Notice: Discontinuation of Acknowledgement Letters for Regulatory Activities received by Health Canada
January 30, 2019
Our file number: 19-101387-751
In an effort to modernize and align internal processes, Health Canada is proposing to discontinue the issuance of letters of Acknowledgement of Information Received (“acknowledgement letters”).
Effective April 1, 2019, Health Canada is proposing to no longer send acknowledgement letters for the following regulatory activity types that fall under Part C, Division 1 and Division 8 of the Food and Drug Regulations:
- Abbreviated Extraordinary Use New Drug Submission (AEUNDS)
- Abbreviated New Drug Submission (ANDS)
- Application for a Drug Identification Number (DINA)
- Application for a DIN - Biological product (DINB)
- Application for a DIN - Disinfectant product (DIN-D)
- Application for a DIN - Category IV product (DIN-F)
- Development Safety Update Report (DSUR)
- Extraordinary Use New Drug Submission (EUNDS)
- Supplement to an Extraordinary Use New Drug Submission (EU SNDS)
- Supplement to an Extraordinary Use Abbreviated New Drug Submission (EU SANDS)
- Notifiable Change (NC)
- New Drug Submission (NDS)
- Periodic Benefit Risk Evaluation Report - Conditional (PBRER-C)
- Periodic Benefit Risk Evaluation Report - Pharmacovigilance (PBRER-PV)
- Post-authorization Division 1 Change (PDC)
- Post-authorization Division 1 Change - Biologics (PDC-B)
- Periodic Safety Update Report - Conditional (PSUR-C)
- Periodic Safety Update Report Pharmacovigilance (PSUR-PV)
- Risk Management Plan - Pharmacovigilance (RMP-PV)
- Supplement to an Abbreviated New Drug Submission (SANDS)
- Supplement to a New Drug Submission (SNDS)
- Supplement to a New Drug Submission - Conditional (SNDS-C)
- Undefined Pharmacovigilance (UD-PV)
Information currently found on acknowledgement letters can be obtained from the Drug Submission Tracking System – Industry Access (DSTS-IA). Sponsors are encouraged to rely on the DSTS-IA to view the following details of their submissions:
- tombstone submission information, i.e. control number (“submission number”), submission type, submission class, Lead Bureau/Office, date of filing (also known as “CR date”), dossier ID
- drug product information, i.e. product name, manufacturer, country, active ingredient
- status history information, i.e. submission status, status date and target date
- review history information, i.e. review details including review type, division, status of the review (i.e. pending, active, completed) and status dates
- document history, i.e. documents issued and received, including dates
For information regarding DSTS-IA, or for account set up, please contact the Office of Submission and Intellectual Property by sending an e-mail to: hc.client.information.sc@canada.ca
Please note that this change will not impact those submissions or supplements that require a certification as per the Patented Medicines (Notice of Compliance) Regulations, these regulatory activities will continue to receive a letter of Acknowledgement and Certification of Information Received once they are deemed administratively complete.
Should you have comments on the proposed changes outlined in this Notice please provide your feedback to Health Canada, within 30 days of the publication of this Notice via e-mail: hc.eReview.sc@canada.ca
Contact Us
Office of Submissions and Intellectual Property
Health Products and Food Branch
Resource Management and Operations Directorate
Address Locator: 0201A1
Health Canada
Ottawa, Ontario
K1A 0K9