THE SOCIALIST REPUBLIC OF VIETNAM Independence - Freedom - Happiness ---------------
No. 02/VBHN-BYT
Hanoi, January 11, 2024
DECREE
GUIDELINES FOR IMPLEMENTATION OF THE LAW ON PHARMACY
The Government’s Decree No. 54/2017/ND-CP dated May 08, 2017 on guidelines for implementation of the Law on Pharmacy, which has been effective since July 01, 2017, is amended by:
The Government’s Decree No. 155/2018/ND-CP dated November 12, 2018 on amendments to certain regulations relating to business conditions under state management of the Ministry of Health, which has been effective since November 12, 2018.
The Government’s Decree No. 88/2023/ND-CP dated December 11, 2023 amendments to Decree No. 54/2017/ND-CP dated May 08, 2017 on guidelines for implementation of the Law on Pharmacy and Government’s Decree No. 155/2018/ND-CP dated November 12, 2018 on amendments to certain regulations relating to business conditions under state management of the Ministry of Health, which has been effective since December 11, 2023.
Pursuant to the Law on Government Organization dated June 19, 2015; Law dated November 22, 2019 on Amendments to some Articles of the Law on Government Organization and Law on Local Government Organization;
Pursuant to the Law on Pharmacy dated April 06, 2016;
At the request of the Minister of Health;
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Chapter I
GENERAL PROVISIONS
Article 1. Scope and regulated entities
1. This Decree provides for pharmacy practice certificate; pharmacy business; export and import of drugs; marketing authorization of herbal materials, excipients, capsule shells; assessment of overseas drug manufacturers; power, method and procedures for recalling medicinal materials; handling of recalled medicinal materials; documents and procedures for issuance of certification of drug advertisement and measures for drug price management.
2. This Decree applies to organizations and individuals in Vietnam and overseas whose operation involves pharmacy in Vietnam.
Article 2. Definitions
For the purpose of this Decree, the terms below are construed as follows:
1. “drug information” means collection and provisions of information about a drug, including indications, contraindications, dose, uses, adverse effects and information relevant to quality, safety and efficacy of the drug provided by a responsible facility in order to provide information for pharmacy authorities, medical practitioners and drug users.
4. “import price” is the customs value of imported drug on the customs value declaration at a Vietnam’s port after customs clearance is granted.
5. “prime cost” of a domestically manufactured drug equals (=) the costs of raw materials, fuel, instruments, energy plus (+) direct labour cost plus (+) depreciation of direct machinery and equipment plus (+) manufacturing overhead plus (+) financing cost plus (+) cost of sales plus (+) management cost minus (-) cost distributed to by products (if any).
6. “wholesale price” is the selling price among pharmacy business establishments or between a pharmacy business establishment and a medical facility.
7. “intended wholesale price” is the price declared by the drug importer, drug manufacturer or outsourcing entity (in case of manufacturing outsourcing) to a competent authority.
8. “retail price” of a drug is the price for selling the drug to buyers imposed by the drug retailer.
9. “retail margin” is the difference between the buying price and selling price at a drug retailer.
10. “retail margin percent” is the ratio (%) of retail margin to buying price at a drug retailer.
Chapter II
PHARMACY PRACTICE CERTIFICATE
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Article 3. Application for the pharmacy practice certificate
1. An application for the pharmacy practice certificate mentioned in Article 24 of the Law on Pharmacy consists of:
c) If the applicant’s scope of practice has to be adjusted, documents proving the adjustment: relevant qualifications, certificate of internship as an appropriate pharmaceutical facility.
2. The original copy or certified true copy of the documents specified in Clause 1b and 1c of this Article.
3. The documents mentioned in Clause 1b and 1c of this Article must be consularly legalized and enclosed with notarized Vietnamese translations if issued by overseas competent authorities.
4. Only 01 set of documents specified in this Article is required.
Article 6. Procedures for issuing, reissuing and adjusting the pharmacy practice certificate
1. The applicant for issuance, reissuance or adjustment of the pharmacy practice certificate shall submit an application directly or by post to:
a) The Ministry of Health if the pharmacy practice certificate has to be obtained after passing an examination;
b) Department of Health of the province if the pharmacy practice certificate may be granted without an examination.
2. After receiving the application, the receiving authority shall give the applicant form No. 01 in Appendix I enclosed herewith.
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7. Within 05 working days from the date of issuance, reissuance or adjustment of the pharmacy practice certificate, the receiving authority shall update the following information on its website:
a) Full name, date of birth of the holder of the pharmacy practice certificate;
b) Number of the pharmacy practice certificate;
c) The scope of practice.
8. The pharmacy practice certificate will be made into 02 copies. One of them will be given to the applicant, the other retained by the issuing authority.
9. When a pharmacy practice certificate is reissued or adjusted, the applicant shall return the old one.
In the cases where a pharmacy practice certificate is lost, the applicant shall submit the Form No. 04 in Appendix I enclosed herewith.
10. Specimen of the pharmacy practice certificate:
a) The specimen of the pharmacy practice certificate issued without an examination is Form No. 06 in Appendix I enclosed herewith;
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11. The Minister of Health shall specify the structure and operation of the advisory council responsible for giving counsel on issuance of the pharmacy practice certificate (hereinafter referred to as “certification advisory council”).
12. In the cases where a pharmacy practice certificate is reissued according to Clause 8 Article 24 of the Law on Pharmacy, the applicant is exempt from fees.
Article 7. Procedures for revocation of the pharmacy practice certificate
1. When a pharmacy practice certificate is revoked according to Clauses 1, 4, 5, 6, 7, 8, 9, 10, 11 Article 28 of the Law on Pharmacy:
Within 05 working days from the day on which the proposal to revoke the pharmacy practice certificate is received or from the discovery of the cases mentioned in Clauses 1, 4, 5, 6, 7, 8, 9, 10, 11 Article 28 of the Law on Pharmacy, the issuing authority shall revoke the pharmaceutical practice certificate it issued, or respond the proposing authority and provide explanation if such proposal is rejected.
2. When a pharmacy practice certificate is revoked according to Clause 2 and Clause 3 Article 28 of the Law on Pharmacy:
Within 05 working days from the day on which the pharmacy practice certificate is found erroneous or the request for revocation of the pharmacy practice certificate is received, the issuing authority shall revoke the pharmaceutical practice certificate it issued, or respond the requesting entity in writing and provide explanation if such request is rejected.
3. Responsibilities of the issuing and revoking authority:
a) Issue the decision to revoke the pharmacy practice certificate;
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c) Update information about revocation of the pharmacy practice certificate on its website;
d) The Ministry of Health and Departments of Health of provinces shall post the decision on revocation of the pharmacy practice certificate on their websites within 05 working days from the day on which it is received from its issuer.
Section 3. DETERMINATION OF QUALIFICATIONS AND POSITIONS TO ISSUE THE PHARMACY PRACTICE CERTIFICATE
Article 17. Qualifications eligible for issuance of the pharmacy practice certificate
1. Bachelor’s degree in pharmacy which is granted by a domestic educational institution and the position written in which is “Dược sĩ” (“Pharmacist”), “Dược sĩ đại học” (“Bachelor of Pharmacy”) or “Dược sĩ cao cấp” (“High-rank pharmacist”).
2. Bachelor’s degree in general medicine which is granted by a domestic educational institution and the position written in which is “Bác sĩ” (“Physician”) or “Bác sĩ đa khoa” (“General physician”).
3. Bachelor’s degree in traditional medicine or traditional pharmacy which is granted by a domestic educational institution.
4. Bachelor’s degree in biology which is granted by a domestic educational institution.
5. Bachelor’s degree in chemistry which is granted by a domestic educational institution.
6. College degree in pharmacy which is granted by a domestic educational institution.
7. Associate degree in pharmacy which is granted by a domestic educational institution and the position written in which is “Dược sĩ trung cấp” or “Dược sĩ trung học” (“pharmacy technician”).
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9. Associate degree in traditional medicine or traditional pharmacy which is granted by a domestic educational institution.
10. Basic diploma in pharmacy which is granted by a domestic educational institution and the position written in which is “Dược tá” (“pharmacist assistant”) or “Sơ cấp dược”.
Article 18. Determination of scope of practice of holders of undefined qualifications and positions
1. If a qualification issued by a domestic training institution does not specify any of the positions specified in Clause 1, 2, 7, 10 Article 17 hereof, the scope of practice shall be decided by the issuer of the pharmacy practice certificate on the basis of counsel provided by the certification advisory council.
2. Scope of practice of holders of qualifications issued by overseas training institutions which have to be certified according to regulations of the Minister of Transport shall be determined in accordance with Clause 1 of this Article.
1. Internship-offering establishments are establishments specified in Clause 2 Article 13 of the Law on Pharmacy, including: pharmacy business establishments, pharmacies of health facilities, pharmacy training institutions, pharmacy research institutions, laboratories testing drugs and medicinal materials, pharmacy authorities, representative offices of foreign drug traders (hereinafter referred to as “pharmacy establishment”); health facilities suitable for the interns’ qualifications.
2. An internship-offering establishment is considered suitable is an establishment mentioned in Clause 1 of this Article and whose operation is suitable for the intern’s qualifications according to Article 20 hereof.
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c) The person in charge of quality assurance of a manufacturer of vaccines and biologicals and ingredients thereof shall complete one of the following internship contents: manufacture, testing, quality assurance, research and development at a facility manufacturing or testing vaccines and biologicals.
3. Pharmacists and persons in charge of quality assurance of manufacturers of herbal materials
a) The pharmacist and the person in charge of quality assurance of a manufacturer of herbal materials shall complete one of the following internship contents: manufacture and processing of herbal materials, traditional drugs and herbal drugs, testing of drugs, quality assurance during the production of medicinal materials and traditional drugs, traditional medicine or traditional pharmacy management at a pharmacy authority;
b) The chief pharmacist and the person in charge of quality assurance of a household business or cooperative manufacturing herbal materials shall complete one of the following internship contents: manufacture of medicinal materials, drug testing, quality assurance during the production of herbal materials and traditional drugs, concoction of traditional drugs, traditional medicine or traditional pharmacy management at a pharmacy authority.
4. Pharmacists of wholesalers of drugs and medicinal materials
a) The chief pharmacist of a drug manufacturer, except for the cases in Point c and d of this Clause, shall complete one of the following internship contents: drug manufacture, drug testing, research and development of drug, pharmacy management at a pharmacy authority;
b) The pharmacist of a wholesaler of medicinal materials shall complete one of the following internship contents: manufacture of medicinal materials and chemicals, testing of drugs and medicinal materials, research into chemical and pharmaceutical technology; wholesaling of drugs, export and import of drugs; storage of drugs and medicinal materials; traditional pharmacy or traditional medicine management at a pharmacy authority;
c) The chief pharmacist of a wholesaler of vaccines and biologicals shall complete one of the following internship contents: manufacture, wholesaling, storage, testing of vaccines and biologicals, research into vaccines and biologicals, pharmacy management at a pharmacy authority;
d) The chief pharmacist of a wholesaler of herbal materials, herbal drugs and traditional drugs shall complete one of the following internship contents: wholesaling of drugs and herbal materials; storage of drugs and herbal materials, testing of drugs and medicinal materials, traditional medicine; research into herbal materials and traditional medicine; traditional pharmacy or traditional medicine management at a pharmacy authority.
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a) The chief pharmacist of an exporter of importer of drugs and medicinal materials, except for the cases in Points b and c of this Clause, shall complete one of the following internship contents: wholesaling of drugs, export and import of drugs; manufacture of drugs; testing of drugs and medicinal materials; Good Storage Practice (GSP); pharmacy management related to sale, export, import, wholesaling of drugs and medicinal materials; pharmacy management at a pharmacy authority;
b) The chief pharmacist of an exporter or importer of vaccines and biologicals shall complete one of the following internship contents: manufacture, wholesaling, storage, testing of vaccines and biologicals, research into vaccines and biologicals; use of vaccines and biologicals; pharmacy management at a pharmacy authority;
c) The chief pharmacist of an exporter or importer of herbal materials, herbal drugs and traditional drugs shall complete one of the following internship contents: wholesaling of drugs and medicinal materials; storage of drugs and medicinal materials; manufacture of drugs and medicinal materials; testing of drugs, medicinal materials and traditional medicine; research into herbal materials and traditional medicine; traditional pharmacy or traditional medicine management at a pharmacy authority.
6. Pharmacists of drug retailers
a) The chief pharmacist of a drugstore or dispensary of a commune shall complete one of the following internship contents: wholesaling and retailing of drugs; export and import of drugs; clinical pharmacology; supply of drugs for health facilities; manufacture of drugs; testing of drugs and medicinal materials; pharmaceutical research; drug storage; drug distribution; pharmacy management at a pharmacy authority;
b) The chief pharmacist of a retailer of herbal materials, herbal drugs and traditional drugs, except for the cases in Point c Clause 2 Article 13 of the Law on Pharmacy, shall complete one of the following internship contents: manufacture, research, sale, traditional medicine; traditional pharmacy or traditional medicine management at a pharmacy authority.
7. Pharmacists of providers of drug/medicinal materials testing services
a) The chief pharmacist of a provider of drug/medicinal materials testing services, except for the cases in Point b of this Clause, shall complete one of the following internship contents: testing of drugs and medicinal materials; research related to manufacture, testing, analysis of drugs and medicinal materials; pharmacy management at a pharmacy authority;
b) The chief pharmacist of a provider of vaccine and biological testing services shall complete one of the following internship contents: testing of drugs and medicinal materials; testing of vaccines and biologicals; research related to manufacture and testing of vaccines and biologicals; storage of vaccines and biologicals; pharmacy management at a pharmacy authority.
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9. Persons in charge of clinical pharmacology of medical facilities
a) The person in charge of clinical pharmacology of a medical facility shall complete one of the following internship contents: bioequivalence study; clinical trial; pharmacology and clinical pharmacology research; pharmacovigilance at the drug information and advert reaction monitoring center;
b) The person in charge of clinical pharmacology of a traditional medicine facility shall complete one of the following internship contents: clinical trial; pharmacology and clinical pharmacology research; pharmacovigilance at the drug information and advert reaction monitoring center.
10. Pharmacists of providers of drug/medicinal materials storage services
a) The chief pharmacist shall complete one of the following internship contents: Drug storage; pharmacy, traditional pharmacy or traditional medicine management at a pharmacy authority;
b) The chief pharmacist of a provider of vaccine and biological storage services shall complete one of the following internship contents: storage of vaccines and biologicals; manufacture of vaccines and biologicals, testing of vaccines and biologicals; pharmacy management at a pharmacy authority.
Article 21. Internship durations of postgraduate degree holders
1. A postgraduate degree is either:
a) a Master’s degree in pharmacy, medicine, traditional medicine, chemistry or biology;
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c) Specialized Level 1 (SL1) or Specialized Level 2 (SL2) degree according to regulations of the Minister of Health.
1. The examination may be held at an examination center or online.
2. Examination contents:
a) General pharmaceutical knowledge;
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3. The Minister of Health shall specify regulations, examination contents, question banks and grading scale.
Article 23. Requirements to be satisfied by examination centers
1. The organization that administers the examination for the pharmacy practice certificate (hereinafter referred to as “examination center”) shall be an institution that provides higher education training in pharmacy or traditional pharmacy.
2. After 05 working days from the day on which the examination results are available, the examination center shall send notifications (Form No. 18 in Appendix I enclosed herewith) to the candidates and send a list of passing candidates to the Ministry of Health.
Article 31. Eligibility for traditional drug business
1. A manufacturer of traditional drugs that are sold nationwide shall meet the requirements in Clause 2a, 2c and 2d Article 69 of the Law on Pharmacy
2. The location, storage area, storage equipment, vehicles, quality control system, documents about technologies and personnel of an importer of traditional drugs shall meet GSP requirements applied to traditional drugs. The chief pharmacist of the exporter or importer of traditional drugs shall satisfy the requirements in Clause 3 Article 17 of the Law on Pharmacy.
3. The location, storage area, storage equipment, vehicles, quality control system, specialized documents and personnel of a provider of traditional drug storage services shall meet GSP requirements applied to traditional drugs. The chief pharmacist of the exporter or importer of traditional drugs shall satisfy the requirements in Clause 1 Article 22 of the Law on Pharmacy.
4. The location, storage area, storage equipment, vehicles, quality control system, specialized documents and personnel of a wholesaler of traditional drugs shall meet Good Distribution Practice (GDP) requirements applied to traditional drugs. The chief pharmacist of the wholesaler of traditional drugs shall satisfy the requirements in Clause 3 Article 16 of the Law on Pharmacy.
5. Requirements to be satisfied by retailers of herbal materials, herbal drugs and traditional drugs:
a) The chief pharmacist of the retailer of herbal materials, herbal drugs or traditional drugs shall satisfy the requirements in Clause 4 Article 18 of the Law on Pharmacy;
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1. Form No. 19, 20 or 21 in Appendix I enclosed herewith for issuance, reissuance or adjustment of the Certificate of eligibility for pharmacy business respectively;
2. Technical documents specified in Clause 1b and Clause 2b Article 38 of the Law on Pharmacy, including the Certificate of eligibility for pharmacy business or Certificate of Good Practice at the business location (if any) and the following documents:
g) If the applicant is a provider of bioequivalence study services, documents about the location, the laboratory for biological fluid analysis, equipment for biological fluid analysis, the area for monitoring drug users serving bioequivalence study, the quality control system, documents about technology and personnel according to GLP requirements for the biological fluid analysis and GCP requirements for the clinical study.
In the cases where the provider of bioequivalence study services signs a contract or cooperate with a clinical trial service provider that meets GCP requirements in carrying out the clinical trial, the technical file may not include documents on the location, laboratory for biofluid analysis, testing equipment for biofluid analysis, accommodations and monitoring of drug users to serve the assessment of bioequivalence, quality management system, professional and technical documents and personnel according to GCP requirements.
8. Within 06 months from the day on which additional documents are requested in writing by the receiving authority, the applicant shall submit additional documents as requested. If the applicant fails to satisfy such request by the aforementioned deadline or the application is not satisfactory within 12 months from the first time it is submitted, the application will be rejected.
9. Within 05 working days from the date of issuance of the Certificate of eligibility for pharmacy business, the receiving authority shall update the following information on its website:
a) The name and address of the holder of the Certificate of eligibility for pharmacy business;
b) Full name of the chief pharmacist and his/her pharmacy practice certificate number;
c) Number of the Certificate of eligibility for pharmacy business.
10. In the case specified in Clause 1b Article 36 of the Law on Pharmacy, the applicant shall return the old certificate, unless it is lost.
11. The Certificate of eligibility for pharmacy business shall be made into 02 copies according to Form No. 22 in Appendix I enclosed herewith. 01 copy will be given to the applicant while the other retained by the issuing authority.
12. If the applicant has met Good Practice requirements, the authority that issues the Certificate of eligibility for pharmacy business shall issue the Certificate of Good Practice.
Article 34. Procedures for reissuing and adjusting the Certificate of eligibility for pharmacy business
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a) the Ministry of Health in any of the cases mentioned in Point a, b, c, e, g, h Clause 2 Article 32 of the Law on Pharmacy;
6. Within 06 months from the day on which additional documents are requested in writing by the receiving authority, the applicant shall submit additional documents as requested. If the applicant fails to satisfy such request by the aforementioned deadline or the application is not satisfactory within 12 months from the first time it is submitted, the application will be rejected.
7. Within 05 working days from the day on which the Certificate of eligibility for pharmacy business is reissued or adjusted, the receiving authority shall update the following information on its website:
a) The name and address of the holder of the Certificate of eligibility for pharmacy business that is reissued or adjusted;
b) Full name of the chief pharmacist and his/her pharmacy practice certificate number;
c) Number of the Certificate of eligibility for pharmacy business.
8. After receiving the new Certificate of eligibility for pharmacy business, the applicant shall return the old one unless it has been lost.
9. The Certificate of eligibility for pharmacy business shall be made into 02 copies according to Form No. 22 in Appendix I enclosed herewith. 01 copy will be given to the applicant while the other retained by the issuing authority.
Article 35. Procedures for revocation of the Certificate of eligibility for pharmacy business
1. Within 05 working days from the day on which the proposal to revoke the Certificate of eligibility for pharmacy business is received or from the discovery of the cases mentioned in Article 40 of the Law on Pharmacy, the issuing authority shall revoke the Certificate of eligibility for pharmacy business it issued, or respond the proposing authority and provide explanation in writing if such proposal is rejected;
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a) Post such decision on its website and send it to the Ministry of Health and Departments of Health nationwide;
b) Update information about revocation on its website.
3. Within 05 working days from the day on which the decision to revoke the Certificate of eligibility for pharmacy business is received, the Ministry of Health and the Departments of Health mentioned shall post it on their websites.
Article 36. Locations of retailing dispensaries and drug counters
1. Locations of retailing dispensaries
a) Retailing dispensaries may be opened in communes and small towns;
b) If the ratio of dispensary to 2,000 people in ward that has just been converted from a commune or small town is smaller than 1, new retailing dispensaries may be opened for up to 03 years from the conversion date.
c) A retailing dispensary which is opened in an area other than those mentioned in Clause 1a of this Article and already granted a certificate of eligibility for drug business before the effective date of this Decree may operate until the expiration date of the certificate. If the certificate of eligibility for drug business does not have an expiration date, it may operate for up to 03 more years from the effective date of this Decree.
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a) In medical stations of communes;
b) In medical stations of communes in ethnic areas, mountainous areas, islands, extremely disadvantaged areas.
Article 37. Scope of operation of retailing dispensaries and drug counters
1. The scope of operation of a retailing dispensary is specified in Clause 1b Article 48 of the Law on Pharmacy.
2. The scope of operation of a drug counter is specified in Clause 1b Article 49 of the Law on Pharmacy.
Article 38. Requirements for operating a mobile drugstore
1. The following entities may operate a mobile drugstore:
a) Drug manufacturers;
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c) Drug retailers;
d) Medical facilities of the military that supply drugs in ethnic areas, mountainous areas, islands, extremely disadvantaged areas.
2. The keeper of the mobile drugstore must be an employee of the mobile drugstore owner mentioned in Clause 1 of this Article and has one of the qualifications mentioned in Points a, b, c, e, g, h, i and k Clause 1 Article 13 of the Law on Pharmacy.
3. Drugs sold by a mobile drugstore must not expire for the next 06 months, be stored with hygienic equipment and protected from the weather.
4. Each mobile drugstore must have a signboard which specifies its owner, full name of the keeper and the operating area.
c) It is meant to serve common purposes of local people.
2. Pursuant to Clause 1 of this Article, the Director of the Department of Health shall publish a list of drugs and areas permissible for mobile drugstores.
Article 40. Procedures for registration of a mobile drugstore
1. The applicant for registration of a mobile drugstore shall submit Form No. 23 in Appendix I enclosed herewith to the Department of Health of the province where the mobile drugstore operates.
Article 41. List of radioactive substances permissible for health facilities and issuance of list of drugs and active ingredients banned from certain fields
1. The list of radioactive substances permissible for health facilities is promulgated in Appendix IV enclosed herewith.
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a) Ministries and ministerial agencies shall send the Ministry of Health their lists of banned substances in their fields or amendments thereto;
1. A manufacturer of narcotic drugs, psychotropic drugs, precursor drugs, medicinal materials that are narcotic active ingredients, psychotropic active ingredients or drug precursors shall:
a) Have a separate storage facility or area that meets GSP requirements. Such separate storage facility or area must have robust doors with locksPlease sign up or sign in to your TVPLPro Membership to see English documents.
11. A provider of clinical study services, bioequivalence study services, testing services or storage services for radiopharmaceuticals:
a) have a separate storage area that meets GSP requirements to store the radiopharmaceuticals; have a documentary management system according to regulations of the Minister of Health; A provider of radiopharmaceutical storage services shall have a camera system;
a) The warehouse-keeper responsible for narcotic drugs, medicinal materials that are narcotic active ingredients shall have at least a bachelor’s degree in pharmacy and had an internship at a pharmacy business establishment that lasted at least 12 monthsPlease sign up or sign in to your TVPLPro Membership to see English documents.
c) The supervisor of research, manufacture, analysis, testing processes shall have at least a bachelor’s degree in radiochemistry, radiology, nuclear medicine or pharmacy.
4. Personnel of an exporter or importer of narcotic drugs, psychotropic drugs, precursor drugs, medicinal materials that are narcotic active ingredients, psychotropic active ingredients or drug precursors:
a) The warehouse-keeper responsible for narcotic drugs, psychotropic drugs, precursor drugs, medicinal materials that are narcotic active ingredients, psychotropic active ingredients or drug precursors shall have at least a bachelor’s degree in pharmacy and had an internship at a pharmacy business establishment that lasted at least 12 monthsPlease sign up or sign in to your TVPLPro Membership to see English documents.
8. Personnel of a retailer of narcotic drugs, psychotropic drugs or precursors:
a) The shopkeeper that sells narcotic drugs shall have at least a bachelor’s degree in pharmacy;
b) The shopkeeper that sells psychotropic drugs or precursors shall have at least an associate degree in pharmacy.
1. The deliverer and recipient of controlled drugs or medicinal materials shall have at least an associate degree in pharmacy; the deliverer and recipient of radiopharmaceuticals shall have a certificate of training in radiation safety according to regulations of the Ministry of Science and Technology in addition to the associate degree in pharmacy.
2. The deliverer of narcotic drugs, psychotropic drugs, precursor drugs, medicinal materials that are narcotic active ingredients, psychotropic active ingredients, drug precursors shall bring the head’s assignment letter, identification paper, and the sale invoice or receipt. In case of delivery of radiopharmaceuticals, the deliverer shall bring the certificate of training in radiation safety in addition to the aforementioned documents.
3. Upon delivery of narcotic drugs, psychotropic drugs, precursor drugs, medicinal materials that are narcotic active ingredients, psychotropic active ingredients or drug precursors, a delivery note shall be made according to Form No. 01 in Appendix II enclosed herewith.
4. The transport of medicinal materials that are narcotic active ingredients, psychotropic active ingredients or drug precursors, narcotic drugs, active ingredients and precursors must ensure security and prevent leakage. The transport of radiopharmaceuticals shall ensure radiation safety in accordance with regulations on safe transport of radioactive materials promulgated by the Minister of Science and Technology.
5. Each establishment participating in the delivery of the radiopharmaceuticals shall have the license to perform radiological works that allows transport of radiation sources as prescribed by the Ministry of Science and Technology.
Article 46. Trading in controlled drugs
1. Regarding medicinal materials that are narcotic active ingredients, psychotropic active ingredients or drug precursors:
a) A manufacture may only import ingredients serving the manufacture of its drugs;
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c) When a drug manufacturer wishes to sell its redundant materials to another manufacturer or importer eligible to trade in controlled drugs, it must obtain a written permission from the Ministry of Health.
2. Regarding narcotic drugs, psychotropic drugs, precursor drugs and combined drugs that contain precursors:
a) A manufacturer may only sell drugs it manufactures to establishments that have the Certificate of eligibility for pharmacy business that allows export, import and wholesaling of drugs, health facilities, research and testing establishments, rehabilitation centers, establishments providing opioid substitution treatment, establishments providing training in medicine or pharmacy nationwide; and may select 01 wholesaler in a province to sell all of its products;
b) An importer may only sell drugs it imports to establishments that have the Certificate of eligibility for pharmacy business that allows export, import and wholesaling of drugs, health facilities, research and testing establishments, rehabilitation centers, establishments providing opioid substitution treatment, establishments providing training in medicine or pharmacy nationwide; and may select 01 wholesaler in a province to sell all of the products it imports;
a) Each exporter and importer of narcotic drugs, psychotropic drugs, precursor drugs, medicinal materials that are narcotic active ingredients, psychotropic active ingredients or drug precursors shall prepare a report on the export or import within 10 days from the date of export or import according to Form No. 02 and Form No. 03 in Appendix II enclosed herewith and send it to the Ministry of Health and the Ministry of Public Security;
b) Each exporter and importer of radiopharmaceuticals shall prepare a report on the export or import according to Form No. 04 and Form No. 05 in Appendix II enclosed herewith and send it to the Ministry of Health within 10 days from the date of export or import;
c) By the 15th of January of the succeeding year, each exporter and importer of combined drugs that contain narcotic active ingredients, combined drugs that contain psychotropic active ingredients, combined drugs that contain precursors or radiopharmaceuticals shall prepare the annual report on export or import of these drugs according to Forms No. 06, 07, 08 in Appendix II enclosed herewith and send it to the Ministry of Health.
2. By the 15th of July and 15th of January, each manufacturer, exporter and importer of narcotic drugs, psychotropic drugs, precursor drugs, medicinal materials that are narcotic active ingredients, psychotropic active ingredients or drug precursors shall prepare a biannual report and an annual report according to Form No. 09 and 10 in Appendix II enclosed herewith and send them to the Ministry of Health.
3. By the 15th of July and 15th of January, each manufacturer, exporter and importer of radiopharmaceuticals, combined drugs that contain narcotic active ingredients, combined drugs that contain psychotropic active ingredients and combined drugs that contain precursors shall prepare a biannual report and an annual report according to Form No. 11 and 12 in Appendix II enclosed herewith and send them to the Ministry of Health.
4. By the 15th of July and 15th of January, each wholesaler and retailer of radiopharmaceuticals, narcotic drugs, psychotropic drugs, precursor drugs, combined drugs that contain narcotic active ingredients, combined drugs that contain psychotropic active ingredients and combined drugs that contain precursors shall prepare a biannual report and an annual report according to Form No. 11, 12, 13 in Appendix II enclosed herewith and send them to the Department of Health of the province where their headquarters are situated.
5.. By the 15th of January, each manufacturer and exporter of drugs or active ingredients on the list of drugs and active ingredients banned from certain fields shall prepare and send a report according to Form No. 09 in Appendix II to the Ministry of Health. Each wholesaler of drugs or active ingredients on the list of drugs and active ingredients banned from certain fields shall prepare a report according to Form No. 09 in Appendix II and send it to the Department of Health of the same province.
6. Within 48 hours from discovery of a mistake, loss of radiopharmaceuticals, narcotic drugs, psychotropic drugs, precursor drugs or medicinal materials that are active ingredients, psychotropic active ingredients or drug precursors, the manufacturer, exporter, importer, drug storage service provider, clinical trial service provider, bioequivalence study service provider or drug testing service provider shall prepare a written report and send it to the Ministry of Health; the wholesaler or retailer shall submit a report to Department of Health according to Form No. 14 in Appendix II enclosed herewith.
7. By the 15th January, the Department of Health of each province shall submit a list of wholesalers of narcotic drugs, psychotropic drugs, precursor drugs and combined drugs that contain precursors in their provinces according to Form No. 15 in Appendix II enclosed herewith to the Ministry of Health.
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1. The applicant for permission to destroy narcotic drugs, psychotropic drugs, precursor drugs, medicinal materials that are narcotic active ingredients, psychotropic active ingredients or drug precursors shall submit an application form which specifies the name of the drug or medicinal material, concentration, quantity, reason for destruction and destruction method.
2. Procedures for granting permission for destruction of narcotic drugs, psychotropic drugs, precursor drugs, medicinal materials that are narcotic active ingredients, psychotropic active ingredients or drug precursors:
c) A written explanation for purchasing a quantity of drugs that exceeds the previous purchase by over 150%.
2. An application for permission to purchase medicinal materials that are narcotic active ingredients, psychotropic active ingredients or drug precursors consists of:
c) A report on sale of drugs and use of medicinal materials according to Form No. 10 and Form No. 20 in Appendix II enclosed herewith.
4. Only 01 set of documents specified in Clause 1, 2, 3 of this Article is required.
Article 54. Procedures for granting permission to purchase narcotic drugs, psychotropic drugs, precursor drugs or medicinal materials that are narcotic active ingredients, psychotropic active ingredients or drug precursors; procedures for granting permission to sell medicinal materials that are narcotic active ingredients, psychotropic active ingredients or drug precursors
1. The applicant shall submit an application directly or by post to:
a) the Ministry of Health if the applicant is a manufacturer, the applicant already has a certificate of eligibility for drug export, import and wholesaling, or the applicant is a health facility, a testing laboratory, a rehabilitation center, an establishment providing opioid substitution treatment or an establishment providing training in medicine or pharmacy that needs to purchase drugs for research or testing purposes;
5. After receiving the supplemented application, the receiving authority shall give the applicant form No. 01 in Appendix I enclosed herewith.
a) If the supplemented application is still unsatisfactory, the receiving authority shall request the applicant to complete it in accordance with Clause 4 of this Article.
b) If the supplemented application is satisfactory, the receiving authority shall follow the instructions in Clause 3 of this Article.
6. Within 06 months from the day on which additional documents are requested in writing by the receiving authority, the applicant shall submit additional documents as requested. If the applicant fails to satisfy such request by the aforementioned deadline or the application is not satisfactory within 12 months from the first time it is submitted, the application will be rejected.
Article 55. Documents and procedures for obtaining permission to retail drugs on the list of drugs restricted from retailing
1. If the applicant has not obtained the Certificate of eligibility for pharmacy business that allows drug retailing:
a) The application shall consist of Form No. 22 in Appendix II enclosed herewith and the documents specified in Clause 2d Article 32 hereof;
b) Procedures and time limit for licensing are the same as those specified in Article 33 hereof.
2. If the applicant has obtained a Certificate of eligibility for pharmacy business that allows drug retailing:
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b) Procedures and time limit:
- The applicant shall submit the application directly or by post to the Department of Health of the same province as the applicant’s business location Please sign up or sign in to your TVPLPro Membership to see English documents.
2. An application shall only be considered after adequate reports are submitted.
Chapter IV
EXPORT AND IMPORT OF DRUGS AND MEDICINAL MATERIALS
Section 1. EXPORT OF CONTROLLED DRUGS, HERBAL MATERIALS ON THE LIST OF CONTROLLED PRECIOUS, RARE AND ENDEMIC MEDICINAL MATERIAL SPECIES AND VARIETIES
Article 57. Procedures for issuance of the license to export narcotic drugs, psychotropic drugs, precursor drugs, medicinal materials that are narcotic active ingredients, psychotropic active ingredients or drug precursors or combined drugs that contain narcotic active ingredients, combined drugs that contain psychotropic active ingredients and combined drugs that contain precursors
1. The export of a drug shall only be licensed when one of the following requirements is satisfied:
a) The drug is manufactured in Vietnam, granted a marketing authorization in Vietnam and granted an import license by a competent authority of the importing country; or
b) The drug is manufactured overseas, granted a marketing authorization in Vietnam and granted an import license by a competent authority of the importing country.
2. The export of a medicinal material shall only be licensed when one of the following requirements is satisfied:
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b) The material is manufactured overseas, granted a marketing authorization in Vietnam and granted an import license by a competent authority of the importing country.
3. Application for the export license:
a) 01 original copy of the purchase order according to Form No. 01 or Form No. 02 in Appendix III enclosed herewith;
b) A report on quantity and origins of drugs/medicinal materials according to Form No. 03 in Appendix III enclosed herewith;
c) An original copy of the unexpired license to import drugs/medicinal materials issued by a competent authority of the importing country. If the import license is written in a language other than Vietnamese or English language, a notarized Vietnamese or English translation shall be included. The import license shall be consularly legalized in accordance with regulations of law on consular legalization, except for the cases in which consular legalization is exempted by law.
4. Only 01 set of documents specified in this Article is required.
Article 58. Requirements and application for the license to export radiopharmaceuticals, drugs or active ingredients on the list of drugs and active ingredients banned from certain fields, toxic drugs or toxic medicinal materials
1. The export of a drug or medicinal material shall only be licensed when one of the following requirements is satisfied:
a) The drug or material is manufactured in Vietnam, whether or not granted the marketing authorization in Vietnam; or
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2. Application for the export license:
a) 03 original copies of the purchase order according to Form No. 04 or Form No. 05 in Appendix III enclosed herewith;
c) A copy of the confirmation of herb origin issued by the People’s Committee of the commune which is authenticated or bears the exporter’s seal. If a copy bearing the exporter’s seal is submitted, the original copy shall be produced for comparison when the application is submitted;
d) A copy of the herbal material purchase order which is authenticated or bears the exporter’s seal. If a copy bearing the exporter’s seal is submitted, the original copy shall be produced for comparison when the application is submitted;
dd) In case of export for non-commercial purposes, the documents specified in Points c and d of this Clause are not required.
3. Only 01 set of documents specified in this Article is required.
Article 60. Licensing non-commercial export of controlled drugs
1. The non-commercial export of a controlled drug shall be granted when the drug is licensed for sale in Vietnam and satisfy one of the following requirements:
a) The drug is personal property shipped under a lading bill or the outbound passenger’s belongings for treatment of his/her own disease and is not a controlled medicinal material;
b) The drug is exported as emergency aid or humanitarian aid;
c) The drug has been granted an import license to serve humanitarian medical services and is not completely used.
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a) 07 days’ dose for narcotic drugs according to the prescription;
b) 10 days’ dose for psychotropic drugs and precursors according to the prescription;
c) 30 days’ dose for combined drugs that contain narcotic active ingredients, combined drugs that contain psychotropic active ingredients, toxic drugs, drugs on the list of banned substances in certain fields according to the prescription.
3. An application for export of the drug mentioned in Clause 1a of this Article consists of:
a) Form No. 07 in Appendix III enclosed herewith;
b) Copies of the prescription and outpatient's medical record which is authenticated or bears the applicant’s signature (if the applicant is an individual) or seal (if the applicant is an organization). These documents shall specify the patient’s name and age; name, concentration and quantity (or doses) of the drug; dosage; the physician’s name and signature, address of the hospital or clinic where the physician practices.
If a copy bearing the applicant’s signature of seal is submitted, the original copy shall be produced for comparison when the application is submitted;
Article 61. Requirements and application for export of controlled drugs for exhibition
1. The export of a narcotic drug, psychotropic drug, precursor, narcotic active ingredient, psychotropic active ingredient, drug precursor, combined drug that contains narcotic active ingredients, combined drug that contains psychotropic active ingredients or combined drug that contains precursors shall only be licensed when one of the following requirements is satisfied:
a) It is manufactured in Vietnam and granted an import license by a competent authority of the importing country regardless of availability of the marketing authorization in Vietnam;
b) It is manufactured overseas, granted a marketing authorization in Vietnam and granted an import license by a competent authority of the importing country.
2. An application for export of a narcotic drug, psychotropic drug, precursor, narcotic active ingredient, psychotropic active ingredient, drug precursor or combined drug that contains narcotic active ingredients, combined drug that contains psychotropic active ingredients or combined drug that contains precursors:
a) 01 original copy of the purchase order according to Form No. 01 or Form No. 02 in Appendix III enclosed herewith;
b) An original copy of the unexpired license to import drugs/medicinal materials issued by a competent authority of the importing country. If the import license is written in a language other than Vietnamese or English language, a notarized Vietnamese or English translation shall be included. The import license shall be consularly legalized in accordance with regulations of law on consular legalization, except for the cases in which consular legalization is exempted by law;
c) Only 01 set of documents specified in this Clause is required.
3. The licensing of export of radiopharmaceuticals, toxic drugs, toxic medicinal materials, drugs and active ingredients on the list of substances banned from certain fields for exhibition shall comply with regulations of law on temporary import of goods.
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1. The export of a narcotic drug, psychotropic drug, precursor, narcotic active ingredient, psychotropic active ingredient, drug precursor or combined drug that contains narcotic active ingredients, combined drug that contains psychotropic active ingredients or combined drug that contains precursors shall only be licensed when one of the following requirements is satisfied:
a) It is manufactured in Vietnam and granted an import license by a competent authority of the importing country regardless of availability of the marketing authorization in Vietnam;
b) It is manufactured overseas, granted a marketing authorization in Vietnam and granted an import license by a competent authority of the importing country.
2. An application for export of a narcotic drug, psychotropic drug, precursor, narcotic active ingredient, psychotropic active ingredient, drug precursor or combined drug that contains narcotic active ingredients, combined drug that contains psychotropic active ingredients or combined drug that contains precursors:
a) 01 original copy of the purchase order according to Form No. 01 or Form No. 02 in Appendix III enclosed herewith;
b) An original copy of the unexpired license to import drugs/medicinal materials issued by a competent authority of the importing country. If the import license is written in a language other than Vietnamese or English language, a notarized Vietnamese or English translation shall be included. The import license shall be consularly legalized in accordance with regulations of law on consular legalization, except for the cases in which consular legalization is exempted by law;
b) It is manufactured overseas and has been granted a marketing authorization in Vietnam.
4. An application for export of a radiopharmaceutical, toxic drug, toxic medicinal material, drug or active ingredient on the list of drugs and active ingredients banned from certain fields:
a) 01 original copies of the purchase order according to Form No. 04 or Form No. 05 in Appendix III enclosed herewith;
dd) After receiving the supplemented application, the Ministry of Health shall give the applicant form No. 01 in Appendix I enclosed herewith. If the application is still unsatisfactory, the Ministry of Health shall request the applicant to complete it in accordance with Point d this Article. If the supplemented application is satisfactory, the Ministry of Health shall issue the export license in accordance with Point c of this Clause;
e) Within 06 months from the day on which additional documents are requested in writing by the Ministry of Health, the applicant shall submit additional documents as requested. If the applicant fails to satisfy such request by the aforementioned deadline or the application is not satisfactory within 12 months from the first time it is submitted, the application will be rejected.
2. Procedures and time limit for issuing the export license in the case specified in Clause 1a Article 60 hereof:
a) The applicant shall submit an application, directly or by post, to Department of Health of the province where the exit checkpoint is located or where the patient is residing or where the applicant’s headquarters are located;
b) After receiving the application, the Department of Health shall give the applicant form No. 01 in Appendix I enclosed herewith;
c) If the application is satisfactory, the Department of Health shall issue the export license within 07 working days from the day on which the application is received;
d) If the application is not satisfactory, the Department of Health shall request the applicant in writing to complete the application within 05 working days from the day on which the application is received;
dd) After receiving the supplemented application, the Department of Health shall give the applicant form No. 01 in Appendix I enclosed herewith. If the application is still unsatisfactory, the Department of Health shall request the applicant to complete it in accordance with Point d of this Clause. If the supplemented application is satisfactory, the Department of Health shall issue the export license in accordance with Point c of this Clause;
e) Within 03 months from the day on which additional documents are requested in writing by the Department of Health, the applicant shall submit additional documents as requested. If the applicant fails to satisfy such request by the aforementioned deadline or the application is not satisfactory within 04 months from the first time it is submitted, the application will be rejected.
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4. The specimens of the export license and permission for export are provided in Form No. 09, 10, 11, 12, 13 in Appendix III enclosed herewith.
Article 64. Management of export and import of drugs and medicinal materials
1. Each shipment of narcotic drugs, psychotropic drugs, precursor drugs, combined drugs that contain narcotic active ingredients, combined drugs that contain psychotropic active ingredients, combined drugs that contain precursors or medicinal materials that are narcotic active ingredients, psychotropic active ingredients or drug precursors is subject to the issuance of an export license; the quantity of exported drugs/medicinal materials must not exceed the quantity written on the import license issued by the competent authority of the importing country.
2. Each export of herbal materials the list of controlled precious, rare and endemic medicinal material species and varieties is subject to issuance of an export license.
3. Narcotic drugs, psychotropic drugs, precursor drugs, radiopharmaceuticals, combined drugs that contain narcotic active ingredients, combined drugs that contain psychotropic active ingredients, combined drugs that contain precursors or medicinal materials that are narcotic active ingredients, psychotropic active ingredients or drug precursors, herbal materials on the list of controlled precious, rare and endemic medicinal material species and varieties other than those specified in Clause 1a Article 60 hereof may only be exported through international checkpoint.
4. A manufacturer of narcotic drugs, psychotropic drugs, precursor drugs, medicinal materials that are narcotic active ingredients, psychotropic active ingredients or drug precursors may export the drugs or medicinal materials it manufactures.
5. An exporter or importer of narcotic drugs, psychotropic drugs, precursor drugs, medicinal materials that are narcotic active ingredients, psychotropic active ingredients or drug precursors may export the drugs or medicinal materials it registered.
6. The applicant for permission for non-commercial export of controlled drugs specified in Clause 1a Article 60 hereof is responsible for their origin, quality, safety, efficacy and conformity with the importing country’ regulations.
7. The exporter shall re-import all the narcotic drugs, psychotropic drugs, precursor drugs, medicinal materials that are narcotic active ingredients, psychotropic active ingredients or drug precursors or combined drugs that contain narcotic active ingredients, combined drugs that contain psychotropic active ingredients and combined drugs that contain precursors that were temporarily exported for exhibition.
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a) The application shall contain 03 copies of the purchase order according to Form No. 14 in Appendix III and a copy of the exporter’s Certificate of eligibility for pharmacy business which is authenticated or bear the exporter’s seal;
b) Procedures for granting the export license are specified in Clause 1 Article 63 hereof.
Section 2. IMPORT OF DRUGS WITHOUT THE marketing authorization IN VIETNAM
Article 65. Requirements and application for licensing import of drugs containing active ingredients without the marketing authorization of drugs or drugs containing herbal materials that are used in Vietnam for the first time
1. The import of such a drug shall only be licensed when the following requirements are satisfied:
h) The original copy or certified true copy of the certificate of GMP of all facilities participating in the manufacture of the imported drug if the drug is manufactured by more than one facility.
Documents specified in this point are not required to be submitted if the manufacturer has been certified conformable with GMP principles on the certificate of pharmaceutical product;Please sign up or sign in to your TVPLPro Membership to see English documents.
b) The original copy or a certified true copy of the certificate of pharmaceutical product;
c) The Minister of Health shall decide licensing of vaccines in special cases with limited quantity according to data about its satisfactory quality, efficacy and safety.
4. Only 01 set of documents specified in Clauses 2 and 3 of this Article is required.
Article 69. Requirements and application for licensing import of rare drugs
1. The import of such a drug shall only be licensed when the following requirements are satisfied:
a) It is on the list of rare drugs;
b) It is licensed in at least one other country.
2. Application for the import license:
a) 03 original copies of the purchase order according to Form No. 15, 16 or 17 in Appendix III enclosed herewith;
b) The original copy or a certified true copy of the certificate of pharmaceutical product;
c) A copy of the document about the quality standards and drug testing method of the manufacturer which bears the importer’s seal;
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dd) 02 sets of specimens of the labels intended to be used in Vietnam and the package insert in Vietnamese language which bear the importer’s seal;
e) A sale report (Form No. 18 in Appendix III enclosed herewith) if the imported drug is a narcotic drug, psychotropic drug, precursor, combined drug that contains narcotic active ingredients, combined drug that contains psychotropic active ingredients, combined drug that contains precursorsPlease sign up or sign in to your TVPLPro Membership to see English documents.
c) The drug is licensed and exported to Vietnam from the manufacturing country, a reference country that is a member state of the ICH or Australia;
d) The drug is not a radiopharmaceutical, vaccine or biological.
2. Application for the import license:
a) 03 original copies of the purchase order according to Form No. 15, 16 or 17 in Appendix III enclosed herewith;
e) 02 sets of specimens of the labels intended to be used in Vietnam and the package insert in Vietnamese language which bear the importer’s seal;
g) The original copy or certified true copy of the written approval issued by a competent authority for use of the drug for the health program of the State;
h) The original copy or certified true copy of the certificate of GMP of all facilities participating in the manufacture of the imported drug if the drug is manufactured by more than one facility.
Documents specified in this point are not required to be submitted if the manufacturer has been certified conformable with GMP principles on the certificate of pharmaceutical product;Please sign up or sign in to your TVPLPro Membership to see English documents.
c) The drug as an emergency aid is used for the state medical programs or projects.
d) The drug as an emergency aid is not specified in points a, b and c of this clause and is not narcotic drug, radiopharmaceutical or vaccine.
c) The drug is used as a reference drug in bioequivalence study. If the reference drug is a new drug, it may only be used under an approved research outline according to Clause 1 Article 100 of the Law on Pharmacy;
d) The drug is used for testing by drug manufacturers or drug-testing laboratories;
dd) The drug is used for scientific research other than those mentioned in Points a, b and c of this Clause.
2. Application for the import license:
a) 03 original copies of the purchase order according to Form No. 15, 16 or 17 in Appendix III enclosed herewith;
b) The original copy or certified true copy of the written approval issued by a competent authority or organization in the cases mentioned in Clause 1a, 1b and 1dd of this Article;
c) The original copy or certified true copy of the written approval for the bioequivalence study outline according to Article 100 of the Law on Pharmacy in case of a new drug mentioned in Clause 1c of this Article.
d) The importer’s document bearing the importer’s seal specifying the purposes and quantity of imported drugs and commitment to use the drugs for intended purposes;
Article 74. Requirements and application for import of drugs for exhibition
1. An application for licensing import of combined drugs that contain narcotic active ingredients, combined drugs that contain psychotropic substances or combined drugs that contain precursors for display a medical, pharmaceutical or medical equipment fair or exhibition consists of:
a) 01 original copy of the purchase order according to Form No. 16 in Appendix III enclosed herewith;
1. The non-commercial import of a drug shall only be licensed when one of the following requirements is satisfied:
a) The drug is personal belonging of an inbound person which is shipped under a lading bill, personal belonging of an inbound person for treatment of his/her own disease.
b) The drug is not a narcotic drug, psychotropic drug, precursor and is property of a diplomatic mission, consular office or representative office of an international organization in Vietnam or overseas diplomatic mission of Vietnam, its employees, organizations introduced by a diplomatic mission or overseas diplomatic mission of Vietnam.
2. The import of drugs mentioned in Clause 1 of this Article is subject to issuance of an import license, unless:
a) The quantity of drugs to be imported does not exceed 07 days’ dose for narcotic drugs or 10 days’ dose for psychotropic drugs and precursors according to the prescription;
b) The drug is not a narcotic drug, psychotropic drug or precursor, the total customs value of a shipment does not exceed USD 200 according to the inter-bank exchange rate on the customs clearance date and not more than 03 shipments are received by an organization or individual in a year.
If the drug is used for treatment of a disease on the list of fatal diseases in the Government's Decree No. 134/2016/ND-CP, the customs value of a shipment must not exceed VND 10,000,000 and not more than 04 shipments are received by an individual in a year.
3. Application for the import license:
a) Form No. 27 in Appendix III enclosed herewith;
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c) A certified true copy of a copy bearing the applicant’s signature or seal of the prescription or outpatient medical record. These documents shall specify the patient’s name and age; name, concentration and quantity (or doses) of the drug; dosage; the physician’s name and signature, address of the hospital or clinic where the physician practices.
If a copy bearing the applicant’s signature of seal is submitted, the original copy shall be produced for comparison when the application is submitted.
The documents specified in Clause 3c of this Article are not required in the case specified in Clause 1b hereof.
2. If any of the documents in the application is written in a language other than Vietnamese or English language, a notarized Vietnamese or English translation shall be included.
3. The following documents shall be consularly legalized in accordance with regulations of law on consular legalization, except for the cases in which consular legalization is exempted by law:
a) Requirements specified in Clauses 2, 3 and 6 of this Article are satisfied;
b) The certificate bears the signer’s signature, name and position and the issuer’s seal;
c) The signer’s signature, name and position and the issuer’s seal are certified by a diplomatic missions, consular office or another organization authorized to perform consular tasks in the home country;
d) The certificate of pharmaceutical product undergoing consular legalization is the original copy;
b) After receiving the application, the Ministry of Health shall give the applicant form No. 01 in Appendix I enclosed herewith;
c) If the application is satisfactory, the Ministry of Health shall issue the import license within 60 days if clinical documents and documents proving equivalence to reference biologicals are not required, or within 90 days if clinical documents and documents proving equivalence to reference biological are required. The import license shall be issued on the basis of counsel given by the certification advisory council;
d) If the application is not satisfactory, the Ministry of Health shall request the applicant in writing to complete it within 60 days if clinical documents and documents proving equivalence to reference biological are not required, or within 90 days if clinical documents and documents proving equivalence to reference biologicals are required;
dd) After receiving the supplemented application, the Ministry of Health shall give the applicant form No. 01 in Appendix I enclosed herewith. If the application is still unsatisfactory, the Ministry of Health shall request the applicant to complete it in accordance with Point d this Article. If the supplemented application is satisfactory, the Ministry of Health shall issue the import license in accordance with Point c of this Clause;
e) Within 06 months from the day on which additional documents are requested in writing by the Ministry of Health, the applicant shall submit additional documents as requested. If the applicant fails to satisfy such request by the aforementioned deadline or the application is not satisfactory within 12 months from the first time it is submitted, the application will be rejected.
d) If the application is not satisfactory, the Ministry of Health shall request the applicant in writing to complete it within 03 working days from the day on which the application is received;
dd) After receiving the supplemented application, the Ministry of Health shall give the applicant form No. 01 in Appendix I enclosed herewith. If the application is still unsatisfactory, the Ministry of Health shall request the applicant to complete it in accordance with Point d this Article. If the supplemented application is satisfactory, the Ministry of Health shall issue the import license in accordance with Point c of this Clause;
e) If the applicant fails to provide the documents mentioned in Clause 2b Article 67 hereof but the drugs are essential for disease prevention and treatment, the Minister of Health shall consider the application on the basis of commitments made by relevant Ministries.
3. In the cases of drug import specified in Article 70, 73, Clause 1 Article 74, Clause 1b and Clause 1c Article 68 hereof:Please sign up or sign in to your TVPLPro Membership to see English documents.
4. In the cases of drug import specified in Article 75 hereof:
a) The applicant shall submit an application, directly or by post, to Department of Health of the province where the entry checkpoint is located or where the patient is residing or where the applicant’s headquarters are located;
b) After receiving the application, the Department of Health shall give the applicant form No. 01 in Appendix I enclosed herewith;
c) If the application is satisfactory, the Department of Health shall issue the import license within 07 working days from the day on which the application is received;
d) If the application is not satisfactory, the Department of Health shall request the applicant in writing to complete it within 07 working days from the day on which it is received;
dd) After receiving the supplemented application, the Department of Health shall give the applicant form No. 01 in Appendix I enclosed herewith. If the application is still unsatisfactory, the Department of Health shall request the applicant to complete it in accordance with Point d of this Clause. If the supplemented application is satisfactory, the Department of Health shall issue the import license in accordance with Point c of this Clause;
Article 78. Management of import of drugs without the marketing authorization in Vietnam
1. The drug that contains an active ingredient that is not granted the marketing authorization or an herbal material that is used in Vietnam for the first time or a drug licensed for import according to Article 65 and Article 69 hereof may only be supplied for health facilities.
7. Drugs licensed for import to be displayed at a medical, pharmaceutical or medical device fair according to Article 74 hereof shall be completely re-exported after the fair is ended and must not be used or sold in Vietnam.
8. The applicant for permission for non-commercial import of drugs according to Article 75 hereof is responsible for their origin and quality.
Section 3. IMPORT OF CONTROLLED DRUGS HAVING THE marketing authorization IN VIETNAM AND CONTROLLED MEDICINAL MATERIALS
Article 79. Composition of the application for licensing import of controlled drugs having the marketing authorization in Vietnam
An application for the license to import narcotic drugs, psychotropic drugs, precursor drugs, combined drugs that contain narcotic active ingredients, combined drugs that contain psychotropic active ingredients, combined drugs that contain precursors or drugs on the list of banned substances in certain fields having an unexpired marketing authorization in Vietnam consists of:
1. 01 original copy of the purchase order according to Form No. 33 or 34 in Appendix III enclosed herewith.
2. A report on sale of the drug according to Form No. 18 in Appendix III enclosed herewith, except for toxic drugs.
g) If the medicinal materials have to be imported for testing or research, the original copy of the importer’s document specifying the purposes and quantity of materials to be imported and the commitment to use them for intended purposes;
h) In the cases where a controlled medicinal material that does not have the marketing authorization in Vietnam or not on the list of active ingredients, excipients or semi-finished drugs used for production of drugs that are already granted the marketing authorization in Vietnam is imported to concoct prescription drugs by pharmacies or health facilities serving epidemic control, the concocting facility’s written request according to Form No. 39 in Appendix III enclosed herewith.
2. If any of the documents mentioned in Clause 1b and 1c of this Article is written in a language other than Vietnamese or English language, a notarized Vietnamese or English translation shall be included.
3. Only 01 set of documents specified in Clauses 1 and 2 of this Article is required
4. Import of medicinal materials that are narcotic active ingredients, psychotropic active ingredients or drug precursors for exhibition shall not be licensed.
5. Procedures for import of toxic medicinal materials and active ingredients on the list of substances banned from certain fields for exhibition are specified in Article 83 hereof.
Article 81. Procedures and deadlines for licensing import of controlled drugs having an unexpired marketing authorization in Vietnam and controlled medicinal materials
1. The applicant shall submit an application to the Ministry of Health directly or by post.
2. After receiving the application, the Ministry of Health shall give the applicant form No. 01 in Appendix I enclosed herewith.
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4. If the application is not satisfactory, the Ministry of Health shall request the applicant in writing to complete it within 15 working days from the day on which it is received.
5. After receiving the supplemented application, the Ministry of Health shall give the applicant form No. 01 in Appendix I enclosed herewith. If the supplemented application is still unsatisfactory, the Ministry of Health shall request the applicant to complete it in accordance with Clause 4 of this Article. If the supplemented application is satisfactory, the Ministry of Health shall issue the import license in accordance with Clause 3 of this Article.
6. Within 06 months from the day on which additional documents are requested in writing by the Ministry of Health, the applicant shall submit additional documents as requested. If the applicant fails to satisfy such request by the aforementioned deadline or the application is not satisfactory within 12 months from the first time it is submitted, the application will be rejected.
7. The specimens of the import license and permission for import are provided in Form No. 28, 29, 30, 40 or 44 in Appendix III enclosed herewith.
Section 4. IMPORT OF MEDICINAL MATERIALS WITHOUT THE MARKETING AUTHORIZATION IN VIETNAM OTHER THAN CONTROLLED MEDICINAL MATERIALS; IMPORT OF REFERENCE MATERIALS AND PRIMARY PACKAGES OF DRUGS
Article 82. Requirements and application for licensing import of active ingredients, herbal materials, semi-finished drugs and semi-finished herbal materials as samples for testing or research
1. Import of an active ingredient, herbal material, semi-finished drug or semi-finished product used for production of herbal drugs in the form of glue, powder, extract, essential oil, resin, gum, gel or agar (hereinafter referred to as “semi-finished herbal material”) without a marketing authorization in Vietnam shall be licensed if:
a) it is used for testing or research by a drug manufacturer or a facility specialized in testing or researching drugs or medicinal materials; or
b) it is used for a scientific research approved by a competent authority.
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a) 03 original copies of the purchase order according to Form No. 36 or 41 in Appendix III enclosed herewith;
a) 03 original copies of the purchase order according to Form No. 36 or 41 in Appendix III enclosed herewith;
b) If the material is imported for production of drugs serving national defense and security, the original copy of the written request of the Ministry of National Defense or the Ministry of Public Security which specifies the drug name, the manufacturer’s name, active ingredients and concentration/content thereof, dosage form, package contents, route of administration and indications;
c) If the material is imported for production of drugs serving epidemic control or disaster relief, a written approval for the list of drugs issued by the Ministry of Health which specifies the drug name, the manufacturer’s name, active ingredients and concentration/content thereof, dosage form, package contents, route of administration and indications;
d) If the material is importer for production or concoction of drugs according to prescriptions at pharmacies or health facilities, the written request of the manufacturing facility or concocting facility according to Form No. 42 in Appendix III enclosed herewith;
dd) After receiving the supplemented application, the Ministry of Health shall give the applicant form No. 01 in Appendix I enclosed herewith. If the application is still unsatisfactory, the Ministry of Health shall request the applicant to complete it in accordance with Point d this Article. If the supplemented application is satisfactory, the Ministry of Health shall issue the import license in accordance with Point c of this Clause;
e) Within 06 months from the day on which additional documents are requested in writing by the Ministry of Health, the applicant shall submit additional documents as requested. If the applicant fails to satisfy such request by the aforementioned deadline or the application is not satisfactory within 12 months from the first time it is submitted, the application will be rejected.
2. In the cases of import of medicinal materials specified in Article 85 hereof:
a) The applicant shall submit an application to the Ministry of Health directly or by post;
b) After receiving the application, the Ministry of Health shall give the applicant form No. 01 in Appendix I enclosed herewith;
c) If the application is satisfactory, the Ministry of Health shall issue the import license within 03 working days from the day on which the application is received;
d) If the application is not satisfactory, the Ministry of Health shall request the applicant in writing to complete it within 03 working days from the day on which it is received;
dd) After receiving the supplemented application, the Ministry of Health shall give the applicant form No. 01 in Appendix I enclosed herewith. If the application is still unsatisfactory, the Ministry of Health shall request the applicant to complete it in accordance with Point d this Article. If the supplemented application is satisfactory, the Ministry of Health shall issue the import license in accordance with Point c of this Clause.
3. The specimens of the import license and permission to import medicinal materials are provided in Form No. 44 or Form No. 45 in Appendix III enclosed herewith.
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Article 89. Effective periods of the license to export drugs/medicinal materials and the license to import drugs/medicinal materials
1. Effective periods of licenses to export drugs/medicinal materials:
a) A license to export drugs/medicinal materials issued according to Articles 57, 59, 60, 62 and Clause 1 Article 61 hereof is effective for up to 01 year;
b) A license to export drugs/medicinal materials issued according to Articles 58 and Clause 8 Article 64 hereof is effective for up to 02 years;
2. Effective periods of licenses and written permissions to import drugs/medicinal materials:
a) A license or written permission to import drugs is effective for up to 01 year;
b) A license to import narcotic drugs, psychotropic drugs, precursor drugs, medicinal materials that are narcotic active ingredients, psychotropic active ingredients or drug precursors is effective for up to 01 year and expires after the import is completed;
c) A license or written permission to import medicinal materials other than those mentioned in Point b of this Clause is effective for up to 02 years.
3. The effective period of a license or permission must be specified therein.
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1. Minimum remaining shelf life of imported modern drugs, herbal drugs, traditional drugs, medicinal materials other than those specified in Clause 3 of this Article when customs clearance is granted:
a) 18 months if the official shelf life is longer than 24 months;
b) 1/2 of the official shelf life if it does not exceed 24 months;
2. The minimum remaining shelf life of imported vaccines and biologicals other than those specified in Clause 3 of this Article when customs clearance is granted is 1/2 of the official shelf life.
3. Imported drugs/medicinal materials specified in Articles 67, 73, 74, 75, 82, 83, 84, 85, 86 and Clause 1b Article 68 hereof must be unexpired when customs clearance is granted.
4. The Minister of Health shall consider permitting import of drugs/medicinal materials whose remaining shelf life is shorter than those specified in Clause 1 or Clause 2 of this Article but they are essential for prevention and treatment of diseases.
5. An application for the permission to import a drug/medicinal material mentioned in Clause 4 of this Article consists of:
a) The importer’s written request which specifies: name of the drug/medicinal material, remaining shelf life when customs clearance is granted and explanation as to why its remaining shelf life is shorter than those specified in Clause 1 or Clause 2 of this Article;
b) Documents proving that the remaining shelf life of the batch of drug/medicinal material when customs clearance is granted is shorter than those specified in Clause 1 or Clause 2 of this Article.
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a) The applicant shall submit an application to the Ministry of Health directly or by post;
b) After receiving the application, the Ministry of Health shall give the applicant form No. 01 in Appendix I enclosed herewith;
c) If the application is satisfactory, the Ministry of Health shall issue the written permission to import within 15 working days from the day on which the application is received;
d) If the application is not satisfactory, the Ministry of Health shall request the applicant in writing to complete it within 15 working days from the day on which it is received;
dd) After receiving the supplemented application, the Ministry of Health shall give the applicant form No. 01 in Appendix I enclosed herewith. If the application is still unsatisfactory, the Ministry of Health shall request the applicant to complete it in accordance with Point d this Article. If the supplemented application is satisfactory, the Ministry of Health shall issue the written permission to import in accordance with Point c of this Clause;
e) Within 03 months from the day on which additional documents are requested in writing by the Ministry of Health, the applicant shall submit additional documents as requested. If the applicant fails to satisfy such request by the aforementioned deadline or the application is not satisfactory within 04 months from the first time it is submitted, the application will be rejected.
Article 91. Import of drugs and medicinal materials
4. Institutions providing medical or pharmaceutical training, drug testing laboratories and drug research institutions may import drugs, medicinal materials and reference materials to serve their operation.
c) The licensed import quantity of drugs serving urgent need for national defense and security, epidemic control or disaster relief specified in Article 67 hereof depends on their purposes;
d) The licensed import quantity of rare drugs specified in Article 69 hereof depends on the importer’s business plan;
dd) The licensed import quantity of drugs that have the same trade name, active ingredients, concentration and dosage form as those of a original brand-name drug having the marketing authorization in Vietnam, are manufactured by the same manufacturer of the original brand-name drug or by an authorized manufacturer and are sold at a lower price than that of the original brand-name drug sold in Vietnam as specified in Article 70 hereof depends on the possibility of achieving the price stabilization target;
e) The licensed import quantity of drugs serving a health program of the State specified in Article 71 hereof depends on the need for drugs of such program;
g) The licensed import quantity of drugs as emergency aid or humanitarian aid specified in Article 72 hereof depends on the recipient’s need;
h) The licensed import quantity of drugs imported for the purpose of clinical trial, bioequivalence study, bioavailability assessment, testing or scientific research specified in Article 73 hereof depends on the approved research outline of the laboratory’s need;
i) The licensed quantity of drugs imported for non-commercial purposes specified in Article 75 hereof depends on the owner’s need for disease treatment;
k) The licensed import quantity of controlled drugs specified in Articles 79 and 80 hereof depends on the importer’s business plan;
l) The licensed import quantity of reference materials, primary packages of drugs, medicinal materials without the marketing authorization in Vietnam specified in Articles 82, 84, 85, 86 and 87 hereof depends on the importer’s need, except controlled drugs.
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10. The entities that are entitled to import but not entitled to distribute drugs and medicinal materials in Vietnam must do activities related to distribution of drugs and medicinal materials in Vietnam except for drugs and medicinal materials they manufacture in Vietnam, including:
a) Selling drugs and medicinal materials, delivery drugs and medicinal materials to health facilities, retailers, individuals and organizations other than wholesalers of drugs and medicinal materials;
b) Receiving orders or payments for drugs and medicinal materials from health facilities, retailers, individuals and organizations other than wholesalers of drugs and medicinal materials;
c) Providing drug/medicinal material transport or storage services;
d) Impose prices for drugs or medicinal materials distributed by other pharmaceutical-trading establishment;
dd) Deciding the strategy or policy on selling drugs/medicinal materials distributed by other pharmaceutical-trading establishment;
e) Developing the plan for supply of drugs and medicinal materials of health facilities in Vietnam;
g) Provide financial assistance for buyers of drugs/medicinal materials to control the distribution of imported drugs and medicinal materials;
h) Other activities related to drug distribution defined by law.
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12. The importer that is not entitled to distribute drugs and medicinal materials in Vietnam shall notify the Ministry of Health in writing before it starts to sell or stops selling drugs to a wholesaler that distributes the drugs or medicinal materials it imported.
Within 03 days from the day on which the importer’s notification is received, the Ministry of Health shall publish information about the wholesaler on its website.
13. The import of herbal materials that are specimens of a species on the list of endangered species for testing or pharmaceutical research shall comply with regulations of law on biodiversity.
14. Testing certificate of the batch of imported drugs/medicinal materials:
a) The testing certificate shall be written in Vietnamese or English language. If it is written in a language other than Vietnamese or English language, a notarized Vietnamese or English translation shall be included;
b) If a batch is manufactured by more than one facilities, it is required to have the testing certificate of the final manufacturing or releasing facility;
c) The testing certificate shall contain: name and address of the manufacturing facility, testing certificate number, name and signature of the responsible for person, date of issue of the testing certificate, product name, batch number, shelf life, applied quality standards and requirements, testing results, conclusion.
c) The applicant for registration of the drug or medicinal material has the marketing authorization in Vietnam which does not expire at the time customs clearance is granted. This applicant must be other than those mentioned in Points a and b of this Clause.
d) An establishment granted the License to trade drugs, medicinal materials, vaccines, biologicals or ingredients thereof in Vietnam;
dd) In cases specified in Points c, d or h of this clause, they are required to be authorized in writing by the entity mentioned in Point a or b of this Clause to supply drugs in Vietnam. Except for those specified in points d and h of this clause, they are specified in point a or b of this clause.
The authorization document may be an authorization letter, seller's license or certificate of partnership. The authorization document must be written in Vietnamese or English and contain: name and address of the authorizing party and authorized party; scope of supply of drugs/medicinal materials in Vietnam; authorization period or sale period; responsibilities of the parties for the quality and origins of drugs/medicinal materials supplied in Vietnam; signatures of the parties;
e) Regulations of this Clause do not apply to suppliers of imported drugs specified in Articles 67, 73 and Clause 1, Article 74 hereof.
g) Regulations of Point dd of this Clause do not apply to suppliers of imported drugs specified in Articles 68 and 70 hereof.
b) The marketing authorization of the imported drug is revoked by the competent authority of the manufacturing country, member state of the ICH or Australia;
c) A competent authority concludes that fraudulent documents are used in the application for licensing drug import;
d) The location where the imported drug is manufactured is not consistent with the address on the application for licensing drug import;
dd) The drug contains an imported active ingredient or herbal material that is not recommended by WHO, a competent authority of Vietnam or the country of origin;
e) The manufacturer or importer requests revocation of the license;
g) A pharmacy authority of the exporting country issues a request for recall of the imported batch.
18. The license to import medicinal materials shall be revoked in the following cases:
a) The medicinal material is recalled according to Clause 2a, 2b, 2d, 2dd or 2e Article 62 of the Law on Pharmacy;
b) The imported active ingredient or herbal material is not recommended by WHO, a competent authority of Vietnam or the country of origin of the active ingredient or herbal material.
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a) Any of the violations mentioned in Clause 17a, 17c and 17d of this Article is committed;
b) Within 12 months, 02 or more batches of the imported drug are recalled because of second-degree violations specified in Clause 2b Article 63 of the Law on Pharmacy or 03 or more batches of the imported drug fails to meet quality standards;
c) Information in the application for the import license is not based on research findings or the manufacturer’s capacity;
d) Information about the efficacy and safety of the imported drug is not updated on its label or package insert as requested by the Ministry of Health.
20. The entire batch of drug or medicinal material shall be suspended from import if its manufacturer:
a) commits a serious violations against GMP requirements as prescribed by the Minister of Health;
b) produces 02 or more batches that constitute first-degree violations specified in Clause 2a Article 63 of the Law on Pharmacy within 12 months;
c) produces 03 or more batches that constitute second-degree violations specified in Clause 2b Article 63 of the Law on Pharmacy within 12 months or produces 04 or more batches that fail to meet quality standards;
d) The duration of suspension shall be 01 – 02 years for the violations mentioned in Points a and b of this Clause; 06 – 12 months for the violations mentioned in Point c of this Clause.
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a) Within 10 days from the date of import of a vaccine that is already granted the marketing authorization in Vietnam or a drug that is not granted a marketing authorization in Vietnam, the importer shall submit a report on each shipment to the Ministry of Health and National Institute for Control of Vaccines and Biologicals (for vaccines) according to Form No. 47 or Form No. 48 in Appendix III enclosed herewith.
b) By the 15th of July and 15th of January, the importer shall prepare biannual and annual reports on import of drugs and medicinal materials according to Form No. 49 or Form No. 50 in Appendix II enclosed herewith and send them to the Ministry of Health.
b) Be the original copies which are written in English or Vietnamese. If the copies cannot be written in English or Vietnamese, provide the certified translated documents in one of these languages.
Article 92. Documents to be produced and submitted upon customs clearance of drugs and medicinal materials
Apart from the documents to be submitted according to regulations of law on customs, the following documents shall be produced and submitted upon customs clearance of drugs and medicinal materials:
1. Regarding export of drugs and medicinal materials:
a) A copy of the Certificate of eligibility for pharmacy business which bears the exporter’s seal if the exporter is a pharmacy business establishment (the original copy or certified true copy shall be produced for comparison);
b) A copy of the export license which bears the exporter’s seal and the original copy or certified true copy thereof for comparison in case of export of herbal materials on the list of controlled precious, rare and endemic medicinal material species and varieties; controlled drugs except for those in Point c of this Clause;
c) Copies of the prescription and outpatient's medical record which is authenticated or bears the applicant’s signature (if the applicant is an individual) or seal (if the applicant is an organization) if the drug is personal property shipped under a lading bill or an outbound passenger’s belongings for his/her treatment and the quantity does not exceed 07 days' dose if the drug is a narcotic drug; 10 days if the drug is a psychotropic drug or precursor drug; 30 days if the drug is a combined drug that contains a narcotic active ingredient, a combined drug that contains a psychotropic active ingredient or a combined drug that contains a precursor, toxic drug or a drug on the list of drugs, an active ingredient on the list of substances banned from certain fields according to the dose written on the accompanying prescription.
c) The original copy or a copy bearing the importer’s seal of the testing certificate of each batch of imported drug or medicinal material (the original copy must be produced for comparison if a copy is submitted);
d) A copy bearing the importer’s seal of the manufacturer’s document authorizing the foreign exporter to export herbal materials or semi-finished herbal materials, unless the manufacturer is also the exporter. The content of such document is specified in Clause 15dd Article 91 hereof;
dd) The original copy or a copy bearing the manufacturer’s seal of the testing certificate of each batch of the imported herbal material or semi-finished herbal materials (the original copy must be produced for comparison if a copy is submitted);
d) Copies of the prescription and outpatient's medical record which is authenticated or bears the applicant’s signature (if the applicant is an individual) or seal (if the applicant is an organization) in any of the following cases:
The quantity of drugs to be imported does not exceed 07 days’ dose for narcotic drugs or 10 days’ dose for psychotropic drugs and precursors according to the prescription;
The drug is not a narcotic drug, psychotropic drug or precursor, the total customs value of a shipment does not exceed USD 200 according to the inter-bank exchange rate on the customs clearance date and not more than 03 shipments are received by an organization or individual in a year. If the drug is used for treatment of a disease on the list of fatal diseases in the Government's Decree No. 134/2016/ND-CP, the customs value of a shipment must not exceed VND 10,000,000 and not more than 04 shipments are received by an individual in a year.
The original copies the prescription and outpatient's medical record shall be produced upon customs clearance for comparison with the copies submitted.
5. The following entities may apply for marketing authorization of herbal materials, excipients or capsule shells:
a) The establishments specified in Clause 3 Article 54 of the Law on Pharmacy;
b) The establishments specified in Clause 1c Article 35 of the Law on Pharmacy that are permitted to apply for marketing authorization of herbal materials.
6. Marketing authorization method, rights and obligations of applicants for marketing authorization of herbal materials, excipients and capsule shells are specified in Article 55 and Article 57 of the Law on Pharmacy
Article 94. Power, documents, procedures and deadline for issuing, renewing, adjusting and revoking the marketing authorization of herbal materials, excipients and capsule shells
The power, documents, procedures and deadline for issuing, renewing, adjusting and revoking the marketing authorization of herbal materials, excipients and capsule shells are specified in Article 56 and Article 58 of the Law on Pharmacy, with the following exceptions:
1. If the applicant is an herbal material collection facility without the Certificate of eligibility for pharmacy business, a certified true copy of the certificate of enterprise registration shall be included in the application.
2. The marketing authorization of herbal materials, excipients and capsule shells shall be issued within 06 months from the day on which the satisfactory application is received.
Section 2. INSPECTION OF FULFILLMENT OF GMP REQUIREMENTS BY OVERSEAS MANUFACTURERS OF DRUGS/MEDICINAL MATERIALS WHEN THEY APPLY FOR REGISTRATION IN VIETNAM
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1. If a drug or medicinal material has not been granted a marketing authorization, the applicant shall submit an application for GMP inspection in addition to the application for the marketing authorization of the drug or medicinal material in the following cases:
a) The foreign manufacturer applies for drug granted marketing authorization in Vietnam for the first time;
b) The production line of the drug has not undergone inspection by the Ministry of Health;
c) The medicinal material is an active ingredient that is granted marketing authorization in Vietnam for the first time;
d) The foreign manufacturer applies for herbal material marketing authorization in Vietnam for the first time.
2. If the marketing authorization of a drug or medicinal material is issued before the effective date of this Decree and its manufacturer has not undergone inspection by the Ministry of Health, an application GMP inspection shall be submitted when:
a) applying for renewal of the marketing authorization of the drug or medicinal material according to Clause 4 Article 55 of the Law on Pharmacy;
b) applying for issuance of the marketing authorization of the drug or medicinal material because of relocation of the factory according to Clause 2b or Clause 2c Article 55 of the Law on Pharmacy.
3. If the drug or medicinal material is manufactured by multiple factories, the applicant shall apply for inspection of all of the factories that participate in the production.
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1. Inspection of documents about the manufacturing conditions shall be carried out in the cases specified in Clause 2 and Clause 3b of this Article.
2. The inspection result given by a pharmacy authority shall be recognized in the following cases:
a) The manufacturer is of a country that has agreement with Vietnam on mutual recognition of GMP inspections according to the list compiled by the Ministry of Health, except for the cases specified in Clause 3 of this Article;
b) The manufacturer is of a member state of ICH or Australia, undergoes GMP inspection and granted the certificate of GMP by either US Food and Drug Administration (USFDA), European Union, European Medicines Agency (EMA), Australia’s Therapeutic Goods Administration (TGA), Japan’s Pharmaceuticals and Medical Devices Agency (PMDA) or Health Canada, except for the cases specified in Clause 3 of this Article.
3. A site inspection shall be carried out when:
a) The application for registration of drug or medicinal material is suspected of falsification or inaccuracy;
b) The manufacturer commits a first-degree violation according to conclusion of the Ministry of Health;
c) The Ministry of Health concludes that documents submitted by the manufacturer are not sufficient for proving its fulfillment of GMP requirements.
3. Contents of inspection in the form of mutual recognition of GMP inspection by foreign pharmacy authorities:
a) Legitimacy of the certificate of GMP, the manufacturing license or the report on GMP inspection;
b) Suitability of the certificate of GMP, the manufacturing license or the report on GMP inspection for the dosage form of the registered drug or medicinal material.
4. Contents of site inspection:
a) Legitimacy of the certificate of GMP, the manufacturing license or the report on GMP inspection;
b) Conditions of the factory, including the floor plan, production line, building materials, environmental conditions, movement of employees, materials, semi-finished products and finished products, movement of equipment for manufacturing, testing, storing drugs/medicinal materials;
c) Operation of the production line for the drug or medicinal material registered;
d) Establishment and operation of the manufacturer’s quality control system;
dd) Application of GMP requirements to the production, testing, storage of drugs/medicinal materials by the manufacturer.
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1. The application for GMP inspection submitted by a manufacturer of drugs/medicinal materials that are active ingredients in any of the cases specified in Clause 2 Article 96 hereof consists of:
a) The certificate of GMP, the manufacturing license or the report on GMP inspection which contains sufficient information about the dosage form of the drug or medicinal material issued by a competent authority of the manufacturer’s home country;
b) The site master file (SMF) prepared by the manufacturer according to instructions of EU, Pharmaceutical Inspection Co-operation Scheme (PIC/S) or WHO.
2. The application for GMP inspection submitted by a manufacturer of drugs/medicinal materials that are active ingredients in any of the cases specified in Clause 1 and Clause 3 Article 96 hereof consists of:
a) The certificate of GMP, the manufacturing license or the report on GMP inspection which contains sufficient information about the dosage form of the drug or medicinal material issued by a competent authority of the manufacturer’s home country; the certificate of GMP or report on GMP inspection issued by the pharmacy authority of a member state of EU or PIC/S (if any);
b) The SMF prepared by the manufacturer according to instructions of EU, Pharmaceutical Inspection Co-operation Scheme (PIC/S) or WHO;
c) A list of GMP inspections carried out by pharmacy authorities of the manufacturer’s home country over the last 03 years before the application is submitted and the report on the latest GMP inspection that involves the registered drug or medicinal material or the dosage form thereof;
3. The application for GMP inspection submitted by a manufacturer of excipients or capsule shells consists of:
a) The certificate of GMP, the manufacturing license or the report on GMP inspection which contains sufficient information about the excipient of capsule shells issued by a competent authority of the manufacturer’s home country;
5. An application for GMP inspection shall satisfy the following requirements:
a) The application is written in English or Vietnam language; documents in the application are clearly printed and arranged in the order specified in Clause 1 through 4 of this Article, the parts are clearly separated; the application has covers and a list of documents;
3. If the certificate of GMP or the manufacturing license is expired on the inspection date or the report on GMP inspection was issued more than 03 years before the inspection date or the SMF does not contain sufficient information, the Ministry of Health shall request the applicant to complete the application.
a) The supplementary SMF shall be submitted within 90 days, the certificate of GMP, manufacturing license or GMP inspection report within 06 months;
b) The Ministry of Health shall notify the applicant of the result within 30 days from the day on which supplementary documents are received.
4. Within 10 working days from the day on which the result is available, the Ministry of Health shall publish information about the inspected and recognized manufacturers on its website.
Article 100. Responsibilities of applicants for registration of drugs/medicinal materials of foreign manufacturers in GMP inspection; cases in which applications for marketing authorization of drugs/medicinal materials are rejected
1. During the GMP inspection, the applicant for registration of a drug or medicinal material of a foreign manufacturer shall:
a) Submit the application for GMP inspection as prescribed;
b) Take responsibility for the adequacy and accuracy of documents in the application for GMP inspection; provide supporting documents requested by the Ministry of Health;
c) Cooperate with the manufacturer in complying with requests of the Ministry of Health;
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d) Pay the cost of GMP inspection as prescribed by law.
2. The application for issuance or renewal of the certificate of drug/medicinal material registration shall be rejected if the applicant or the manufacturer commits any of the following violations:
3. From the day on which the violation is notified by a competent authority, the applicant shall be suspended from submitting the application for issuance or renewal of the marketing authorization of drug/medicinal material;
a) 03 – 05 years in the cases specified in Clause 1d Article 58 of the Law on Pharmacy;
b) 01 – 02 years in the cases specified in Clause 1a and 1 dd Article 58 of the Law on Pharmacy and Points b, c, d, dd and e of Clause 2 of this Article;
b) Voluntary recall: by the applicant for registration, manufacturer or importer of medicinal materials.
2. Scale of recall:
a) Medicinal materials shall be recalled from establishments that sell or use them, except for the case in Point b of this Clause;
b) If the material fails to meet quality standards because of an error during the process of storage, transport or distribution, or used for unintended purposes, only the affected materials at establishments that sell or use it shall be recalled;
c) The scale of recall must be specified in the decision on recall issued by the competent authority (in case of mandatory recall) or by the applicant for registration, the manufacturer or the importer (in case of voluntary recall).
Article 102. The power to recall and procedures for recalling medicinal materials
1. Power to issue the decision on recall:
a) The Ministry of Health shall decide the recall of medicinal materials and issue the decision on recall in case of mandatory recall;
b) Domestic manufacturers and importers of medicinal materials shall decide the recall of medicinal materials and issue the decision on recall in case of voluntary recall.
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a) Within 48 hours from the time a recall is decided, the Ministry of Health or the establishment mentioned in Clause 1b of this Article shall issue the decision on recall and inform the Ministry of Health of the recall. Decision on mandatory recall shall be sent to domestic manufacturers of medicinal materials, importers of medicinal materials, Departments of Health of provinces and posted on the website of the Ministry of Health;
b) Within 05 working days from the day on which the decision on recall is issued, the domestic manufacturer or importer of medicinal materials inform buyers of the materials of the recall and organize receipt of the materials returned;
c) The recall of medicinal materials must be finished within 30 days from the day on which the decision on recall is issued;
d) Within 10 days from the day on which the recall is finished, the establishment responsible for the recall shall submit a report to the Ministry of Health which is enclosed with copies of the documents about the recall bearing the establishment’s seal. Documents about the recall are documents that specify quantity of materials manufactured or imported, quantity of materials recalled, time of manufacture, date of import, list of buyers and evidence that materials have been returned by the buyers and users;
dd) The Ministry of Health shall verify the report, assess the effectiveness of the recall or enforce the recall if the domestic manufacturer or importer fails to carry out the recall in accordance with Point b or Point c of this Clause.
Article 103. Responsibility to recall medicinal materials
1. The domestic manufacturer or importer of the recalled medicinal material shall:
a) Give a conclusion that the material has to be recalled and issue a decision on recall in case of voluntary recall;
b) Stop selling the recalled material;
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d) Handle the recalled material;
dd) Pay for the recall and handling of recalled material (even if the recall is enforced) and pay damages as prescribed by law;
e) Submit a report on the recall to the Ministry of Health.
2. Each distributor of the recalled material shall:
a) Stop buying and selling the recalled material;
b) Return the material to its supplier.
c) Return the material to its supplier;
d) Pay for the recall and handling of recalled material (even if the recall is enforced) and pay damages if the distributor is at fault.
3. The manufacturer that uses the recalled material shall:
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b) Return the material to its supplier.
4. The Ministry of Health shall:
a) Draw a conclusion that the medicinal material has to be recall and issue the decision on recall in case of mandatory recall;
b) Verify the report on recall and comment on the handling and recycling of the recalled material;
c) Inspect and supervise the recall; take actions against violators as prescribed by law;
d) Instruct the Department of Health of the province to inspect and supervise recall of medicinal materials and take actions against violators in its province;
dd) Decide enforcement of recall if the domestic manufacturer or importer fails to carry out the recall as requested;
e) Publish information about the recalled medicinal materials on its website if they have to be destroyed.
5. The Department of Health of the province shall:
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b) Inspect and supervise recall of medicinal materials and take actions against violators in the province;
c) Inform the Ministry of Health of the establishments that fail to properly recall medicinal materials.
Article 104. Handling recalled materials
1. Recalled medicinal materials that are herbal materials or active ingredients shall be destroyed in the following cases:
a) The medicinal materials are not meant for human use but labeled for human use;
b) The marketing authorization was obtained by submission of fraudulent documents;
c) The origin of the materials is unknown;
d) The active ingredient is displayed or labeled under another manufacturer or manufacturing country or country of origin;
dd) The herbal material is counterfeit;
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g) The medicinal materials are used to produce drugs that are not recommended by WHO.
2. Medicinal materials may be recycled in the following cases:
a) The medicinal materials are recalled because they fail to comply with regulations on labels or medicinal materials specified in Article 61 of the Law on Pharmacy or relevant regulations of law;
b) The medicinal materials are recalled because they are produced at factory other than the registered factory but the former is granted a manufacturing license by a competent authority.
3. Recalled medicinal materials that are not psychotropic active ingredients, narcotic substances, drug precursors and are not those mentioned in Clause 1 and Clause 2 of this Article may be recycled if they are domestically produced or re-exported if they are imported or repurposed under the procedures in Clause 4 of this Article.
Recalled medicinal materials that are not recycled, re-exported or repurposed shall be destroyed.
a) The head of the establishment whose medicinal materials have to be destroyed shall establish a medicinal material destruction council. The council consists of at least 03 persons, including the head and the chief pharmacist of the establishment;
b) The destruction of medicinal materials must ensure long-term health of human and animals and avoid causing environmental pollution in accordance with regulations of law on environmental protection;
c) The establishment having the recalled medicinal materials shall pay for their destruction;
d) Destruction of controlled medicinal materials shall comply with regulations of Article 48 of this Decree.
Chapter VII
CERTIFICATION OF DRUG INFORMATION AND DRUG ADVERTISEMENTS
1. Provision of drug information via “Sale representatives”.
2. Publishing of documents containing drug information.
3. Holding pharmaceutical conferences.
Article 106. Applicants for certification of drug information
1. The following entities may apply for certification of drug information:
a) Establishments applying for drug registration in Vietnam;
b) Representative offices in Vietnam authorized by the overseas establishments that apply for drug registration in Vietnam;
c) Vietnamese pharmacy business establishments authorized by the establishments mentioned in Clause 1a of this Article;
d) Vietnamese drug importers, which may only provide information about the drugs they import using the method specified in Clause 3 Article 105 of this Decree.
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c) The drug information is written in Vietnamese language, except for untranslatable information;
d) Minimum font size: 12; Font: VnTime or Times New Roman; Page: A4.
2. The text “Tài liệu thông tin thuốc” (“Drug information”) must be displayed on the top of all pages. Pages of a multi-page document must be numbered. The first page must contain the table of content and the text “Số Giấy xác nhận nội dung thông tin thuốc của Bộ Y tế…/XNTT/…, ngày ... tháng ... năm ...” (“Number and date of the certification of drug information issued by the Ministry of Health: …”).
3. In case of a pharmaceutical conference, the drug information must include the names and academic ranks of the speakers, whose medical or pharmaceutical qualifications are suitable for the drug introduced.
Article 113. Procedures for issuance of the certification of drug information
1. The applicant shall submit the application for the certification of drug information to the competent authority specified in Article 116 of this Decree.
c) Within 90 days from the date on which the additional documents are requested in writing by the receiving authority, the applicant shall submit additional documents as requested. Otherwise, the application will be rejected.
4. While the application is being processed, the receiving authority shall suspend granting the confirmation and issue a notification of the suspension if the information about drug safety and efficacy in the package insert is found unsatisfactory or not updated as requested by competent authority or according to instructions given or recognized by the Ministry of Health. The suspension will be lifted when the applicant submits adjusted or updated information that ensures safety of drug users.
5. At least 03 working days before providing drug information using the method mentioned in Clause 3 Article 105 of this Decree, the holder of the certification of drug information shall send a notification of the time and location and a copy of the certification of drug information to the Department of Health of the province where drug information is provided.
If the time or location is changed, the Department of Health shall be informed at least 01 (one) working day before drug information is provided.
6. The application will be rejected if the applicant, including authorized applicants mentioned in Clause 1b and Clause 1c Article 106 of this Decree, commits any of the following violations:
a) Legal documents issued by regulatory authorities in the application for certification of drug information are falsified or forged;
b) The drug information is provided or the drug advertisement is run before its contents are certified by a competent authority or against the contents certified by a competent authority;
c) A certificate not recognized by the Ministry of Health, another organization’s or individual’s name, symbol, images, letters or reputation is included in the drug information or advertisement.
d) A clinical trial result, pre-clinical trial result, test result or bioequivalence study result not recognized by the Ministry of Health is included in the drug information or advertisement;
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7. From the day on which the violation is notified by a competent authority, the applicant shall be suspended from submitting the application for the certification of drug information or drug advertisement for:
a) 01 – 02 years in the cases specified in Clause 6a of this Article;
b) 06 – 12 months in the cases specified in Clause 6b, Clause 6c or Clause 6d of this Article;
c) 03 – 06 months in the cases specified in Clause 6dd of this Article.
1. The certification of drug information is effective nationwide.
2. The certification of drug information does not have a specific expiration date and shall be invalidated in the following cases:
a) The marketing authorization or the license for drug import is revoked;
b) A change to drug information is made that requires issuance of another certification of drug information according to Clause 1b Article 107 of this Decree.
Section 2. CONFIRMATION OF DRUG ADVERTISEMENT CONTENTS
Article 118. Means of advertising drugs
Drugs may be advertised through the means of advertising defined by advertising laws.
Article 119. Applicants for confirmation of drug advertisement contents
1. The following entities may apply for confirmation of drug advertisement contents:
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b) Representative offices in Vietnam authorized by the overseas establishments that apply for drug registration in Vietnam;
c) Vietnamese pharmacy business establishments authorized by the establishments mentioned in Clause 1a of this Article.
2. Applicants for drug registration, including those authorizing the entities mentioned in Clause 1b or 1c of this Article to apply for confirmation of drug advertisement contents, shall take responsibility for the drug advertisement contents.
1. An application for the certification of drug advertisement contents, except for advertisements in the form of conferences, conventions or events, consists of:
a) Form No. 01 in Appendix VI enclosed herewith;
b) The graphic design of the drug advertisement; the audio or video track of the advertisement on audio or video news and other means of audio and video advertisements defined by advertising laws;
c) Specimens of the label and package insert approved by the Ministry of Health;
d) Reference documents about the drug advertisement contents to be certified (if any);
Article 125. Requirements applied to drug advertisement contents
1. The drug advertisement contents shall comply with the following documents:
a) The label and package insert approved by the Ministry of Health;
b) The treatise on the drug in the National Pharmacopoeia of Vietnam;
c) Related instructions provided or recognized by the Ministry of Health.
2. The drug advertisement contents have the following compulsory information:
a) Drug name;
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c) Indications;
d) Uses;
dd) Dosage;
e) Contraindications and warnings for special users (pregnant women, breast-feeding women, children, old people, people having chronic diseases);
g) Cautions and what to avoid when using the drug;
h) Side effects and adverse effects;
i) Name and address of the manufacturer;
k) The text “Đọc kỹ hướng dẫn sử dụng trước khi dùng" (“Read the instructions carefully before use”);
l) The text “Số Giấy xác nhận nội dung quảng cáo thuốc của Bộ Y tế: .../XNQC..., ngày ... tháng ... năm...;” (“Number and date of the certification of drug advertisement contents issued by the Ministry of Health: …”) at the end of the first page;
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n) Reference documents and extracts therefrom are specified. The extracts must be accurate without addition or removal of information which leads to misunderstanding of the safety and efficacy of the drug.
3. The contents of an audio or video advertisement must contains sufficient information specified in Points a, b, c, e, i, k Clause 2 of this Article. Information mentioned in Points a, b, c, e, k Clause 2 of this Article must be read aloud.If the drug consists of 03 or more active ingredients, each of them or the groups of vitamins, minerals and herbal materials must be read aloud.
4. Contents of advertisements on online newspapers, websites, electronic devices, advertising screens and other means of advertising defined by advertising laws:
a) The contents of an advertisement that has sounds shall comply with regulations of Clause 3 of this Article;
b) The contents of an advertisement without sounds shall comply with regulations of Clause 2 of this Article.
If the advertisement is an audio or video track that has multiple pages or footages, the pages or footages must be continuous and stay still for viewers to read all information; the page or footage that contains product information must be still for viewers to read such information. The script must specify how the pages of a multi-page advertisement are shown.
Such an advertisement must not advertise more than one drugs to avoid confusion.
5. The contents of an outdoor advertisement shall be shown on one side of the board and contains the information specified in Points a, b, i, k, l Clause 2 of this Article If the advertisement contains information about the effects and indications of the drug, sufficient information specified in Clause 2 of this Article must be provided.
6. Voice and text in a drug advertisement shall comply with the Law on Advertising.
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8. The script must clearly describe the graphics, dialogues, text and music.
9. A drug advertisement may only provide information about the drug and may not provide information not related to the drug.
Article 126. Information and images banned from drug advertisements
1. Information and images prescribed in the Law on Advertising.
2. Information that causes misunderstanding about the ingredients, effects, indications or origin of the drug.
3. Information causing the viewers to believe that the drug is the best, the drug can be used without physician’s counsel, the drug is completely harmful, the drug has no contraindications or adverse effects.
4. Sentences, words and images which are excessively deductive resulting in a misunderstanding about or an overestimation of the approved effects, indications and efficacy of a drug.
5. Information that equates effects of some ingredient of the drug with effects of the drug.
6. The following words and phrases: “điều trị tận gốc”, “tiệt trừ”, “chuyên trị” (“complete treatment"), “hàng đầu”, “đầu bảng”, “đầu tay” (“best”, “top”), “lựa chọn”, “chất lượng cao” (“high-quality”), “đảm bảo 100%” (“100% guarantee”), “an toàn” (“safe”), “dứt”, “cắt đứt”, “chặn đứng” (“stop”, “end”), “giảm ngay”, “giảm liền”, “giảm tức thì” (“relieve instantly”), “khỏi ngay”, “khỏi hẳn” (“treat instantly”), “yên tâm”, “không lo”, “khỏi lo” (”no worries”), “khuyên dùng” (“recommended”), “hotline”, “điện thoại tư vấn” (“hotline”) and those with similar meanings.
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a) Treatment of tuberculosis or leprosy;
b) Treatment of sexually transmitted diseases;
c) Treatment of insomnia;
d) Aphrodisiac indications;
dd) Treatment of cancers or tumors;
e) Drug detoxification;
g) Treatment of diabetes mellitus or similar metabolic disorders;
h) Treatment of viral hepatitis or new dangerous diseases.
8. Drug or medicinal material quality test results
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10. Clinical study results or bioequivalence study results that have not been recognized by the Ministry of Health.
11. Names, positions, letters of other organizations or individuals used for advertising purposes.
12. Origin of the drug or medicinal material used for advertising purposes.
13. Image, name or symbol of a health worker.
14. Images of an animal or plant on the list of priority protected endangered, precious and rare species.
15. Sentences and words that are expressed as advice or tips that recommend the drug.
16. Images of patients used for description of symptoms or effects of the drug that are not conformable with relevant documents and instructions provided or recognized by the Ministry of Health.
Article 121. Procedures for issuance of the certification of drug advertisement contentsPlease sign up or sign in to your TVPLPro Membership to see English documents.
Article 131. Receipt of declarations and re-declarations of drug prices, adjustment to declared drug prices and verification of declared drug prices
1. Regarding imported drugs:
a) The importer shall declare the intended wholesale price and retail price for the imported drug (in case of retailing) before launching the first shipment in Vietnam. Price declaration is not required for the next shipments if the price declared is not adjusted;
b) The importer shall re-declare the intended wholesale price and retail price if the price that was declared/re-declared and posted on the website of the Ministry of Health is increased.
a) request pharmacy business establishments making declarations in writing to produce reports on declaration and redeclarations in conformity to declarations of similar commodities on the market, fluctuations of price factors to serve price stabilization, price management, examination, and inspection as per the law;
b) examine and inspect drug pricing in pharmacy business establishments as per the law;
c) request competent authority to take actions if pharmacy business establishments are found to: fail to declare or redeclare; fail to adequately declare price prices or fail to adjust prices and report at written request of competent drug pricing authority in respect of declarations and redeclarations of enterprises; fail to adequately declare price factors or sell drugs at a higher price than applicable declarations or redeclarations;
d) consider measures taken if pharmacy business establishments have committed at least 2 violations in a year: temporarily suspend reception of request for verification of drug information and advertising; temporarily suspend reception of request for import of drugs without marketing authorization in Vietnam; temporarily suspend reception of request for issuance, extension of drug, medicinal material marketing authorization.
Temporary suspension under this Point shall last for 03 months to 12 months from the date on which violate notice is issued by competent authority.
2. Drug pricing authorities have the responsibility to:
a) adhere to regulations on receiving declarations and redeclarations in accordance with Article 131 hereof;
b) review declarations and redeclarations of drug prices made by pharmacy business establishments in accordance with Clause 1, Clause 2, Clause 4 Article 130 hereof;
c) maintain confidentiality of declarations and redeclarations of organizations and individuals during the period in which declarations and redeclarations of organizations and individuals have not entered into effect as per the law.
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1. Pharmacy business establishments have the right to:
Purchase, sell drugs at declared, redeclared price from the date on which manufacturing facilities, processing service buyers, importing facilities submit adequate declarations or redeclarations to competent authority as per the law. Purchase, sell drugs at a lower price while declaring price reduction if importing facilities, manufacturing facilities, or processing service buyers lower declared price relative to previous declarations.
2. Pharmacy business establishments have the responsibility to:
a) adequately comply with regulations on declaration and redeclaration of drug price, notify price in accordance with regulations and this Decree; assume total legal responsibility for accuracy and veracity of drug price declarations, redeclarations; produce reports on declared, redeclared price at request of drug pricing authorities; comply with examination and inspection of competent authority (if any);
b) not sell drugs in bulk or retail drugs at a price higher than declared or redeclared price which has been declared, redeclared by manufacturing facilities, processing service buyers, importing facilities;
c) if competent authority request pharmacy business establishments to produce reports on drug prices declared and redeclared by the pharmacy business establishments, the pharmacy business establishments shall respond in form of reports on declared prices conforming to price level of similar products on the market or fluctuations of price factors within 30 days from the date on which request of competent authority is issued or adjust declared, redeclared prices in accordance with feedback of drug pricing authority. If pharmacy business establishments fail to respond in writing within the time limit above, submitted declarations and redeclarations shall be voided;
d) comply with actions taken against drug price declaration in accordance with regulations on administrative penalties in prices, fees, charges, and invoices.
b) Declared, redeclared drug prices conforming to market price of similar drugs (if any).
2. If necessary, depending on review contents under Clause 1 of this Article, drug pricing authorities shall request Vietnam Social Security, pricing authorities, and relevant authorities to permit post-inspection review of declared, redeclared drug prices.
Section 2. LISTING OF DRUG PRICES, RETAIL SURPLUS APPLIED TO RETAILERS IN HEALTH FACILITIES
Article 135. Listing of drug prices
1. Responsibility to list drug price:
a) Drug wholesalers shall list the wholesale price of each drug at the wholesale stores;
b) Drug retailers shall list the retail price of each drug at the retail stores;
c) Drug wholesalers and retailers must not sell drugs at prices higher than listed prices.
2. Price listing:
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b) The retail price must be printed, written or stuck on the primary package or secondary package of the drug, written on a board or paper or in other forms as long as it does not block the drug label, is suitable and noticeable by buyers and the authorities;
c) The listed currency shall be VND;
d) The listed price shall be inclusive of taxes and charges (if any).
Article 136. Retail margins applied to retailers in health facilities
1. The retail price equals (=) buying price according to the invoice plus (+) the retail margin percent rate multiplied by (x) buying price. Formula:
3. Maximum retail margin percent applied to drug retailers in health facilities:
a) If the buying price is not exceeding 1,000 VND per smallest pack: 15%;
b) If the buying price is exceeding VND 1,000 but not exceeding VND 5,000 per smallest pack: 10%;
c) If the buying price is exceeding VND 5,000 but not exceeding VND 100,000 per smallest pack: 7%;
d) If the buying price is exceeding VND 100,000 but not exceeding VND 1,000,000 per smallest pack: 5%;
dd) If the buying price is exceeding VND 1,000,000 per smallest pack: 2%.
4. Definitions of smallest pack:
a) If the dosage form is tablets, pills or capsules, the smallest pack is a tablet, pill or capsule;
b) If the dosage form is liquid, the smallest pack is an ampoule, bottle, sachet or pre-filled syringe;
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dd) If the dosage form is orally administered powder or granules, the smallest pack is a pack, bottle or sachet;
dd) If the dosage form is cream, salve or gel for topical administration, the smallest pack is a tube or bottle;
e) If the dosage form is transdermal patch, the smallest pack is a patch;
g) If the dosage form is a drug in the form of spray or aerosol, the smallest package unit shall be spray bottle, metered dose inhaler or drug jar of aerosol nebulizer;
h) If the dosage form is a kit, the smallest pack is a kit.
Section 3. BIDDING FOR DRUG PURCHASE, DRUG PRICE NEGOTIATION AND MEASURES FOR DRUG PRICE STABILIZATION
Article 137. Bidding for drug purchase
1. Bidding for drug purchase from state capital, health insurance fund, revenue from provision of medical services and other lawful sources of revenue of public health facilities shall comply with regulations of law on bidding, the principles in Clause 4 Article 7 and Clause 6 Article 107 of the Law on Pharmacy.
2. Criteria for determination or ration prices as the basis for promulgation of the list of domestic herbal materials that can be domestically obtained with adequate quantity and at rational prices:
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b) Fulfillment of Good Agricultural and Collection Practices (GACP) by domestic manufacturer of traditional drugs or herbal drugs; active ingredients of herbs and concentrations thereof.
3. The Minister of Health shall provide guidelines for bidding for the drugs specified in Clause 1 and Clause 2 of this Article; publish the list of original brand-name drugs; promulgate regulations on purchase of original brand-name drugs that are not on the list of drugs and herbal materials eligible for price negotiation specified in Article 138 of this Decree by selecting suitable contractors according to bidding laws.
Article 138. List of drugs and herbal materials eligible for price negotiation
The Minister of Health shall promulgate the list of drugs and herbal materials eligible for price negotiation according to Clause 6 Article 107 of herbal materials on the basis of counsel of the National Advisory Council for Drug Bidding.
Article 139. Drug price negotiation
Regulations of the Law on Pricing and its instructional documents shall apply to implementation of measures for drug price stabilization, power responsibility to implement of measures for drug price stabilization.
Chapter IX
IMPLEMENTATION CLAUSES
Article 140. Deadlines for obtaining the pharmacy practice certificate
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From July 01, 2019, manufacturers of orient drugs that have obtained the Certificate of eligibility for pharmacy business before the effective date of this Decree shall fulfill GMP requirements applied to traditional drugs. By this deadline, the business conditions specified in the Certificate must be maintained.
5. From January 01, 2021, manufacturers of excipients or capsule shells, manufacturers and processors of herbal materials or prepared traditional medicinal materials shall meet corresponding GMP requirements.
Article 142. Deadlines for fulfillment of Good Practice requirements by non-commercial pharmacy business establishments
1. From the effective date of this Decree, non-commercial establishments specified in Clause 1a Article 35 of the Law on Pharmacy that have not fulfilled Good Practice requirements may operate within a scope corresponding to their fulfillment of Good Practice requirements and have to fulfill all corresponding Good Practice requirements by the following deadlines:
a) Establishments that store and supply vaccines shall fulfill corresponding Good Practice requirements from July 01, 2019;
b) Non-commercial pharmacy establishments other than those mentioned in Point a of this Clause shall fulfill corresponding Good Practice requirements from January 01, 2021.
2. From the effective date of this Decree, non-commercial establishments specified in Clause 1a Article 35 of the Law on Pharmacy that have just been inaugurated or changed its scope of operation shall fulfill corresponding Good Practice requirements.
10. Certifications of drug information and certifications of drug advertisement contents issued before the effective date of this Decree shall remain effective until their expiration dates.
4. Transitional clauses for Decree No. 54/2017/ND-CP:
a) If the applications for the practice certificates or the Certificates of Eligibility for Pharmacy Business or the import and export licenses which are specified in the Decree No. 54/2017/ND-CP are submitted before this Decree takes effect, they shall be processed according to the regulations in the aforesaid Decree;
b) The medicinal materials, which are used for producing drugs and are licensed before this Decree takes effect, shall continue to be imported until the expiration date of the license;
c)The drugs which are procured by the retailers in the health facilities before this Decree takes effect shall comply with the regulations in the Decree No. 54/2017/ND-CP.”
Article 4 of the Government’s Decree No. 88/2023/ND-CP on amendments to Decree No. 54/2017/ND-CP dated May 08, 2017 on guidelines for implementation of the Law on Pharmacy and Government’s Decree No. 155/2018/ND-CP dated November 12, 2018 on amendments to regulations relating to business conditions under state management of the Ministry of Health, which has been effective since December 11, 2023, stipulates that:
“Article 4. Transition clauses
Applications submitted before the effective date hereof shall conform to regulations applicable at the time of application unless applicants request conformity to this Decree.”.
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Ministers, Heads of ministerial agencies, Heads of governmental agencies and Chairpersons of People’s Committees of provinces and central-affiliated cities shall implement this Decree./.”
Article 5 of the Government’s Decree No. 88/2023/ND-CP on amendments to Decree No. 54/2017/ND-CP dated May 08, 2017 on guidelines for implementation of the Law on Pharmacy and Government’s Decree No. 155/2018/ND-CP dated November 12, 2018 on amendments to regulations relating to business conditions under state management of the Ministry of Health, which has been effective since December 11, 2023, stipulates that:
“Article 5. Responsibility for implementation
Ministers, Heads of ministerial agencies, Heads of governmental agencies, Chairpersons of People’s Committees of provinces and central-affiliated cities and relevant organizations and individuals shall be responsible for the implementation of this Decree./.”
File gốc của Integrated document No. 02/VBHN-BYT dated January 11, 2024 Decree on guidelines for implementation of the Law on Pharmacy đang được cập nhật.
