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:
- Revised fees
- Annual fee adjustment
- Fee reduction measures, including for small businesses, and fee exemptions
- Performance standards for specific fee lines
- Refunds for performance standards that are not met
- Fee payment/timing of payment
- Specific fee line changes
- “Pause the Clock” mechanism
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.
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Management of Regulatory Submissions
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