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Chief Pharmaceutical Inspectorate

The competence of the Chief Pharmaceutical Inspector

The mission of the Chief Pharmaceutical Inspector is ensuring the safety of patients by supervising the manufacture and marketing of medicinal products.

  • The Chief Pharmaceutical Inspector, as a central government administration authority, manages the State Pharmaceutical Inspection and performs tasks with the help of the Chief Pharmaceutical Inspectorate;
  • The Inspector is appointed and dismissed by the President of the Council of Ministers upon the request of the minister in charge of health, as well as is supervised by the minister in charge of health;
  • The Inspector constitutes an appeal authority for matters related to the performance of the tasks;
  • and responsibilities of the Pharmaceutical Inspection (the Inspector acts as a second instance authority in relation to the decisions of voivodeship pharmaceutical inspectors);
  • The Inspector acts as a first instance authority for matters specified in the Pharmaceutical Law Act;
  • Together with the Voivodeship Pharmaceutical Inspectorates it forms the State Pharmaceutical Inspection, the tasks of which are described here.

Key tasks of the Chief Pharmaceutical Inspector

  • The Inspector determines the course of actions of the Pharmaceutical Inspection as well as coordinates and controls the performance of tasks by voivodeship pharmaceutical inspectors;
  • The Inspector supervises the conditions of the manufacture of medicinal products for human and veterinary use, collaborates with competent Pharmaceutical Inspections of third countries, including the EU Member States;
  • The Inspector makes sure that manufacture and wholesale distribution are subject to inspections;
  • The Inspector supervises the compliance with the Pharmaceutical Law Act in terms of advertising pharmacies and medicinal products;
  • The Inspector issues decisions within the scope described here;
  • The Inspector issues licences within the scope described here;
  • The Inspector issues permits for import, export, intra-Community supply, or intra-Community acquisition of narcotic drugs and psychotropic substances, as well as permits for import and export of category 1 precursors;
  • The Inspector supervises the manufacture, processing, reprocessing, storage, marketing, and destruction of narcotic drugs, psychotropic substances, and category 1 precursors by controlling the performance of the obligations resulting from Regulation 273/2004, Regulation 11/2005, and the Counteracting Addiction Act.

 

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