THE MINISTRY OF HEALTH
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SOCIALIST REPUBLIC OF VIET NAM
Independence - Freedom - Happiness
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No. 11/2010/TT-BYT
Hanoi, April 29, 2010
 
 
CIRCULAR
GUIDING ACTIVITIES RELATED TO PSYCHOTROPIC MEDICINES AND PRE-SUBSTANCES USED AS MEDICINES
THE MINISTRY OF HEALTH
Pursuant to the Government's Decree No. 188/2007/ND-CP of December 27, 2007, defining the functions, tasks, powers and organizational structure of the Ministry of Health;
Pursuant to June 14, 2005 Pharmacy Law No. 34/2005/QH11;
Pursuant to the Government's Decree No. 79/ 2006/ND-CP of August 9, 2006, detailing a number of articles of the Pharmacy Law;
Pursuant to December 19, 2000 Law No. 23/ 2000/QH10 on Drug Prevention and Fighting;
Pursuant to the Government's Decree No. 80/ 2001/ND-CP of November 5, 2001, guiding the control of domestic lawful activities related to drug;
Pursuant to the Government's Decree No. 67/ 2001/ND-CP of October 1, 2001, promulgating the lists of narcotics and pre-substances;
Pursuant to the Government's Decree No. 58/ 2003/ND-CP of May 19, 2003, providing for the control of import, export and transit via the Vietnamese territory of narcotics, pre-substances, habit-forming medicines and psychotropic medicines;
Pursuant to the Government's Decree No. 133/2003/ND-CP of November 6, 2003, adding a number of substances to the list of narcotics and pre-substances promulgated together with the Government's Decree No. 67/2001/ND-CP of October 1, 2001;
Pursuant to the Government's Decree No. 163/2007/ND-CP of November 12, 2007, renaming, adding, transferring or removing a number of substances on the list of narcotics and pre-substances promulgated together with the Government's Decree No. 67/2001/ND-CP of October 1, 2001;
The Ministry of Health guides activities related to psychotropic medicines and pre-substances used as medicines in Vietnam.
Chapter I GENERAL PROVISIONS
Article 1. Scope of regulation
1. This Circular guides activities related to psychotropic medicines and pre-substances used as medicines (below referred to as pre-substances) in the health sector and for analysis, testing and scientific research which are on the lists of psychotropic medicines (Appendices I and III) or the lists of pre-substances (Appendices II and IV) to this Circular.
2. Finished-product medicines with different active ingredients which contain psychotropic active ingredients or pre-substances combined with other active ingredients (other than habit-forming medicines, psychotropic medicines or pre-substances) with the content of psychotropic active ingredients or pre-substances equal to or smaller than the content specified in the list of combined psychotropic medicines (Appendix III) or the list of combined pre-substances used as medicines (Appendix IV) are free from being compliant with the provisions of this Circular, except Article 4; Point b, Clause 1, Article 7; Clause 2, Article 9; Clauses 1 and 3, Article 11; Clauses 2 and 4, Article 12; Article 15; and Clause 1, Article 20.

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