Analysis of good distribution practice inspection deficiency data of pharmaceutical wholesalers in Malta

Abstract

The EU Good Distribution Practice (GOP) guidelines apply to manufacturers, wholesalers and other actors involved in the distribution of medicinal products. The revised GOP guidelines of the European Union were published on 8 March 2013 and became effective six months later, nineteen years after the previous publication of 1 March 1994. The revised guidelines brought about the much-needed changes in requirements to better reflect the complex distribution networks in supply chains and to be in line with Directive 2011 /62/EU to prevent falsified medicinal products from entering the legal supply chain. These guidelines were later replaced by the 2013/C .343/01 guidelines of 5 November 2013 in order to correct two factual mistakes.