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Chief Pharmaceutical Inspectorate

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Inspection Department

  • supervising the conditions for the manufacture and import of medicinal products, the conditions for the manufacture of advanced therapy medicinal products - hospital exceptions, the conditions for the manufacture, import and distribution of active substances;
  • supervising the conditions of wholesale trade in medicinal products and intermediation in wholesale trade in medicinal products;
  • conducting general and ad hoc inspections at entrepreneurs manufacturing or importing medicinal products; manufacturing of advanced therapy medicinal products - hospital exceptions; manufacturing, import and distribution of active substances; dealing with wholesale trade in medicinal products and dealing with intermediation in wholesale trade in medicinal products;
  • conducting inspections and securing medicinal products and active substances intended for disposal in entities subject to the supervision of the Inspection Department under the Act on counteracting drug addiction;
  • carrying out inspections at the request of the manufacturer or importer, the competent authority of the EU or EFTA, the European Medicines Agency, the European Commission in order to assess the conditions for the manufacture of medicinal products or the conditions for the manufacture, import and distribution of active substances in the territory of the Republic of Poland or in third countries;
  • conducting inspections upon request in order to assess compliance with the requirements of Good Manufacturing Practice of manufacturers, importers and distributors of excipients used in the manufacture of medicinal products;
  • supervision and maintenance of registers and records, including the Register of Manufacturers and Importers of Medicinal Products, the National Register of Manufacturers, Importers and Distributors of Active Substances, the Register of Pharmaceutical Wholesalers and entering data into the European EudraGMDP database;
  • keeping the National Register of Intermediaries in the Trade in Medicinal Products, supervision over the National Register of Permits to Operate Public Pharmacies, Pharmacy Points and the Register of Authorizations Granted to Operate Hospital and Company Pharmacies;
  • conducting explanatory proceedings in the event of a suspected quality defect or falsification of a medicinal product, if they concern an entity holding a manufacturing or import authorization issued by the Chief Pharmaceutical Inspector;
  • conducting explanatory proceedings in the event of a suspected quality defect or falsification of an active substance, if they concern an entity entered in the National Register of Manufacturers, Importers and Distributors of Active Substances;
  • conducting proceedings related to applications for:
  1.           granting or amending an authorization to manufacture or import medicinal products
  2.          granting or changing consent for the manufacture of advanced therapy medicinal products - hospital exceptions
  3.          entry or change of entry in the National Register of Manufacturers, Importers and Distributors of Active Substances
  4.          granting or amending a permit to operate a Pharmaceutical Wholesale Store
  5.          entry or change of entry in the National Register of Intermediaries in Medicinal Products

 

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