Terms and concepts

Based on the Technical Code of the Practice TCP 564-2015 (33050) "GOOD PHARMACOVIGILANCE PRACTICE (GVP)"

Pharmacovigilance system is a system used by the marketing authorisation holders and authorized bodies of states to carry out tasks and responsibilities for pharmacovigilance, and intended to control the safety of medicines, to detect timely all changes in the assessment of the "benefit-risk" ratio of medicines, to develop and implement measures when the benefits exceed the risk.

Adverse reaction: A response to a medicinal product which is noxious and unintended. Response in this context means that a causal relationship between a medicinal product and an adverse event is at least a reasonable possibility. Adverse reactions may arise from use of the product within or outside the terms of the marketing authorisation or from occupational exposure. Conditions of use outside the marketing authorisation include off-label use, overdose, misuse, abuse and medication errors.

Adverse event: Any untoward medical occurrence in a patient or clinical trial subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment . An adverse event can therefore be any unfavourable and unintended sign (e.g. an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.

Unexpected adverse reaction: An adverse reaction, the nature, severity or outcome of which is not consistent with the summary of product characteristics or Investigator’s Brochure for the non-authorised medicinal product.

Misuse of a medicinal product: Situations where the medicinal product is intentionally and inappropriately used not in accordance with the authorised product information.

Consumer: A person who is not a healthcare professional such as a patient, lawyer, friend or relative/parent/child of a patient.

Serious adverse reaction: An adverse reaction which results in death, is life-threatening, requires in-patient hospitalisation or prolongation of existing hospitalisation, results in persistent or significant disability or incapacity, is a congenital anomaly/birth defect or require intervention to prevent one of the other outcomes listed above. Any suspected transmission via a medicinal product of an infectious agent is also considered a serious adverse reaction.