A Drug Establishment Licence (DEL) is a licence issued to a person in Canada allowing them to conduct licensable activities in a building which has been inspected and assessed as being in compliance with the requirements of Divisions 2 to 4 of the Food and Drug Regulations.
A person who wishes to fabricate, package / label, test, import, distribute, or wholesale in Canada a finished dosage drug or bulk process intermediate or wishes to fabricate, package / label, test or import in Canada an active pharmaceutical ingredient is required to hold a DEL.