A Correct Use of our Products for Patient Safety. One of our goals.
Pharmacovigilance encompasses the activities connected
with the ongoing evaluation of information on the safety
of medicinal products, with a view to guaranteeing that
they can be used by patients who need them with a
favourable risk-benefit ratio.
Pharmacovigilance emerged from the need to extend the
surveillance of the safety and tolerance of a drug even
after its discovery and development, in order to monitor
the effects when it is used on a large scale.
In adherence to the regulations in force, Menarini is
constantly engaged in the evaluation of reports of suspected
adverse reactions to the medicinal products present in
Europe, Africa, Asia, Central and South America.
This is why we have set up the Central Drug Safety Unit in
the Florence headquarters, to deal with the “centralised”
collection of the information originating from all the places
where the medicinal products of the Group are used.
Then, as regards abroad, each of our foreign affiliates
has a Local Drug Safety Unit which, pursuant to the
regulations in force in that country, gathers the data
relating to all the suspected adverse reactions which
come to its knowledge. It then proceeds to forward these
data in real time to the central unit of the Group, where all
the information is brought together in a global database.
This mechanism makes it possible to elaborate analyses
that enable a constant, ongoing risk-benefit analysis for
Whenever a variation in the safety profile is detected, the
specific corrective actions are decided and implemented.
Where particularly significant problems are identified,
it may even be decided to suspend production or to
withdraw the medicinal product from the market.