Circular No. 06/2006/TT-BYT guiding the export and import of medicines and cosmetics

CIRCULAR

Guidelines for the export and import of medicines and cosmetics

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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;

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

Pursuant to the Decree No. 12/2006/NĐ-CP dated January 23, 2006 of the Government detailing the implementation of the Law on Trade regarding international trade activities and agency buying, selling, processing, and transiting goods with foreign countries;

Pursuant to the Decree No. 49/2003/NĐ-CP dated May 15, 2003 of the Government on the functions, tasks, powers, and organizational structure of the Ministry of Health;

The Ministry of Health issues guidelines for the export and import of medicines and cosmetics as follows:

This technical regulation sets out technical requirements, testing methods, sampling procedures; management requirements; responsibilities of organizations and individuals producing, trading, and importing cigarettes.

Thông tư này quy định chi tiết khoản 4 Điều 38 Luật Thủy sản số 18/2017/QH14 đã được sửa đổi, bổ sung tại điểm c khoản 21 Điều 14 Luật số 146/2025/QH15.

1.1. This Circular regulates the export and import activities of medicines for human disease prevention and treatment (referred to as medicines), including finished medicines, raw materials for medicines (active pharmaceutical ingredients, herbal medicines, excipients, medicine capsules, and direct contact packaging materials with medicines), and cosmetics that directly affect human health under the management of the Ministry of Health (referred to as cosmetics).

1.2. For the import of finished medicines without registration numbers and new raw materials for medicines not yet used in Vietnam (excluding addictive drugs, psychotropic drugs, and precursors used as medicines), the Ministry of Health will provide guidance in separate documents.

1.3. Humanitarian aid medicines; temporarily imported and re-exported, temporarily exported and re-imported, and transshipped medicines; medicines imported and exported through non-commercial channels; and vaccines are not within the scope of regulation of this Circular.

2. Scope of Application

This Circular applies to Vietnamese traders; other organizations and individuals involved in the export and import of medicines and cosmetics.

3. Rights to Engage in Export and Import of Medicines and Cosmetics

3.1. For Vietnamese enterprises without foreign direct investment, including:

a) Enterprises holding a certificate of qualification for medicine business and having a warehouse meeting the Good Storage Practice (GSP) standard may directly import medicines and accept consignment imports of medicines.

b) Enterprises currently importing medicines directly before the effective date of this Circular but lacking a certificate of qualification for medicine business and a warehouse meeting the GSP standard must continue to import medicines directly while urgently completing procedures to obtain from the Ministry of Health a certificate of qualification for medicine business and implementing the principles of Good Storage Practice according to Decision No. 19/2005/QĐ-BYT dated July 5, 2005 of the Minister of Health on adjusting the plan for implementing the principles and standards of "Good Manufacturing Practice for Medicines" issued together with Decision No. 3886/2004/QĐ-BYT dated November 3, 2004 of the Minister of Health on implementing the principles and standards of "Good Manufacturing Practice for Medicines" recommended by the World Health Organization and "Good Storage Practice for Medicines" issued together with Decision No. 2701/2001/QĐ-BYT dated June 29, 2001 of the Minister of Health on implementing the principles of "Good Storage Practice for Medicines."

c) Medicine manufacturing enterprises holding a certificate of qualification for Good Manufacturing Practice (GMP) may import raw materials for medicines to produce their own medicines.

3.2. For enterprises with foreign direct investment in Vietnam, including:

a) Foreign-invested medicine manufacturing enterprises holding a certificate of qualification for medicine business may directly import and consign the import of raw materials for medicines to produce medicines in accordance with the provisions of the investment license.

b) Foreign-invested enterprises (except those specified in point a of Article 3.2 above) are not allowed to directly import and distribute medicines in Vietnam, except through Vietnamese enterprises with the function of exporting, importing, and distributing medicines (unless otherwise provided by Vietnamese law).

3.3. Traders are permitted to export and consign the export of medicines (except addictive drugs, psychotropic drugs, and precursors used for export, which require a permit from the Ministry of Health).

3.4. Traders are permitted to consign the import of medicines (except those prohibited from importation) within the scope defined in the certificate of qualification for medicine business.

3.5. Traders are permitted to export and import cosmetics regardless of registered business operations.

3.6. Organizations and individuals who are not traders, based on contracts signed in accordance with the law, may consign the export and import of medicines for their own use (except medicines prohibited from importation and temporarily suspended from export).

3.7. Regarding foreign companies supplying imported medicines to Vietnam:

a) Foreign companies holding a license for medicine and raw material business in Vietnam may supply finished medicines and raw materials to Vietnamese enterprises importing medicines within the scope defined in the license.

In cases where rare medicines needed for treatment or raw materials needed for production are not supplied by licensed companies, the Ministry of Health will consider importing from reputable companies worldwide.

For imported herbal medicines, excipients, medicine capsules, and direct contact packaging materials with medicines, foreign companies supplying them are not required to have a license for medicine and raw material business in Vietnam.

b) Foreign companies holding a license for medicine and raw material business in Vietnam may supply finished medicines and raw materials with registration numbers produced by the company itself to Vietnamese enterprises named in the registration or to Vietnamese enterprises importing directly with qualifications as stipulated in this Circular.

4. General Conditions for Exporting and Importing Medicines and Cosmetics

4. 1. Exporting, importing narcotic drugs, psychotropic substances, and precursor chemicals for medicinal purposes must be carried out in accordance with the following regulations:

a) The Narcotic Drug Management Regulation issued together with Decision No. 2033/1999/QĐ-BYT dated July 9, 1999, of the Minister of Health, and Decision No. 1442/2002/QĐ-BYT dated April 25, 2002, of the Minister of Health regarding the supplementation of certain articles of the Narcotic Drug Management Regulation issued together with Decision No. 2033/1999/QĐ-BYT dated July 9, 1999;

b) The Psychotropic Substance Management Regulation issued together with Decision No. 3047/2001/QĐ-BYT dated July 12, 2001, and Decision No. 1443/2002/QĐ-BYT dated April 25, 2002, of the Minister of Health regarding the amendment and supplementation of certain articles of the Psychotropic Substance Management Regulation issued together with Decision No. 3047/2001/QĐ-BYT dated July 12, 2001; Decision No. 71/2004/QĐ-BYT dated January 9, 2004, of the Minister of Health regarding the supplementation of certain substances into the List of Psychotropic Substances and Precursors of the Psychotropic Substance Management Regulation issued together with Decision No. 3047/2001/QĐ-BYT dated July 12, 2001;

c) The provisions of this Circular and other relevant laws.

4. 2. Quality of imported medicines and cosmetics

Merchants producing, exporting, and importing medicines and cosmetics; merchants entrusting or accepting entrustment to export and import medicines and cosmetics shall be responsible for the quality of exported and imported medicines and cosmetics according to the provisions of the Medicine Law, the Trade Law, the Quality Control Regulation for Medicines issued together with Decision No. 2412/1998/QĐ-BYT dated September 15, 1998, of the Minister of Health, and other relevant laws.

4. 3. Expiry date of medicines

a) Finished products of medicines imported into Vietnam must have at least 18 months remaining from the date of arrival at the Vietnamese port. For medicines with an expiry period of 24 months or less, the remaining expiry period from the date of arrival at the Vietnamese port must be at least 12 months. In special cases, the Ministry of Health will consider and resolve specifically.

b) Raw materials imported for the production of medicines must have more than three years remaining from the date of arrival at the Vietnamese port. For raw materials with an expiry period of three years or less, the date of arrival at the Vietnamese port must not exceed six months from the date of production. This provision does not apply to herbal medicines.

4. 4. Original test report

When processing customs clearance procedures, enterprises importing medicines and cosmetics must present the original test report from the manufacturer certifying compliance with quality standards for each batch of imported medicines or cosmetics to the customs office. The customs office will only retain a copy of the original test report stamped with confirmation by the importing enterprise.

4. 5. Intellectual property rights of imported medicines and cosmetics

Merchants producing, exporting, and importing medicines and cosmetics; merchants entrusting or accepting entrustment to export and import medicines and cosmetics shall be responsible for the intellectual property rights of medicines and cosmetics produced, exported, and imported by themselves and those entrusted to export and import.

4. 6. Order placement and documentation

Export and import orders for medicines and cosmetics shall be established in three copies according to the model prescribed in this Circular (For finished narcotic drugs, psychotropic substances, and precursors for medicinal purposes without an import registration number, each drug must be established in a separate order). After approval, two copies shall be kept at the Directorate of Pharmaceutical Administration, and one copy shall be sent to the enterprise. The copy sent to the enterprise shall be stamped "Copy for Enterprise" to be presented to the customs office when processing customs clearance procedures.

Documentation and accompanying files attached to the order must be bound securely, with a cover page clearly stating: name of the importing enterprise, order number, date of order placement, type of order.

4. 7. Labels of exported and imported medicines and cosmetics.

Follow the provisions strictly set forth in the Labeling Regulation for Domestic Circulation Goods and Exported and Imported Goods issued together with Decision No. 178/1999/QĐ-TTg dated August 30, 1999, of the Prime Minister, Decision No. 95/2000/QĐ-TTg dated August 15, 2000, of the Prime Minister regarding the adjustment and supplementation of certain contents of the Labeling Regulation for Domestic Circulation Goods and Exported and Imported Goods issued together with Decision No. 178/1999/QĐ-TTg dated August 30, 1999, Circular No. 14/2001/TT-BYT dated June 26, 2001, of the Ministry of Health guiding labeling of medicines and cosmetics directly affecting human health, and other related legal documents.

a) The secondary label of medicines may be printed directly or affixed on the outer packaging of the medicine by the manufacturer.

b) If the manufacturer has not printed or affixed the secondary label on the outer packaging of the medicine, the medicine must be imported into the warehouse of the importing enterprise to print or affix the secondary label before being put into circulation.

In the case of a merchant entrusting the importation, the secondary label must be printed or affixed at the warehouse of the importing enterprise or the merchant entrusting the importation.

c) The secondary label must not obscure information on the outer packaging of the medicine and must ensure the following contents:

- For medicines that already have an import registration number, the secondary label must include all the following information: full name and address (province, city) of the importing enterprise and the entrusted importing merchant (if any).

Example 1:

- For narcotic drugs, psychotropic substances, and precursors for medicinal purposes without an import registration number, the secondary label must include all the following information: full name and address (province, city) of the importing enterprise and the entrusted importing merchant (if any); number and date of issuance of the import permit. Example 2: DNNK: Name of the importing enterprise, address Import Permit No.: .../QLD-... Date ...

Example 2:

4.8. Declaration of medicine prices

a) Enterprises importing medicines

For drugs without an import registration number, the importing enterprise must submit an import order form and a price declaration form for each imported drug item, depending on whether it is wholesale or retail trade, including: the import price to Vietnam (CIF price excluding import tax); the wholesale price in Vietnam, and the estimated retail price in Vietnam (Form No. 1). The drug prices must be declared in Vietnamese Dong (VND) for the smallest unit of packaging.

For finished drugs that already have a registration number, if there is a change in price compared to the previously declared price at the time of registration, the importing enterprise must re-declare this information to the Ministry of Health in accordance with regulations.

b) Entrusted Importer of Drugs

Must provide complete and accurate information about the drug prices from foreign partners (foreign manufacturing enterprises or exporting enterprises) to the entrusted importing enterprise.

4.9. Reporting

Each month, the importing enterprise must report to the Ministry of Health (Vietnam National Drug Administration, Department of Planning and Finance) the situation of drug imports and exports of the previous month (Forms No. 2a, 2b, 2c, 2d, 2e). The deadline for submitting the report is before the 10th day of each month.

4.10. Fees and Charges

The importing enterprise of drugs and cosmetics must pay fees and charges as prescribed by law.

4.11. Validity Period of Import Permit

The import permit has a maximum validity period of one year from the date of issuance.

II. LIST AND FORMS OF MANAGEMENT FOR EXPORTING AND IMPORTING DRUGS AND COSMETICS

1. Exporting Drugs

1.1. Narcotic drugs, psychotropic substances, and precursor chemicals used in drugs (Annex No. 1) must have an export permit issued by the Ministry of Health when exported.

1.2. Exporting drugs (excluding those specified in point 1.1 above) shall be carried out at customs offices according to current regulations. In cases where the importing country requires an export permit, the Ministry of Health will issue an export permit upon request of the enterprise.

2. Exporting and Importing Cosmetics

2.1. Exporting cosmetics shall be carried out at customs offices according to current regulations. In cases where the importing country requires an export permit, the Ministry of Health will issue an export permit upon request of the enterprise.

2.2. Cosmetics directly affecting human health, which have been registered for circulation by the Ministry of Health, can be imported based on demand.

3. Importing Drugs

3.1. Prohibited raw materials and finished drugs: Annex No. 2.

3.2. Finished drugs and raw materials for drugs imported based on demand do not require confirmation of import orders: This includes finished drugs and raw materials for drugs (excluding narcotic drugs, psychotropic substances, and precursor chemicals used in drugs) that still have valid registration numbers. Specific lists are published by the Vietnam National Drug Administration at different stages.

3.3. Drugs requiring an import permit from the Ministry of Health:

a) Finished drugs containing narcotic substances, psychotropic substances, or precursor chemicals used in drugs, either with or without a registration number, whether as single substances or combinations.

b) Raw materials for drugs that have a registration number as narcotic drugs, psychotropic substances, or precursor chemicals used in drugs.

c) Raw materials for drugs without a registration number (including raw materials that are narcotic drugs, psychotropic substances, or precursor chemicals used in drugs).

III. DOCUMENTATION AND PROCEDURES FOR IMPORTING DRUGS AND COSMETICS

1. Importing Drugs with Valid Registration Numbers for Circulation

1.1. Narcotic Drugs, Psychotropic Substances, and Precursor Chemicals Used in Drugs

The importing enterprise must prepare an import order requesting an import permit (Form Nos. 3a, 3b, 8d) along with a stock report (Form No. 4).

Within seven working days from receiving a valid application and documentation, the Ministry of Health will issue an import permit. If the permit is not granted, the enterprise must be notified in writing with the reasons stated.

1.2. Other Drugs (excluding those specified in point 1.1 above)

The importing enterprise must handle the procedures directly at the border customs office and submit the import order (Form No. 5) along with the following documents:

- Product circulation permit or Decision granting registration number for circulation; other documents allowing changes, additions, or corrections (if applicable).

- Certificate of operation regarding drugs and raw materials for drugs in Vietnam issued by the foreign company supplying the drugs.

2. Importing Finished Drugs Containing Narcotic Substances, Psychotropic Substances, and Precursor Chemicals Used in Drugs Without a Registration Number for Circulation

2.1. Conditions

The Ministry of Health will consider issuing an import permit if one of the following conditions is met:

a) Drugs containing active ingredients belonging to therapeutic groups or dosage forms with few registration numbers for circulation in Vietnam based on the list of drugs with registration numbers for circulation published by the Vietnam National Drug Administration at different stages;

b) Drugs containing active ingredients that do not have registration numbers in Vietnam:

- Active ingredients that had registration numbers for circulation in Vietnam but whose registration numbers expired or were not renewed at the time of submitting the import application;

- Active ingredients that have been circulating worldwide but have never been registered in Vietnam, except for new active ingredients;

c) Rare drugs, specialty drugs, and drugs with special formulations to meet treatment needs;

d) Drugs under technology transfer contracts or production licensing agreements that have submitted registration applications and are awaiting registration numbers;

e) Drugs imported for specific hospital treatment needs (must include hospital forecasts according to prescribed forms and commitments from the hospital director) and can only be supplied to hospitals according to these forecasts.

f) Foreign-invested manufacturing enterprises may be considered for import permits to market their products during the production implementation period as stipulated by the Ministry of Trade and the Ministry of Health.

2.2. Import Documentation

The importing enterprise must prepare an import order requesting an import permit (Form No. 6) along with related documents to be submitted to the Ministry of Health (Vietnam National Drug Administration). The documentation includes:

a) A Drug Product Certificate (DPC) according to the World Health Organization's quality certification system issued by the competent authority of the country of origin. In the absence of a Drug Product Certificate, a Free Sale Certificate (FSC) of the product and Good Manufacturing Practice (GMP) certificate of the manufacturing plant issued by the competent authority of the country of origin can be substituted.

These certificates must be original or certified copies in Vietnam or the country of origin.

b) Quality standards and testing methods for the drug.

c) Two sets of drug label samples (including: outer label, intermediate label, direct label) and the user guide with the seal of the importing enterprise, specifically:

- The original label sample of the drug currently circulating in the country of origin. In cases where the language on the original label of the drug is not English or French, a design label for importation into Vietnam must be submitted, with the language on the label translated into English or Vietnamese.

- User guide (one original copy, one Vietnamese version). For herbal drugs and traditional Chinese medicine, the Vietnamese user guide must fully list all components of the drug, and the names of medicinal ingredients must be written in both Vietnamese and Latin.

d) Price declaration form for imported drugs (Form No. 1).

e) Inventory report (Form No. 4).

f) For active pharmaceutical ingredients that have been circulated worldwide but have not yet obtained registration numbers in Vietnam, additional documentation regarding pharmacological effects and clinical studies must be submitted.

g) For drugs imported based on special hospital needs:

- Establish a separate order (according to Form No. 6) and clearly state that it is an order for importing drugs based on special hospital needs.

- Hospital budget estimate (Form No. 7).

- A commitment letter from the hospital director stating that the drugs will only be used within the hospital according to the budget estimate.

- All documents specified in items a, b, c, d, e, f, point 2.2 above. In exceptional cases, if the hospital needs to use drugs containing active ingredients, concentrations, quantities, and formulations that do not have registration numbers for circulation in Vietnam but are recorded in professional literature and the importing enterprise cannot provide the required documents as specified in items a, b, c, d, e, f, point 2.2 above, the following documents must be submitted:

+ A document from the enterprise requesting permission to import drugs to meet the hospital's special treatment needs, explaining the reasons why the required documents for imported drugs cannot be provided, and committing to the quality of the imported drugs.

+ A report on drug usage (usage requirements, safety, and effectiveness of treatment) and a commitment from the hospital director to responsibly accept and use the drugs rationally and safely.

2.3. Licensing Procedure

Within twenty working days from the date of receipt of the order and valid documents, the Ministry of Health will review and issue an import permit. In case of refusal to issue a permit, a written response must be provided to the enterprise, clearly stating the reasons.

3. Importing Raw Materials for Drugs Without Registration Numbers for Circulation

3.1. Import Documents

The importing enterprise submits an order requesting an import permit along with relevant documents to the Ministry of Health (Vietnam National Medicines Administration). The documents include:

a) Import Order (Form No. 8a, 8b, 8c, 8d)

b) Quality standards and testing methods for raw materials with quality standards and testing methods from the manufacturer, confirmed by the seal of the importing enterprise. This requirement does not apply to herbal medicines.

c) For raw materials used to produce narcotic drugs, psychotropic substances, and precursor chemicals, an inventory report (Form No. 4) must also be submitted.

3.2. Licensing Procedure

Within seven working days from the date of receipt of the order and valid documents, the Ministry of Health will review and issue an import permit. In case of refusal to issue a permit, a written response must be provided to the enterprise, clearly stating the reasons.

4. Importing Drugs and Cosmetics in Special Cases

4.1. Importing Drugs for Epidemic Prevention and Disaster Relief

In cases of refusal, the State Bank will issue a document refusing approval to use foreign currency within the territory and clearly state the reasons.

a) Import Order for Drugs (Form No. 9).

b) A document requesting the importation of drugs for epidemic prevention and disaster relief, confirmed by the competent health management authority.

4.2. Importing Drugs for National Health Programs and Projects

In cases of refusal, the State Bank will issue a document refusing approval to use foreign currency within the territory and clearly state the reasons.

a) Import Order (Form No. 10).

b) Supporting documents: legal documents related to the importation of drugs for national health programs and projects.

c) Drugs for national health programs and projects must be imported through enterprises authorized to directly import drugs. On the drug labels, there must be a line stating "National Health Program Drug" or "National Health Project Drug".

4.3. Importing Drugs and Cosmetics for Registration Samples

In cases of refusal, the State Bank will issue a document refusing approval to use foreign currency within the territory and clearly state the reasons.

a) Import Order: (Form No. 11a, 11b).

b) Each finished drug or cosmetic product imported should not exceed five units of packaging suitable for the intended registration sample.

c) Raw materials for drugs can be imported in one package, with each package sufficient for three test runs appropriate to each type of raw material.

4.4. Importing Drugs for Testing and Research Production

In cases of refusal, the State Bank will issue a document refusing approval to use foreign currency within the territory and clearly state the reasons.

a) Import Order (Form No. 12).

b) The Ministry of Health will consider the specific quantity suitable for the purpose of importation.

IV. DOCUMENTS AND PROCEDURES FOR EXPORTING DRUGS AND COSMETICS

1. Exporting Narcotic Drugs, Psychotropic Substances, and Precursor Chemicals Used in Drugs:

1.1. Narcotic Drugs, Psychotropic Substances, and Precursor Chemicals Used in Drugs Registered as Single Ingredients or Combinations

In cases of refusal, the State Bank will issue a document refusing approval to use foreign currency within the territory and clearly state the reasons.

a) Export Order (Form No. 13).

b) Permit for Import issued by the competent authority of the importing country.

1.2. Narcotic Drugs, Psychotropic Substances, and Precursor Chemicals Used in Drugs Not Registered as Single Ingredients or Combinations

In cases of refusal, the State Bank will issue a document refusing approval to use foreign currency within the territory and clearly state the reasons.

a) Export Order (Form No. 13).

b) Permit for Import issued by the competent authority of the importing country.

c) A commitment from the enterprise to comply with the export contract and not circulate products without a registration number issued by the Ministry of Health. The enterprise director is responsible for the quality and intellectual property rights of exported drugs.

2. Other Drugs (excluding narcotic drugs, psychotropic substances, and precursor chemicals used in drugs) and Cosmetics

Export procedures are carried out at customs authorities according to current regulations. In cases where the importing country requests and the exporting enterprise proposes, the export of drugs and cosmetics shall be conducted as follows:

2.1 Exporting Drugs

a) Export List (Form No. 14).

b) Supporting documents as specified in item c, point 1.2, section 1, part IV of this Circular.

2.2 Exporting Cosmetics

Export Order (Form No. 15).

3. Licensing Procedure

Within seven working days from the date of receipt of the order and valid documents, the Ministry of Health will issue an export permit upon request of the enterprise. In case of refusal to issue an export permit, a written response must be provided to the enterprise, clearly stating the reasons.

V. IMPLEMENTATION AND HANDLING OF VIOLATIONS

1. The Vietnam National Medicines Administration shall within its scope and authority receive applications, review, and issue import permits and export permits for medicines and cosmetics.

2. The Inspectorate of the Ministry of Health shall cooperate with relevant departments and administrations under the Ministry of Health to inspect, audit, and handle violations concerning medicine prices and import and export activities of medicines and cosmetics throughout the country according to the provisions of the law.

3. The Health Service Inspectorates of provinces and centrally governed cities shall be responsible for organizing inspections, audits, and handling violations concerning medicine prices and import and export activities of medicines and cosmetics within their respective jurisdictions.

4. Enterprises participating in the import and export activities of medicines and cosmetics that violate the provisions of this Circular shall be subject to administrative penalties or the Ministry of Health may consider suspending the issuance of export and import permits for a period of six months to one year, or they may be held criminally liable according to the law if they cause damage, which must be compensated according to the relevant laws.

VI. IMPLEMENTATION PROVISIONS

1. Import orders for medicines and medicinal ingredients without registration numbers that have been granted import permits by the Ministry of Health (Vietnam National Medicines Administration) from January 1, 2006, with validity until April 30, 2006, shall be extended until September 30, 2006.

2. Lists of medicines with import registration numbers confirmed by the Ministry of Health (Vietnam National Medicines Administration) during the period from January 1, 2006, to April 30, 2006, and valid until April 30, 2006, shall be extended as follows:

- Extended until September 30, 2006, for medicines whose registration number validity extends beyond September 30, 2006.

- Extended until the expiration date of the registration number for medicines whose registration number validity falls between the effective date of this Circular and September 30, 2006.

3. This Circular shall take effect fifteen days after its publication in the Official Gazette and shall repeal any previous regulations inconsistent with this Circular.

4. The Vietnam National Medicines Administration, subordinate units of the Ministry of Health, Health Services of provinces and centrally governed cities, the Vietnam Pharmaceutical Corporation, enterprises exporting and importing medicines and cosmetics, foreign companies with operating licenses in the pharmaceutical sector, treatment facilities, and drug testing institutions shall be responsible for implementing this Circular.

In the course of implementation, if there are difficulties or obstacles, the relevant units are requested to report to the Ministry of Health (Vietnam National Medicines Administration) for consideration and resolution./.