Circular No. 10/2003/tt-Byt: Guide The Foreign Company Registered Activity On Vaccines, Medical Products With Vietnam

Original Language Title: Thông tư 10/2003/TT-BYT: Hướng dẫn các công ty nước ngoài đăng ký hoạt động về vắc xin, sinh phẩm y tế với Việt Nam

Subscribe to a Global-Regulation Premium Membership Today!

Key Benefits:

Subscribe Now for only USD$20 per month, or Get a Day Pass for only USD$4.99.
CIRCULAR guide foreign companies register activity on vaccines, medical products with Vietnam.
_ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ pursuant to the law on people's health protection 30/6/1989 Charter base preventive medicine, healing, issued according to the Decree of the Council of Ministers of the Socialist Republic of Vietnam the number 23-dated 24/1/1991 pursuant to Decree No. 11/1999/ND-CP dated 3/3/1999 of the Government rules on goods prohibited the circulation , commercial services banned; goods, trade service limiting business, business condition based decision No 3922/2003/QD-BYT on 30/7/2003 by the Minister of Health issued the "regulation on the registration of vaccines, medical products To manage and facilitate the development of sources of imported vaccines , medical products, quality assurance, user safety, Ministry of health of the Socialist Republic of Vietnam Guide to the registration of the foreign company (hereinafter referred to as the parties) be allowed to trade in, import of vaccines, biological products and medical products vaccine production, raw materials, medical products through the company of the Socialist Republic of Vietnam (hereinafter referred to as the Vietnam party).
I. The OBJECT And CONDITIONS Of REGISTRATION 1. Audience: organizations, foreign companies wanting to operate in the form of import contracts with enterprises business Vietnam vaccines, biological products, semi-finished products and raw materials for the production of vaccines, biological.
2. registration conditions: 2.1. For a new subscription business: a. active business Is the production, trafficking, vaccine, vaccine production raw materials, products are established as required by the law.
b. providing vaccines, products, raw materials for the production of vaccines, products on Vietnam in the form of import contracts through the business functions of Vietnam.
c. registration records complete and valid d. If business is producing the production facilities must meet GMP standards (Good Manufacturing Practice), if the distribution business to business is allowed to trade, export, import, preservation of vaccines, vaccine production, raw material products by the competent authorities of the country.
e. business experience and financial capability: the business must have a minimum of 3 years experience in manufacturing, business.
g. committed to seriously implement the provisions of the law of Vietnam and the provisions on the management of vaccines, medical products of the Vietnam Ministry of health.
After being licensed, the foreign party is allowed to trade contracts vaccines, biological products and semi-finished products, raw materials for the production of vaccines, products with the business function of the Vietnam Ministry of Health's regulations and the provisions of the law of Vietnam.
2.2. For business registration: when the license expires, the business must do the registration and records must meet the following conditions:-during the operation no offense-profile full registration and valid II. REGISTRATION PROCEDURES 1. New registration records, including: 1.1. Application for registration of works in the field of vaccines, biological products, semi-finished products, raw materials for the production of vaccines, biological (model 1).
1.2. Company profile (model 2).
1.3. Sales, export and import vaccines, products of competent authority country for business trade and vaccine production licenses, birth, certificate of the competent authority for the country of production enterprise (original or certified copy).
The document must be valid at the time of registration, please. During operation if the document expires, the business must supplement.
1.4. the verification of current account business in country Bank (Bank confirmation) (original).
Registration includes 2 sets: 1 the original (English) and 1 set by Vietnamese notarized the documents referred to in item 1.3 of the clause.
2. Profile registration includes: 2.1. Application for registration (form 3).
2.2. Sales, export and import vaccines, products of competent authority country for business trade and vaccine production licenses, birth, certificate of the competent authority for the country of production enterprise (original or certified copy).
The document must be valid at the time of registration, please. During operation if the document expires, the business must supplement.
2.3. The paper to confirm the current accounts of the enterprise in country Bank (Bank confirmation) (original) 2.4. Activity reports (form 4) record registration includes 2 sets: 1 the original (English) and 1 set by Vietnamese notarized the documents mentioned in section 2.2 of this clause.
3. within 3 months from the receipt of complete and valid dossier, The tếsẽ review of medical license. No case level, the Ministry of health will notice in writing stating the reason.
4. license worth 2 years from the date of signing. Three months before the expiration date, if want to continue operating the business must do the procedure please register again as defined in section II. 2 of this circular. The registration documents must be valid at the time of applying for registration.
5. for cases of change of name, address, merger, corporate separation during the license term is still in use, they must inform the Ministry of health (the Department of preventive medicine and HIV/AIDS), accompanied by the relevant legal documents of the country (the original or a copy). The Department of health will consider and reply in writing. 
6. When the new registration or registration, business must file charges according to the current regulations and must complete the application and get a license within a period of 6 months from when the license is signed. So the time limit on, default license is no longer worth using.
III. RIGHTS And RESPONSIBILITIES Of FOREIGN ENTERPRISE REGISTRATION Of Vaccines, PRODUCTS And RAW MATERIALS For The PRODUCTION Of Vaccines, PRODUCTS With VIETNAM 1. Foreign enterprises have the right to:-the name is foreign Registrar when registering circulating vaccine product, biological products, products in Vietnam.
-Supply of vaccines, products, raw materials for the production of vaccines, products on Vietnam in the form of the contract with businesses to import function to import and export products of Vietnam, vaccine.
-Open scientific conferences, exchange of professional experience, the exchange of information and promotion of vaccine products, as required by the Ministry of health.
2. the foreign enterprise is responsible for:-serious observance of the provisions of the law of Vietnam and the Ministry of Health's regulations on the management of biological vaccines.
-Not be imported into Vietnam vaccines, products are not allowed to circulate, vaccines, poor quality products ...-not a direct distribution of vaccines, products in Vietnam under any form whatsoever.
-Bear full responsibility before the law of Vietnam, Vietnam's Ministry of health and consumers in quality products, vaccines were provided to Vietnam. Compensation for consumers and Vietnam partners in case of damage caused by the fault of the business to provide vaccines, biological cause as required by law.
-The annual report with the Vietnam Ministry of health (the Department of preventive medicine and HIV/AIDS) on the activities in the field of vaccines, medical products in Vietnam.
-Report to the Vietnam Ministry of health (the Department of preventive medicine and HIV/AIDS) and submit the relevant legal documents in the case: + the change manager, who is responsible for the operation of vaccines, products and raw materials for the production of vaccines, biological + termination of activities in the field of vaccines with Vietnam-born, foreign enterprises are responsible for unscheduled statements in the case: + When the agency requests

+ When discovered by the enterprise product offers in Vietnam did not meet quality standards, violated the professional rules + when the serious hazard due to the use of vaccines, products of the enterprise.
IV. Test, Inspection And HANDLING VIOLATION 1. Test, inspection: foreign enterprises are licensed works about vaccines, products and raw materials for the production of vaccines, products with Vietnam are subject to supervision as required by the law.
2. Handle violation: foreign enterprises are licensed works about vaccines, products and raw materials for the production of vaccines, products with Vietnam if the offense defined in this circular, then depending on the extent and nature of the violation will be dealt with according to the law If the damage compensation as required by law.
V. TERMS of ENFORCEMENT of the Ministry of health assigned responsibility for the Department of preventive medicine and HIV/AIDS work standing in the review of the registration level and directly monitor the activities of foreign companies in the field of vaccines, medical products in Vietnam.
This circular effect after 15 days from the date the quote and replace the circular No. 01/TT-BYT on 29/1/1997 of the Ministry of Health instructed the registration of the foreign company is allowed to import vaccines, born immune products with the company, organization of the Socialist Republic of Vietnam.

Related Laws