Pharmacovigilance report – the system should be set by the SpTP submitter within the plan. The following system is recommended: Immediately report serious unexpected adversary effects = SUAE (within 7 days in case of death or threat to life +8 days for amending the report; other SUAE within 15 days); record unexpected effects and serious expected effects and send them within the Continuous Report. The person responsible for SpTP monitoring is obliged to report the above.
Form of the report:
- filling of the CIOMS form (CIOMS%20form) and sending by post or e-mail (klinsekret@suklcz or tomas.boran@suklcz) or
- reporting via the electronic form, the note must include the text – medicine within SpTP