| THE MINISTRY OF PUBLIC HEALTH ------- | SOCIALIST REPUBLIC OF VIET NAM Independence - Freedom - Happiness ---------- |
| No: 30/2006/QD-BYT | Hanoi, September 30, 2006 |
DECISION
PROMULGATING THE REGULATION ON DATA SECURITY OF DRUG REGISTRATION RECORDS
THE MINISTER OF HEALTH
Pursuant to the June 14, 2005 Pharmacy Law;
Pursuant to the November 29, 2005 Intellectual Property Law;
Pursuant to 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 Intellectual Property Law regarding industrial property;
Pursuant to the Government's Decree No. 49/2003/ND-CP of May 15, 2003, defining the functions, tasks, powers and organizational structure of the Ministry of Health;
Pursuant to Official Letter No. 200/UB-VP of September 22, 2006, of the National Committee for International Economic Cooperation, notifying the results of negotiations with the United States on the protection of test data;
At the proposal of the Director of the Vietnam Drug Administration,
DECIDES:
Article 1.- To promulgate together with this Decision the Regulation on data security of drug registration records.
Article 2.- This Decision takes effect 15 days after its publication in "CONG BAO."
Article 3.- The director of the Office and the director of the Inspectorate of the Health Ministry, the directors of the Vietnam Drug Administration and the Preventive Medicine Department, heads of units under the Health Ministry, directors of provincial/municipal Health Services, and heads of concerned drug-trading establishments, testing establishments and medical treatment establishments shall implement this Decision.
| | MINISTER OF HEALTH Tran Thi Trung Chien |
REGULATION
ON DATA SECURITY OF DRUG REGISTRATION RECORDS
(Promulgated together with the Health Minister's Decision No. 30/2006/QD-BYT of September 30, 2006)
(Promulgated together with the Health Minister's Decision No. 30/2006/QD-BYT of September 30, 2006)
Chapter I
GENERAL PROVISIONS
Article 1.- Scope of regulation and subjects of application
1. Scope of regulation: This Regulation provides the order and procedures related to the security of data of drug registration records.
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