1. Post-Authorisation Safety Studies (PASS)

The main aims for initiating a PASS should include any of the following objectives:

• to quantify potential or identified risks, e.g., to characterise the incidence rate, estimate the rate ratio or rate difference in comparison to a non-exposed population or a population exposed to another medicinal product, and investigate risk factors, including effect modifiers;

• to evaluate the risks of a medicinal product used in a patient population for which safety information is limited or missing (e.g., pregnant women, specific age groups);

• to evaluate the risks of a medicinal product after long-term use;

• to provide evidence about the absence of risks;

• to assess patterns of medicines utilisation that add knowledge regarding its safety or appropriateness of risk management measures (e.g. information on indication, off-label use, dosage, co-medication or medication errors in clinical practice);