Performance-linked access system

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.

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