In accordance with Federal Law No. 61-FZ dated 12.04.2010 “On Drug Circulation”: “In the order established by the authorized Federal Executive Body, subjects of drug circulation are obliged to report to the authorized Federal Executive Body about side effects, adverse reactions, serious adverse reactions, unforeseen adverse reactions when using drugs…”
WHY IS IT IMPORTANT TO REPORT ADVERSE REACTIONS?
- responsibility for the patient’s health and safety;
- compliance with the requirements of international legislation and the legislation of the Russian Federation;
- for additional information about the drug (may entail the need to amend the instructions or withdraw the medicinal product from the market);
- legal component — litigation and fines against the MA Holder in case of non-compliance with pharmacovigilance legislation;
- safe products — reliable business.
The purpose of pharmacovigilance is to identify, evaluate, understand, prevent adverse reactions or other problems associated with drug use.
Patient safety is one of the main priorities of AlPharma LLC, therefore our company pays great attention to pharmacological safety.
You can report an adverse event/reaction (side effect) when using a drug of AlPharma LLC by: