Chief Pharmaceutical Inspectorate

State Pharmaceutical Inspection:

• It operates under the Pharmaceutical Law Act of 6 September 2001 and the Counteracting Addiction Act of 29 July 2005;
• The Inspection supervises:
  • the conditions of the manufacture and import of medicinal products and veterinary medicinal products;
  • the conditions of the manufacture, import, and distribution of active substances;
  • the quality and marketing of medicinal products, excluding veterinary medicinal products;
  • the trade in medical devices, excluding medical devices for animal use – in order to protect the social interest in terms of the safety of human health and life when using medicinal products and medical devices available at pharmaceutical wholesalers, pharmacies, hospital pharmacy departments, limited service pharmacies, and non-pharmacy outlets.

The tasks of the State Pharmaceutical Inspection are executed by:

• the Chief Pharmaceutical Inspector as a central government administration authority, assisted by the Chief Pharmaceutical Inspectorate;
• a voivodeship governor assisted by a voivodeship pharmaceutical inspector.

The tasks of the Pharmaceutical Inspection (specified in detail in Article 109 of the Pharmaceutical Law) include:

• Conducting controls, inspections, and supervision as set forth in the Pharmaceutical Law and other acts of law;
• Collaboration with the pharmaceutical self-government and other self-governments as set forth in acts of law;
• Keeping appropriate registers, such as registers of pharmacies, wholesalers, manufacturers, and importers;
• Issuing opinions relating to pharmacies where internships can be undertaken;
• Supervising the quality of marketed medicinal products;
• Preparing annual control plans for pharmacies and pharmaceutical wholesalers and sharing them as part of the collaboration with the European Medicines Agency.