The State Pharmaceutical Inspection and the Office of Registration of Medicinal Products, Medical Devices and Biocidal Products are the institutions that ensure that the medicines sold in Poland are safe. Their tasks include the quality testing of products, storage conditions, and documentation.
The State Pharmaceutical Inspection supervises the conditions in which medicinal products are produced and imported. Marketing authorisations for medicinal products are issued by the Office of Registration of Medicinal Products, Medical Devices and Biocidal Products.
The State Pharmaceutical Inspection (PIF)
PIF monitors the quality of medicinal products, their trade in wholesale companies, pharmacies, hospital pharmacy divisions, limited service pharmacies, and other establishments.
Pharmaceutical inspectors also control the transport, reloading and storage conditions for medicinal products. They can issue decisions on suspending or cancelling the marketing authorisations of such products. PIF also issues permissions for running pharmacies.
Its work is supervised by the Main Pharmaceutical Inspector.
Decisions regarding medicinal products are published on www.gif.gov.pl.
The Office of Registration of Medicinal Products
The Office of Registration of Medicinal Products, Medical Devices and Biocidal Products issues marketing authorisation decisions for medicinal products. It runs a register of these products and provides information regarding e.g. the required documentation.
It is also authorised to issue permissions for conducting clinical trials. To this end, it runs the Central Register of Clinical Trials and Clinical Trials Inspection. It also monitors trials to ensure their compliance with the requirements of Good Clinical Practice.
In addition, the Office collects reports and information regarding adverse drug reactions and supervises the safety of medicinal product use.
At least once a year the Office publishes a list featuring the names of medicinal products and information regarding their form, qualitative composition, dispensing category, packaging dimensions, authorisation number, EAN UCC code, name of the entity responsible for marketing, and the name and country of the producer.
The Office also runs a website on adverse drug reactions: www.dzialanianiepozadane.urpl.gov.pl.
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