Drug Establishment License Overview
Drug Establishment licenses are granted to Canadian-based companies. Also, fabricating, packaging, labelling, testing, or importing an API (active pharmaceutical ingredient) requires a Drug Establishment License for the respective activity. However, foreign sites that fabricate, package, label drugs must be annexed to a Canadian importer’s Drug Establishment License. Annexing to their license is an attestation of GMP compliance.
- Warehousing and storing of drugs are not considered licenseable 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.