Canadian Establishment Licenses: Drugs, Supplements and Medical Devices

Karen Friedman
Karen Friedman
60 Minutes
Product Id:
6 months

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Price Details
$143 Recorded
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Overview of the different licenses for sites involved with exporting, importing and manufacturing of drugs, natural health products and medical marijuana to be provided. Specific focus will be on which information is required for the various types of facility licenses, for both Canadian and non-Canadian buildings involved in the pharmaceutical product supply chain. Sourcing of active pharmaceutical ingredient sources (API) must now be covered in some types of licensing, details will be provided on API requirements with examples using Health Canada’s required application forms.

Application processes and relevant fees, and Health Canada review times will be discussed for the various facility license processes. For those licenses that require a Health Canada pre-inspection, information will be provided for what to expect during a Health Canada inspection and how to prepare for a Health Canada pre-license inspection. Guidance on post-license activities, such as further inspections and license renewals will be covered during the webinar to assist those licensed facilities with ongoing compliance.

Seminar will also include some instruction on how to best use the Health Canada website for these licenses, and how to stay on track and receive the latest updates as they become available. An introduction to Health Canada’s newly proposed consultation document Consumer Health Products Framework will be introduced along with a brief discussion of its relevance to the current establishment license procedures in Canada.

Why should you Attend: Consumer goods such as over-the-counter drugs and natural health products (dietary supplements) may not be sold in Canada without prior receipt of a Health Canada drug establishment license or site license for the buildings involved with their import, manufacture and sale. This supply chain challenge is met by a combination of efforts amongst foreign exporters and Canadian importers. All who are involved should understand the Canadian requirements in order to ship consumer products such as over-the-counter drugs and natural health products to Canadian consumers without delay or obstacles.

Canadian facilities who are also interested in producing medical marijuana or importing medical marijuana to their licensed facilities would first need to understand which additional responsibilities are required under the Marijuana for Medical Purposes Regulations (MMPR) of Health Canada.

Areas Covered in the Session:

  • Drug Establishment Licenses (drug products)
    • Who requires a drug establishment license (DEL).
    • How to apply for a DEL and which documents are required.
    • Health Canada definitions for license holders and supply chain participants.
    • DEL application forms, procedures and DEL fees.
    • DEL pre-license inspections.
    • Significance of standard operating procedures (SOP).
    • Quality technical agreements.
    • DEL maintenance.
    • Applications for DEL amendments.
    • Foreign facility compliance requirements.
    • Which forms are required for drug establishment licenses.
    • Active pharmaceutical ingredients requirements for DEL.
    • Post license - inspection cycles, renewals
  • Site Licenses (natural health products)
    • How to apply.
    • Required documentation for site license applications
    • Post license - renewal of site licenses
    • Future changes for site license applications.
    • Product recall and sampling procedure expectations of Health Canada.
    • Marijuana for Medical Purposes Regulations in Canada.
    • Benefits of Health Canada’s website for compliance management and business opportunities

Who Will Benefit:
  • Regulatory Affairs
  • Quality Affairs and Quality Control
  • Consumer health care product marketing & sales groups
  • Compliance departments
  • Exporters of consumer health products to Canada.
  • Manufacturers of consumer health products for Canada.
  • 3rd party logistics
  • Supply chain management for pharmaceuticals and dietary supplements
  • Canadian distributors and wholesalers of consumer health products

Speaker Profile
Karen Friedman (Her Consulting), provides specialized regulatory affairs guidance for drug products, natural health products, foods and cosmetics intended for the Canadian market. Services include product and label compliance management, quality assurance leadership, and supply chain management.

K Friedman consulting has helped Canadian and international companies of all sizes successfully steer through the regulatory mazes that govern the sale of health products in Canada, enabling clients to get their products into Canadian without delay. Typical clients include raw material and finished product manufacturers, packagers and labellers of consumer health products and dietary supplements, Canadian importers and non-Canadian suppliers to Canada of dietary supplements and natural health products, third party logistic groups and distributors.

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