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GMP Establishment Licenses

The purpose of Establishment Licensing (for Drugs) and Site Licensing (for NHPs) is to ensure that manufacturers and other parties responsible throughout the continuum of distribution will comply with GMP. For medical devices, the goal of establishment licensing is to ensure compliance with the Medical Device Regulations.

For drug products, the following activities are subject to drug establishment licensing:
  • Fabricating
  • Packaging
  • Labelling
  • Testing
  • Importing
  • Distributing
  • Wholesaling

Click here for more information on drug establishment licensing.

 

For natural health products, the following activities are subject to NHP site licensing:
  • Fabricating
  • Packaging
  • Labelling
  • Importing

Click here, for more information on NHP Site Licensing.

 

For medical devices, the following activities are subject to Medical Device Establishment Licensing:
  • Importing
  • Distributing

Click here, for more information on Medical Device Establishment Licensing.

 

Contact us to find out more about our GMP Consulting Solutions or to receive a free copy of our white paper on marketing a healthcare product in Canada, click here.

 

"In case we missed saying it, sincere thanks for all the help in gaining our Establishment License."

Rob, General Manager
 

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