Circular 7/tt-Byt: A Guide To The Registration Of The Foreign Company Is Allowed To Import And Export Drugs-Drug Materials With The Organization Of The Socialist Republic Of The Abbey.

Original Language Title: Thông tư 07-BYT/TT: Hướng dẫn việc đăng ký của các công ty nước ngoài được phép xuất nhập khẩu thuốc - nguyên liệu làm thuốc với các tổ chức công ty của nước Cộng hoà xã hội chủ nghĩa Việ...

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 guiding the registration of the foreign company is allowed to import and export drugs-drug materials with the Organization of the Socialist Republic of Vietnam to base the health protection law of the people's Socialist Republic of Vietnam (Chapter VI – article 38 of production management , circulation, export and import of drugs and raw materials);
Based on the Statute of the drug prevention, healing, issued according to the Decree of the Council of Ministers of the Socialist Republic of Vietnam/23 dated 24/1/1991 (Chapter VIII: export, import of medicines and raw materials);
Pursuant to decision No. 113/CT on 9/5/1989 of Chair of Council of Minister of the Socialist Republic of Vietnam on the unification of import-export management-mend materials (hereinafter referred to as the smoking-materials).
The Ministry of health of the Socialist Republic of Vietnam on the specific instructions of the registration of the foreign company organization (hereinafter referred to as foreign Parties) are allowed to import and export drugs raw material on the Organization of the Socialist Republic of Vietnam (hereinafter referred to as the Vietnam Party).
 
I. PURPOSE of the REGISTRATION of the drug prevention, healing for the people is a kind of special goods. Therefore, the foreign Party would like to practise in the field of smoking-ingredients for drugs in Vietnam are in accordance with the provisions of the law of Vietnam and must meet the condition of professional expertise. The registration for the foreign Party is one of the measures to manage and facilitate the development of sources of imported drugs, investing in the field of drugs-drug materials, quality assurance, safety for the user.
 
II. OBJECTS and CONDITIONS GRANTED REGISTRATION of every organization, foreign companies wanting to operate in the form of import-export contracts, venture on the drug-drug materials with organizations, companies of Vietnam must have a permit of the Ministry of health the country Vietnam.
Vietnam Ministry of health assigned responsibility for Service medicine-TTB in Vietnam Ministry of health review grant tracking registration practice of smoking materials of organizations, foreign companies.
Foreign parties want to register must satisfy the following conditions: 1. To implement its activities in the field of drugs-drug materials through the Vietnamese Side has the function of production, business smoking-Vietnam material (in the form of economic contracts, project collaboration, investing ...) fit the investment law of Vietnam.
2. is there a legal confirmation of the country on the right business, production, import and export of drugs-raw materials.
3. Have committed serious implementation of the regulations of the law of Vietnam and the regulation on the management of smoking-material of the Vietnam Ministry of health.
Once registered, foreign Parties are allowed to purchase the manufacturing venture in the field of smoking-material in Vietnam according to the regulations of the Ministry of health and other relevant sectors.
 
III. REGISTRATION PROCEDURES 1. Foreign parties want to register must submit to the Ministry of health (Pharmaceutical Services-TTB) following registration profile (1 a by Vietnamese, 1 a in English or French): business registration application in the field of smoking-material stating the purpose would sign, the range of activities after registration (form 1).
Active summary record (form 2) committed to enforce the regulations of Vietnam Paper certified by the State administration of the drug in the country (Ministry of health ...) on the right to operate the production, import and export business of smoking-material.
The relevant legal texts (documents prove the existence of foreign Parties, the certificate of the Bank on capital...)
2. During 60 days from the receipt of the record, the Department of health will inform the foreign Party his opinion. If registered, foreign Parties will be granted a license to have the registration number.
3. the validity of registration of foreign parties are specified in the license issued by the Ministry of health, SOCIALIST Vietnam, depending on the purpose and content of the activities of the foreign Party.
4. Upon receipt of the license, ngoàiphải water Party filed a fee (the Ministry of health will have specific announcements after the reunification with the Socialist Republic of Vietnam Finance Ministry).
5. When the license for foreign Parties, the Department of health will inform the Ministry of commercial, General Department of customs to co-ordinate import and export management according to their functions.
 
IV. RESPONSIBILITY Of FOREIGN PARTIES UPON REGISTRATION 1. Accepted the provisions of the law of Vietnam;
2. To comply with the terms set in the contract, the project was concluded with Vietnam, the party must obey regulations smoking-smoking materials of the Vietnam Ministry of health, ensuring the health benefits the people of Vietnam;
3. Have the responsibility to inform the Vietnam Ministry of health (Pharmaceutical Services-TTB) before 30 June of the following circumstances: change of name, location of the foreign party.
Change of Directors and persons responsible for the manufacture of smoking-material business.
Termination of business activities in drug manufacturing-raw materials of foreign parties in General and with Vietnam in particular.
4. Every year, from 25/12 to 31/12 foreign Parties must send a situation report of activities in the field of smoking-material with Vietnam about The medical (Pharmaceutical Services-TTB) 5. If the foreign Party violate the provisions of this circular, then depending on the level of violation will be handled in accordance with the law of Vietnam.

This circular in force from the date of signing and replaced the previous provisions contrary to the provisions of this circular.