EBE comments on the regulation on Advance Therapies

28 Mar 2013

The paper identifies 6 consultation topics:

  • Marketing authorisation application requirements for advanced therapy medicinal products
  • Requirements for combined advanced therapy medicinal products
  • Hospital exemption
  • Incentives
  • Scope: elements that could be considered to ensure that the scope of the Regulation takes account of technical progress 
  • Additional comments

EBE comments on the regulation on Advance Therapies

EBE paper on Hospital Exemption

Joint industry letter of 17 December 2012