Pharmacy Practice 2017/2018
PharmDr. Tünde Ambrus, Ph.D., Department of Applied Pharmacy, ambrust@vfu.cz
PHARMACEUTICAL INDUSTRY AND WHOLESALING
LOGISTICS IN THE PHARMACY
Medicinal products in most European countries reach the patients by this classic distribution chain:
Manufacturer (producer) > Wholesaler (distributor) > Pharmacy > Patient
PHARMACEUTICAL INDUSTRY
The function of the industry (manufacturers):
 mass producing of pharmaceutical products
Good Manufacturing Practice (GMP)
Basic requirements of quality: European Pharmacopoeia
Pharmaceutical industry
 contact with wholesalers
 contact with pharmacies
PHARMACEUTICAL DISTRIBUTION
Possible ways of distribution:
 Direct distribution
 Indirect distribution
Types of wholesalers:
 Full-line wholesalers
 Short-line wholesalers
 Specialized wholesalers
Wholesaler’s obligations
The basic obligations of the holders of a wholesale dealing authorisation are defined by the directive of the
European Community 2001/83/EC.
PHARMACEUTICAL DISTRIBUTION IN THE CZECH REPUBLIC
National legislation:
 Act on Pharmaceuticals No. 378/2007 Coll.
 Health Ministry Decree on Manufacture and Distribution of Pharmaceutical No. 229/2008 Coll.
 Methodical instructions of national medicine agencies
Authorisation for wholesaling is issued by:
 human medicinal products: State Institute for Drug Control (SÚKL)
 veterinary medicinal products: Institute for State Control of Veterinary Biologicals and Medicines
(ÚSKVBL)
Pharmacy Practice 2017/2018
PharmDr. Tünde Ambrus, Ph.D., Department of Applied Pharmacy, ambrust@vfu.cz
LOGISTICS IN THE PHARMACY
Ordering – possible forms:
 via internet
 by phone
 in written form
Receipt of the delivery
- confirmation of receipt
- control of the delivery
Medicine storage in the pharmacy
- basic sources and rules (Decree on Good Pharmacy Practice, Pharmacopoeia, marketing authorisation)
- storage conditions
- separate storage
 separately from human medicines: veterinary medicines, medical devices, other products
 separately, marked: medicines after date of exspiration, defective packages, unusable medicines
Control activities
 storage conditions
 exspiration
 batches with quality defects
 documentation