Drug Establishment License

All Canadian drug establishments are required to hold an establishment licence to fabricate, package, label, distribute, import, wholesale, or test a drug. Under Canadian Law, it is not permissible to fabricate, package/label, distribute, import or wholesale a drug; or perform tests, required under Division 2 of the Food and Drugs regulation, unless it is in accordance with the organization’s establishment licence.

Licensing Activities:

If your company fabricates, packages, labels, distributes, imports, wholesales, or tests a drug you must apply to receive a Drug Establishment Licence (DEL).

Once the application is received and processed by Health Canada in Ottawa it is sent to the local Regional Office for assignment to a Compliance Officer.

The Compliance Officer will contact the applicant and arrange for an Investigative Inspection.

The company is audited to ensure compliance with all required sections of Canadian Good Manufacturing Practices (GMP).

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Q&R Canada Inc. will represent your company during all licensing activities and routine GMP inspections by working with the Health Products and Food Branch Inspectorate.

Rely on Q&R Canada as your trusted partner for Canadian Regulatory Compliance. Working with you as your regulatory partner, we can and will provide exceptional, personalized and expert service as an integral component in building and protecting your company’s brand and profits.