Chief Pharmaceutical Inspectorate

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

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

After the above decisions are issued, the trade in specified lots of a particular medicinal product are withheld at all wholesalers and pharmacies until laboratory test results that confirm or rule out the quality defect are obtained.

Decision to recall a medicinal product
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.  The above decision can also be taken upon the request of the marketing authorisation holder in relation to its own decision, upon the request of the President of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products if the use of the medicinal product leads to serious side effects, as well as upon the request of the Minister of Health or the President of the Office if there is a public health hazard.

A medicinal product recalled based on the Chief Pharmaceutical Inspector’s decision cannot be marketed. All the rules governing the recall of medicinal products have been set forth in the Regulation of the Minister of Health of 12 March 2008 on the Specification of Detailed Rules and Mode of Withholding and Recalling Medicinal Products and Medical Devices (Journal of Laws 2008.57.347).
In addition, in the computer systems of pharmacies, the withheld/recalled medicinal product is blocked by a special computer program as part of the Nationwide Health Care System (Ogólnopolski System Ochrony Zdrowia, OSOZ), which makes it impossible to sell the medicinal product.
 
Announcements of the Chief Pharmaceutical Inspector
Pursuant to Article 121(3b) of the Pharmaceutical Law Act of 6 September 2001, if it is reasonably suspected that a medicinal product has a quality defect or has been falsified, which constitutes a serious public health hazard, the Chief Pharmaceutical Inspector – within 24 hours – issues an announcement to inform the patients of the possibility to return the medicinal product to the pharmacy. The announcement is published in the Electronic Official Journal of the Minister of Health and contains information about the suspected quality defect or falsification of the medicinal product and related hazards.