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DRUGS


DRUG ESTABLISHMENT REGISTRATION

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.

MEDERA 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.

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.

If medical device licenses are required for your products, MEDERA will work with you to determine product registration requirements.

For drug products, the following activities are subject to drug establishment licensing:

  • Fabricating
  • Packaging
  • Labelling
  • Testing
  • Importing
  • Distributing
  • Wholesaling

To find out more about marketing a therapeutic product in Canada, please click here. to receive a copy of our free white paper. To find out more about using our Regulatory Affairs Services for Drugs, please contact us for more information.