Chapter I: General provisions

Pharmacovigilance is carried out : 1° For medicinal products and for products which must be covered by the marketing authorisation provided for in article L. 5121-8, after this authorisation has been issued; 2° For the medicinal products mentioned in article L. 5121-12 and in II of article L. 5121-12-1, after the issue of the early access authorisation or the compassionate access authorisation, subject to the specific rules laid down for…

Pharmacovigilance includes: 1° The reporting of adverse reactions suspected to be due to a medicinal product or a product mentioned in article R. 5121-150, including cases of overdose, misuse, abuse and medicinal errors as defined in article R. 5121-152, as well as the monitoring of adverse reactions related to occupational exposure and the collection of information concerning them. In the case of medicinal products covered by a marketing authorisation or…

For the purposes of this chapter, the following definitions shall apply 1° “Adverse reaction”: a noxious and unintended response to a medicinal product or to a product mentioned in Article R. 5121-150 ; 2° “Serious adverse reaction”: an adverse reaction which is lethal or life-threatening, or which results in persistent or significant disability or incapacity, or which results in, or prolongs, hospitalisation, or which manifests itself as a congenital anomaly…