two photographs measuring 4cm x 6cm.

4. Documents for Application to Extend the Pharmaceutical Practice Certificate:

a) An application form for extension of the Pharmaceutical Practice Certificate;

b) A health certificate for practicing issued by a medical examination and treatment facility within six months from the date of issuance according to the Ministry of Health's regulations;

c) A legal copy of the already issued Pharmaceutical Practice Certificate.

d) Two photographs measuring 4cm x 6cm.

5. Documents for Application to Reissue the Pharmaceutical Practice Certificate due to loss, include::

a) An application form for reissuance of the Pharmaceutical Practice Certificate;

b) A report of loss of the Pharmaceutical Practice Certificate confirmed by the police station of the commune, ward where the certificate was lost;

c) Two photographs measuring 4cm x 6cm..

Article 17. Validity and Duration of the Pharmaceutical Practice Certificate

1. The Pharmaceutical Practice Certificate has a validity period of five years from the date of issuance. Three months before expiration, if wishing to continue practicing, the individual must submit an application for extension according to Article 16 of this Decree. The maximum extension period is five years and there is no limit on the number of extensions..

2. The value of the Pharmaceutical Practice Certificate:

a) The Pharmaceutical Practice Certificate issued and extended by the Minister of Health is valid for registration to practice throughout the country;

b) The Pharmaceutical Practice Certificate issued and extended by the Director of the Department of Health is valid within the province or centrally-administered city where it was issued.

In case of transferring the place of practice to another province or centrally-administered city, the individual registered for pharmaceutical practice must apply for a new Pharmaceutical Practice Certificate. The application documents for the new location shall follow Clause 1 of Article 16 of this Decree, accompanied by the original certificate confirming the termination of practice as a professional manager of pharmaceuticals at a drug business establishment or retail pharmacy, and the return of the Pharmaceutical Practice Certificate to the Department of Health that issued or extended it. Within five days from receiving the application for confirmation of termination of practice to transfer the place of practice, the Department of Health of the issuing location must issue a response.

3. The validity period of the reissued Pharmaceutical Practice Certificate due to loss or replacement is equivalent to the remaining validity period of the lost or replaced Pharmaceutical Practice Certificate.

Article 18. Procedures and Authority for Issuing, Reissuing, Amending, and Extending the Pharmaceutical Practice Certificate

1. Within thirty days from the date of receiving a valid application for issuing, reissuing, amending, or extending the Pharmaceutical Practice Certificate, the agency receiving the application must organize an assessment to issue, amend, or extend the Pharmaceutical Practice Certificate; if it does not issue, reissue, amend, or extend the certificate, the agency receiving the application must provide a written response stating the reasons.

2. The authority for issuing, reissuing, amending, and extending the Pharmaceutical Practice Certificate shall be implemented according to the provisions of Clause 3, Article 13 of the Medicine Law. The Pharmaceutical Practice Certificate shall be made in two copies: one copy retained by the issuing agency and one copy given to the individual applying for issuance, reissuance, amendment, or extension.

3. The Ministry of Health shall prescribe the model of the Pharmaceutical Practice Certificate.

Article 19. Revocation of the Pharmaceutical Practice Certificate

1. The Pharmaceutical Practice Certificate shall be revoked in the following cases:

a) Issued beyond the authorized authority;

b) The person holding the Pharmaceutical Practice Certificate subsequently falls under one of the circumstances stipulated in Clause 2, Article 13 of the Medicine Law;

c) The person holding the Pharmaceutical Practice Certificate dies or is declared dead by a court.

2. When violations requiring the revocation of the Pharmaceutical Practice Certificate as provided for in Clause 1 of this Article are discovered, the agency issuing the Pharmaceutical Practice Certificate shall decide to revoke it.

3. The Pharmaceutical Practice Certificate issued by the Ministry of Health previously, which according to this Decree falls within the authority of the Department of Health to issue, when revoked as provided for in Clause 1 of this Article, the Department of Health shall be responsible for revoking, retaining, and reporting to the Ministry of Health.

Section 2

CONDITIONS AND PROCEDURES FOR ISSUING THE CERTIFICATE OF SATISFACTORY CONDITIONS FOR MEDICINE BUSINESS

Article 20. Recipients of the Certificate of Satisfactory Conditions for Medicine Business

1. The Certificate of Satisfactory Conditions for Medicine Business shall be issued to medicine business establishments that meet the conditions for each form of medicine business as prescribed 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 21. Conditions for Medicine Production Establishments

1. The professional manager in charge of pharmaceuticals must have a Pharmaceutical Practice Certificate appropriate to the organizational form of the medicine production establishment.

2. The physical facilities, technical equipment, and personnel of the medicine production establishment must meet the standards for Good Manufacturing Practices for Medicines as set out in the implementation schedule for good practices standards specified in Article 27 of this Decree.

Article 22. Conditions for Issuing the Certificate of Satisfactory Conditions for Medicine Business for Wholesale Medicine Establishments

1. The professional manager in charge of pharmaceuticals must have a Pharmaceutical Practice Certificate appropriate to the organizational form of the wholesale medicine establishment.

2. The physical facilities, technical equipment, and personnel of the wholesale medicine establishment must meet the standards for Good Distribution Practices for Medicines as set out in the implementation schedule for good practices standards specified in Article 27 of this Decree.

Article 23. Conditions for Issuing the Certificate of Satisfactory Conditions for Medicine Business for Retail Medicine Establishments

1. The owner of the retail medicine establishment must have a Pharmaceutical Practice Certificate appropriate to the organizational form of the retail medicine establishment.

2. The physical facilities, technical equipment, and personnel of the retail medicine establishment must meet the standards for Good Pharmacy Practices as set out in the implementation schedule for good practices standards specified in Article 27 of this Decree.

Article 24. Conditions for Issuing a Certificate of Eligibility to Operate Pharmaceutical Business for Export and Import Enterprises

1. Manufacturing enterprises and wholesale pharmaceutical enterprises that have a Certificate of Eligibility to Operate Pharmaceutical Business and a drug warehouse meeting the Good Storage Practices standards shall be permitted to import drugs in accordance with the laws on pharmaceuticals, regulations of the Ministry of Health, and related legal provisions.

2. Enterprises holding a Certificate of Eligibility to Operate Pharmaceutical Business shall be permitted to export drugs.

Article 25. Conditions for Issuing a Certificate of Eligibility to Operate Pharmaceutical Business for Service Providers of Drug Storage

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

2. The physical facilities, technology, and personnel of service providers of drug storage must meet the Good Storage Practices standards according to the implementation schedule of the good practices standards set forth in Article 27 of this Decree.

Article 26. Conditions for Issuing a Certificate of Eligibility to Operate Pharmaceutical Business for Service Providers of Drug Testing

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

2. The physical facilities, technology, and personnel of service providers of drug testing must meet the Good Testing Practices standards according to the implementation schedule of the good practices standards set forth in Article 27 of this Decree.

Article 27. Implementation Schedule for Applying Good Practices Standards

The Minister of Health shall stipulate the implementation schedule for applying good practices standards in production, distribution, storage, pharmacies, drug testing, and cultivation, harvesting, and processing of medicinal materials.

Article 28. Documents for Application for Issuance, Supplement, Extension, Reissuance, and Replacement of a Certificate of Eligibility to Operate Pharmaceutical Business

1. The application documents for issuing Certificate of Eligibility for Pharmaceutical Business include:

a) An application form for issuance of a Certificate of Eligibility to Operate Pharmaceutical Business;

b) A certified copy of the Professional Practice Certificate of the pharmaceutical management specialist appropriate to the business organization form; a certified copy of the Business Registration Certificate;

c) A list of staff, specialized equipment, and technical facilities;

d) For agents selling drugs to pharmaceutical businesses, and agents selling vaccines and medical products to vaccine and medical product manufacturers, in addition to the documents specified in points a, b, and c, they must also provide a certified copy of the agency contract between the enterprise establishing the agency and the head of the agency.

2. The application dossier for supplementing the scope of pharmaceutical business operations in the Certificate of Compliance with Conditions for Pharmaceutical Business Operations includes:

a) An application form for supplementing the scope of pharmaceutical business operations;

b) A certified copy of the previously issued Certificate of Eligibility to Operate Pharmaceutical Business;

c) A list of staff, specialized equipment, and technical facilities for the supplemented scope of business operations.

3. Documents for Application for Extension of a Certificate of Eligibility to Operate Pharmaceutical Business include:

a) An application form for extension of a Certificate of Eligibility to Operate Pharmaceutical Business;

b) A certified copy of the Professional Practice Certificate of the pharmaceutical management specialist appropriate to the business organization form; a certified copy of the Business Registration Certificate; a certified copy of the previously issued Certificate of Eligibility to Operate Pharmaceutical Business;

c) A list of staff, specialized equipment, and technical facilities;

d) A report on business operation results over the past five years as prescribed by the Ministry of Health.

4. Documents for Application for Reissuance of a Certificate of Eligibility to Operate Pharmaceutical Business due to loss include:

a) An application form for reissuance of a Certificate of Eligibility to Operate Pharmaceutical Business;

b) A lost certificate report of the Certificate of Eligibility to Operate Pharmaceutical Business with confirmation from the police station at the place where the person lost the certificate.

5. Documents for Application for Replacement of a Certificate of Eligibility to Operate Pharmaceutical Business due to damage or wear; change of the pharmaceutical management specialist; change of the business name but not the business location; change of the registered business address when the registered business address is not the business location already certified by the Certificate of Eligibility to Operate Pharmaceutical Business, including:

a) An application form for replacement of a Certificate of Eligibility to Operate Pharmaceutical Business;

b) A certified copy of the Professional Practice Certificate of the new pharmaceutical management specialist for cases involving a change of the pharmaceutical management specialist;

c) A certified copy of the approval document for changing the business name from the registration authority for cases involving a change of the business name;

d) A certified copy of the approval document for changing the registered business address from the registration authority for cases involving a change of the registered business address;

e) The original previously issued Certificate of Eligibility to Operate Pharmaceutical Business.

Article 29. Value and Duration of the Certificate of Eligibility for Medicines Business

1. The Certificate of Eligibility for Medicines Business has a validity period of five years from the date of issuance. Three months before the expiration date, if wishing to continue business operations, individuals and organizations must submit procedures to request an extension of the Certificate of Eligibility for Medicines Business in accordance with Article 28 of this Decree. The extension period is five years.

2. The usage period of the reissued Certificate of Eligibility for Medicines Business due to loss or replacement shall be equivalent to the remaining validity period of the lost or replaced Certificate of Eligibility for Medicines Business.

Article 30. Procedures and Authority for Issuance, Reissuance, Supplement, Replacement, and Extension of the Certificate of Eligibility for Medicines Business

1. The procedures for issuance, reissuance, supplementation, replacement, and extension of the Certificate of Eligibility for Medicines Business are stipulated as follows:

a) Within thirty days from the date of receipt of a valid application for issuance, reissuance, supplementation, replacement, or extension of the Certificate of Eligibility for Medicines Business, the agency receiving the application must organize an assessment to issue, reissue, supplement, replace, or extend the Certificate of Eligibility for Medicines Business; if not issuing, reissuing, supplementing, replacing, or extending, the agency receiving the application must provide a written response and clearly state the reasons.

b) In cases where the application for issuance, reissuance, supplementation, replacement, or extension of the Certificate of Eligibility for Medicines Business is not valid, within ten working days from the date of receipt of the application, the agency receiving the application must provide a written notice to the organization or individual applying for issuance, reissuance, supplementation, replacement, or extension of the Certificate of Eligibility for Medicines Business to complete the application.

2. The authority for issuance, reissuance, supplementation, replacement, and extension of the Certificate of Eligibility for Medicines Business is implemented according to the provisions of Clause 3, Article 11 of the Medicine Law. The Certificate of Eligibility for Medicines Business shall be made in two copies: one copy retained at the issuing agency, and one copy provided to the applicant organization or individual.

3. The Ministry of Health prescribes the model of the Certificate of Eligibility for Medicines Business.

Article 31. Revocation of the Certificate of Eligibility for Medicines Business

1. The Certificate of Eligibility for Medicines Business will be revoked in the following cases:

a) The Certificate of Eligibility for Medicines Business was issued beyond the authority;

b) The professional manager of the medicines business establishment does not have a Pharmaceutical Practice Certificate;

c) The medicines business establishment does not meet the business conditions for each form of business organization as prescribed in Articles 21, 22, 23, 24, 25, and 26 of this Decree;

d) Twelve months after the issuance of the Certificate of Eligibility for Medicines Business, the medicines business establishment does not operate;

e) The medicines business establishment ceases operations.

2. When violations requiring the revocation of the Certificate of Eligibility for Medicines Business as stipulated in Clause 1 of this Article are discovered, the agency authorized to issue the Certificate of Eligibility for Medicines Business as prescribed in Clause 3, Article 11 of the Medicine Law decides to revoke the Certificate of Eligibility for Medicines Business.

3. The Certificate of Eligibility for Medicines Business previously issued by the Ministry of Health, which falls under the authority of the Department of Health according to this Decree, when revoked as stipulated in Clause 1 of this Article, the Department of Health is responsible for revoking, retaining, and reporting to the Ministry of Health.

Chapter V

MANAGEMENT OF MEDICINES IN THE SPECIAL CUSTOMS CONTROL LIST

Section 1

MANAGEMENT OF ADDICTIVE MEDICINES, PSYCHOACTIVE MEDICINES,

 PRECURSOR CHEMICALS USED AS MEDICINES

Article 32. Conditions for Business Operations

The business establishments dealing with addictive drugs, psychotropic drugs, and precursor substances used as drugs must meet the following conditions:

a) Business conditions for drugs as prescribed in Chapter II of the Drug Law and Chapter IV of this Decree;

b) Conditions as prescribed in Government Decree No. 80/2001/NĐ-CP dated November 5, 2001, guiding the control of lawful activities related to narcotics within the country, and Government Decree No. 58/2003/NĐ-CP dated May 29, 2003, concerning the control of import, export, and transit through Vietnam of narcotic substances, precursors, addictive drugs, psychotropic drugs, and other relevant legal provisions.

Section 2

MANAGEMENT OF RADIOACTIVE DRUGS

Article 33. Conditions for Business Operations

In addition to meeting the drug business conditions as prescribed in Chapter II of the Drug Law and Chapter IV of this Decree, business establishments dealing with radioactive drugs 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 according to a program jointly established by the Ministry of Science and Technology and the Ministry of Health, and must hold a radiation safety training certificate issued by a training institution authorized by the Ministry of Science and Technology.

Article 34. Preparation and Use of Radioactive Drugs

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 medicine facilities that have been licensed and require the use of radioactive drugs must prepare a forecast table according to the prescribed model for review by the Ministry of Health, and simultaneously report to the Ministry of Science and Technology (National Radiation Control and Safety Center) for monitoring.

Chapter VI

QUALITY STANDARDS FOR DRUGS, STATE TESTING INSTITUTIONS FOR DRUGS AND RESOLUTION OF COMPLAINTS REGARDING CONCLUSIONS

QUALITY OF DRUGS

Article 35. Issuance of the Vietnamese Pharmacopoeia

1. The Vietnamese Pharmacopoeia is a national standard for drugs compiled by the Pharmacopoeia Council and promulgated by the Minister of Health. The Vietnamese Pharmacopoeia Council is established by the Minister of Health.

2. The procedures and formalities for developing and issuing national standards for drugs shall be carried out in accordance with the laws on standards and technical regulations.

Article 36. Application of Foreign and International Pharmacopoeias

Domestic drug business establishments are permitted to apply standards recorded in foreign pharmacopoeias and international pharmacopoeias that they have registered and been accepted by the Ministry of Health.

Article 37. Organizational Structure of State Testing Institutions for Drugs

1. Central state testing institutions for drugs include: The Central Institute for Drug Testing, the Ho Chi Minh City Institute for Drug Testing, Regional Drug Testing Centers, and the National Institute for Vaccine and Biological Product Quality Control.

2. Local state testing institutions for drugs include: Provincial Drug Testing Centers under centrally governed cities.

3. The organization and operation of state testing institutions for drugs shall be implemented in accordance with current laws.

Article 38. Activities of State Testing Institutions for Drugs

1. Central state testing institutions for drugs shall perform the following tasks:

a) Inspection, evaluation of drug quality, and certification of drug quality standards and other products at the request of the Ministry of Health;

b) Scientific research; technical guidance for local state testing institutions for drugs; in c) Training and retraining of drug testing staff in technical expertise;

d) Provision of testing services;

đ) Proposing technical measures to the Minister of Health for managing drug quality in line with the country's economic and social development conditions;

e) Other activities as prescribed by relevant laws.

2. Local state testing institutions for drugs shall conduct inspections of circulating drugs within their provincial or centrally governed city jurisdiction and other activities as prescribed by relevant laws.

3. The Minister of Health shall specify the functions and responsibilities of state testing institutions for drugs after consultation with the Ministry of Home Affairs.

3. The Minister of Health shall specify in detail the functions and duties of state pharmaceutical testing facilities after coordinating with the Ministry of Home Affairs.

Article 39. Authority to Determine the Results of Pharmaceutical Quality Testing

Clause 1. The State Central Pharmaceutical Testing Facility has the authority to determine the results of pharmaceutical quality testing in accordance with the quality standards registered by the production facilities and importers seeking permission for circulation, and assists the Minister of Health in determining the quality of pharmaceuticals nationwide according to the division of labor by the Minister of Health, in compliance with this Decree and other relevant laws.

The National Medicines Administration is the agency that assists the Minister of Health in concluding on the quality of pharmaceuticals nationwide based on the results of pharmaceutical quality testing conducted by the State Central Pharmaceutical Testing Facilities.

Clause 2. The State Local Pharmaceutical Testing Facility has the authority to determine the results of pharmaceutical quality testing in accordance with the quality standards registered by the production facilities and importers seeking permission for circulation, and assists the Director of the Provincial Health Department in determining the quality of pharmaceuticals within their jurisdiction according to this Decree and other relevant laws.

The Provincial Health Department is the agency that assists the Chairman of the People's Committee of the province or centrally-administered city in concluding on the quality of pharmaceuticals within their jurisdiction based on the results of pharmaceutical quality testing conducted by the State Local Pharmaceutical Testing Facilities.

Clause 3. In cases of complaints about the conclusion on pharmaceutical quality, the Ministry of Health designates a pharmaceutical testing facility to determine the results of pharmaceutical quality testing on the principle that such testing facility shall not be one of the disputing parties; it must meet minimum standards equivalent to those of the testing facility whose results led to the dispute.

Clause 4. The procedures, formalities, and authority to handle complaints about conclusions on pharmaceutical quality are carried out in accordance with the provisions of the law on complaints and denunciations.

Chapter VII

ASSIGNMENT OF RESPONSIBILITIES FOR NATIONAL MANAGEMENT OF PHARMACEUTICALS

Article 40. Responsibilities of the Ministry of Health

The Ministry of Health is responsible before the Government for implementing national management tasks regarding pharmaceuticals throughout the country, including:

Point 1. Leading the drafting and submission to competent authorities for issuance, or issuing directly within its authority, legal normative documents on pharmaceuticals; policies, strategies, planning, development plans for pharmaceuticals, and guidance on implementation after issuance.

Point 2. Drafting and submitting specific projects to the Government and Prime Minister for priority and preferential investment in the pharmaceutical industry annually; directing the implementation of these projects after approval.

Point 3. Leading and coordinating with related ministries and sectors to issue and implement legal normative documents on pharmaceuticals; conditions for pharmaceutical business operations, drug pricing management, and the phased application of good practices standards.

Point 4. Leading and coordinating with the Ministry of Planning and Investment and the Ministry of Finance to provide detailed guidance on tendering for types of drugs specified in Article 49 of the Pharmaceutical Law.

Point 5. Leading and coordinating with the Ministry of Finance and related ministries and sectors to manage drug prices.

Point 6. Leading and coordinating with the Ministry of Education and Training to develop human resource training and retraining plans for the pharmaceutical sector to be decided by the Prime Minister.

Point 7. Leading and coordinating with the Ministry of Home Affairs, the Ministry of Labor, Invalids and Social Affairs to provide guidance on the implementation of personnel policies and systems for the pharmaceutical sector at primary healthcare levels; prioritizing areas with special difficulties in socio-economic conditions and areas with difficult socio-economic conditions.

Point 8. Implementing international cooperation and United Nations activities in the pharmaceutical sector in accordance with the law.

Point 9. Conducting inspections and supervision of compliance with pharmaceutical laws; handling complaints and denunciations, and dealing with violations of pharmaceutical laws in accordance with the law.

Article 41. Responsibilities of Ministries

1. The Ministry of Finance, the Ministry of Trade, and the Ministry of Industry shall cooperate with the Ministry of Health to establish and publish the maximum prices for types of drugs specified in Article 49 of the Medicine Law.

2. The Ministry of Finance shall cooperate with the Ministry of Health to develop, submit to competent authorities for issuance, or issue within its authority policies, measures, and regulatory documents guiding the implementation of drug price management, tax rates on drugs, statistics on actual exports and imports of drugs through border gates, and solutions to stabilize drug prices and national drug reserve circulation as prescribed by law.

3. The Ministry of Planning and Investment:

a) Cooperate with the Ministry of Health to develop and submit to the Prime Minister for issuance the planning for the development of the pharmaceutical industry; allocate investment projects for the pharmaceutical industry, approve plans for the national drug reserve fund;

b) Cooperate with the Ministry of Finance and the Ministry of Health in developing and submitting to competent authorities for issuance, or issuing within their authority policies, measures, and regulatory documents guiding the implementation of drug price management, solutions to stabilize drug prices, and drug circulation reserves as prescribed by law.

4. The Ministry of Trade:

a) Take the lead and cooperate with the Ministry of Health to monitor fluctuations in the domestic and international pharmaceutical market, serving the development and proposal of drug pricing management policies to be submitted to competent authorities for issuance or issued within their authority;

b) Cooperate with the Ministry of Health to develop and submit to competent authorities for issuance, or issue within their authority the planning for the distribution network of drug circulation nationwide; promote drug exports and imports; prevent and combat counterfeit drugs, smuggled drugs, and drugs of unknown origin circulating in the market;

c) Cooperate with the Ministry of Health to develop and submit to competent authorities for issuance, or issue within their authority and implement regulations on e-commerce in the field of drug business as prescribed by law.

5. The Ministry of Industry shall cooperate with the Ministry of Health to develop and submit to competent authorities for issuance, or issue within their authority and implement the planning for the development of Vietnam's pharmaceutical industry and chemical raw material production.

6. The Ministry of Science and Technology shall cooperate with the Ministry of Health to establish and issue a list and specific guidelines for conditions for operating and using radioactive drugs.

7. The Ministry of Home Affairs shall cooperate with the Ministry of Health to define functions, tasks, and specific activities of state drug testing facilities.

8. The Ministry of Culture and Information shall cooperate with the Ministry of Health to issue guidance documents for information and advertising activities for drugs on mass media and the Internet.

9. The Ministry of Agriculture and Rural Development shall cooperate with the Ministry of Health in developing and organizing the implementation of plans for cultivating and developing medicinal plant resources.

10. The Ministry of Public Security shall cooperate with the Ministry of Health to combat and prevent crimes related to the production and circulation of counterfeit drugs, substandard drugs, smuggled drugs, and drugs of unknown origin in the market.

Article 42. Responsibilities of Provincial People's Committees and Municipal People's Committees under Central Government

1. Issue within their authority guidance documents on pharmaceutical matters in their respective areas.

2. Organize and direct the implementation of drug price management policies and measures in their respective areas as prescribed by law.

3. Inspect and audit organizations and individuals operating in their areas to ensure compliance with pharmaceutical laws at the local level; handle violations of pharmaceutical laws within their authority.

4. Direct specialized agencies in their areas to cooperate with the Department of Health to implement national drug policies and support local pharmaceutical enterprises in developing drug production.

Chapter VIII

IMPLEMENTING PROVISIONS

Article 43. Effective Date

1. This Decree takes effect fifteen days from the date of publication in the Official Gazette and replaces the Drug Regulation for Disease Prevention and Treatment issued together with Decision No. 23-HĐBT dated January 24, 1991 of the Council of Ministers; provisions on private practice of traditional Chinese medicine, private practice of pharmacy, and private practice of vaccine and medical products in Decision No. 103/2003/NĐ-CP dated September 12, 2003 of the Government detailing the implementation of certain provisions of the Private Practice of Medicine and Pharmacy Ordinance; provisions in Decision No. 120/2004/NĐ-CP dated May 12, 2004 of the Government on drug price management for disease prevention and treatment; and all previous provisions contrary to this Decree are abolished.

2. Organizations and individuals who have been granted a Practicing Certificate for Pharmacy or a Certificate of Eligibility for Practicing Pharmacy before October 1, 2005 may continue practicing until the expiration date stated in their Practicing Certificate for Pharmacy or Certificate of Eligibility for Practicing Pharmacy. Three months prior to the expiration date, if they wish to continue practicing, they must apply for a new Practicing Certificate for Pharmacy and a Certificate of Eligibility for Operating a Pharmacy according to the Medicine Law and this Decree.

3. State-owned pharmaceutical enterprises, including state-owned pharmaceutical enterprises that have been privatized where the professional manager of the enterprise does not yet have a Practicing Certificate for Pharmacy, and the enterprise does not yet have a Certificate of Eligibility for Operating a Pharmacy, the professional manager of the enterprise must prepare an application for a Practicing Certificate for Pharmacy appropriate to the form of business organization; the enterprise must prepare an application for a Certificate of Eligibility for Operating a Pharmacy immediately upon meeting the requirements for material, technical, and human resources conditions according to the implementation schedule of good practices set out in Article 27 of this Decree.

Article 44. 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 and centrally governed city People's Committees are responsible for implementing this Decree./.