Circular No. 01/2007/TT-BYT dated January 17, 2007 of the Ministry of Health guiding the management of curative medicines for human use which are imported or exported through non-commercial channel

CIRCULAR

GUIDING THE MANAGEMENT OF CURATIVE MEDICINES FOR HUMAN USE WHICH ARE IMPORTED OR EXPORTED THROUGH NON-COMMERCIAL CHANNEL

Pursuant to December 9, 2000 Law No. 23/2000/QH10 on Drug Prevention and Fight;

Pursuant to June 14, 2005 Pharmacy Law No. 34/2005/QH11;

Pursuant to the Government's Decree No. 49/2003/ND-CP of May 15, 2003, defining the functions, tasks, powers and organizational structure of the Ministry of Health;

Pursuant to the Government's Decree No. 58/2003/ND-CP of May 29, 2003, controlling the import, export and transit via Vietnamese territory of narcotics, pre-substances, addictive drugs and psychotropics;

Pursuant to the Prime Minister's Decision No. 71/2002/QD-TTg of June 7, 2002, on the management of curative medicines for human use which are imported or exported through non-commercial channel;

The Ministry of Health guides the management of curative medicines for human use which are imported or exported through non-commercial channel as follows:

I. GENERAL PROVISIONS

1. This Circular governs activities related to the import or export of medicines for human use (below referred to as medicines for short) through non-commercial channel.

2. Curative medicines for human use which are brought along or sent into Vietnam by overseas Vietnamese, Vietnamese citizens going abroad for work, study or tour, or foreigners lawfully entering Vietnam, for personal or family use are called non-commercial imported medicines, while medicines which are sent abroad from Vietnam or brought along abroad by those people for personal or family use are called non-commercial exported medicines.

3. Non-commercial imported or exported medicines shall be used only for disease treatment; they may

4. Non-commercial imported or exported medicines must bear labels indicating appellations of medicines, appellations of active substances, concentration, content, and use duration.

5. Prescriptions made up by Vietnamese physicians must comply with the form set in the Regulation on prescription of medicines and sale of medicines based on prescriptions (Appendix I, not printed herein).

6. A prescription made up by a foreign physician must have the following contents:

a/ Name and age of the patient;

b/ Appellation of the medicine, its content or concentration and volume;

c/ Quantity of the medicine (or the number of days for medicine use);

d/ Dosage;

e/ Full name and signature of the physician;

f/ Address of the physician (address of the physician's practice place: hospital, clinic, etc.).

7. For medicines imported or exported through non-commercial channel or brought along upon entry or exit by individuals specified at Points a and b, Clause 1, Section III of this Circular, such individuals shall, when carrying out relevant import or export procedures or upon their entry or exit, declare all the medicines and present their prescriptions to the customs office.

II. MEDICINES BANNED FROM NON-COMMERCIAL IMPORT OR EXPORT

1. Medicine materials and auxiliary materials.

2. Medicines containing active substances on the list of active substances banned from non-commercial import or export in Appendix II (not printed herein).

III. SPECIFIC REGULATIONS ON THE LIST AND QUANTITY OF MEDICINES ELIGIBLE FOR NON-COMMERCIAL IMPORT OR EXPORT

1. List of medicines eligible for non-commercial import or export

a/ Finished addictive medicines on the list enclosed with the Regulation on management of addictive medicines promulgated by the Health Minister may be brought along by individuals upon their entry or exit if those medicines are accompanied with physicians' prescriptions according to the provisions of Clause 5 or 6, Section I of this Circular.

b/ Finished psychotropics and medicines containing pre-substances used as medicines on the list of psychotropics and pre-substances used as medicines, enclosed with the Regulation on management of psychotropics promulgated by the Health Minister, may be imported or exported through non-commercial channel when they are accompanied with physicians' prescriptions according to the provisions of Clause 5 or 6, Section I of this Circular.

c/ Other finished medicines not on the list of those banned from non-commercial import or export specified in Section II of this Circular may be imported or exported through non-commercial channel.

2. Quantity of medicines eligible for non-commercial export

a/ The quantity of addictive medicines brought along by individuals upon their exit must neither exceed the quantity written in the accompanied physician's prescription of the physician nor the quantity prescribed for 7 days. For medicines which are exported in excess of the set quantity, the opinion of the Health Ministry (Vietnam Drug Administration) is required. Apart from complying with this requirement, persons on exit shall also abide by regulations of the country which they enter.

b/ Finished psychotropics, medicines containing pre-substances used as medicines and other finished medicines may be exported through non-commercial channel in unrestricted quantities and regardless of the number of times of exportation but such export must not contravene regulations of the country permitting non-commercial import.

3. Quantity of medicines eligible for non-commercial import

a/ The quantity of addictive medicines brought along upon entry must neither exceed the quantity written in the accompanied physician's prescription nor the quantity prescribed for 7 days. For medicines imported in excess of the set quantity, the opinion of the Health Ministry (Vietnam Drug Administration) is required.

b/ The quantity of psychotropics and medicines containing pre-substances used as medicines which are imported through non-commercial channel must neither exceed the quantity written in the accompanied physician's prescription nor the quantity prescribed for 10 days.

c/ The value of other finished medicines permitted for non-commercial import must not exceed USD 30/time of importation; when there are many kinds of medicine, the total value of those medicines must not exceed USD 100/time of importation. Each individual may receive medicines three times a year at most.

d/ When psychotropics, medicines containing pre-substances used as medicines and other finished medicines which are imported through non-commercial channel for treatment purposes have a value or they are received in a number of times higher than the limits specified at Points b and c of this Clause, local Health Services shall, based on relevant professional medical regulations and pharmaceutical regulations, consider and permit the receipt of medicines which are specific or rare. Specifically:

- For medicines which are brought along by individuals lawfully entering Vietnam, the Health Service of the locality where gate of entry shall consider and permit the receipt of those medicines.

- For medicines which are sent from abroad to individuals, the Health Service of the locality where the patient lives or lawfully temporarily stays shall consider and permit the receipt of those medicines.

IV. HANDLING OF VIOLATIONS

1. Medicines which are imported or exported through non-commercial channel in contravention of the provisions of this Circular shall be regarded as illegal imports or exports, and be confiscated and destroyed.

2. Units or individuals that transport or trade in non-commercial imported or exported medicines in contravention of the provisions of this Circular shall be regarded as illegal transporters or traders, and be handled according to law.

V. IMPLEMENTATION PROVISIONS

This Circular takes effect 15 days after its publication in "CONG BAO" and replaces the Health Ministry's Circular No. 09/2002/TT-BYT of July 2, 2002, guiding the implementation of the Prime Minister's Decision No. 71/2002/QD-TTg of June 7, 2002, on the management of curative medicines for human use which are imported or exported through non-commercial channel.