Guidance notes for patient safety and pharmacovigilance in patient support programmes

Many pharmaceutical companies run Patient Support Programmes (PSPs) to help patients or healthcare professionals or both better manage disease and optimise treatment. When conducting PSPs safety data may be generated relating to the use of a medicinal product. For the purposes of these guidance notes, the word ‘patient’ refers to any user of the medication.

It is imperative that patient safety is a priority in such programmes and that the marketing authorisation holder (MAH) is able to meet ethical, legal and regulatory obligations including pharmacovigilance (PV) requirements.