Pharmacovigilance is both medicinal product monitoring and further to the product use, undesirable effects risk prevention whether this risk is potential or verified.
It is based on :
· Collection of side effects is based on spontaneous declaration by healthcare profesionnals, patients, patient associations and pharmaceutical company staff, with the support of the 31 local pharmacovigilance centres.
· Data registration and assessment
· Survey organisation, risk analysis studies, participation to risk management plan organisation and followup.
· Further to data collection, evaluation of medicinal product use safety profile
· Management of corrective actions (warning or use restriction, contraindications, even product market withdrawal), communication with healthcare professionals and the public.
· Communication and distribution of any medicinal product information on safe use
· Participation to public health policy fight against medicinal iatrogenic risk.
Pharmacovigilance is based on national and European legislation : laws, decrees, directives, good pharmacovigilance practices legally published.
To declare a pharmacovigilance case to OHRE Pharma pharmaceuticals, here are the different options :
· By phone: +33 (0)2 46 10 29 71
· By fax: +33 (0)2 46 10 78 26
· By email: firstname.lastname@example.org
For fax or email notifications, you can use the form available on the hereunder link:
or declare on line using the following link: