Guidance on preparing and submitting summary reports for marketed drugs and natural health products: Submitting annual summary reports
On this page
- When to submit an annual summary report
- ASR note to reviewer
- How to submit annual summary reports
- Foreign reviews
When to submit an annual summary report
Market authorization holders (MAHs) and licence holders must maintain all annual summary reports (ASRs) on site or ensure they're easily accessible.
Although ASRs must be prepared annually, they are only to be submitted:
- upon our request
- to fulfill a term or condition imposed by the Minister under the Food and Drug Regulations
Note: ASRs submitted as data to support a market entry submission or application, or to support a supplement to a submission (for example a change to labelling, packaging or indication) are out of scope of this guidance document. For more information on supporting data for a submission or application, consult:
- Guidance on management of drug submissions and applications
- Guidance Document: Post-Notice of Compliance (NOC) Changes: Safety and Efficacy Document (for pharmaceutical, biologic and radiopharmaceutical drugs for human use only)
- Natural Health Products Management of Applications Policy
- Natural Health Product Licence Amendment and Notification Form User Guide
Submitting annual summary reports under the Food and Drug Regulations
To assess the safety or effectiveness of a drug, we may ask you to provide an ASR or case reports relating to adverse drug reactions and serious adverse drug reactions known to you. This is set out in sections C.01.018(5) and (6) of the Food and Drug Regulations (FDR).
The ASR must be submitted within the period specified in our request letter. You will have an opportunity to provide comments on the period outlined in the request letter for the submission of the report.
The request letter may also specify supporting documents to accompany the submission of the ASR.
The review of an annual summary report may help us track post-market follow-up actions, resolve questions about safety issues and monitor safety issues closely.
Submitting annual summary reports under the Natural Health Products Regulations
If we have reasonable grounds to believe that the NHP may no longer be safe when used under the recommended conditions of use, we may ask you to provide a copy of any ASR prepared. This is set out in sections 24(3) of the Natural Health Products Regulations (NHPR). The ASR must be submitted to Health Canada within 30 days of the request.
ASR note to reviewer
An ASR note to reviewer should accompany the submission of all ASRs.
The ASR note to reviewer should include:
- unique product identifier (such as DIN, NPN or DIN-HM)
- the reason for submission
- submission details such as the final sign-off date, data lock point and period covered by the ASR
- additional information including the status of review of the submitted documents in other jurisdictions (where relevant) and any other details that would aid the review
The ASR note to reviewer template is available upon request by emailing no-reply.MHPD.publications.DPSC.non-reponse@hc-sc.gc.ca. Ensure that only the exact text "ASR note to reviewer template" is in the subject line of the email.
How to submit annual summary reports
ASRs should be provided to Health Canada in either English or French.
For DIN products, submit the ASR with the ASR note to reviewer in an electronic common technical document (eCTD) or non-eCTD format via the electronic submissions gateway (ESG) using the regulatory enrolment process (REP).
For information on transactions in eCTD or non-eCTD format, consult:
For NPN or DIN-HM products, our request letter will outline instructions on how to submit the ASR with the ASR note to reviewer.
Contact us if you have questions about your submission.
Note: There may be instances when the MAH or licence holder contracts another party to carry out certain activities on their behalf. Activities could be maintaining records on adverse reaction data, conducting pharmacovigilance activities or preparing or submitting ASRs. Even if this is the case, the MAH or licence holder must ensure that documents requested by Health Canada are sent within the timeframe requested.
Foreign reviews
When submitting ASRs, you should provide, if available, reviews by the United States (Food and Drug Administration) or European Union (European Medicines Agency) of:
- periodic summary reports or equivalent
- safety assessments
If FDA or EMA reports are not available you should send an available review from another foreign regulatory authority, if available, in English or French.
You should provide these foreign reviews at the same time you submit the ASR. Inform us if a foreign review report becomes available soon after the submission.