State Pharmaceutical Inspection

State Pharmaceutical Inspection

The mission of the Chief Pharmaceutical Inspectorate is to ensure the safety of patients through supervising and controlling the manufacture of and trade in medicinal products.

State Pharmaceutical Inspection supervises the conditions of manufacture and import of medicinal products for human and veterinary use, as well as the quality of and trade in medicinal products and medical devices, except devices for veterinary use, in order to secure the public interest within the scope of health and life of the citizens using medicinal products and medical devices from pharmaceutical wholesalers, pharmacies and pharmacy outlets.

The tasks of the Pharmaceutical Inspection are specified in the Act of 6 September 2001 - Pharmaceutical law. The Pharmaceutical Law is enforced by following entities:

  • Chief Pharmaceutical Inspector, as the central government administration authority with the assistance of the Chief Pharmaceutical Inspectorate with its office in Warsaw,
  • governors with the assistance of voivodship pharmaceutical inspectors as managers of the voivodship pharmaceutical inspection included in the integrated voivodship administration. The tasks of the Pharmaceutical Inspection are fulfilled by 16 pharmaceutical inspectors located in each voivodship.

Tasks of the State Pharmaceutical Inspection

Tasks of the State Pharmaceutical Inspection include, in particular:

  • controlling the conditions of manufacturing of medicinal products as well as, transport, handling and storage of medicinal products and medical devices,
  • supervising the quality of medicinal products and medical devices that are subject to trade,
  • controlling pharmacies and wholesalers of medicinal products and medical devices,
  • controlling the quality of magisterial and officinal formulas prepared in pharmacies,
  • controlling whether medicinal products are properly labelled and advertised, and whether medical devices are properly labelled,
  • controlling the trade in narcootics, psychotropic substances and precursors of the I-R group,
  • cooperating with a team of specialised pharmacy consultants,
  • giving opinions on the suitability of premises intended for pharmacy and pharmacy outlet,
  • cooperating with the Pharmacy Chamber  and other relevant Chambers,
  • maintaining a register of public pharmacies, hospital pharmacies, and pharmacy outlets,
  • maintaining the Register of Wholesalers and Manufacturing/Importing Sites.

Within the scope described above, the Inspection is authorised to issue administrative decisions.