• New process type: “Transfer Scientific Advice”. Owners of Scientific Advice Regulatory Entitlements (Letters of Advice) are now able to transfer them automatically to another owner, similarly to the RPI transfer process. Only scientific advice entitlements can be transferred with this new automated process, which is necessary when the applicant for a follow-up scientific advice or protocol assistance is not the same of the initial advice. No fee is charged.
  • New process type: “Reassignment of notices for parallel distribution”. This new type of bulk change procedure is now available for Parallel Distribution. The procedure allows reassigning all notices for parallel distribution held by an applicant to a new owner, where as a result of a merger/acquisition the parallel distributor is dissolved, or the legal form has changed.  Applicants are invited to consult the updated FAQ and User guide for Parallel Distribution for more information. 
  • Applicants have to add at least one therapeutic area (top level MedDRA term / SOC) when requesting a new RPI.
  • The Regulatory Entitlements section in the Industry portal now shows the Entitlement Status (active, expired, withdrawn, etc.)