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THE MINISTRY OF PUBLIC HEALTH
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SOCIALIST REPUBLIC OF
VIET NAM
Independence
- Freedom - Happiness
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No: 01/2007/TT-BYT
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Hanoi, January 17, 2007
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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 individual or family
disease treatment; not being permitted to sell in the market or use for other
illegal purpose.
4. Non-commercial
imported or exported medicines must bear labels indicating appellations of
medicines, appellations of active substances, concentration, content, and use
duration.
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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
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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.
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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.
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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.
THE
MINISTER
Tran Thi Trung Chien