Regulation on Pharmaceutical Wholesalers

Minister of Health Regulation No. 1148/MENKES/PER/VI/2011 on Pharmaceutical Wholesalers (“Regulation”) has been issued to protect the public from dangerous drugs and drug materials. The Regulations is also aimed at improving the previous regulation regarding pharmaceutical drugs, which was out of touch with recent developments.

Article 1 sets out important key terms that will be used throughout the Regulation. The terms are, amongst others, pharmaceutical wholesalers (pedagang besar farmasi/PBF, as elaborated on in Article 1 (1)); PBF branch (as elaborated on in article 1 (2)); and proper drug distribution system (cara distribusi obat yang baik/CDOB, as elaborated on in Article 1 (5)). CDOB was not stipulated in the previous regulation regarding pharmaceutical wholesalers (Minister of Health Regulation No: 918/MENKES/PER/X/1993 on Pharmacy Wholesalers as Amended by Minister of Health Decree No: 1191/MENKES/SK/IX/2002 (“Previous Regulation”)