| THE MINISTRY OF HEALTH | SOCIALIST REPUBLIC OF VIETNAM Independence – Freedom - Happiness |
| No.: 05/2010/TT-BYT | Hanoi, March 01, 2010 |
CIRCULAR
GUIDING THE KEEPING OF CONFIDENTIALITY OF TRIAL DATA IN MEDICINE REGISTRATION
THE MINISTRY OF HEALTH
Pursuant to June 14, 2005 Law No. 34/2005/ QH11 on pharmacy;
Pursuant to November 29, 2005 Law No. 50/ 2005/QI-t]3, on Intellectual Property, which was amended and supplemented by June 19, 2009 Law N/£H 36/2009/QH12 Amending and Supplementing a Number of Articles of the Law on Intellectual Property;
Pursuant to the Government's Decree No. 188/20&HND-CP of December 27, 2007, defining the functions, tasks, powers and organizational structure of the Ministry of Health;
Pursuant to the Government's Decree No. 103/200-MND-CP of September 22, 2006, detailing and guiding the implementation of a number of articles of the Law on Intellectual Property on industrial property;
The Ministry of Health guides the keeping of confidentiality of trial data in medicine registration as follows:
Chapter I
GENERAL PROVISIONS
Article 1. Scope of regulation
1. This Circular guides the request and procedures for keeping confidentiality of trial data in medicine registration.
2. This Circular applies only to finished medicine products containing new active ingredients and does not apply to medicine materials.
Article 2. Subjects of application
This Circular is applicable to Vietnamese and foreign organizations and individuals that conduct medicine registration related activities in Vietnam.
Article 3. Interpretation of terms
In this Circular, the following terms and expressions are construed as follows:
1. Medicine means a substance or mixture or substances for human use for disease prevention, treatment or diagnosis or adjustment of physiological functions of human body, including finished medicine products, medicine materials vaccines and medical biological other than functional foods.
