Bulgarian pharmacies inspection reveals serious infringements
This article was originally published in SRA
Pharmacies are operating without licences and are in frequent breach of dispensation conditions. In short, this is the summary of a recent inspection that the Bulgarian medicines agency (BDA) carried out in 48 pharmacies across the country. The inspections took place in July, late September and early October 2008.
During these inspections, the authority’s officials came across five pharmacies that offered medicines to patients without having an appropriate licence issued by the ministry of health. In addition, one of these "pharmacies" was found to be storing narcotic medicinal products for the distribution of which a separate licensing document is required according to Bulgarian law.
The authority also discovered a number of drug stores that were offering medicines that should only be available in pharmacies, for example drugs dispensed against a medical prescription. On numerous occasions prescription medicines where dispensed in pharmacies to patients without a prescription. Another problem highlighted by the authority was the frequent breach of storage conditions for medicines. This particularly concerned the storing of medicines under inappropriate temperatures.
Depending on the gravity of offences discovered, the BDA may launch an administrative procedure against the offender and impose financial penalties. The fine for the retail distribution of medicines without an appropriate licence amounts to BGN50,000 (€25,570), whilst the penalty for a breach of licensing conditions is in the region of BGN25,000-50,000. Drug stores that offers medicines that are only allowed to be dispensed in pharmacies may expect a fine of between BGN2,500-5,000. This amount, however, can be doubled for repetitive offenders. The agency has also advised patients to purchase their medicines from pharmacies that have appropriate licensing documents, which should be displayed in the outlet in a visible place.