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Home Pharmacovigilance MA holders Electronic reporting Guidelines for electronic report
Guidance for electronic reporting PDF Print E-mail
Written by Eva Zubrová   

MA holders can electronically report an adverse reaction suspicion through: 

  1. web tool EVWEB for direct and safe access to EudraVigilance Veterinary (http://eudravigilance.emea.europa.eu/veterinary/). It is prefered way within European pharmacovigilance system.

  2. Portal (Gateway) - it is a packet of software which enable to MAH to concentrate all report in one place from which are then transferred to central EMEA database and to relevant competent authorities. Transfer of data is fully automatic and safe.

  3. ÚSKVBL accepts also electronic reporting using simplified internet template which can be fulfilled on-line on web page EudraVigilance Veterinary (http://eudravigilance.emea.europa.eu/veterinary/login.html).

The MA holders have to follow the guidance "Schemas for guidance on the electronic data interchange of safety data for veterinary medicinal products in the EU", which is published on web page EMEA:http://eudravigilance.emea.europa.eu/veterinary/reporting.html

Last Updated on Sunday, 26 July 2009 11:24