Notice: Guidance document updates to reflect new fees and policies for April 1, 2020 

Date: March 16, 2020

In 2017 Health Canada began engaging stakeholders to revise fees and policies for regulatory activities related to human drugs, veterinary drugs, and medical devices. These revised fees and policies come into effect on April 1, 2020.

Affected guidance documents and forms have been updated accordingly (see list below). In particular, documents were updated to reflect the following changes:

Updated guidance documents are now available on the Health Canada website to inform stakeholders of new requirements effective April 1, 2020. Note that the previous guidance documents are still available for reference as they will continue to apply for submissions and applications filed prior to April 1, 2020.

Product Line Guidance/Policy Title
Human Drugs

Fees for the Review of Human Drugs and Disinfectant Submissions and Applications

Fees for the Right to Sell Drugs

Management of Drug Submissions and Applications

Management of Disinfectant Drugs Applications

Questions and Answers: Plain Language Labelling Regulations for Prescription Drugs

Questions and Answers: Plain Language Labelling Regulations for Non-prescription Drugs

Drug Identification Numbers for Schedule C Drugs (Radiopharmaceuticals and Kits)

Administrative Processing of Submissions and Applications Involving Human or Disinfectant Drugs

Post-Notice of Compliance Changes: Safety and Efficacy Document

Post-Notice of Compliance Changes: Framework Document

Guidance for Completing the Drug Submission Application Form

Fees for the Review of Human and Veterinary Drug Establishment Licence Applications

Guidance on Drug Establishment Licences (GUI-0002)

Management of Applications and Performance for Drug Establishment Licences (GUI-0127)

Medical Devices

Fees for the Review of Medical Device License Applications

Medical License Renewal and Fees for the Right to Sell Licensed Medical Devices

Management of Application for Medical Device Licenses

Fees for the Review of Medical Device Establishment Licence Applications

Guidance on Medical Device Establishment Licensing (GUI-0016)

Veterinary Drugs

Fees for the Review of Veterinary Drug Submissions and Applications

Fees for the Right to Sell Drugs

Management of Regulatory Submissions

Fees for the Review of Human and Veterinary Drug Establishment Licence Applications

Guidance on Drug Establishment Licences (GUI-0002)

Management of Applications and Performance for Drug Establishment Licenses (GUI-0127)

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