2022-06-27 08:00:25
The Regulatory Registration Process (REP) facilitates the filing and processing of regulatory information related to:
- a company
- a file and a product
- regulatory activity
- a regulatory transaction
The PIR consists of web templates that capture information in a structured format. The PIR templates replace existing Health Canada forms, such as the HC-SC3011 Drug Submission Form, and the Human Drug Submission Fee Form.
This process helps move towards a common intake process for all product lines and allows Health Canada to:
- receive a wider range of regulatory information through the Common Electronic Application Portal (ECSP)
- automate the import of regulatory transactions into its repositories
| Product range | Functional driver | Production (voluntary use) | Mandatory |
|---|---|---|---|
| Medicines for human use (pharmaceuticals, biologicals and radiopharmaceuticals) and disinfectants | ended | ended | Current (implemented October 2020) |
| medical instruments | Current (implemented March 2019) | January 2024 | The 18 months following the date of production |
| Clinical tests | date to be determined | date to be determined | date to be determined |
| Veterinary drugs | ended | ended | Current (implemented October 2022) |
Medicines for human and veterinary use as well as disinfectants
Templates, style sheets, forms and tutorials
Guidelines and Notices
medical instruments
PIR piles
Draft pilot guidance documents and links to pilot PIR templates are sent to participants via email.
Medical Devices (Functional Pilot)
Related Information
contact us
If you have any questions regarding the regulatory listing process, please contact us by email at: [email protected]
1689836647
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