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