A performance-linked access system is a system used to minimise known safety risks of a medicine, once it is on the market. These systems guide prescribing, dispensing, and use of the medicine.
They are put in place when products have significant or unique benefits in a particular patient group or condition, but when unusual risks also exist, such as irreversible disability or death. These systems can include:
- prescription only by specially certified healthcare practitioners,
- product dispensing limited to pharmacies or practitioners that are specially certified,
- product dispensing only after patients have, for example, undergone certain laboratory tests.