Drug Establishment Licenses

Since 1997, every manufacturer, packager, labeller, tester, and importer in Canada is required to apply for and maintain a Canadian Drug Establishment Licence in order to carry out activities in Canada. The Canadian Establishment Licensing requirements also apply to some distributors and wholesalers. DSA Consultants can help you determine if licensing requirements apply to you. It is important to note that foreign companies who want to sell their drug products in Canada, must ship their products directly to the designated Canadian importer who is licensed by Health Canada. It is a violation of the Canadian Food and Drugs Act (FDA) for foreign companies to ship products directly to Canadian retailers. If you don’t have a Canadian Importer, DSA Consultants can refer you to our network of licensed establishments.

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.

A DSA GMP Consultant works with our clients to ensure that they are prepared to handle an inspection. Our GMP Consultants will 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 prepared.

DSA Consultants work with the Health Protection and Food Branch Inspectorate (HPFBI) to represent the client during all licensing 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 marketing a therapeutic product in Canada, please request a copy of our white paper.