Circular No. 39/2013/TT-BYT on the management of medicines for human treatment through non-trade export and import

CIRCULAR

Article 24Regulations on managing medicines for human treatment through export and non-commercial import.

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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 Government Decree No. 58/2003/NĐ-CP dated May 29, 2003 on controlling import, export, and transit of narcotics, precursor chemicals, addictive drugs, and psychotropic substances through Vietnam's territory;

This Circular prescribes procedures for receiving, providing health care for domestic violence victims and statistical reports on domestic violence victims at medical facilities.

Pursuant to the Prime Minister's Decision No. 42/2013/QĐ-TTg dated July 15, 2013 on managing medicines for human use through export and non-commercial import, and amending and supplementing certain provisions of the regulations on importing medicines not yet registered in Vietnam issued together with the Prime Minister's Decision No. 151/2007/QĐ-TTg dated September 12, 2007;

At the proposal of the Director of the Drug Administration Department,

The Minister of Health issues this Circular to regulate the management of medicines for human treatment through export and non-commercial import.

Article 1. Scope of Regulation

1. This Circular regulates activities related to the export and import of medicines for human use (hereinafter referred to as "medicines") through non-commercial channels.

2. Medicines for human treatment through export and non-commercial import regulated by this Circular include:

a) Medicines given as gifts from organizations and individuals in Vietnam to organizations and individuals abroad; and from organizations and individuals abroad to organizations and individuals in Vietnam;

b) Medicines belonging to diplomatic agencies, international organizations in Vietnam, or diplomatic agencies and organizations of Vietnam abroad and their staff. In cases where customs procedures are exempted or waived, such actions shall be carried out in accordance with international conventions to which Vietnam is a member.

c) Medicines included in personal luggage of persons exiting or entering the country sent under a transport document, or carried personally by persons exiting or entering the country.

3. Other forms of non-commercial export and import of medicines (export and import of samples for registration, samples and reference materials for testing and research, aid medicines, humanitarian aid) are not within the scope of regulation of this Circular.

Article 2. General Provisions on Medicines Exported and Imported Through Non-Commercial Channels

1. Medicines exported and imported through non-commercial channels are only for the treatment of the individual and his/her family who request the export and import of medicines through non-commercial channels, or for individuals working in organizations that request the export and import of non-commercial medicines. Medicines imported through non-commercial channels may not be sold on the market or used for any other illegal purposes.

2. Individuals and organizations requesting the export and import of medicines through non-commercial channels are responsible for the origin and quality of the medicines they export and import.

3. Medicines exported and imported through non-commercial channels must have labels clearly stating the name of the medicine, active ingredient, concentration, dosage, and expiration date.

4. In addition to complying with the provisions of this Circular, persons exiting the country must also comply with the laws of the country of entry.

Article 3. Medicines Prohibited from Export and Import Through Non-Commercial Channels

1. Raw materials for medicines.

2. Types of medicines containing active ingredients listed in the Catalogue of Active Ingredients Prohibited from Export and Import for Medicinal Purposes as stipulated in the Circular No. 47/2010/TT-BYT dated December 21, 2010 of the Minister of Health guiding the operation of exporting and importing medicines, and subsequent amendments and supplements, as well as notifications from the Ministry of Health regarding cessation of use and import.

Article 4. Quota for export and non-commercial import of drugs

1. The quantity of finished narcotic drugs carried by individuals when exiting or entering the country shall not exceed the amount stated on the prescription accompanying them and shall not exceed the amount prescribed for use within seven days.

2. The quantity of finished psychotropic drugs and precursor substances imported through non-commercial channels shall not exceed the amount stated on the prescription accompanying them and shall not exceed the amount prescribed for use within ten days.

3. Other finished drugs permitted to be exported through non-commercial channels are not limited in quantity and number of shipments or carried by individuals abroad; they are also permitted to be imported through non-commercial channels but the total value of imported drugs shall not exceed the equivalent of 100 USD (calculated based on inter-bank exchange rates) per transaction, with a maximum of three times per year for an individual or organization.

4. In cases where the quantity of drugs exported or imported through non-commercial channels exceeds the quota specified in Clauses 1, 2, and 3 of this Article, permission from the competent health management authority must be obtained in accordance with Article 6 of this Circular.

Article 5. Documents for Export and Import of Drugs Through Non-Commercial Channels

1. The documents for export and import of drugs through non-commercial channels as stipulated in Clause 1 and Clause 2 of Article 4 of this Circular include:

a) Prescription, outpatient medical record: Prescription issued by a Vietnamese physician, outpatient medical record implemented according to the model prescribed in Appendix I promulgated by Decision No. 04/2008/QD-BYT dated February 1, 2008 of the Minister of Health on the issuance of the regulation on drug prescriptions in outpatient treatment, foreign physician's prescription must be written in English or Vietnamese, if in other languages then it must be translated into English or Vietnamese and must contain the following information:

- Name, age of the patient

- Drug name, dosage or concentration and volume

- Quantity of drugs (or number of days of use)

- Dosage instructions

- Physician's full name, signature

- Physician's address (address of the place where the physician practices: hospital, clinic)

b) Individuals handling the export and import of drugs through non-commercial channels must declare fully and present the prescription to Customs.

2. The documents for export and import of drugs through non-commercial channels as stipulated in Clause 4 of Article 4 of this Circular include:

a) Application form (Form 1a/PMD or 1b/PMD)

b) Copy of Identity Card or Passport of the person exporting or importing drugs through non-commercial channels (when handling customs procedures, the original identity card or passport must be presented)

c) Supporting documents: Prescription, outpatient medical record, medical file, or corresponding documents.

d) Prescription issued by a Vietnamese physician, outpatient medical record implemented according to the model prescribed in Appendix I promulgated by Decision No. 04/2008/QD-BYT dated February 1, 2008 of the Minister of Health on the issuance of the regulation on drug prescriptions in outpatient treatment. Foreign physician's prescription, outpatient medical record, medical file must contain the contents as stipulated in Clause 1 of this Article.

Article 6. Procedures and Authority for Permission to Export and Import Drugs Through Non-Commercial Channels

1. For individuals exporting or importing drugs through non-commercial channels that comply with the quota regulations set out in Clauses 1, 2, and 3 of Article 4 of this Circular, the individual directly handles the export and import procedures at the border customs office.

2. In cases where the value or number of times an individual receives drugs for treatment through non-commercial channels exceeds the quota specified in Clauses 2 and 3 of Article 4 of this Circular, based on professional medical regulations and relevant pharmaceutical regulations, the local Department of Health will consider granting permission to receive drugs for treatment as follows:

a) For drugs carried legally by individuals when exiting or entering Vietnam, the local Department of Health at the border entry or exit point or the Department of Health where the patient resides or stays temporarily legally is the authority to grant permission.

b) For drugs received from abroad sent back, the local Department of Health where the patient resides or stays temporarily legally is the authority to grant permission.

3. In cases where organizations export or import drugs through non-commercial channels, the Ministry of Health (Drug Administration Department) will grant permission based on professional medical regulations and relevant pharmaceutical regulations.

4. In cases where the value or number of times drugs are exported or imported through non-commercial channels exceeds the quota specified in Clause 1 of Article 4 of this Circular, the Ministry of Health (Drug Administration Department) will grant permission based on professional medical regulations and relevant pharmaceutical regulations.

5. Within seven working days, the competent authority will respond with the result, issue an export or import permit, or provide a written response stating the reasons for not issuing the permit.

6. In cases where the export or import of drugs through non-commercial channels exceeds the quota specified in Clause 4 of Article 4 of this Circular, while waiting for the approval document from the competent health management authority as stipulated in Clauses 2, 3, and Clause 4 of this Article, individuals and organizations are allowed to receive drugs according to the quota specified in Clauses 1, 2, and Clause 3 of Article 4 of this Circular.

Article 7. Handling Violations

1. Drugs exported or imported through non-commercial channels contrary to the provisions of this Circular will be treated as illegally exported or imported drugs, confiscated, and dealt with according to Decree No. 176/2013/NĐ-CP dated November 14, 2013 of the Government on administrative penalties for violations in the field of health care and other relevant laws.

2. Organizations and individuals transporting or trading drugs exported or imported through non-commercial channels contrary to the provisions of this Circular will be considered as illegally transporting or trading drugs and will be dealt with according to Decree No. 176/2013/NĐ-CP dated November 14, 2013 of the Government on administrative penalties for violations in the field of health care and other relevant laws.

Article 8. Transitional Provisions

1. Documents permitting the export and import of medicines through non-commercial channels issued by the Ministry of Health (the Drug Administration Department) and the Health Departments of centrally governed cities and provinces to individuals and organizations in accordance with Circular No. 01/2007/TT-BYT dated January 17, 2007, guiding the management of medicines for treatment purposes through non-commercial export and import channels, shall remain valid until their expiration date as stated on the documents.

2. In cases where the legal regulatory documents referred to in this Circular are amended, supplemented, or replaced, they shall be implemented in accordance with the amended, supplemented, or replacing legal regulatory documents.

Article 9. Implementation responsibilities

The Director of the Drug Administration Department and the Heads of Health Departments of centrally governed cities and provinces are responsible for organizing the implementation of this Circular.

Article 10. Effective Date

1. This Circular takes effect from January 1, 2014.

2. Circular No. 01/2007/TT-BYT dated January 17, 2007, of the Minister of Health guiding the management of medicines for treatment purposes through non-commercial export and import channels shall cease to be effective from the date this Circular takes effect.

During the implementation process, if there are difficulties or obstacles, it is requested that agencies, organizations, and individuals promptly report them to the Ministry of Health (Drug Administration Department) for guidance or amendment and supplementation to ensure compliance./.