Myth 1: Only serious cases are reportable
Both are reportable. The difference lies in the deadline: serious suspected adverse reactions must be reported within 15 days, non-serious ones within 90 days. GVP Module VI distinguishes between the deadlines, not the obligation.
Myth 2: This only concerns the pharmacovigilance department
The clock starts on the day anyone in the company becomes aware of the case — not only when the case reaches the specialist department. This makes sales, field force, customer service and reception part of the pharmacovigilance system.
The practical effect is unwelcome: a case that sits with the field force for two weeks arrives in the specialist department with half of its deadline already used up.
Myth 3: Without a confirmed diagnosis it is not a case
Four minimum criteria are sufficient for a reportable case: an identifiable patient, an identifiable reporter, a suspected adverse reaction and a medicinal product.
A confirmed diagnosis is not one of them. What matters is the suspicion of a possible causal relationship — not proof of it.
Myth 4: Known reactions do not need to be reported individually
Reactions already listed in the product information are also reported as individual cases. The frequency of a known reaction is itself safety-relevant information — and it can only be evaluated if the cases are available.
Myth 5: Incomplete information makes the report invalid
If the four minimum criteria are present, the report is valid. Missing details are added through follow-up.
The error in the other direction is the more costly one: holding back a case until it is complete and letting the deadline pass in the meantime.
Why this is more than detailed knowledge
Pharmacovigilance compliance begins with a correct understanding of these basics — among everyone who has customer contact, not only at the next audit. This is precisely why training for employees outside the specialist department is regularly examined during inspections.