Drug safety control


European Parliament and EU Directive 2010/84 / EU of 15 December 2010 – In the field of pharmacovigilance – Directive 2001/83 / EC the right to report directly on the adverse effects of substances (hereinafter – “ndl”). So far, only reports of confirmed cases by a health worker have been legally valid.

There have been many new solutions in the amendment to the provisions of the Pharmaceutical Law aimed at replacing the provisions of the above directive and thus improving the pharmacovigilance system, including expanding the range of people authorized to provide NDL. The decision to allow patients or their representatives or caregivers to report individual cases of adverse reactions is based on long-term observations and special pilot programs in several countries (UK, Netherlands, Scandinavia).

Programs that encourage patients to report NSD have shown that the information they receive complements the information they receive from physicians and pharmacists as the most direct and most interested in the effects of treatment. In addition, patients report a new, as-yet-unexplained NDL earlier than physicians, which is information that takes care of everyone first and foremost. They also pay attention to the symptoms that differ from doctors.


In the EU Directive 2010/84 / EU, an adverse drug reaction is any adverse and unexpected adverse drug reaction. The amended provisions of the Pharmaceutical Law imply that the adverse effects of a medicinal product must be equated not only with the adverse and unintended effects of the use of this product in the permitted manner, but also with the effects of misuse. use outside the conditions specified in the marketing permit, including misuse of the drug due to overdose or medical error in the use of the drug.

Note: we can talk about the side effects of the drug – an adverse reaction (ie the effect of the drug or the patient’s reaction) when considering the problem on the part of the drug used or on the part of the patient. This means that we can treat any adverse, disturbing, or even harmful reaction that occurs during or as a result of the use of one or more drugs as an adverse reaction. Sometimes this reaction can occur even after stopping treatment.