Bản dịch văn bản 06/2003/TT-BYT
thong-tu-06-2003-tt-byt
Cơ quan ban hành: Bộ Y tế
Ngày ban hành: 2003-05-15

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 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 Vietnam for use in special cases, the Ministry of Health hereby guides the management and use thereof as follows: 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 Vietnam must send to the National Center for Expertise of Medical Bio-Products the following documents: 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 National Center for Expertise of Medical Bio-Products shall inspect the cooling chains, take samples and evaluate vaccines and medical bio-products according to the following requirements: a/ Laboratory testing of safety with conclusions on the satisfaction of the prescribed standards; b/ Field testing of safety on human beings with conclusions on the satisfaction of the prescribed standards. Particularly for vaccines and medical bio-products without circulation registration numbers, which are provided to Vietnam as emergency aid by international organizations having constant cooperation with Vietnam in the field of health such as WHO, UNICEF,..., on a case-by-case basis, the National Center for Expertise of Medical Bio-Products shall inspect the cooling chains, take samples and test safety in laboratories. After considering the above-said documents, and with the expertising and testing results showing the satisfaction of the prescribed quality, the National Center for Expertise of Medical Bio-Products shall request in writing the Ministry of Health (the Preventive Medicine Department) to permit the units to receive and use the vaccines and medical bio-products which are provided as aid. II. FOR VACCINES AND MEDICAL BIO-PRODUCTS WITHOUT REGISTRATION NUMBERS, WHICH ARE IMPORTED INTO VIETNAM FOR USE IN SPECIAL CASES 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 Vietnam, Vietnamese going abroad for working missions, study or labor in countries where such epidemics exist. The above-said vaccines and medical bio-products may be used only at medical establishments permitted to conduct vaccination. 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 Vietnam. 4. The importing companies’ written commitments on the import, preservation and transportation of vaccines and medical bio-products meeting the quality requirements. 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: a/ To receive dossiers related to vaccines and medical bio-products provided as aid, expertise and test them in laboratories and in the field according to the current regulations. 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. In the course of implementation, if any difficulties or problems arise, the units must promptly report them to the Ministry of Health (the Preventive Medicine Department) for study and settlement. For the Health Minister Vice Minister NGUYEN VAN THUONG