Establishment License Overview
All Canadian drug establishments need to have an Establishment Licence to manufacture, package, label, sell, distribute, wholesale, import a finished drug or bulk process intermediate drug. Establishment licenses are granted to Canadian-based companies. Also, fabricating, packaging, labelling, testing or importing an API (active pharmaceutical ingredient) requires an Establishment License for the respective activity. However, foreign sites that 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. They do not require an Establishment License.
- Health Canada charges a fee for the initial registration and an annual fee thereafter, depending on the activity.
- Health Canada 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.