Adverse Drug Reaction (ADR) reporting

What are Czech requirements for reporting serious adverse reactions and non-serious adverse reactions to MP?

Should suspicions on drug abuse , misuse or medication error of MP or generally off-label use of MP be reported in the case that these do not lead to adverse effects?

Reporting from post-authorisation studies – which information compiled during these studies should be reported to the SUKL or to the EV database within the terms of pharmacovigilance?

What should not be reported from the Patient Support Programme - PSP?

Reporting ADRs related to MP of biological origin