Pharmacovigilance is the science and activities relating to the detection, assessment, understanding and prevention of adverse reactions or any other medicine-related problem. The European Medicines Agency (EMA) coordinates the European Union (EU) pharmacovigilance system and operates services and processes to support pharmacovigilance in the EU.
Local requirementsIn France, pharmacovigilance is based on the national and European regulatory framework. The registration of a local Person Responsible for Pharmacovigilance (RPV) is required.
The RPV ensures that the obligations related to risk reduction actions and the implementation of post-authorisation safety studies are respected on the national territory. They are responsible for the effective provision of risk reduction documents.
To report a case of pharmacovigilance to Cevidra :
– By phone: +334 93 70 58 31
– By fax: +334 93 77 24 62
– By email: email@example.com
You can also download the declaration form cerfa_15031-04.pdf or make your declaration online here: Portail de signalement des événements sanitaires indésirables (social-sante.gouv.fr)