Establishment Licensing

Establishment Licencing is covered by Division 1A of Part C of the Food and Drug Regulations. Since 1997, every manufacturer, packager, labeller, tester, and importer is required to apply for and maintain a Canadian Drug Establishment Licence. These Establishment Licencing requirements also apply to some distributors and wholesalers. DSA can help you determine if licencing requirements apply to you.

Required companies must apply to receive a Drug Establishment Licence (DEL). The application is received and processed by Health Canada in Ottawa before the application is routed to the local Regional Office and assigned to a Compliance Officer. The Compliance Officer then contacts the applicant to arrange for an Investigative Inspection. During the Inspection, the company is audited to ensure compliance with all required sections of Canadian Good Manufacturing Practices (GMP). The Compliance Officer will review Standard Operating Procedures (SOPs) and other related documentation and evidence to ensure that the firm has a strong grasp of their duties and responsibilities under Canadian GMP. Where needed, DSA can act as your Quality Control department to ensure that your firm meets the requirements which are set forth by the GMPs.

We work with our clients to ensure that they are prepared to handle an inspection. We review and/or prepare the required SOPs which will be subject to inspection and ensure that all required documentation is available to be reviewed. Because we handle so many inspections on behalf of our clients each year, we are always aware of the latest inspection trends so that we can ensure our clients are not caught off guard.

We work with the Health Protection and Food Branch Inspectorate (HPFBI) to represent the client during all licencing activities and routine GMP inspections. We also work with the Office of Controlled Substances (OCS) to handle applications for Narcotic and Controlled Drug licences and permits.

Contact us today to find out how we can help you apply for an Establishment Licence or prepare for your upcoming audit. For more information on services offered, click here to request a copy of our free brochure.

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