PHARMACOVIGILANCE SYSTEM

 

ALLERTEC HELLAS S.A., in order to follow with the Greek and E.E. regulations, maintains a Pharmacovigilance System in co-operation with Pharmassist L.td. who has been appointed responsible for the management of the system.
The System includes the Reporting and Management of the incoming Undesirable Effects, the Reporting to the Competent Authorities (EOF/EMA), the submission of Periodic Safety Update Reports (PSUR), the Surveillance of Scientific/Medical Bibliography, the Training, the Preparation and Submission of Risk Management Plan and the constant Surveillance of the Approved Products Safety Profile.
Through the constant surveillance of the system, the company guarantees the provision of safe drugs to the patients and therefore meets with its own requirements.
The Reporting of Undesirable Effects with regard to ALLERTEC HELLAS S.A. products can be done either through the “Yellow Card” of EOF, or through the 24 Pharmacovigilance Line in 210.65.61.435.