Health Canada
Symbol of the Government of Canada

Common menu bar links

Drugs and Health Products

Notice to Industry to change procedures for the Reporting of Adverse Events Following Immunization (AEFI) and Periodic Safety Update Reports (PSURs) for vaccines

Help on accessing alternative formats, such as Portable Document Format (PDF), Microsoft Word and PowerPoint (PPT) files, can be obtained in the alternate format help section.

March 25, 2011
Our file number: 10-126749-180

By way of this notice, Health Canada's Health Products and Food Branch (HPFB) is informing vaccine market authorization holders (MAH) of its intent to change the reporting process for AEFIs and PSURs for prophylactic vaccines.

Part of Health Canada's mandate is to manage the ongoing safety, efficacy and quality of all health products, including vaccines. The Public Health Agency of Canada (PHAC) works closely with public health authorities in the provinces and territories to gather and analyse information on the safety of vaccines and collaborates with Health Canada to assess the safety of vaccines on an ongoing basis.

It is the intent of Health Canada to fully incorporate the post-market surveillance of vaccines into the lifecycle management of products over the next few weeks, including Post-Market Reporting Compliance (PMRC) Inspections. To that end, and in order for MAH to fulfil their regulatory obligations under C.01.016 of the Food and Drug Regulations, vaccine market authorization holders shall report serious AEFIs that occur in Canada, as well as serious unexpected AEFIs that occur outside of Canada to HPFB's Marketed Health Products Directorate (MHPD) via the Canada Vigilance Program, as is the case for all human drug products. This change becomes effective on March 25, 2011 and is retroactive to January 1, 2011.

In addition, as of March 25, 2011 all PSURs are to be filed through Submission and Information Policy Division (SIPD). As per guidance documents posted on the Health Canada Web site, currently there are two acceptable formats in which sponsors can file electronic PSUR submissions. The two formats are:

  • Electronic submission in eCTD format
  • Electronic submission in non-eCTD format

PSUR submissions in eCTD format on CD/DVD should be accompanied by a paper cover letter as announced in the Notice Increased Scope of Submissions being accepted in Electronic Common Technical Document (eCTD) Format and acceptance of electronic-only submissions.

If PSUR submissions are not submitted in eCTD format, MAH are recommended to submit them in  electronic format as PDF files in accordance to the notice published on the Health Canada website in February 2008, Release of Health Canada's Revisions to"1.6 Electronic Review Documents" in Draft Guidance for Industry: Preparation of New Drug Submissions in the CTD Format.

The electronic submission in PDF format is the legal document for PSUR submissions in the "non-eCTD format". The naming convention used for the PDF file is up to the MAH's discretion; however meaningful names should be applied. The CD/DVD including both the electronic copy of the PSUR and the cover letter should be accompanied by a paper cover letter. No paper copy of PSUR submissions should be submitted to Health Canada.

The HPFB is working collaboratively with PHAC and encourages continued communication as in the past between market authorization holders and PHAC on aspects of safety related information.

Questions regarding this notice should be directed to the Canada Vigilance Program.