A license to fabricate (manufacture), package, label, test, import, distribute or wholesale a finished drug or bulk process intermediate drug. As well, fabricating, packaging, labeling, testing or importing an API (active pharmaceutical ingredient) requires an Establishment License for the respective activity.
Establishment licenses are granted to Canadian based locations. However, foreign sites who fabricate, package, label drugs must be annexed to a Canadian importer’s Establishment License. Annexing to their license is an attestation of GMP compliance.
Warehousing and storing of Drugs are not considered licensed activities and, as such, do not require an Establishment License.
Depending on the activity, Health Canada charges a fee for the initial registration and an annual fee thereafter.
Health Canada also conducts routine inspections of sites that hold an establishment license to verify they are following Good Manufacturing Practices (GMP) as per Division 2 of the Food and Drug Regulations.
Quality Smart Solutions can register your facility for an Establishment License including annexing foreign sites to Canadian import license holders.