LICENSING ISSUES FOR FOREIGN COMPANIES TO ACTIVATE ON VACCINES AND BIOPHARMACEUTICAL IN VIET NAM

Vaccines and biopharmaceutical are biological products used to prevent, cure and diagnose diseases in humans. In particular, vaccine means a drug that contains antigens which helps the body develop immunity and is used for the prevention or treatment of diseases.

Mục lục

Vaccines and biopharmaceutical are biological products used to prevent, cure, and diagnose diseases in humans. In particular, a vaccine means a drug that contains antigens that helps the body develop immunity and is used for the prevention or treatment of diseases. The vaccine contains weakened versions of the virus or a near-viral version (called the antigen). This proves that the antigens cannot produce any signs or symptoms of the disease, but they stimulate the immune system to produce antibodies. These antibodies will protect the body when it comes into contact with viruses in the future. A biopharmaceutical is a drug produced by technology or biological process from a substance or mixture of polymeric substances of biological origin, including derivatives of human blood and plasma. Currently, many foreign companies are operating in the field of vaccines and medical bio-products in Vietnam. That is why the issuance of an operating license is very necessary. So how is this procedure done? Please follow the article below of Doanh Tri Law for more useful information.

I. Dossier

- Application for operation in the field of vaccines and finished and semi-finished medical-biological products and raw materials for producing vaccines and medical-biological products (Appendix 2, Form 1 – Circular on amendment and supplement of a number of articles of Circular No.17/2001/TT-BYT dated on August 01, 2001 of the Ministry of Health guiding foreign companies in registration for trading medicines and medicine materials in Vietnam and Circular No.10/2003/TT-BYT on December 16, 2003, guiding the foreign companies for registration on the operation of trading vaccines, medical-biological products with Vietnam).

- Company Profile (Appendix 2, Form 2 – Circular on amendment and supplement of a number of Articles of Circular No.17/2001/TT-BYT dated on August 01, 2001, of the Ministry of Health guiding foreign companies in registration for trading medicines and medicine materials in Vietnam and Circular No.10/2003/TT-BYT on December 16, 2003, guiding the foreign companies for registration on the operation of trading vaccines, medical-biological products with Vietnam).

- License for trading, exporting, and importing vaccines and/or biopharmaceutical of the competent authorities of the host country, for enterprises trading in, and licenses for the production of vaccines, biologicals, and GMP certificates issued by competent agencies Home country for the manufacturing company (original or notarized copy).

The above documents must be valid at the time of application for registration. During the operation period, if these documents expire, the enterprise must supplement the current account certificate of the enterprise at the bank of the host country (certified by the bank) (original).

II. Procedure for licensing issues for foreign companies to activate on vaccines and biopharmaceutical

Step 1: Enterprises send registration documents to the Drug Administration of Vietnam - the Ministry of Health;

Step 2: The Drug Administration of Vietnam receives and verifies documents and submits them to the approval Council for registration of foreign drug-related companies for approval and decision to license or not. In case of refusal, the Ministry of Health (the Department of Management and Administration) shall notify in writing the reason;

Step 3: Return results to the business;

III. Execution conditions

For newly registered businesses:

a. Being an enterprise operating in the production and trading of vaccines, biologicals, and raw materials for the production of vaccines and biologicals established in accordance with the law of the host country;

b. Only supply vaccines, biologicals, raw materials for the vaccine, and biological production into Vietnam in the form of import contracts through Vietnamese functional enterprises;

c. Full and valid registration profile;

d. If the manufacturer is a manufacturer, the manufacturer must satisfy GMP (Good Manufacturing Practice) standards, if it is a distributor, it must be an enterprise permitted to trade, export, import, and preserve vaccines and biologicals. and raw materials for the production of vaccines and biologicals issued by a competent authority of the host country;

e. Business experience and financial ability: Enterprises must have at least 3 years of experience in production and trading;

g. Commitment to strictly comply with the provisions of Vietnamese law and regulations on the management of vaccines and medical bio-products of the Ministry of Health of Vietnam. After being licensed, the foreign party is allowed to contract for vaccine trading vaccines, finished and semi-finished products, raw materials for the production of vaccines and biologicals with Vietnamese functional enterprises according to the regulations of the Ministry of Health and the provisions of Vietnamese law.

- Authority: The Ministry of Health

- The agency directly implements administrative procedures

- Settlement term: 30 working days