ABSTRACT
The concept of postmarketing surveillance and vigilance for medicinal products became of utmost importance after discovering, in the early 1960s, congenital anomalies in children whose mother had used thalidomide during the rst months of pregnancy, although the product had fullled extensive toxicity and premarketing clinical studies [1]. In 1968, the World Health Organization decided to set up a pilot international project aiming at developing a system, applicable internationally, for detecting previously unknown or poorly understood adverse effects of medicinal products. This program was the basis of what is known today as pharmacovigilance. For nonmedicinal products, postmarketing vigilance programs were considered only later as the risk to cause serious adverse reactions was incomparably much lower.
