This legal text contains specific measures on Local contact in Spain,
PSURs handling, Risk Management Plans, Suspected Adverse Reactions and
PAS.
Local contact:The MAH must have permanently and continuously available in Spain a contact person for pharmacovigilance Maintained,
and must communicate to AEMPS the contact details through an electronic
system provided for this purpose. MAH must communicate this information
the CA of the Autonomous Communities.
Periodic safety update reports (PSURs):
- The Submission of PSURs should be electronically using the enabled application for the time being New (https://enviotelematico.aemps.es/enviotelematico/psur/solicitud.do).
Risk Management Plans (RMPs):
- The RMP should be presented to AEMPS together with a summary in Spanish, according to the established format. New
Suspected
adverse reactions: Until functionality of Eudravigilance (EV), the MAH
will send information electronically to Fedra (Spanish database) and
AEMPS will forward it to EV.
adverse reactions: Until functionality of Eudravigilance (EV), the MAH
will send information electronically to Fedra (Spanish database) and
AEMPS will forward it to EV.
- Suspected serious adverse reactions which are known to the
MAH, which occurred outside the EU should be sent electronically to EV
by the MAH. New - Include the autonomous community information when reporting suspected adverse reactions. Maintained
- Report suspected adverse drug reactions for medicines in clinical research obtained through compassionate use. New
- Include in the notification of suspected adverse reactions the exposure as a descriptive and integrated Spanish text exactly as it was notified, and a summary in English. Maintained
Post-authorisation studies:
- In some circumstances, the autonomous communities will evaluate those applications of prospective post-authorization studies. A system of mutual recognition between the regions will be established. New
