Farmacovigilanza

In the pharmaceutical industry the Pharmacovigilance service has the task of gathering all information regarding the safety of the active principles of the medicines it is responsible for, from their authorization to their launch on the market (AIC) to improve the way of using them and reduce, where possible, the risk of side effects.

To this end the Pharmacovigilance service gathers and analyzes all reports of adverse reactions spontaneously provided and passes them on to the competent authorities in order to supply them with information needed to safeguard the health of patients.

Furthermore the Pharmacovigilance service makes sure that all information related to the safety of medicines be rapidly brought to the attention of health personnel.

Who should report?
Health operators (doctors, pharmacists)

Any citizen may report the side effects of a medication to his/her doctor and ask him/her to inform the competent authorities of adverse reactions directly or to contact us It is also possibly to report directly to the competent authorities.

How to report?
By filling out a special form:
Health operator (pdf) (different depending on country). 

When to report?
When there is the suspicion (or reasonable doubt) that a medication is the cause of the adverse reaction.

The pharmacovigilance service for the medical products distributed by the company Ibisqus (sales agent) is carried out by the respective people responsible in the AIC. It is possible to contact the company by clicking on the following link:

Information and Reporting IBI

Information and Reporting IBIGEN

Modules for Reporting (all languages):

Module for Reporting for the Czech Republic