Changing Establishment Licensing Fees for Human and Veterinary Drugs (DEL)

 In Regulatory Affairs

By: Teri Dickinson, Regulatory Affairs Group Manager, email

Starting April 1, 2020, new Drug Establishment Licensing (DEL) fees will come into effect. DEL fees for human drugs and veterinary drugs have increased.  The new DEL fee structure is a simpler fee scheme as compared to the current one.

The phase-in period for the implementation of new fees will be:

  • Human Drugs: 4 years
  • Veterinary Drugs: 7 years

Not only are the fees changing but the time at which you pay is also changing.  Once your submission has been accepted for further review an invoice will be generated and payment is required within 30 days.

There will be some changes to establishment licensing policies, including:

  • Updated DEL application form.
  • The new performance standard will be 250 days of Health Canada time for each application, for all application types. The only exception will be applications requiring a foreign on-site inspection.
  • The pause-the-clock policy will be implemented – this provides 30 business days to respond to deficiency notice and two opportunities to address any given deficiency
  • Guide-0127 offers more transparency about the process used by Health Canada to process DEL applications.

Fee calculations will depend on:

  • The number of domestic buildings on the application.
  • The most upstream activity at each domestic building.
  • Foreign buildings on the application (both FDF and API).
  • For new applications and new sites, the quarter of the Government of Canada fiscal year when the application was received (does not apply at Annual Licence Renewal).
  • Small business mitigation and fee exemption eligibility.

Need help sorting through the new policies?

Contact:
Dell Tech Laboratories
Teri Dickinson
Manager, Regulatory Affairs
519-858-5068
tdickinson@delltech.com


Dell Tech has provided professional, confidential consulting services to the chemical specialty industry in Canada, the USA, Europe and, Asia for the last 40 years. Contact us today for more information.

www.delltech.com

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