Circular No. 09/2001/TT-BYT guiding the implementation of vaccine and immunological products export and import for the period of 2001-2005

CIRCULAR

OF THE MINISTER OF HEALTH NO. 09/2001/TT-BYT
DATE 21 MAY 2001 ON GUIDELINES FOR IMPLEMENTATION
OF EXPORT AND IMPORT OF VACCINES AND IMMUNOBIOLOGICALS
FOR HUMAN USE PERIOD 2001-2005

Pursuant to Decision No. 46/2001/QĐ-TTg of the Prime Minister on management of export and import of goods during the period 2001-2005, the Ministry of Health guides the implementation of export and import of vaccines and immunobiologicals for human use during the period 2001-2005 as follows:

I. OBJECTS AND SCOPE OF BUSINESS IN EXPORT AND IMPORT

1.1. Enterprises producing vaccines and immunobiologicals that meet production conditions and have registered enterprise codes for import and export with customs authorities may import raw materials, auxiliary materials, packaging, semi-finished products for their own production and export products produced by themselves.

1.2. Enterprises trading in vaccines and immunobiologicals that meet business conditions and have registered enterprise codes for import and export with customs authorities may export and import raw materials, auxiliary materials, packaging, semi-finished products, finished products. Raw materials, auxiliary materials, packaging, and semi-finished products can only be imported to supply enterprises with functions of producing vaccines and immunobiologicals.

II. REGULATIONS ON PROCEDURES FOR IMPORTING FINISHED PRODUCTS OF VACCINES AND IMMUNOBIOLOGICALS, RAW MATERIALS FOR PRODUCTION OF VACCINES AND IMMUNOBIOLOGICALS

1. General provisions:

Vaccines and immunobiologicals intended for importation and circulation in Vietnam must be registered by the Ministry of Health.

The importation of vaccines and immunobiologicals for human use and raw materials, auxiliary materials, and semi-finished products for the production of vaccines and immunobiologicals shall be carried out based on a request letter (from enterprises with functions of exporting and importing vaccines and immunobiologicals) approved by the Ministry of Health (Preventive Medicine Department). Based on the request letter for importation and according to the needs of vaccines and immunobiologicals for use and research..., the Ministry of Health (Preventive Medicine Department) will examine and respond within 15 days from the date of receipt of the application form and accompanying documents.

2. Vaccines and immunobiologicals that have been registered for importation for trade:

- Enterprises with import functions shall prepare orders, accompanied by budget estimates from healthcare facilities (Department of Health, Provincial/Central City Preventive Health Centers, units with functions of using vaccines and immunobiologicals, Central and Regional Institutes of Hygiene and Pasteur) and send them to the Ministry of Health (Preventive Medicine Department) for approval.

- Foreign enterprises supplying vaccines and immunobiologicals must be enterprises licensed by the Ministry of Health to operate in the field of trading vaccines and immunobiologicals in Vietnam. Export and import activities must be conducted by Vietnamese enterprises permitted to export and import vaccines and immunobiologicals.

- Import enterprises when processing customs clearance procedures must present to the customs authority the permit for importation issued by the Ministry of Health, original test certificates meeting quality standards from the testing agency of the country of origin or the manufacturer attached to each consignment. At the same time, they must send copies of the original test certificates meeting quality standards from the testing agency of the country of origin or the manufacturer for the imported consignment (with a stamp of true copy affixed by the Director of the importing enterprise) to the National Institute of Medical Biological Product Testing under the Ministry of Health. Afterward, they must distribute vaccines and immunobiologicals according to regulations.

- The National Institute of Medical Biological Product Testing under the Ministry of Health bases on the test certificate and performs the function of inspecting and supervising the quality of circulating vaccines and immunobiologicals. If cases of vaccines and immunobiologicals not meeting quality standards as stated in the test certificate are discovered, the importing enterprise shall bear full responsibility under the law.

- Imported finished vaccines and immunobiologicals into Vietnam must still have at least two-thirds of their shelf life remaining from the date of arrival in Vietnam.

3. Vaccines and immunobiologicals imported for testing, field trials, and sample registration:

The quantity of vaccines and immunobiologicals used for testing and field trials depends on the requirements of the testing agency and the field trial agency. The quantity of vaccines and immunobiologicals used for sample retention shall be implemented according to the Registration Regulation for Vaccines and Immunobiologicals promulgated together with Decision No. 2010/BYT-QĐ dated October 28, 1996, of the Minister of Health on the issuance of the Registration Regulation for Vaccines and Immunobiologicals. These samples are only used for registration purposes and not for other purposes.

The registering entity sends a letter requesting the importation of testing samples, field trial samples, and retention samples along with the requirements of the testing and field trial agencies to the Ministry of Health (Preventive Medicine Department) for permission to import.

4. Vaccines and immunobiologicals imported for display and exhibition: Specific consideration is given to quantities suitable for display and exhibition purposes, and they cannot be sold. After completing the display and exhibition, they must be re-exported.

5. Vaccines and immunobiologicals used for research:

Specific consideration is given to quantities suitable for field research or other scientific research projects approved by competent authorities, and they cannot be used for other purposes.

6. Vaccines and immunobiologicals imported for national programs or humanitarian aid must still have at least two-thirds of their shelf life remaining from the date of importation into Vietnam. Receiving units are responsible for storage, distribution, and use to ensure product quality reaches consumers, and they cannot be sold. On the outer packaging of vaccines and immunobiologicals, the phrase "Vaccine (immunobiological) aid, not for sale" or "Vaccine (immunobiological) for national program, not for sale" (to be printed by the importing unit after importation) must be printed.

When processing customs clearance procedures, enterprises importing must present to the customs authority the original test certificate meeting the standards issued by the vaccine and immunological product testing agency of the country of origin or the manufacturer, accompanying each imported consignment. At the same time, they must send a copy of the original test certificate meeting the standards issued by the vaccine and immunological product testing agency of the country of origin or the manufacturer for the imported consignment (stamped with a true copy seal by the enterprise's General Director) to the National Institute of Medical Biological Product Testing Center.

- For vaccines and immunological products that have been granted a Circulation Permit by the Ministry of Health: after customs clearance, the enterprise shall deliver the vaccines and immunological products to the receiving aid unit for use.

- For vaccines and immunological products that have not been granted a Circulation Permit by the Ministry of Health: After customs clearance, the imported vaccines and immunological products must be stored in the importer’s warehouse and notify the National Institute of Medical Biological Product Testing Center so that the Center or units authorized by the Center can take samples for quality testing. The National Institute of Medical Biological Product Testing Center must send the Quality Test Certificate of the imported consignment to the enterprise after conducting the test.

After receiving the Quality Test Certificate meeting the standards from the National Institute of Medical Biological Product Testing Center for the aid consignment, the importing enterprise may deliver the goods to the receiving aid unit. The General Director of the importing company is responsible for the quality of the product at the time of importation.

7. Vaccines and semi-finished biological products that have registration numbers:

- Units must submit orders accompanied by production forecasts from the manufacturing facility to the Ministry of Health (Preventive Medicine Department) for approval.

- Foreign supplying companies must be companies that have been granted permission to operate in the field of vaccine and immunological product business by the Ministry of Health, with units permitted to export and import vaccines and immunological products in Vietnam.

- When processing customs clearance procedures, enterprises importing must present to the customs authority the permit for importation issued by the Ministry of Health, the original test certificate of semi-finished products meeting the standards issued by the vaccine and biological product testing agency of the country of origin or the manufacturer, accompanying each imported consignment.

- Imported semi-finished vaccines and immunological products into Vietnam (those requiring standardization, formulation... or products awaiting packaging) must still have at least two-thirds of their shelf life remaining from the date of arrival in Vietnam.

- Semi-finished vaccines and immunological products after being formulated and packaged must be tested for quality at the National Institute of Medical Biological Product Testing Center before being released from the factory.

III. IMPORTATION BY TRUST

Entrusted importation must comply with the provisions of trade laws. The General Director of the importing enterprise is responsible for the quality of the product at the time of importation.

IV. EXPORT OF RAW MATERIALS AND FINISHED PRODUCTS OF VACCINES AND IMMUNOLOGICAL PRODUCTS

Enterprises shall carry out export procedures in accordance with the provisions of trade laws, without quantity restrictions.

V. VIOLATION HANDLING

The Preventive Medicine Department and the Inspectorate of the Ministry of Health shall conduct inspections and audits nationwide on business activities, exports, and imports of vaccines and immunological products.

- Provincial Health Departments under centrally governed cities shall conduct inspections and audits on business activities, exports, and imports of vaccines and immunological products within the province or centrally governed city where the enterprise is headquartered.

- Enterprises exporting and importing vaccines and immunological products that violate regulations on vaccine and immunological product business operations will be subject to legal sanctions.

VI. IMPLEMENTATION PROVISIONS

This Circular takes effect fifteen days from the date of issuance and replaces Circular No. 12/2000/TT-BYT dated May 22, 2000, of the Ministry of Health guiding the implementation of the export and import of vaccines and immunological products for human use in 2000. The Preventive Medicine Department, the Inspectorate of the Ministry of Health, the National Institute of Medical Biological Product Testing Center, Provincial Health Departments under centrally governed cities, and enterprises with functions of exporting and importing vaccines and immunological products are responsible for strictly implementing the provisions of this Circular.