How To Report An Undesirable Effect?

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: pharmacovigilance@ohre-pharma.com

For fax or email notifications, you can use the form available on the hereunder link:

Download the declaration form

or declare on line using the following link:

http://ansm.sante.fr/How-To-Declare-a-side-effect/