Abstract
The pharmaceutical industry operates in a highly regulated environment, imposing many specific requirements. In the European Union (EU), the production of medicines for human use is governed by mandatory European rules and directives requiring compliance with the principles and guidelines of Good Manufacturing Practice (GMP). In order to be admitted and started to be offered on the pharmaceutical market, the medicinal products must meet the requirements for quality, efficacy and safety. Bulgaria. The article examines and analyzes the registered under Art. 148, item 2 / art. 161, para. 2, item 1 of LMPHM qualified persons and under Art. 149 of LMPHM – Production Manager (RP) and Quality Control Manager (RKK). The distribution by education and the interrelation between the working qualified persons by sex and region for planning in Bulgaria, as well as between the regions for planning or the so-called statistical areas (NUTS-2) and number of storage facilities.
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