Circular 47/2010/TT-BYT guiding the export and import of drugs and direct contact drug packaging issued by the Ministry of Health.

 CIRCULAR

GUIDELINES FOR THE EXPORT AND IMPORT OF MEDICINES AND PRIMARY PACKAGING MATERIALS IN DIRECT CONTACT WITH MEDICINES

Pursuant to the Medicine Law No. 34/2005/QH11 dated June 14, 2005;

Pursuant to the Law on Prevention and Control of Narcotics No. 23/2000/QH10 dated December 9, 2000 and the Law Amending and Supplementing Certain Provisions of the Law on Prevention and Control of Narcotics No. 16/2008/QH12 dated June 3, 2008;

Pursuant to Decree No. 188/2007/NĐ-CP dated December 27, 2007 of the Government stipulating the functions, tasks, powers, and organizational structure of the Ministry of Health;

Pursuant to the Decree No. 79/2006/NĐ-CP dated August 9, 2006 of the Government detailing the implementation of certain provisions of the Medicine Law;

Pursuant to the Decree No. 58/2003/NĐ-CP dated May 29, 2003 on the control of import, export, and transit of narcotic substances, precursor chemicals, addictive drugs, and psychotropic drugs through Vietnam;

Pursuant to the Decree No. 12/2006/NĐ-CP dated January 23, 2006 of the Government detailing the implementation of the Commercial Law on international trade activities and agency purchase, sale, processing, and transit of goods with foreign countries; Pursuant to Decision No. 151/2007/QĐ-TTg dated September 12, 2007 of the Prime Minister promulgating regulations on the import of medicines not yet registered in Vietnam;

The Ministry of Health issues guidelines for the export and import of medicines and primary packaging materials in direct contact with medicines as follows:

Article 1. These Circulars guide the export and import activities of medicines and primary packaging materials in direct contact with medicines.

Chapter I GENERAL PROVISIONS

Article 1. Scope of Regulation

Clause 2. Medicines exported or imported for personal and family treatment purposes via non-commercial channels are not within the scope of these Circulars.

Article 2. Definitions.

Article 2. Interpretation of Terms

In this Circular, the following terms are understood as follows:

Point 1. Country of origin means the country where the final dosage form was manufactured and/or where the batch was shipped out, or the country where the product was transported to the importing country.

Point 2. Manufacturing facility means a facility that performs at least one production process and/or ships out finished products.

Point 3. Finished product packaging of medicines refers to packaging containing medicines and circulating together with them. Finished product packaging of medicines includes two types:

- Direct packaging is packaging that directly contains and comes into contact with medicines;

- Outer packaging is packaging used to package one or more units of medicines with direct packaging.

Point 4. Radioactive material is a substance that emits radiation due to nuclear decay or energy level transition processes, having individual or total radioactivity levels exceeding the exemption limit.

Point 5. Radiopharmaceutical is a pharmaceutical substance containing radioactive material used for diagnosis and treatment of diseases.

Point 6. Radioactive medicine is a medicine containing one or more radiopharmaceuticals used for diagnostic or therapeutic purposes.

Point 7. Exemption threshold for declaration and licensing is the radioactivity level below which radioactive material is considered harmless to humans and the environment.

Article 3. Conditions and Scope of Participation in Export and Import Activities of Medicines and Primary Packaging Materials in Direct Contact with Medicines

Clause 1. For domestic traders who are Vietnamese enterprises:

Subclause a) Enterprises holding a Certificate of Eligibility for Pharmaceutical Business and a warehouse meeting Good Storage Practice (GSP) standards may directly import and accept consignment imports of finished medicines, raw materials for medicines, vaccines, medical biological products, traditional Chinese medicines, traditional Vietnamese medicines, and exempted radiopharmaceuticals in accordance with their business scope as stated in the Certificate of Eligibility for Pharmaceutical Business and the GSP certificate.

Subclause b) Enterprises engaged in medical equipment trading and enterprises holding a Certificate of Eligibility for Pharmaceutical Business may directly import and accept consignment imports of in vitro diagnostic biological products.

Subclause c) Enterprises holding a Certificate of Eligibility for Pharmaceutical Business and a Good Manufacturing Practice (GMP) certificate may import raw materials for their own drug production and sell them to other drug manufacturing enterprises.

Subclause d) Enterprises producing traditional Chinese medicines and holding a Certificate of Eligibility for Pharmaceutical Business may import medicinal herbs for their own production needs and sell them to other drug manufacturing facilities and traditional Chinese medicine hospitals.

Subclause e) Enterprises holding a Certificate of Eligibility for Pharmaceutical Business and a valid Radiation Work Permit issued by the competent authority may directly import non-exempted radiopharmaceuticals.

Clause 2. For foreign-invested enterprises holding a Certificate of Eligibility for Pharmaceutical Business (production scope), they may import raw materials for their own drug production. Other export and import activities of medicines not serving the enterprise's production will be guided by other documents of the Ministry of Health.

Clause 3. Vietnamese traders holding a Certificate of Eligibility for Pharmaceutical Business may export, consign exports, and accept consignment exports of medicines, except for addictive drugs, psychotropic drugs, precursors used in drug production, and non-exempted radiopharmaceuticals.

Clause 4. Traders are permitted to accept consignment imports of medicines within the scope of operations specified in their Certificate of Eligibility for Pharmaceutical Business, except for addictive drugs, psychotropic drugs, precursors used in drug production, and non-exempted radiopharmaceuticals.

Clause 5. Organizations and individuals who are not traders, based on contracts signed in accordance with the law, may consign exports and consign imports of medicines for their own use, except for addictive drugs, psychotropic drugs, precursors used in drug production, and non-exempted radiopharmaceuticals.

Clause 6. Representative offices of foreign traders holding a License for Drug and Raw Material Trading in Vietnam, and Vietnamese traders holding a Certificate of Eligibility for Pharmaceutical Business are permitted to import medicines for registration purposes (including medicines for testing and certification required for drug registration).

Clause 7. Research and testing facilities, and drug manufacturing facilities are permitted to import medicines for research and testing purposes.

Clause 8. Medical examination and treatment facilities of provinces and cities, sectoral health services, and organizations in Vietnam (referred to as the Vietnamese side) are permitted to accept donated and aid medicines from charitable organizations, non-governmental organizations, foreign individuals, and overseas Vietnamese individuals (referred to as the foreign side) and are responsible for using the medicines effectively, safely, reasonably, and in accordance with the purpose of the donation.

9. Organizations and individuals possessing clinical trial test kits may import drugs for serving clinical trials according to the research protocol approved by the Ministry of Health.

10. Organizations and individuals possessing a bioequivalence research outline that has been approved by the specialized technical agency authorized by the Ministry of Health may import drugs for serving bioequivalence research.

11. Merchants permitted to import and export packaging materials directly contacting with drugs.

12. For foreign merchants supplying drugs to Vietnam:

a) Foreign merchants supplying drugs, medicinal materials, drugs from medicinal materials, traditional medicine to Vietnam must be enterprises holding a License for Drug Business Activities in Vietnam;

b) Foreign merchants supplying excipients, packaging materials directly contacting with drugs, and organizations and individuals specified in Clauses 5, 6, 7, 8, and 9 of this Article are not required to be enterprises holding a License for Drug Business Activities in Vietnam;

c) In cases where drugs needed for disease prevention and treatment and raw materials needed for domestic drug production but domestic enterprises holding a License for Drug Business Activities in Vietnam do not supply or supply insufficiently, the Department of Medicines - Ministry of Health shall consider and decide to allow imports from reputable pharmaceutical suppliers worldwide.

Article 4. General Provisions on Importing and Exporting Drugs

1. Quality of imported drugs, packaging materials directly contacting with drugs: Merchants producing, importing, exporting, supplying, entrusting, or receiving entrusted imports of drugs and packaging materials directly contacting with drugs must be responsible for the quality and safety of imported drugs in accordance with the provisions of the Pharmacy Law, the Trade Law, and other current regulations on drug quality management.

2. Expiry date of imported drugs:

a) Finished drugs imported into Vietnam with an expiry date exceeding 24 months must have at least 18 months remaining from the date of arrival at Vietnamese ports. For drugs with an expiry date equal to or less than 24 months, the remaining expiry date must be at least 12 months from the date of arrival at Vietnamese ports;

b) Vaccines and medical products without registration numbers, when imported into Vietnam, must have at least two-thirds of their expiry date remaining from the date of arrival at Vietnamese ports;

c) Vaccines and medical products with valid circulation registration numbers in Vietnam, when imported into Vietnam, must have at least half of their expiry date remaining from the date of arrival at Vietnamese ports;

d) In vitro diagnostic reagents with an expiry date equal to or less than 12 months, when imported into Vietnam, must have at least three months remaining from the date of arrival at Vietnamese ports;

đ) Raw materials for drugs imported into Vietnam, except medicinal materials, must have more than 36 months remaining from the date of arrival at Vietnamese ports. For raw materials with an expiry date equal to or less than 36 months, the date of arrival at Vietnamese ports must not exceed six months from the date of production;

g) Drugs and raw materials for drugs that do not meet the expiry date requirements for drugs stipulated in Points a, b, c, d, đ of this Clause but ensure quality and are necessary for importation to serve treatment needs and domestic drug production needs, the Department of Medicines - Ministry of Health shall consider, decide, and be responsible for allowing imports.

3. Requirements for test certificates: When processing customs clearance procedures, enterprises importing drugs and packaging materials directly contacting with drugs must present the original test certificate issued by the manufacturing facility certifying compliance with quality standards for each imported drug batch to the customs office, except for medicinal materials and drugs specified in Articles 12, 13, 14, 15, 17, and 18 of this Circular. The customs office will retain a copy of the test certificate stamped with the confirmation seal of the importing enterprise.

4. Intellectual property rights over drugs and packaging materials directly contacting with drugs: Merchants producing, importing, exporting, supplying, entrusting, or receiving entrusted imports of drugs and packaging materials directly contacting with drugs must be responsible for the intellectual property rights of such drugs and packaging materials produced, imported, exported, supplied, entrusted, or received entrusted imports by themselves.

5. Inspection and clinical testing of vaccines and medical products containing antibodies imported:

a) For vaccines and medical products containing antibodies used for disease prevention and treatment with registration numbers or without registration numbers in Vietnam, after customs clearance, they must be stored in the warehouse of the enterprise in accordance with regulations and can only be released for use upon receipt of a confirmation letter from the National Institute of Hygiene and Epidemiology confirming that the imported vaccine and antibody-containing serum batches meet quality and safety standards in animal testing.

b) For vaccines and medical products containing antibodies used for disease prevention and treatment without registration numbers imported for national programs and projects, clinical testing must be conducted in accordance with Decision No. 01/2007/QĐ-BYT dated January 11, 2007, of the Minister of Health regarding clinical testing. Specifically, for vaccines and medical products containing antibodies used for disease prevention and treatment without registration numbers but pre-qualified by the World Health Organization (WHO) and widely circulated globally through international organizations regularly cooperating with Vietnam in the health sector such as WHO, UNICEF, etc., and provided as aid to Vietnam, depending on specific circumstances, the Department of Medicines - Ministry of Health requires evidence of cold chain implementation and satisfactory results from field safety testing before allowing their use.

c) For vaccines and medical biological products such as serum containing antibodies imported for disease prevention and treatment in accordance with Articles 13, 14, 15, and 16 of this Circular, if necessary, the Department of Medicine Management under the Ministry of Health will require on-site safety testing on humans, and only after achieving satisfactory results from such on-site safety testing will permission be granted for their use.

6. Imported drug labels: Imported drug labels must comply with the provisions of Decree No. 89/2006/NĐ-CP dated September 30, 2006, issued by the Government regarding product labeling, and the provisions of Circular No. 04/2008/TT-BYT dated May 12, 2008, issued by the Minister of Health regarding drug label instructions, except for the labels of drugs specified in Articles 12, 13, 14, 15, 16, 17, and 18 of this Circular.

7. Declaration and re-declaration of drug prices: The declaration and re-declaration of prices for imported drugs shall be carried out in accordance with the provisions of Joint Circular No. 11/2007/TTLT-BYT-BTC-BCT dated August 31, 2007, issued by the Ministry of Health, Ministry of Finance, and Ministry of Industry and Trade guiding state management over drug prices for human use.

8. Reporting:

a) Within ten days from the date of importation of vaccines and medical biological products such as serum containing antibodies into the warehouse, the importing enterprise must submit an import report for each batch to the Department of Medicine Management under the Ministry of Health and the National Institute of Vaccines and Medical Biological Products (Form No. 1a).

b) Importing enterprises must report to the Department of Medicine Management under the Ministry of Health on the monthly import and export situation of drugs via electronic files to the email [email protected] before the tenth day of the following month; semi-annual reports in writing before July 10th and annual reports before January 10th of the following year (Form Nos. 1b1 to 1b13).

c) For enterprises importing drugs for exhibition, trade fairs, and other temporary imports and re-exports: within ten days after the end of the exhibition, trade fair, or expiration of the temporary import period, they must re-export and submit a written report to the Department of Medicine Management under the Ministry of Health regarding the quantity and re-export situation (Form No. 1c).

9. Fees: Importing enterprises of drugs must pay fees in accordance with Decision No. 44/2005/QĐ-BTC dated July 12, 2005, issued by the Minister of Finance regarding the system of collection, payment, management, and utilization of fees for business trade conditional approval in the health sector, fees for standard and condition assessment of medical practice, fees for issuing import and export permits, and certificates of medical practice; Decision No. 59/2008/QĐ-BTC dated July 21, 2008, amending and supplementing Decision No. 44/2005/QĐ-BTC dated July 12, 2005, issued by the Minister of Finance regarding the system of collection, payment, management, and utilization of fees for business trade conditional approval in the health sector, fees for standard and condition assessment of medical practice, fees for issuing import and export permits, and certificates of medical practice, and other relevant legal documents.

10. Validity period of drug import and export permits: Drug import and export permits are valid for one year from the date of issuance.

11. Legal documents in the drug import dossier:

a) Drug Product Certificate (CPP), Free Sale Certificate (FSC), Good Manufacturing Practice (GMP) certificate, or equivalent certificates for In Vitro diagnostic medical devices may be submitted in original form, copy, or Vietnamese translation from foreign languages but must comply with specific requirements stipulated in sub-clauses b, c, or d of this clause and general regulations as follows:

- In case of submission of original documents: Original documents must bear full signatures, names, positions, clearly stated issue date, and stamps of the competent authority of the country of origin issuing the certificate; they must be legalized at the Vietnamese diplomatic mission according to the laws on legalization of foreign public documents, except for legal documents issued by authorities of countries that have signed mutual legal assistance treaties with Vietnam.

- In case of submission of copies: Copies must be certified as true copies by a competent Vietnamese authority in accordance with Vietnamese laws on certification of true copies.

- In case of submission of Vietnamese translations from foreign languages: Vietnamese translations must be notarized according to the regulations (here, notarization means the signature of the translator must be certified by a local notary office, diplomatic mission, consulate, or other authorized body of the foreign country according to the laws) and must be accompanied by the original or certified copy of the certificate as stipulated above.

- Validity period of certificates: The validity period must be clearly stated on the certificates and remain valid at the time of evaluation; extension letters for these certificates will not be accepted. If the certificate does not specify the validity period, only certificates issued within 24 months from the date of issuance will be accepted.

b) Drug Product Certificates, in addition to complying with the requirements set forth in sub-clause a of this clause, must also meet the following requirements:

- There must be confirmation that the drug is permitted for circulation in the exporting country; if the drug is not circulating in the exporting country, the supplying company must provide an explanation for the Department of Medicine Management under the Ministry of Health to consider.

- In cases where the drug is produced through multiple stages in different countries and cannot be determined as having a single country of origin, the importing entity must submit the CPP of the country producing the final formulation or the CPP of the country shipping the batch. If there is no CPP from both countries mentioned above, the Department of Medicine Management under the Ministry of Health will consider accepting the CPP of the country where the product is transported to the importing country.

- In cases where there is no CPP from the aforementioned countries, only the CPP issued by the competent authority of one of the United Kingdom, France, Germany, the United States, Japan, Australia, Canada, or the European Medicines Agency (EMA) will be accepted.

- Issued by the competent drug management authority (as listed by WHO on the website http://www.who.int) of the exporting country; issued according to WHO's model applicable to the Quality Certification System for pharmaceutical products circulating in international trade.

c) The Free Circulation Certificate, in addition to complying with the provisions set out in point a of this clause, must also comply with the following provisions:

- There must be confirmation that the drug is permitted for circulation in the exporting country; if the drug is not circulating in the exporting country, the supplying company must provide an explanation for the Department of Medicine Management under the Ministry of Health to consider.

- Issued by the competent authority of the exporting country, containing all necessary information about the ingredients, dosage, formulation type, and validity period of the certificate.

d) Certificates of Good Manufacturing Practice for medicines, or other quality management system certificates (such as ISO 9001...), issued by the competent authority of the exporting country, confirming the name and address of the manufacturer.

Article 5. Provisions on Order Placement, Language, and Form of Documentation

1. Import and export orders for drugs and direct contact packaging materials shall be established in three copies according to the appropriate form provided in this Circular for each type of drug. After approval, two copies shall be retained at the Department of Drug Management - Ministry of Health, and one copy shall be sent to the importing/exporting enterprise. The copy sent to the importing/exporting enterprise shall bear the stamp "Copy for Enterprise" for customs procedures. For import and export orders of narcotic, psychotropic, and precursor drugs that have valid registration numbers, they shall be established in two copies.

2. In cases where enterprises act as agents for importing and exporting drugs, the name of the agency importing and exporting enterprise must be clearly stated on the order.

3. Supporting documents accompanying the order must be prepared on A4 paper size, bound into one secure set. Documents must be arranged in accordance with the table of contents, with clear divisions between sections. Each section division must be numbered for easy reference and stamped with the confirmation seal of the importing enterprise on the first page of each section throughout the entire documentation, and include a cover page stating: the name of the importing unit, order number, date of order placement, and type of order.

4. Language used in drug import documentation: Foreign drug import documentation must be written in Vietnamese or English. In cases where documentation is written in English, information in the Drug Usage Instructions must be written in Vietnamese, except for the following content which may be written in other Latin-based languages:

a) Brand name, generic name, or international nonproprietary name of the drug;

b) International nonproprietary name or scientific name of the drug components, quantified components when it cannot be translated into Vietnamese or can be translated but does not make sense in Vietnamese;

c) Name and address of the foreign enterprise producing or holding the production rights for the drug.

5. For finished drugs without an import registration number as stipulated in Article 11 of this Circular, each drug must be established in a separate order, except in cases where drugs share all the following factors and can be imported in the same documentation:

a) Medicine name;

b) Formulation type;

c) Formula for a single dose (for single-dose formulations) or the same concentration (for multi-dose formulations);

d) Manufacturer;

Article 6. Other Provisions

1. Imported drugs circulating in the market must comply with the provisions set out in Clause 1, Article 36 of the Medicine Law.

2. Imported drugs for national health projects, programs, aid, humanitarian aid; imported drugs for clinical trials, sample registration, research work, testing, inspection; imported drugs for exhibition, fair participation must be used for their intended purpose, for the designated target group, and are not allowed to circulate in the market.

3. Drugs received through aid by organizations and individuals specified in Clause 8, Article 3 of this Circular, after acceptance by the receiving unit, must establish a Committee to inventory, evaluate, classify the drugs, and store them for management. Only those drugs that meet quality standards and are within their expiration date may be used for treatment purposes. For drugs that are not permitted to be used, a Committee must be established to carry out destruction in accordance with Circular No. 09/2010/TT-BYT dated April 28, 2010, on Quality Management, ensuring no environmental pollution.

Heads of units receiving drug aid must fully assume responsibility for the quality of the drugs, effective and rational use, and safety.

4. Drug aid and humanitarian aid must meet the following requirements:

a) Must be authorized for circulation in the home country. For vaccines and medical biological products containing antibodies, they must belong to the list of vaccines and medical biological products recommended for use by the World Health Organization;

b) Must meet the actual usage requirements of the recipient unit and Vietnam's national drug policy;

c) Not included in the list of narcotic drugs, raw materials, and finished products prohibited from importation for human use (except in cases of importation for national programs approved by the Government);

d) Must have a clear origin and meet quality standards, safety, and effectiveness for use in both the donor country and Vietnam. Vaccines and medical biological products donated must have a test report meeting the quality standards of the national testing agency of the home country or the competent authority for the imported batch, and must be evaluated for quality by the National Institute of Hygiene and Epidemiology before importation;

đ) Must be packaged in suitable containers, clearly marked with: drug name, active ingredient, dosage, formulation type, packaging specifications, accompanied by drug usage instructions, and detailed lists attached to each package unit;

e) In special cases, drug aid for research programs that do not meet the provisions of points a, b, c, d, and đ of this clause may be considered for acceptance based on relevant legal and technical documents of the research program;

5. Raw medicinal materials used for production, compounding, and prescriptions at traditional medicine manufacturing facilities and traditional medicine clinics serving disease prevention and treatment must meet quality standards and be supplied by facilities with the necessary conditions for drug business operations.

6. Radioactive drugs, in addition to complying with the provisions of this Circular, must also adhere to relevant laws concerning radiation safety.

Chapter II FORMS OF MANAGEMENT FOR IMPORTING AND EXPORTING MEDICINES AND PACKAGES IN DIRECT CONTACT WITH MEDICINES

Article 7. Importing medicines and packages in direct contact with medicines

1. It is prohibited to import finished medicines and raw materials for medicines listed in the Catalogue of Prohibited Finished Medicines and Raw Materials for Medicines for Importation (Annex).

2. Medicines with valid registration numbers, except for addictive substances, psychotropic substances, and precursors used as medicines, may be imported based on demand without the need to apply for an import permit or confirmation of the import order.

3. Medicines and packages in direct contact with medicines that are imported must have an import permit from the Drug Administration Department under the Ministry of Health, including:

a) Addictive substances, psychotropic substances, and precursors used as medicines, including single substances or combinations thereof, which have valid registration numbers;

b) Finished medicines, raw materials for medicines, vaccines, and medical products that do not yet have registration numbers;

c) Packages in direct contact with medicines.

Article 8. Exporting medicines and packages in direct contact with medicines

1. When exporting addictive substances, psychotropic substances, and precursors used as medicines, including single substances or combinations thereof, an export permit from the Drug Administration Department under the Ministry of Health must be obtained.

2. Medicines and packages in direct contact with medicines, except those specified in Clause 1 of this Article, when exported, the exporting entity directly handles procedures with the customs office at the border gate without needing an export permit from the Ministry of Health.

Chapter III DOCUMENTATION, PROCEDURES FOR IMPORTING MEDICINES AND PACKAGES IN DIRECT CONTACT WITH MEDICINES, AND INSPECTION OF IMPORTED MEDICINES

Section I IMPORTING MEDICINES WITH VALID REGISTRATION NUMBERS

Article 9. Addictive substances, psychotropic substances, and precursors used as medicines

1. Documents:

a) Import order (Form No. 2a, 2b);

b) Report on stock of addictive substances (or psychotropic substances, precursors used as medicines) (Form No. 3).

2. Procedures:

The enterprise sends the dossier to the Drug Administration Department under the Ministry of Health. Within fifteen working days from the date of receipt of a complete dossier, the Drug Administration Department under the Ministry of Health issues an import permit. In case of non-issuance of the permit, the Drug Administration Department under the Ministry of Health will notify the enterprise in writing and specify the reasons.

Article 10. Other medicines, excluding those specified in Article 9 of this Circular

The importing enterprise directly handles procedures at the customs office at the border gate and presents to the customs office at the border gate the list of imported medicines (Form No. 4), along with the original or certified true copy of the following documents:

a) Product circulation permit or Decision on issuance of registration number; other documents allowing changes, supplements, corrections (if any);

b) Operating permit for medicines and raw materials for medicines in Vietnam for foreign companies supplying medicines, except for traders specified in point b, c Clause 12 Article 3 of this Circular.

Section II IMPORTING MEDICINES WITHOUT REGISTRATION NUMBERS

Article 11. Finished medicines containing active pharmaceutical ingredients without registration numbers or where such ingredients have registration numbers but do not meet treatment needs, medical products used for disease prevention, treatment, and diagnosis

1. Conditions and quantity of medicines considered for issuance of an import permit: Implemented according to the provisions of Article 7 of Decision No. 151/2007/QĐ-TTg dated September 12, 2007

2. Documents:

a) Import order (Form No. 5a, 5b, 5c, 5d, 5đ);

b) Certificate of product quality. If there is no Certificate of Product Quality, it can be replaced by FSC and GMP. If multiple production facilities are involved in the production process, the importing enterprise must submit GMP certificates of all production facilities involved in the production of the finished product;

c) Quality control standards and methods for medicines;

d) Medicine labels and instructions for use stamped by the importing enterprise, including: one set of original labels and original instructions for use of the medicine currently circulating in the exporting country (excluding vaccines, medical products); two sets of labels intended for circulation in Vietnam with Vietnamese instructions for use;

đ) Stock report for addictive substances, psychotropic substances, and precursors used as medicines (Form No. 3);

e) Preclinical and clinical documentation for medicines containing new active pharmaceutical ingredients, medicines with new combinations of these ingredients in circulation.

3. Procedures:

The enterprise sends the dossier to the Drug Administration Department under the Ministry of Health. Within twenty working days from the date of receipt of a complete dossier, the Drug Administration Department under the Ministry of Health considers issuing an import permit. In case of non-issuance of the permit, the Drug Administration Department under the Ministry of Health will notify the enterprise in writing and specify the reasons.

Article 12. Rare drugs and drugs for hospital treatment needs in special cases

1. Documents:

a) Import order form (Form number 6a);

b) Stockpile of rare drugs and drugs for hospital treatment needs in special cases (Form number 6b);

c) Documents specified in points b, c, d, đ, and e Clause 2 Article 11, except for the following cases:

- Enterprises organizing pharmacy chains that meet the "Good Pharmacy Practice" (GPP) standards need to import rare drugs and imported drugs for hospital treatment needs in special cases to sell at pharmacies within their system that have achieved GPP standards: must provide a document clearly stating the reasons for not being able to provide the file, original test certificates, and commit to ensuring the quality of imported drugs;

- Enterprises importing drugs listed in the rare drug category, imported drugs for hospital treatment needs in special cases, or drugs with active ingredients, concentrations, contents, and formulations not yet registered for circulation in Vietnam but recorded in specialized documents without providing the files stipulated in Clause 2 Article 11 of this Circular and the original test certificate of the imported drug batch: the file must include a document clearly stating the reasons for not being able to provide the imported drug file, the original test certificate of the drug batch, and a commitment to ensure the quality of imported drugs; Drug usage report (usage demand, safety, and therapeutic effectiveness of the drug).

The enterprise sends the file to the Department of Medicine Management - Ministry of Health. Within fifteen working days from the date of receiving the valid file, the Department of Medicine Management - Ministry of Health will consider issuing an import permit. If the permit is not issued, the Department of Medicine Management - Ministry of Health will provide a written response to the enterprise and clearly state the reasons.

Article 13. Vaccines and medical products according to special treatment needs of healthcare facilities, vaccination centers, and testing centers

1. Documents:

a) Import order form (Form number 7a);

b) Stockpile of vaccines and medical products of vaccination centers and testing centers (Form number 7b);

d) Commitment letter from the supplying company regarding the assurance of vaccine and medical product quality provided to Vietnam (Form number 7c);

đ) Attached documents (if any) including: Certificate of production facility meeting Good Manufacturing Practice (GMP) standards or Quality Management System (ISO) certification issued by the competent authority (for In Vitro diagnostic medical devices), Vaccine and Medical Product Circulation Permit, Circulation Permit in other countries where these vaccines and medical products are registered and circulated. In special cases, if the company has not provided all these documents or the vaccines and medical products do not meet the requirements specified in points b, c, and point d Clause 2 Article 4 of this Circular but are necessary for usage needs, the Department of Medicine Management - Ministry of Health will consider and decide.

2. Procedures:

The enterprise sends the file to the Department of Medicine Management - Ministry of Health. Within fifteen working days from the date of receiving the valid file, the Department of Medicine Management - Ministry of Health will consider issuing an import permit and request the submission of the file and samples to the National Institute of Vaccines and Medical Products Inspection when necessary. If the permit is not issued, the Department of Medicine Management - Ministry of Health will provide a written response to the enterprise and clearly state the reasons.

Article 14. Medicines to meet urgent needs for disease prevention and control, disaster relief, and mitigation of natural disasters and catastrophes

1. Documents: Import order form (Form No. 8);

2. Procedures:

The enterprise sends the documents to the Drug Administration under the Ministry of Health. Within five working days from the date of receipt of valid documents, the Drug Administration under the Ministry of Health shall consider issuing an import permit. In case of not issuing the permit, the Drug Administration under the Ministry of Health shall notify the enterprise in writing and specify the reasons.

Article 15. Medicines for national health target programs

1. Documents:

a) Import order form (Form No. 9);

b) Document of the competent authority on the importation of medicines for national health target programs (if necessary, the Drug Administration under the Ministry of Health may request additional documents as stipulated in points b, c, d, and e, Clause 2, Article 11 of this Circular);

c) For vaccines and medical biological products containing antibodies used for disease prevention and treatment, in addition to the documents specified in points a and b, Clause 1 of this Article, the following documents must also be provided:

- Certificate of permission for circulation or export issued by the competent authority of the country of origin for vaccines and medical biological products;

- Certificate of production facility meeting GMP standards;

- Quality test report of the batch of imported vaccines and medical biological products issued by the national inspection agency or another authorized agency of the country of origin (with confirmation of true copy by the importing enterprise);

- Clinical trial results or safety testing results on humans conducted according to point b, Clause 5, Article 4 of this Circular.

d) For vaccines and medical biological products imported based on the tender results of national or international tenders in Vietnam, the documents required under items 1, 2, and 3 of point c, Clause 1 of this Article are not necessarily included in the import application if they have been reviewed during the tender process.

2. Procedures:

a) Medicines of national health target programs must be imported through enterprises with direct import functions. The label of such medicines must bear the phrase "Programmed Medicine Not for Sale."

b) Within fifteen working days from the date of receipt of valid documents, the Drug Administration under the Ministry of Health shall consider issuing an import permit. In case of not issuing the permit, the Drug Administration under the Ministry of Health shall notify the enterprise in writing and specify the reasons.

Article 16. Donated medicines and humanitarian aid medicines

1. Documents:

a) Letter requesting importation from the recipient organization of donated medicines or humanitarian aid medicines;

b) List of donated medicines and humanitarian aid medicines (Form No. 10);

c) Document of the competent authority granting permission for the recipient organization to accept donated medicines or humanitarian aid medicines;

d) For vaccines and medical biological products containing antibodies used for disease prevention and treatment, in addition to the documents specified in points a, b, and c, Clause 1 of this Article, the additional documents required under items 1, 2, and 3 of point c, Clause 1 of Article 15 of this Circular must also be provided.

2. Procedures:

The importing entity sends the documents to the Department of Health in its locality; in cases involving new drug substances, new combinations of drug substances, vaccines, and medical biological products, the importing entity sends the documents to the Drug Administration under the Ministry of Health. Within fifteen working days from the date of receipt of the valid order and documents, the Department of Health or the Drug Administration under the Ministry of Health shall consider issuing an import permit. In case of not issuing the permit, the Department of Health or the Drug Administration under the Ministry of Health shall notify the entity in writing and specify the reasons.

Article 17. Medicines for clinical trials, sample registration, and research, testing, verification, bioequivalence/bioavailability studies

Shall be implemented in accordance with the provisions of Clause 1, 2, and 4 of Article 9 of Decision No. 151/2007/QĐ-TTg dated September 12, 2007

a) Import order (Form No. 11a, 11b, 11c);

b) The clinical trial drug research protocol approved by the Minister of Health for imported drugs for clinical trials;

c) The bioequivalence/bioavailability research protocol approved by the technical agency authorized by the Ministry of Health for imported drugs for bioequivalence/bioavailability research;

d) The approval document of the competent authority allowing the implementation of research projects that have been approved or the request document of the competent authority regarding the import of drugs for testing and verification;

2. Procedures:

The importer sends the application to the Department of Medicine Management - Ministry of Health. Within fifteen working days from the date of receipt of the valid order and application, the Department of Medicine Management - Ministry of Health shall consider issuing an import permit. If the permit is not issued, the Department of Medicine Management - Ministry of Health shall notify the importer in writing and specify the reasons.

Article 18. Medicines for exhibition, trade fairs, and other temporary imports and re-exports

Shall be implemented in accordance with the provisions of Clause 3 of Article 9 of Decision No. 151/2007/QĐ-TTg dated September 12, 2007 of the Government on the importation of medicines without registration numbers in Vietnam and the provisions of Article 12 of Decree No. 12/2006/NĐ-CP dated January 23, 2006 of the Government detailing the implementation of the Law on Trade concerning international trade activities and foreign goods brokerage, purchase, sale, processing, and transit

Article 19. Raw materials for medicines, medicinal herbs without circulation registration numbers, and direct contact pharmaceutical packaging

1. Documents:

a) Import order (Form No. 12a, 12b, 12c, 12d);

b) Quality standard and testing method for raw materials, medicinal herbs, and direct contact pharmaceutical packaging, if there are quality standards and testing methods provided by the manufacturer, or a copy of the pharmacopoeia quality standard if the raw material does not apply the European, British, American, International, or Japanese pharmacopoeia quality standards;

c) For raw materials for medicines that are narcotic drugs, psychotropic substances, or precursor substances, a stock report (Form No. 3) must be submitted.

2. Procedures:

The enterprise submits the application to the Department of Medicine Management - Ministry of Health. Within seven working days from the date of receipt of the valid application, the Department of Medicine Management - Ministry of Health shall consider issuing an import permit.

For raw materials for medicines that are narcotic drugs, psychotropic substances, or precursor substances, within fifteen working days from the date of receipt of the valid application, the Department of Medicine Management - Ministry of Health shall consider issuing an import permit.

If the permit is not issued, the Department of Medicine Management - Ministry of Health shall notify the enterprise in writing and specify the reasons.

Article 20. Radioactive Drugs

1. For radioactive drugs in cases exempted from declaration and licensing: shall be implemented in accordance with the provisions of Article 11 of this Circular.

2. For radioactive drugs in cases not exempted from declaration and licensing: shall be implemented in accordance with the provisions of Article 11 of this Circular and accompanied by a Radiation Work Permit issued by the competent authority to the business directly trading in radioactive drugs.

Chapter III INSPECTION OF IMPORTED DRUGS

Article 21. Vaccines and medical biological products containing antibodies

1. Documents:

a) Sample submission form for inspection;

b) Summary production and inspection file of the imported batch of vaccines and medical biological products (a copy stamped with confirmation seal of the manufacturer);

c) Certificate of release for distribution issued by the authorized agency of the exporting country or equivalent agency attached to each imported consignment (a copy stamped with confirmation seal of the Importing Business Director);

d) Evidence ensuring cold chain during transportation of the imported consignment.

e) Imported samples of vaccines and medical biological products containing antibodies for inspection (the number of samples according to regulations for each type of vaccine and medical biological product).

2. Procedures:

The importing business sends the dossier to the National Institute for Vaccine and Medical Biological Product Control. Within seven working days from the date of receipt of all samples and documents as prescribed, the National Institute for Vaccine and Medical Biological Product Control will reply in writing on the quality of vaccines and medical biological products and their safety on experimental animals to the business.

Chapter IV Dossier and Procedures for Exporting Drugs and Direct Contact Packaging Materials

Article 22. Narcotic Drugs, Psychotropic Substances, and Precursors

1. Documents:

a) Export Order (Form No. 13a, 13b);

c) Finished narcotic drug products combined as specified in Clause 2 of Article 1 of Circular No. 10/2010/TT-BYT dated April 29, 2010 guiding activities related to narcotic drugs; finished psychotropic substance and precursor products combined as specified in Clause 2 of Article 1 of Circular No. 11/2010/TT-BYT dated April 29, 2010 guiding activities related to psychotropic substances and precursors used for export as samples for registration, trade fairs, exhibitions, and non-mandatory research do not necessarily require a dossier as stipulated in Point b, Clause 1 of this Article but must have a document explaining clearly the reasons and purpose of exporting the drug by the exporting business;

2. Procedures:

Within fifteen working days from the date of receipt of valid orders and dossiers, the Drug Administration Department - Ministry of Health will consider issuing an export permit. In case of refusal to issue a permit, the Drug Administration Department - Ministry of Health will notify the business in writing and specify the reasons.

Article 23. Other Drugs Not Being Narcotic Drugs, Psychotropic Substances, and Precursors Used in Single Form or Combined Form, and Direct Contact Packaging Materials

Domestic-produced drugs are granted a Free Sale Certificate (FSC) or a Pharmaceutical Product Certificate (CPP) for export. The quantity of FSCs and CPPs granted is based on the requirements of the entity.

1. Documents:

Application for issuance of FSC or CPP (Form No. 14); If the importing country requires the entity to submit FSC or CPP according to its own model, the Drug Administration Department - Ministry of Health may consider issuing FSC based on the required model.

2. Procedures:

a) Reissuance procedure for FSC as prescribed in Article 13 of Decision No. 10/2010/QĐ-TTg dated February 10, 2010 of

b) Exporting entities do not need to additionally register a trader dossier to obtain FSC.

c) Within five working days from the date of receipt of valid dossiers, the Drug Administration Department - Ministry of Health will issue FSC or CPP (Form No. 15a, 15b).

Chapter V SANCTIONS FOR VIOLATIONS

Article 24. Handling of violations

1. In cases where enterprises exporting or importing engage in acts of forgery or擅自修改或伪造越南或外国主管机关的文件、资料、法律文件；使用假印章或者伪造进口单位、生产单位及其他相关单位在进出口药品文件上的签字或印章，则国家卫生部药物管理局将向该单位发出警告信，并停止受理和审查其药品进出口文件，具体如下：

a) Stop accepting and reviewing the export and import drug application files of the entity for a period of three months for the first violation;

b) Stop accepting and reviewing the export and import drug application files of the entity for six to twelve months for two violations within twelve months;

c) Depending on the severity of the violation, the National Medicines Administration of the Ministry of Health will send a letter to the manufacturing company and the supplying company, and stop accepting and reviewing drug registration applications or stop accepting and reviewing applications for drug and pharmaceutical raw material activities in Vietnam from foreign companies. In addition to the above measures, the National Medicines Administration of the Ministry of Health will publicly disclose the content of the violation on the Ministry of Health's electronic information website; notify the inspection agency, customs agency, and other competent authorities to consider and handle according to the provisions of the law.

2. Agencies, organizations, and individuals who violate the law will be stopped from having their export and import drug application files accepted and reviewed, or they will be subject to administrative penalties or criminal liability追究刑事责任，视情节轻重而定。

Chapter VI IMPLEMENTATION PROVISIONS

Article 25. Effective Date

This Circular shall take effect forty-five days from the date of signature. The Circular No. 06/2006/TT-BYT dated May 16, 2006 of the Ministry of Health guiding the export and import of drugs and cosmetics; the Circular No. 13/1998/TT-BYT dated October 15, 1998 of the Ministry of Health guiding the acceptance, management, and use of foreign aid medicines in Vietnam; the provisions on the import of vaccines and medical products at Circular No. 08/2006/TT-BYT dated June 13, 2006 of the Ministry of Health guiding the import of vaccines and medical products; chemicals, insecticides, bactericides used in household and medical fields, and medical equipment are hereby abolished. During implementation, if there are difficulties or obstacles, units are requested to report to the National Medicines Administration of the Ministry of Health for consideration and resolution.

During implementation, if there are difficulties or obstacles, units are requested to report to the National Medicines Administration of the Ministry of Health for consideration and resolution./.