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 of 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 biologicals other than functional foods.
2. Active ingredient (also pharmaceutical active ingredient or pharmakon) means a substance or mixture of substance of substances having a therapeutic activity and used in medicine manufacture.
3. New active ingredient means an active ingredient which has never been permitted for circulation in Vietnam and not yet permitted for circulation in anywhere else in the world for 12 months counting back from the date of filing the application for registration of a medicine containing such ingredient in Vietnam.
4. Keeping confidentiality of data and trial data (below collectively referred to as keeping data confidentiality) means keeping confidentiality of pharmaceutical trial data in the process of medicine registration specified in Article 128 of the Law on Intellectual Property and Article 20 of the Government's Decree No. 103/2006/ND-CP of September 22, 2006, detailing and guiding the implementation of a number of articles of the Law on Intellectual Property on industrial property.
5. Circular on medicine registration means the Minister of Health's Circular No. 22/2009/ TT-BYT of November 24, 2009, on medicine registration.
Article 4. Responsibility to keep data confidentiality
The Vietnam Drug Administration is the agency responsible for keeping data confidentiality in medicine registration under this Circular.
Tìm kiếm
Thông tư 05/2010/TT-BYT hướng dẫn bảo mật dữ liệu thử nghiệm trong đăng ký thuốc do Bộ Y tế ban hành (Bản Word)