Chief Pharmaceutical Inspectorate

In accordance with the Pharmaceutical Law Act, each patient can report side effects of a medicinal product. A side effect of a medicinal product is each adverse and unintended effect of a medicinal product.

An authority that is competent in terms of pharmacovigilance, i.e. collecting reports and information on side effects, is the President of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products. If it is reasonably suspected that using a particular medicinal product causes a serious side effect changing the benefit to risk ratio, the Chief Pharmaceutical Inspector, upon the request of the President of the Office, makes a decision to prohibit the marketing of the product temporarily, to withhold the trade in the product, or to recall the product.

Where to report side effects of medicinal products?
The President of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products or the marketing authorisation holder.

Who can file a report?

• Patients, their statutory representatives, or de facto caregivers;
• Health care professionals.