Decision No. 1906/2004/QĐ-BYT on parallel importation of medicines for disease prevention and treatment issued by the Minister of Health

Pursuant to …;

OF THE MINISTER OF HEALTH DECREE NO. 1906/2004/QĐ-BYT DATED MAY 28, 2004 ISSUING REGULATIONS ON PARALLEL IMPORTATION OF MEDICINES FOR PREVENTION AND TREATMENT OF DISEASES

THE MINISTER OF HEALTH

Pursuant to the Law on Health Care for the People;
Pursuant to Decree No. 49/2003/NĐ-CP dated May 15, 2003 of the Government stipulating the functions, tasks, powers, and organizational structure of the Ministry of Health;
Pursuant to Decree No. 57/1998/NĐ-CP dated July 31, 1998 of the Government detailing the implementation of the Law on Trade regarding export, import, processing, and agency sales of goods with foreign countries, and Decree No. 44/2001/NĐ-CP dated August 2, 2001 of the Government amending and supplementing certain articles of Decree No. 57/1998/NĐ-CP dated July 31, 1998 of the Government;
Pursuant to Decree No. 120/2004/NĐ-CP dated May 12, 2004 of the Government on management of drug prices for prevention and treatment of diseases;
At the proposal of the Director of the Vietnam Drug Administration, the Head of the Department of Planning and Finance, Ministry of Health,

DECISION:

Article 1. This Decision promulgates Regulations on Parallel Importation of Medicines for Prevention and Treatment of Diseases.

Article 2.This Decision shall take effect fifteen days from the date of publication in the Official Gazette.

Article 3.The Heads of the Office, the Director of the Vietnam Drug Administration, the Head of the Department of Planning and Finance, Ministry of Health, and the Heads of relevant units shall be responsible for implementing this Decision.

REGULATIONS

ON PARALLEL IMPORTATION OF MEDICINES FOR PREVENTION AND TREATMENT OF DISEASES
(Issued together with Decree No. 1906/2004/QĐ-BYT dated May 28, 2004 of the Minister of Health).

To ensure sufficient supply of medicines for disease prevention and treatment for the people and contribute to stabilizing the medicine market, the Ministry of Health issues regulations on parallel importation of medicines into Vietnam.

Chapter 1:

GENERAL PROVISIONS

Article 1. Scope of Regulation

Finished medicines bearing the same brand name, containing the same active ingredient, having the same dosage form, and the same strength (hereinafter referred to as medicines bearing the same brand name) that have been registered for circulation in Vietnam by the Ministry of Health but which the manufacturer or distributor does not supply or supplies insufficiently according to treatment needs or sells at a higher price in Vietnam compared to the retail price of such medicines in the country of origin or in other countries with similar economic conditions where such medicines are circulating.

Article 2. Applicability

These regulations apply to Vietnamese enterprises with direct import/export functions for medicines; and foreign enterprises supplying medicines to Vietnam.

Article 3. Explanation of Concepts

Parallel importation of medicines refers to the importation of medicines bearing the same brand name as those already registered for circulation in Vietnam when pharmaceutical companies abroad price their medicines lower in one country than another. Specifically:

1. Importation of medicines bearing the same brand name as those already registered in Vietnam but produced by different manufacturers of the same company or pharmaceutical production group. Such medicines are supplied either directly by the manufacturer or through another supplier. For example: If two manufacturers A and B of the same company or pharmaceutical group produce product S. Product S by manufacturer A has been registered in Vietnam and is sold in the Vietnamese market at price G1. Product S by manufacturer B has not been registered in Vietnam and is sold abroad at price G2. If price G2 is lower than price G1, a Vietnamese importer may purchase product S from abroad and sell it in Vietnam at price G3 provided that G3 is always lower than G1 (G3 < G1).

2. Importation of medicines bearing the same brand name as those already registered in Vietnam by the same manufacturer and from the same country of manufacture but from a different supplier. For example: Manufacturer X produces product S which has been registered and is sold in the Vietnamese market at price G1. The same product S, manufacturer X sells to country A at price G2. If price G2 is lower than price G1, a Vietnamese importer may import product S from country A to sell in Vietnam at price G3 provided that G3 is always lower than G1 (G3 < G1).

Article 4. Expiry date of parallel imported drugs

The remaining expiry date of parallel imported drugs upon arrival at Vietnam's port must be at least 18 months. For drugs with an expiry period of two years or less, the remaining expiry date of the drug upon arrival at the port must be at least 12 months. In special cases, the Department of Medicine Administration of Vietnam will consider and resolve within its authority.

Article 5. Printing or affixing labels for parallel imported drugs circulating in Vietnam.

1. Parallel imported drugs must be stored in the importer's warehouse, and labeling must be printed or affixed before being put into circulation.

2. The label must be printed or affixed on the outer packaging of the drug.

3. The label must include all the following information: parallel imported drug; name of the importing entity; import permit number; date of issuance. Example:

4. In the case of affixing labels: the label must be printed in red ink on white paper (except for the import permit number; date... month... year... which can be printed in the same color or different color).

Chapter 2:

SPECIFIC PROVISIONS

Article 6. Conditions for issuing parallel import permits for drugs

1. Regarding the quality assurance of parallel imported drugs:

a. Foreign drug suppliers must have pharmaceutical trading functions and commit to ensuring the quality of drugs imported into Vietnam.

b. Vietnamese enterprises with pharmaceutical import-export functions must commit to taking responsibility for the quality of parallel imported drugs.

2. Regarding the price of parallel imported drugs: the wholesale and retail prices must be set by the importer and must be lower than the wholesale and retail prices of drugs with the same brand name that are currently subject to high pricing in Vietnam.

Article 7. Documents for requesting a parallel import permit for drugs

1. The enterprise applying for parallel importation of drugs sends the application documents to the Department of Medicine Administration of Vietnam. The documents include:

a. Application form for parallel importation of drugs (Form No. 1). The application includes commitments: - Compliance with the "Regulations on Parallel Importation of Drugs for Human Medical Treatment" issued by the Ministry of Health. - Responsibility for the quality of parallel imported drugs. - Parallel imported drugs will be sold at wholesale and retail prices lower than those currently subject to high pricing in Vietnam.

b. Order form for parallel importation of drugs (Form No. 2). The order form is made in three copies. After approval, one copy is sent to the enterprise, and two copies are kept at the Department of Medicine Administration of Vietnam.

c. Samples of packaging and labels of each drug.

d. Instructions for use (original and Vietnamese translation) of each drug.

All documents in the application must be stamped with the seal of the importing enterprise. The importing enterprise is responsible for the legality of the documents provided.

Article 8. Responsibilities of exporting and importing entities for parallel imported drugs

1. The exporting enterprise must provide necessary documents to the Vietnamese importing enterprise and bear responsibility for the legality of the documents provided.

2. The importing enterprise must:

a. Take responsibility for the quality of drugs it imports and distributes. For batches of drugs without original test certificates, they must be inspected and certified by the Institute or Branch Inspection Institute. Only batches meeting quality standards may be put into circulation and use.

b. Sell drugs at the committed prices;

c. Affix labels and provide instructions for use in Vietnamese according to regulations.

d. Bear responsibility for intellectual property rights for the drugs it imports.

Chapter 3

e. Report in writing to the Department of Medicine Administration of Vietnam on the results of parallel drug imports and supply (Form No. 3).

Article 9. Competence and Procedures for Issuing Parallel Import Medicine Import Permits

1. The Director of the Vietnam Drug Administration shall be responsible for organizing the review and issuing permits.

2. Within fifteen working days from the date of receipt of a valid application, the Vietnam Drug Administration must resolve the parallel import medicine import request of the entity; in cases where a permit is not issued, the reasons must be clearly stated.

Article 10. Handling of violations

Any violation of the "Regulations on Parallel Import of Medicines for Disease Prevention and Treatment" will be subject to administrative penalties or criminal liability, depending on the severity, in accordance with current Vietnamese law. During implementation, if there are any difficulties, entities are advised to report them to the Ministry of Health (Vietnam Drug Administration) for consideration and resolution.

  APPLICATION FOR PARALLEL IMPORT OF MEDICINES Respectfully submitted to: Vietnam Drug Administration - Ministry of Health

To ensure sufficient medicines for disease prevention and treatment for the people and contribute to stabilizing medicine prices, we respectfully request the Vietnam Drug Administration to approve the parallel import of the items listed in the parallel import order number … dated … attached hereto.được gửi kèm theo.

(Entity) hereby commits:

- To comply with the "Regulations on Parallel Import of Medicines for Disease Prevention and Treatment" promulgated together with Decision No. .../2004/QĐ-BYT dated .../.../... of the Minister of Health.

- (Entity) accepts full responsibility for the quality of the imported medicines it distributes. All batches of parallel imported medicines have test certificates and only batches meeting quality standards will be released for circulation. Parallel imported medicines will be sold at wholesale and retail in Vietnam at prices lower than those set by the manufacturer/distributor currently selling in Vietnam. Specifically:

(Entity) respectfully requests the Vietnam Drug Administration to consider and resolve this matter.

Director of Entity

(Signature, stamp)