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Print articleIndonesia's New Regulation on Pharmaceutical Wholesalers
September, 2011 -
The Ministry of Health recently issued Minister of Health Regulation No. 1148/Menkes/Per/VI/2011 on Pharmaceutical Wholesalers, which replaces and repeals two earlier decrees. The new regulation is aimed at protecting the public from dangerous drugs and drugs materials as well as improving previous regulations on pharmaceutical drugs.
Under the new regulation, a Pharmaceutical Wholesaler Company can be established after obtaining a permit from the Director General of Pharmaceuticals and Medical Supplies. The term of the permit is valid for 5 (five) years. The new regulation allows a Pharmaceutical Wholesaler Company to establish a branch.
The requirements for obtaining a permit to establish a Pharmaceutical Wholesaler Company include having a taxpayer number (NPWP), a permanent Indonesian pharmacist, as well as storage room meeting the applicable requirements.
A Pharmaceutical Wholesaler Company and its branch are prohibited from selling retail drugs or drug materials and receiving a doctor’s prescription. A Pharmaceutical Wholesaler Company and its branch can, however, distribute drugs to pharmacies, pharmacy installations at hospitals, public health centers, clinics, and drug stores. Moreover, a Pharmaceutical Wholesaler Company must report its activities to the Director General of Pharmaceuticals and Medical Supplies on a quarterly basis.
Violations to the provisions of the Regulation are subject to administrative sanctions ranging from a simple warning to the revocation of the offender’s permit.
Under the new regulation, a Pharmaceutical Wholesaler Company can be established after obtaining a permit from the Director General of Pharmaceuticals and Medical Supplies. The term of the permit is valid for 5 (five) years. The new regulation allows a Pharmaceutical Wholesaler Company to establish a branch.
The requirements for obtaining a permit to establish a Pharmaceutical Wholesaler Company include having a taxpayer number (NPWP), a permanent Indonesian pharmacist, as well as storage room meeting the applicable requirements.
A Pharmaceutical Wholesaler Company and its branch are prohibited from selling retail drugs or drug materials and receiving a doctor’s prescription. A Pharmaceutical Wholesaler Company and its branch can, however, distribute drugs to pharmacies, pharmacy installations at hospitals, public health centers, clinics, and drug stores. Moreover, a Pharmaceutical Wholesaler Company must report its activities to the Director General of Pharmaceuticals and Medical Supplies on a quarterly basis.
Violations to the provisions of the Regulation are subject to administrative sanctions ranging from a simple warning to the revocation of the offender’s permit.
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