Circular No. 07-BYT/TT guides the registration of foreign companies permitted to import and export drugs - drug raw materials with organizations and companies of Vietnam, aiming to manage and develop sources of drug imports. The Circular stipulates conditions, registration procedures, and responsibilities of the foreign party after registration.
适用范围
Foreign companies permitted to import and export drugs - drug raw materials with organizations and companies of Vietnam.
要点
- Any foreign organization or company wishing to operate under contracts for importing and exporting, joint ventures in producing drugs - drug raw materials with organizations and companies of Vietnam must have a permit from the Ministry of Health of Vietnam.
- The foreign party wishing to register must meet conditions such as conducting activities through the Vietnamese party, having legal confirmation from their home country, and committing to comply with Vietnamese laws.
- The registration procedure includes submitting a registration dossier (one copy in Vietnamese, one copy in English or French) to the Ministry of Health within 60 days from receipt of the dossier.
- After registration, the foreign party is permitted to enter into purchase and sale joint venture production contracts in the field of drugs - drug raw materials in Vietnam according to the regulations of the Ministry of Health and related sectors.
- The foreign party must strictly comply with Vietnamese laws, and fulfill all terms of the contract signed with the Vietnamese party.
🌐 本文件的社会影响
- Positive impacts include managing and developing sources of drug imports, ensuring quality and safety for users.
- Negative impacts may be administrative burdens on foreign companies wishing to operate in this field.
❓ 常见问题
What conditions must a foreign company meet to register?
The foreign party must conduct activities through the Vietnamese party, have legal confirmation from their home country, and commit to comply with Vietnamese laws.
What does the registration procedure include?
The foreign party must submit a registration dossier (one copy in Vietnamese, one copy in English or French) to the Ministry of Health within 60 days from receipt of the dossier.
What can a foreign company do after registration?
After registration, the foreign party is permitted to enter into purchase and sale joint venture production contracts in the field of drugs - drug raw materials in Vietnam according to the regulations of the Ministry of Health and related sectors.
When must a foreign company notify the Ministry of Health?
The foreign party must notify the Ministry of Health at least 30 days in advance in cases of changing the name or location of the foreign party; changing the director and person responsible for producing and trading drugs - drug raw materials; ceasing operations in producing and trading drugs - drug raw materials.
What penalties will a foreign company face if it violates the provisions of this Circular?
Depending on the severity of the violation, the foreign party will be dealt with according to Vietnamese laws.
全文
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MINISTRY OF HEALTH |
SOCIALIST REPUBLIC OF VIETNAM |
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NUMBER: 07-BYT/TT |
Hanoi, March 30, 1991 |
CIRCULAR
OF THE MINISTER OF HEALTH NO. 07-BYT/TT ON MARCH 30, 1991 GUIDING
REGISTRATION OF FOREIGN COMPANIES PERMITTED TO EXPORT AND IMPORT
MEDICINES AND RAW MATERIALS FOR MEDICINES WITH ORGANIZATIONS AND COMPANIES IN
SOCIALIST REPUBLIC OF VIET NAM
Pursuant to the Law on Health Protection of the Socialist Republic of Vietnam (Chapter VI - Article 38 on management of production, circulation, export, and import of medicines and raw materials for medicines).
Pursuant to the Pharmaceutical Regulations for Prevention and Treatment issued pursuant to the Decree of the Council of Ministers of the Socialist Republic of Vietnam No. 23-HĐBT dated January 24, 1991 (Chapter VIII: Export and Import of Medicines and Raw Materials for Medicines).
Pursuant to Decision No. 113/CT dated May 9, 1989 of the Chairman of the Council of Ministers of the Socialist Republic of Vietnam on the unification of management of export and import of medicines and raw materials for treatment (hereinafter referred to as medicines and raw materials).
The Ministry of Health of the Socialist Republic of Vietnam guides specifically the registration of foreign organizations and companies (hereinafter referred to as Foreign Party) permitted to export and import medicines and raw materials into organizations and companies of the Socialist Republic of Vietnam (hereinafter referred to as Vietnamese Party).
I. PURPOSE OF REGISTRATION
Medicines for prevention and treatment of diseases are a special type of goods. Therefore, the Foreign Party wishing to operate in the field of medicines and raw materials for medicines in Vietnam must comply with the laws of Vietnam and meet certain professional conditions. Registration for the Foreign Party is one of the measures to manage and create conditions for the development of imported medicines, investment in the field of medicines and raw materials for medicines, ensuring quality and safety for users.
II. OBJECTS AND CONDITIONS FOR REGISTRATION
All foreign organizations and companies wishing to operate under contracts for export and import, joint venture production of medicines and raw materials for medicines with Vietnamese organizations and companies must have a permit from the Ministry of Health of Vietnam.
The Ministry of Health of Vietnam assigns the Department of Pharmacy - TT to examine and issue registration permits to monitor the activities of foreign organizations and companies in the field of medicines and raw materials.
The Foreign Party wishing to register must meet the following conditions:
1. Must carry out their activities in the field of medicines and raw materials for medicines through the Vietnamese Party having the function of producing and trading medicines and raw materials (in the form of economic contracts, cooperation projects, investments...) in accordance with the Investment Law of Vietnam.
2. Have legal confirmation from the competent authority of the home country regarding the right to trade, produce, and export/import medicines and raw materials.
3. Commitment to strictly implement the regulations of Vietnamese law and the management regime of medicines and raw materials of the Ministry of Health of Vietnam.
After registration, the Foreign Party is allowed to enter into purchase and sale joint venture production contracts in the field of medicines and raw materials in Vietnam according to the regulations of the Ministry of Health and related sectors.
III. REGISTRATION PROCEDURES
1. The Foreign Party wishing to register must submit to the Ministry of Health (Department of Pharmacy - TT) the following registration dossier (one copy in Vietnamese, one copy in English or French):
- Application for registration to conduct business in the field of medicines and raw materials clearly stating the purpose of registration and scope of activities after registration (model 1).
- Summary of activities (model 2)
- Commitment to implement the management regulations of medicines in Vietnam
- Legal confirmation document from the competent national authority regarding medicines in the home country (Ministry of Health...) regarding the right to operate in production, trade, and export/import of medicines and raw materials.
- Relevant legal documents (documents proving the existence of the Foreign Party, bank certification of statutory capital...)
2. Within 60 days from receipt of the dossier, the Ministry of Health will notify the Foreign Party of its opinion. If registered, the Foreign Party will be issued a registration number permit.
3. The validity period of the registration of the Foreign Party is specified in the permit issued by the Ministry of Health of the Socialist Republic of Vietnam, depending on the purpose and content of the activities of the Foreign Party.
4. Upon receiving the permit, the Foreign Party must pay a registration fee (the Ministry of Health will provide specific notification after reaching agreement with the Ministry of Finance of the Socialist Republic of Vietnam).
5. When issuing a permit to the Foreign Party, the Ministry of Health will inform the Ministry of Trade and the General Customs Department to coordinate in managing exports and imports according to their functions.
IV. RESPONSIBILITIES OF THE FOREIGN PARTY AFTER REGISTRATION
1. Strictly comply with the laws of Vietnam;
2. Must fulfill all terms of the contracts and projects signed with the Vietnamese Party, must comply with the management regulations of medicines and raw materials for medicines of the Ministry of Health of Vietnam, ensuring the health interests of the Vietnamese people;
3. Shall have the responsibility to notify the Ministry of Health of Vietnam (Department of Pharmacy - TT) at least 30 days in advance in the following cases:
- Change of name and address of the Foreign Party.
- Change of director and person responsible for production and trade of medicines and raw materials.
- Termination of business and production activities of the Foreign Party generally and specifically with Vietnam.
4. Annually, from December 25 to December 31, the Foreign Party must submit a report on the situation of activities in the field of medicines and raw materials with Vietnam to the Ministry of Health (Department of Pharmacy - TT).
5. If the Foreign Party violates the provisions of this Circular, it shall be dealt with according to the level of violation in accordance with the laws of Vietnam.
This Circular takes effect from the date of signature and replaces previous regulations inconsistent with the provisions of this Circular.
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Nguyen Van Dan (Signed) |
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