Thông tư 09/2001/TT-BYT

CIRCULAR

GUIDING THE EXPORT AND IMPORT OF VACCINES AND IMMUNE BIO-PRODUCTS FOR HUMAN USE IN THE 2001-2005 PERIOD

In furtherance of the Prime Ministers Decision No. 46/2001/QD-TTg on the management of goods export and import in the 2001-2005 period, the Ministry of Health hereby guides the export and import of vaccines and immune bio-products for human use in the 2001-2005 period as follows:

I. SUBJECTS AND SCOPE OF EXPORT AND IMPORT BUSINESS

1.1. Enterprises which produce vaccines and immune bio-products, meet all production conditions and have registered export-import enterprise codes with the customs offices, may import raw materials, auxiliary materials, packages and semi-finished products in service of their production, and export products turned out by themselves.

1.2. Enterprises which deal in vaccines, immune bio-products, meet all the business conditions and have registered export-import enterprise codes with the customs offices, may export and import raw materials, auxiliary materials, packages, semi-finished and finished products. Particularly for raw materials, auxiliary materials, packages and semi-finished products, they may import them only for supply to enterprises having the function of producing vaccines and immune bio-products.

II. PROVISIONS ON THE PROCEDURES FOR IMPORT OF VACCINES, IMMUNE BIO-PRODUCTS AND RAW MATERIALS FOR PRODUCTION THEREOF

1. General provisions:

To be imported into and circulated in Vietnam, the vaccines and immune bio-products for human use must be given registration numbers by the Ministry of Health.

The import of vaccines and immune bio-products for human use and raw materials, auxiliary materials and semi-finished products for production thereof shall be conducted on the basis of written requests (made by enterprises with the function of exporting and importing vaccines and immune bio-products) already approved by the Ministry of Health (the Prophylactic Medicine Department). Basing itself on the written requests for import as well as the needs of vaccines and immune bio-products for use or research, the Ministry of Health (the Prophylactic Medicine Department) shall consider and make replies within 15 days after receiving the written requests and sufficient attached documents.

2. Vaccines, immune bio-products which have already been given import registration numbers for business:

- Enterprises having the import function shall make goods lists (according to set form), enclosed with the goods quantities estimated by health establishments (the Health Services and the Prophylactic Medicine Centers of the provinces and centrally-run cities, units having the function of using vaccines and immune bio-products and the central and regional Hygiene and Epidemiology/Pasteur institutes), then send them to the Ministry of Health (the Prophylactic Medicine Department) for approval.

- Foreign enterprises that supply vaccines and immune bio-products must be those already licensed by the Ministry of Health to deal in vaccines and immune bio-products in Vietnam. The import and/or export must be conducted by Vietnamese enterprises permitted to export and import vaccines and immune bio-products.

- The importing enterprises, when carrying out the customs clearance procedures, shall have to produce to the customs offices the Health Ministrys written permissions for the import, the original quality standard compatibility testing cards issued by the host countries agencies in charge of testing vaccines and immune bio-products or by the manufacturers, which accompany each imported goods lot. At the same time, they shall send the copies of such testing cards (stamped as true copies by the directors of the importing enterprises) to the National Center for Testing of Medical Bio-Products under the Ministry of Health, then proceed with the distribution of vaccines and immune bio-products according to regulations.

- The National Center for Testing of Medical Bio-Products under the Ministry of Health shall base itself on the testing cards to perform the function of examining and supervising the quality of vaccines and immune bio-products circulated on the market. In case of detection of vaccines and immune bio-products which fail to meet the quality standards as stated in the testing cards, the enterprises that have imported them shall take full responsibility therefor before law.

- To be imported into Vietnam, vaccines and finished bio-products must still be valid for at least two thirds of their use duration as from their arrival in Vietnam.

3. Vaccines and immune bio-products imported for testing, field experiment or use as registration samples

The quantities of vaccines and bio-products for testing and field experiment may vary, depending on the requirements of the testing agencies or field experiment agencies. The quantities of vaccines and bio-products for use as filed samples shall comply with the Regulation on registration of vaccines and immune bio-products, issued together with the Health Minister�s Decision No. 2010/BYT-QD of October 28, 1996 promulgating the Regulation on registration of vaccines and immune bio-products. These samples shall be only used for the registration purpose but not for other purposes.

The registering units shall send written requests for import of samples for testing, field experiment and/or filed samples, enclosed with the requirements of the testing or field experiment agencies, to the Ministry of Health (the Prophylactic Medicine Department) for consideration and permission of such import.

4. Vaccines and immune bio-products imported as objects on display or exhibition

They shall be considered on a case-by-case basis with quantity suited to the display and exhibition purposes, must not be sold, and must be re-exported upon the end of the display or exhibition.

5. Vaccines and immune bio-products used for research

They shall be considered on a case-by-case basis with quantity suited to the field experiment purpose or other scientific researches already approved by competent authorities but not for other purposes.

6. Vaccines and immune bio-products imported for the national programs or as humanitarian aid must still be valid for at least two thirds of their use duration as from their import into Vietnam. The aid-receiving units shall have the responsibility to preserve, distribute and use them in order to ensure their quality until they reach the users, and must not sell them. On the outer packages of such vaccines and immune bio-products, the words "Donated vaccines (bio-products), not for sale" or "Vaccines (bio-products) of the national programs, not for sale" must be inscribed (printed by the importing units after importing them).

- The importing enterprises, when carrying out the customs clearance procedures, shall have to produce to the customs offices the original standard compatibility testing cards issued by the host countries agencies in charge of testing vaccines and immune bio-products or by the manufacturers, which accompany each imported goods lot. At the same time, they shall send the copies of such cards (stamped as true copies by the directors of the importing enterprises) to the National Center for Testing of Medical Bio-Products.

- For vaccines and immune bio-products already granted the circulation permits by the Ministry of Health: After completing the customs clearance procedures, the enterprises shall deliver them to the aid-receiving units for use.

- For vaccines and immune bio-products not yet granted the circulation permits by the Ministry of Health: After completion of the customs clearance procedures, the imported vaccines and immune bio-products must be transported to the preservation warehouses of the importing enterprises and the National Center for Testing of Medical Bio-Products shall be informed thereof in order to collect by itself, or authorize other units to collect samples thereof for quality testing. After conducting such testing, the National Center for Testing of Medical Bio-Products shall have to send the quality-testing cards of the imported goods lots to the enterprises.

Only after receiving the quality-testing cards of the aid goods lots from the National Center for Testing of Medical Bio-Products, can the importing enterprises deliver the goods to the aid-receiving units. The directors of the importing companies shall take responsibility for the quality of the products when importing them.

7. Vaccines and semi-finished bio-products already given registration numbers:

- The units shall make goods lists (according to set form), enclosed with their quantities estimated by the production units in need thereof, then send them to the Ministry of Health (the Prophylactic Medicine Department) for approval.

- The foreign supply companies must be those licensed by the Ministry of Health to deal in vaccines and immune bio-products with the Vietnamese units permitted to export and import vaccines and immune bio-products.

- The importing enterprises, when carrying out the customs clearance procedures, shall have to produce to the customs offices the Health Ministrys written permissions for the import, and the original standard compatibility testing cards issued by the host countries agencies in charge of testing vaccines and immune bio-products or by the manufacturers, which accompany each imported goods lot.

- To be imported into Vietnam, vaccines and semi-finished immune bio-products (those to be standardized or undergo preparation or those to be packed) must still be valid for at least two thirds of their use duration as from their arrival in Vietnam.

- After being prepared or packed, vaccines and semi-finished immune bio-products must have their quality tested at the National Cen ter for Testing of Medical Bio-Products before delivery.

III. ENTRUSTED IMPORT

The entrusted import shall have to comply with the law provisions on commerce. The directors of the importing enterprises shall take responsibility for the quality of products when importing them.

IV. EXPORT OF RAW MATERIALS AND FINISHED VACCINES AND IMMUNE BIO-PRODUCTS

The enterprises shall carry out the export procedures according to the law provisions on commerce, without any quantity restrictions.

V. HANDLING OF VIOLATIONS

- The Prophylactic Medicine Department and the Inspectorate of the Health Ministry shall supervise and inspect activities of dealing in, exporting and importing vaccines and immune bio-products nationwide.

- The Health Services of the provinces and centrally-run cities shall supervise and inspect activities of dealing in, exporting and importing vaccines and immune bio-products in the provinces and centrally-run cities where the enterprises are headquartered.

- Enterprises exporting and/or importing vaccines and immune bio-products shall be handled according to law provisions if they violate the regulations on dealing in vaccines and immune bio-products.

VI. IMPLEMENTATION PROVISIONS

This Circular takes effect 15 days after its signing for promulgation and replaces the Health Ministrys Circular No. 12/2000/TT-BYT of May 22, 2000 guiding the export and import of vaccines and immune bio-products for human use in 2000.

The Prophylactic Medicine Department, the Inspectorate of the Health Ministry, the National Center for Testing of Medical Bio-Products, the Health Services of the provinces and centrally-run cities and the enterprises having the function of exporting and/or importing vaccines and immune bio-products shall have to strictly abide by the provisions of this Circular.