Early Access – PIM and EAMS

Executive Summary

  • PIM and EAMS provide early access to medicines that are not yet available as licensed treatments access for seriously debilitating or life-threatening conditions
  • It is a two-step process:
    • PIM designation – valid indefinitely
    • EAMS scientific opinion – valid for one year but can be renewed
  • This section guides you through the application process, with downloadable templates to facilitate your submission, and highlights the advantages and disadvantages of obtaining a PIM and/or EAMS on your overall market access strategy