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Chief Pharmaceutical Inspectorate

Quality supervision

Out of numerous tasks of the State Pharmaceutical Inspection specified in the Pharmaceutical Law Act of 6 September 2001 (Journal of Laws 2008.45.271, consolidated text), the most important one for the protection of human health and life is the supervision over the quality of medicinal products. This task is carried out both at the voivodeship level by pharmaceutical inspectors from the 16 Voivodeship Pharmaceutical Inspectorates and at the state level by the services of the Chief Pharmaceutical Inspector.


The said supervision includes preventive measures within the quality of medicinal products, such as:

  • controlling the conditions of transport, reloading, and storage of medicinal products;
  • controlling pharmacies and other units conducting retail and wholesale trade in medicinal products;
  • controlling the proper labelling and advertising of medicinal products.

The direct control of medicines quality involves:

  • controlling the quality of magistral and officinal medicines prepared in pharmacies;
  • directing – by the Pharmaceutical Inspection – medicinal products approved for marketing in the Republic of Poland for the first time based on the act of law, for quality tests in specialised institutes and research laboratories;
  • directing medicinal products for tests as part of the State Scheduled Control, according to an approved schedule and control scope – medicines are sampled for tests at various units within all the voivodeships.

If controls and examinations result in reasonable suspicions that a medicinal product does not meet the relevant requirements, the authorities of the State Pharmaceutical Inspections issue respective decisions:

  • voivodeship pharmaceutical inspector – decision to withhold the trade in certain lots of the medicinal product within the inspector’s area of operations;
  • Chief Pharmaceutical Inspector – decision to withhold the trade in certain lots of a medicinal product within the entire country;

After making such decisions, the trade in specified lots of the medicines is withheld at all wholesalers and pharmacies until laboratory test results that confirm or rule out a quality defect are obtained.
If the test results confirm that the medicinal product does not meet the quality requirements, the Chief Pharmaceutical Inspector makes the decision to recall the medicinal product (or prohibit its marketing if the medicine has not been marketed yet).


In order to ensure medicine therapy safety, not directly related to the medicine quality itself but a reasonable suspicion that using the medicinal product leads to a serious adverse reaction, the law allows the Chief Pharmaceutical Inspector to issue a relevant decision.
This includes a decision to:

  • prohibit the marketing of this product temporarily;
  •  withhold the marketing of this product;
  • recall this product.

Such decisions are issued upon the request of the President of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products.
If a public health hazard related to medicinal products is possible, the Chief Pharmaceutical Inspector – upon the request of the Minister of Health or the President of the Office – makes a decision to prohibit the marketing of the product temporarily, withhold the marketing of the product, or recall the product.

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