SpTP from the viewpoint of pharmacovigilance (collection and provision of monitoring sheets, SAE reports, non-SAE by a doctor, pharmacist, distributor)?

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:

  1. filling of the CIOMS form (CIOMS%20form) and sending by post or e-mail (klinsekret@sukl_cz or tomas.boran@sukl_cz) or
  2. reporting via the electronic form, the note must include the text – medicine within SpTP