THE MINISTRY OF HEALTH
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SOCIALIST REPUBLIC OF VIETNAM
Independence- Freedom- Happiness
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No.17/2001/TT-BYT
Hanoi, August 01, 2001
 
IRCULAR
GUIDING FOREIGN COMPANIES IN REGISTRATION FOR TRADING IN MEDICINES AND MEDICINE MATERIALS IN VIETNAM
THE MINISTER OF HEALTH
Pursuant to the Law on People’s Health Protection of July 11, 1989;
Pursuant to Decision No. 113/CT of May 9, 1989 of the Chairman of the Council of Ministers (now called the Prime Minister) on management of import and export of medicines and medicine materials for making curative medicines for human beings;
Pursuant to the Statute on preventive and curative medicines issued together with Decree No. 23/HDBT of January 24, 1991 of the Council of Ministers (now called the Government);
Pursuant to Decree No. 11/1999/ND-CP March 3, 1999 of the Government prescribing goods banned from circulation, services banned from commercial business and goods and services subject to business restriction and conditional business;
Pursuant to Decree No. 57/1998/ND-CP of July 31, 1998 of the Government detailing the implementation of the Commercial Law on import, export, processing and sale and purchase agency activities with foreign countries;
The Ministry of Health of the Socialist Republic of Vietnam guides in detail the foreign companies in registration for trading in medicines and medicine materials in Vietnam as follows:
Chapter I
GENERAL PROVISIONS
Article 1.
1. As a special item of goods, medicine is the conditional business goods professionally controlled by the Ministry of Health of Vietnam. Foreign enterprises must register the activities concerning medicines and medicinal materials in Vietnam so as to ensure the imported medicines with good quality, safety and effect for the users.
2. The foreign enterprises who can satisfy the conditions stipulated in this Circular shall be issued the foreign companies’ operation license on medicines and medicinal materials ( hereinafter referred to as "License") by the Ministry of Health of Vietnam.
Article 2. Medicines and medicinal materials are stipulated in this Circular as follows:
- The medicinal materials include the materials, pharmaceutical material, excipients, capsules and immediate packing.
- The medicines includes pharmaceutical products and medicines made from medicinal herbs.
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