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THE MINISTRY OF HEALTH
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SOCIALIST REPUBLIC OF VIETNAM
Independence- Freedom- Happiness
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No.1906/2004/QD-BYT
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Hanoi, May 28, 2004
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DECISION
PROMULGATING THE REGULATION ON PARALLEL IMPORT OF MEDICINES FOR
PREVENTION AND CURE OF HUMAN DISEASES
THE
MINISTER OF HEALTH
Pursuant to the Law on Protection of
People's Health;
Pursuant to the
Government's Decree No. 49/2003/ND-CP dated May 15, 2003 defining the
functions, tasks, powers and organizational structure of the Ministry of
Health;
Pursuant to the
Government's Decree No. 57/1998/ND-CP dated July 31, 1998 detailing the
implementation of the Commercial Law regarding activities of import, export,
processing and agency for purchase and sale of goods with foreign countries;
and the Government's Decree No. 44/2001/ND-CP dated August 2, 2001 amending and
supplementing a number of articles of the Government's Decree No. 57/1998/ND-CP
dated July 31, 1998;
Pursuant to the
Government's Decree No. 120/2004/ND-CP on management of the prices of medicines
for prevention and cure of human diseases;
At the proposal
of the director of Vietnam Pharmacy Management Department and the director of
the Planning and Finance Department of the Ministry of Health,
DECIDES:
Article 1. To promulgate together with this Decision
the Regulation on parallel import of medicines for prevention and cure of human
diseases.
Article 2. This Decision takes effect 15 days
after its publication in the Official Gazette.
Article 3. The director of the Office, the
director of Vietnam Pharmacy Management Department, the director of the
Planning and Finance Department of the Ministry of Health and the heads of the
concerned units shall have to implement this Decision.
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MINISTER OF HEALTH
Tran Thi Trung Chien
REGULATION
ON PARALLEL IMPORT OF MEDICINES FOR PREVENTION AND CURE OF HUMAN
DISEASES
(Promulgated
together with Decision No. 1906/2004/QD-BYT dated May 28, 2004 of the Minister
of Health)
In order to ensure enough medicines
for prevention and cure of people's diseases and contribute to stabilizing the
medicine market, the Ministry of Health hereby provides for the parallel import
of medicines into Vietnam.
Chapter I
GENERAL
PROVISIONS
Article 1. Scope of regulation
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Article 2. Subjects of application
This Regulation applies to
Vietnamese enterprises having the function of directly exporting and/or
importing medicines and foreign enterprises supplying medicines into Vietnam.
Article 3. Interpretation of terms
Parallel import of medicines means
the import of medicines which have the same specific names as medicines already
granted registration numbers for circulation in Vietnam when the foreign
pharmaceutical companies set the prices of such medicines in a country lower
than those in another country, specifically:
1. Import of medicines which have
the same specific names as medicines already granted registration numbers in Vietnam but are manufactured by different manufactures of the same
pharmaceutical-manufacturing company or group. These medicines are supplied by
the manufacturers themselves or by other suppliers.
For example: If two manufacturers A
and B of the same pharmaceutical-manufacturing company or group manufacture of
the same product S. Product S of manufacturer A has been granted a registration
number in Vietnam and is currently on sale in the Vietnamese market at the
price G1. Product S of manufacturer B has not been granted a registration
number in Vietnam and is currently on sale in another country at the price G2.
If the price G2 is lower than the price G1, a Vietnamese importer may purchase
product S in such country for sale in Vietnam at the price G3, provided that
the price G3 is always lower than the price G1 (G3<G1).
2. Import of medicines which have
the same specific names as medicines already granted registration numbers in Vietnam and are manufactured by the same manufacturer in the same country but are supplied
from different countries.
For example: Manufacturer X
manufactures products S, which has been granted a registration number and is
currently on sale in the Vietnamese market at the price G1. Product S is,
however, sold by manufacturer X into country A at the price G2. If the price G2
is lower than the price G1, a Vietnamese importer may import product S from
country A for sale in Vietnam at the price G3, provided that G3 is always lower
than G1 (G3<G1).
Article 4. Use duration of parallel-imported
medicines
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Article 5. Printing or sticking of additional
labels on parallel-imported medicines for circulation in Vietnam.
1. Parallel-imported medicines must
be put into the warehouses of the importing enterprises, be printed or stuck
with additional labels before being put into circulation.
2. Additional labels shall be
printed or stuck on the outer medicine packages.
3. Additional labels must fully
contain the following contents: parallel-imported medicine; the importer's
name, serial number of import permit; date of grant of permit. For example:
PARALLEL-IMPORTED
MEDICINE
Importer's name:
Import permit
No../QLD
PARALLEL-IMPORTED
MEDICINE
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Import permit
No.450/QLD
4. In case of sticking additional
labels: Additional labels must be printed in red on white paper (particularly,
the serial numbers and dates of grant of import permits may be printed in the
same color or in another color).
Chapter II
SPECIFIC
PROVISIONS
Article 6. Conditions for grant of parallel
import permits
1. On assurance of the quality of
imported medicines:
a) Foreign enterprises that supply
medicines must have the function of dealing in medicines and commit to assuring
the quality of medicines imported into Vietnam.
b) Vietnamese enterprises with the
medicine exporting-importing function must commit to taking responsibility for
the quality of medicines they parallel-import.
2. On the prices of
parallel-imported medicines: The wholesale and retail prices shall be set by
the importing enterprises and must be lower than the wholesale and retail
prices of the medicines which have the same specific names and have been
granted registration numbers but are tagged with high prices in Vietnam.
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1. Enterprises applying for
medicine-parallel import permits shall send their dossiers to Vietnam Pharmacy
Management Department. Such a dossier comprises:
a) The application for parallel
import of medicines (made according to a set form), which contains the
following commitments:
- To strictly observe the Ministry
of Health's Regulation on parallel import of medicines for prevention and cure
of human diseases.
- To bear responsibility for the
quality of medicines parallel-imported by the enterprise.
- To wholesale and retail the
parallel-imported medicines at prices lower than their current high wholesale
and retail prices in Vietnam.
b) The goods order of the to
be-parallel imported medicines, which shall be made in 3 sets. After the permit
is granted, 1 set shall be returned to the enterprise and 2 other sets kept at
Vietnam Pharmacy Management Department.
c) The sample packages and labels of
each kind of medicine.
d) The use instruction sheet (the
original and its Vietnamese version) of each kind of medicine.
The importing enterprise must affix
its hanging or overlapping stamps on all documents of the dossiers and take
responsibility for the legality of such documents.
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1. The exporting enterprises must
supply to the Vietnamese importing enterprises necessary documents and take
responsibility for the legality of such documents.
2. The importing enterprises must:
a) Take responsibility for the
quality of medicines they import and distribute. For lots of medicines which
have no original testing certificates, they must be tested and granted testing
certificates by the testing institutes or sub-institutes. Only those lots of
medicines which satisfy the quality standards shall be put into circulation and
use.
b) Sell medicines at the committed
prices;
c) Stick additional labels on the
medicines and enclose them with the Vietnamese-language use instruction sheets
as prescribed.
d) Take responsibility for the
intellectual property rights over the medicines they import.
e) Report in writing to Vietnam
Pharmacy Management Department on the results of import and supply of
parallelly-imported medicines (made according to a set form).
Chapter III
PERMIT-GRANTING
COMPETENCE AND HANDLING OF VIOLATIONS
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1. The director of Vietnam Pharmacy
Management Department shall be responsible for organizing the evaluation and
grant of permits.
2. Within 15 working days after
receiving the valid dossiers, Vietnam Pharmacy Management Department shall
process the units' applications for parallel import of medicines; if refusing
to grant permits, it must give the reasons therefor.
Article 10. Handling of violations
All acts of violating the regulation
on parallel import of medicines for prevention and cure of human diseases
shall, depending on their seriousness, be administratively sanctioned or
examined for penal liability strictly according to current Vietnamese law
provisions.
If facing any problems in the course
of implementation, the units should report them to the Ministry of Health
(Vietnam Pharmacy Management Department) for examination and settlement.
MINISTER OF HEALTH
Tran Thi Trung Chien