Hospital Exemption


The purpose of the Hospital Exemption (HE) LVFS 2011:3 (in Swedish) is to provide an ATMP without marketing authorisation. HE is to be used in hospital when there is high unmet medical need and for an individual patient under the exclusive professional responsibility of a medical practitioner. This may include any ATMP manufactured under GMP:

  • On a non-routine basis
  • According to specific quality standards
  • On an individual patient basis
  • Used in the same EU member state.