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The current study analyses the regulatory inspection findings of the wholesalers in Bulgaria in 2017 and compares the results with the findings from some other EU member-states. In total, 48 GDP inspections were performed in 2017. 50% of the inspections were performed in relation with issuing an authorization for wholesale of medicines, the rest half were related to changes in already granted authorizations. During the inspections, 17 non-conformities (NCs) have been documented. The NCs were identified in 3 wholesalers and 6 deficiencies were classified as major. No critical deficiencies were found. NCs were found in 6.25% of the inspected companies. No critical NCs were identified and only 6 NCs were classified as major which demonstrated high level of compliance of distributions sites in Bulgaria with the requirements of GDP.

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