Canadian Establishment Licenses: Drugs, Supplements and Medical Devices 2015

Key Topics

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

Who should Attend

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