report an adverse event or product quality complaint

Pharmacovigilance (PV) is defined by the World Health Organisation (WHO) as “the science and activities relating to the detection, assessment, understanding and prevention of adverse effects or any other drug-related problem.”

The aims of pharmacovigilance are:

  • to enhance patient care and patient safety in relation to the use of medicines
  • to support public health programs by providing reliable, balanced information for the effective assessment of the risk-benefit profile of medicines


The WHO established its Programme for International Drug Monitoring in response to the thalidomide disaster detected in 1961. In close collaboration with the WHO “Collaborating Centre for International Drug Monitoring”, located in Swedish Uppsala, the WHO promotes PV at the country level.

At the end of 2010, 134 countries were part of the WHO PV program. Dafra Pharma has elaborated a pharmacovigilance system compliant to the current European guidelines with the aim to protect the health of our patients. By investigating the side effects, drug interactions and other drug related problems, Dafra Pharma contributes to global healthcare.
Adverse Events (AE) can be reported here, an AE is any undesirable experience associated with the use of a medical product in a patient.
When you want to report an AE, you need to provide us with the following information.

Patient info
Reporter's details