Pharmacovigilance

Definitions

Pharmacovigilance is a set of activities related to identification, assessment, understanding, prevention and procedure in case of adverse reactions, as well as new information about the medicinal product safety.

Adverse reaction is every response to a medicinal product which is noxious and unintended. This includes adverse reactions arising from use of the product within or outside (including overdose, off-label use, misuse, abuse and medication errors) the terms of the marketing authorisation or from occupational exposure.

Unexpected adverse reaction is an adverse reaction, the nature, severity or outcome of which is not is not consistent with the summary of product characteristics or the investigator’s brochure for medicinal products in clinical trials.

Adverse event is any unfavourable and unintended sign (including an abnormal laboratory finding), symptom or disease coinciding with the administration of a medicinal product, but not necessarily in any causal relation to it.

Serious adverse reaction/event is any adverse event or adverse reaction that is fatal, life-threatening, requires inpatient hospitalisation or prolongation of existing hospitalisation, results in persistent or serious disability or incapacity, including a congenital anomaly/birth defect and other medically significant conditions.

Qualified Person Responsible for Pharmacovigilance (QPPV) in the Republic of Croatia is a medical doctor specialised in clinical pharmacology, or a medical doctor, or a doctor of dental medicine, or a graduate pharmacist, or a master of medical biochemistry, or a doctor of veterinary medicine with two years of experience in pharmacovigilance or two years of experience in his/her profession with appropriately documented training in pharmacovigilance.