THE MINISTRY OF PUBLIC HEALTH |
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No: 06/2003/TT-BYT | |
CIRCULAR
GUIDING THE MANAGEMENT AND USE OF VACCINES AND MEDICAL BIO-PRODUCTS WITHOUT CIRCULATION REGISTRATION NUMBERS, WHICH ARE PROVIDED AS EMERGENCY AID OR IMPORTED INTO
In order to enhance the management and use of vaccines and medical bio-products without circulation registration numbers, which are provided as emergency aid or imported into
I. FOR VACCINES AND MEDICAL BIO-PRODUCTS WITHOUT REGISTRATION NUMBERS, WHICH ARE PROVIDED AS EMERGENCY AID
1. Foreign organizations and individuals that provide vaccines and medical bio-products without circulation registration numbers as emergency aid to
1.1. The written certifications by competent agencies of their countries, permitting the circulation or export of vaccines and medical bio-products;
1.2. Testing cards certifying the satisfaction of quality standards of vaccines and medical bio-products by the host countries national expertising agencies or other competent agencies for imported goods lots (with the importing companies certification of the true copies of the originals).
2. Upon receiving the documents prescribed at Point 1 above, the
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Particularly for vaccines and medical bio-products without circulation registration numbers, which are provided to After considering the above-said documents, and with the expertising and testing results showing the satisfaction of the prescribed quality, the II. FOR VACCINES AND MEDICAL BIO-PRODUCTS WITHOUT REGISTRATION NUMBERS, WHICH ARE IMPORTED INTO These vaccines and medical bio-products shall be used only in special cases in service of the epidemics prevention and combat and for a group of special subjects like foreigners living and working in In order to import the above-said vaccines and medical bio-products, the importing companies must send to the Ministry of Health (the Preventive Medicine Department) the following documents: 1. Statements of the demands for volumes and types of vaccines and medical bio-products as well as to be-vaccinated subjects of vaccinating establishments. 2. Vaccinating establishments written commitments on the use, preservation and vaccination of vaccines and medical bio-products for the right purposes, right subjects and right prescriptions, and on the responsibility for vaccination with such vaccines and medical bio-products. 3. The distributing companies written commitments on ensuring the quality of vaccines and medical bio-products provided for ... ... ... The vaccinating establishments, the distributing companies and the importing companies must bear responsibility before law for the quality standards of vaccines and medical bio-products, which are used, distributed or imported by the units. III. IMPLEMENTATION PROVISIONS 1. The Minister of Health shall assign the director of the Preventive Medicine Department to consider and permit the import of several vaccines and medical bio-products, which are provided as emergency aid or for use in special cases, strictly according to the current regulations. 2. The National Center for Expertise of Medical Bio-Products shall have the responsibilities: b/ After obtaining the expertising and testing results, the National Center for Expertise of Medical Bio-Products shall report them to the Ministry of Health (the Preventive Medicine Department). 3. The director of the Central Institute for Epidemics Hygiene and the director of the Expanded Vaccination Program shall take full responsibility for the use of assorted vaccines permitted to be circulated under the program and make periodical or extraordinary reports on the use of vaccines: side-effects caused by the use of vaccines and other abnormal cases in the course of using them. 4. The heads of the aid-receiving units shall have to preserve, distribute and use products to ensure their quality for consumers, and must not sell them. This Circular takes effect 15 days after its publication in the Official Gazette. ... ... ... FOR THE HEALTH MINISTER
VICE MINISTER
Nguyen Van Thuong
- 1Circular No. 12/2014/TT-BYT dated March 20, 2014, providing guidance on management of vaccine usage in vaccination
- 2Circular No. 08/2006/TT-BYT of June 13, 2006, guiding the import of vaccines, medical biologicals; chemicals, insecticidal or germicidal preparations for domestic and medical use; and medical equipment
- 3Circular No. 09/2001/TT-BYT of May 21, 2001 guiding the export and import of vaccines and immune bio-pruducts for human use in the 2001 - 2005 period.
- 1Circular No. 08/2006/TT-BYT of June 13, 2006, guiding the import of vaccines, medical biologicals; chemicals, insecticidal or germicidal preparations for domestic and medical use; and medical equipment
- 2Circular No. 08/2006/TT-BYT of June 13, 2006, guiding the import of vaccines, medical biologicals; chemicals, insecticidal or germicidal preparations for domestic and medical use; and medical equipment
- 1Circular No. 12/2014/TT-BYT dated March 20, 2014, providing guidance on management of vaccine usage in vaccination
- 2Circular No. 08/2006/TT-BYT of June 13, 2006, guiding the import of vaccines, medical biologicals; chemicals, insecticidal or germicidal preparations for domestic and medical use; and medical equipment
Circular No. 06/2003/TT-BYT of May 15, 2003, guiding the management and use of vaccines and medical bio-products without Circulation registration numbers, which are provided as emergency aid or imported into Vietnam for use in special cases
- Số hiệu: 06/2003/TT-BYT
- Loại văn bản: Thông tư
- Ngày ban hành: 15/05/2003
- Nơi ban hành: Bộ Y tế
- Người ký: Nguyễn Văn Thưởng
- Ngày công báo: Đang cập nhật
- Số công báo: Đang cập nhật
- Ngày hiệu lực: 22/06/2003
- Ngày hết hiệu lực: 09/07/2006
- Tình trạng hiệu lực: Hết hiệu lực