In accordance with the Circular No. 19/2014/TT-BYT dated June 02, 2014 of the Ministry of Health managing the addictive drugs, psychotropic drugs, and drug precursor substances.
Drugstores must not buy, sell raw materials or semi-finished products that contain addictive ingredients, psychotropic ingredients, or drug precursor substances.In accordance with this Circular, any drugstore that comply with GPP may retail commercial addictive drugs, commercial psychotropic drugs, commercial precursor drugs, commercial combined drugs that contain addictive ingredients, combined drugs that contain psychotropic ingredients, or combined drugs that contain drug precursor substances to outpatients.
Every drugstore that sells commercial addictive drugs must apply for a registration. Owners of drugstores and persons in charge of expertise are responsible for management and retailing of commercial addictive drugs. Holders of associate degrees in pharmacy or higher may manage and retail commercial psychotropic drugs and precursor drugs.
At the same time, any of the drugstores may buy commercial addictive drugs, commercial psychotropic drugs, and commercial precursor drugs; commercial combined drugs that contain addictive ingredients, commercial combined drugs that contain psychotropic ingredients, or commercial combined drugs that contain drug precursor substances from drugs exporters and importers, and from drug wholesalers.
Commercial combined drugs that contain addictive ingredients, commercial combined drugs that contain psychotropic ingredients, or commercial combined drugs that contain drug precursor substances on the list of OTC drugs promulgated by the Ministry of Health may be sold to patients without prescriptions. Information about customers must be recorded.
Besides, any facility that manufactures addictive drugs, psychotropic medicines, or drug precursor substances must comply with the regulations such as meeting standards of GMP applied to each dosage form for at least 02 years. With regard to personnel, keepers of addictive drug warehouses must have bachelor’s degrees in pharmacy and have worked for at least 02 years for drug manufacturers; keepers of psychotropic drug and precursor warehouses must have bachelor’s degrees or associate degrees in pharmacy and be authorized in writing by the head of the facility; employees in charge of log-keeping and reporting must have bachelor’s degrees in pharmacy and have worked for at least 02 years for drug manufacturers.
This Circular takes effect on July 15, 2014 and replaces the Circular No. 10/2010/TT-BYT dated April 29, 2010 and the Circular No. 11/2010/TT-BYT dated April 29, 2010.
Source: luatvietnam.vn
