Validation rules for regulatory transactions provided to Health Canada in the “non-eCTD electronic-only” format

November 30, 2018
Our file number: 17-108289-287

Health Canada is publishing a set of validation rules for regulatory activities in the “non-eCTD electronic-only” format. These rules build on the information provided in the Guidance Document: Preparation of Regulatory Activities in “Non-eCTD Electronic-Only”format and will assist sponsors in preparing their regulatory transactions for filing to Health Canada.

It is important for sponsors to ensure that the validation rules are followed accurately in order to avoid encountering validation errors. Although they may be updated in the future, Health Canada is currently validating regulatory transactions in “non-eCTD electronic-only” format using the rules listed in the table below. Stakeholders are encouraged to use a commercially available tool to validate their regulatory transactions in “non-eCTD electronic-only” format, prior to filing them to Health Canada.

Although the profile may be updated without further notice, as of March 30, 2019, Health Canada will be validating regulatory transactions in non-eCTD format using version 4.4 of the “non-eCTD electronic-only” validation rules.

Should you have any questions regarding the content of the notice, please contact hc.ereview.sc@canada.ca.

Health Canada “Non-eCTD Electronic-Only” Validation Rules version 4.4

ID # Rule Name Rule Description Severity
A – GENERAL
A01 Empty Folders This rule is configured to detect empty folders (folders without any files or subfolders) in the transaction structure. Error
TIP: All empty folders must be deleted before submitting the transaction to Health Canada.
A03a File Size  This rule is configured to verify the size of the files.  A warning will be generated for PDF files between 150 MB and 200 MB.  A warning will be generated for other file types (excluding SAS XPT) between 100 MB and 200MB. Revised Warning
TIP: Check the size of each file before submitting to ensure it does not exceed the maximum limits.
A03b File Size  This rule is configured to verify the size of the transaction. An error will be generated for PDF files greater than 200 MB, SAS XPT files greater than 1GB and other files greater than 200MB. Error
TIP: Check the size of each file before submitting to ensure it does not exceed the maximum limits.
A08 File types This rule is configured to verify if the file extensions are valid. The acceptable file extensions are: .pdf, .doc, .docx, .xls, .xlsx, .wpd, .ppt, .pptx, .dat, .inf, .txt, .jpg, .png, .gif, .svg, .wav, .mp3, .mp4, .wmv, .jpeg, .tiff, .tif, .bmp, .sas, .xpt. Error
TIP:
  • Ensure that the file types for your documents are accepted before submitting.
  • File extensions written in uppercase letters are not accepted.
  • Do not change the file extension manually.
A09 Corrupt and password protected WORD documents Word document will be reported as corrupted or password protected if one or more of the following situations occur:
  1. Document is corrupt or unreadable
  2. Document has password protection
  3. Document has external DOTX references
Note: This rule applies only to Word version 2007 or later (.docx). New
Error
B - PDF ANALYSIS
B01 Corrupt or unreadable PDF documents This rule is configured to detect corrupt or unreadable PDF files within the transaction. An Error will be generated if the document:
  1. Cannot be opened because it is damaged or the encryption is too strong.
  2. Appears to have zero number of pages.
  3. Appears to be an application form, but the form content cannot be read.

An example of situation number (3) could be a document appearing to have one page only and the page contains the text phrase “Please wait… If this message is not eventually replaced by the proper contents of the document, your PDF viewer may not be able to display this type of document.”

Revised

Error
B24 PDF Protection This rule is configured to detect if the PDF documents are password protected. An error will be generated if there is a password. Error
TIP: Before submitting to Health Canada, ensure PDF documents are not password protected.
B25 PDF version checking This rule is configured to verify that if the PDF document versions are valid.  The acceptable PDF versions are 1.4, 1.5, 1.6, and 1.7. Warning
TIP: Ensure the PDF documents are created using the acceptable PDF versions.
B32 PDF Protection: Owner password Finds all documents with an owner password set, excluding forms regardless of their location in the folder structure. Revised Warning
TIP: Ensure that “No Security” is selected for the “Security Method” displayed in “File”, “Properties” and then, “Security”.
B36 Bookmarks - multi action This rule is configured to detect all bookmarks with multiple actions assigned to them. Error
TIP: Ensure that all bookmarks have only one action assigned to it. This action should open the destination page. These settings should be verified in the bookmark properties.
B40 PDF documents with attachments are not allowed This rule is configured to detect attachments and portfolio documents found in PDF documents. Error
TIP: Ensure that the PDF document does not include attachments or portfolio documents.
B44 PDF documents with more than 10 pages must have bookmarks This rule is configured to verify if PDF documents greater than 10 pages have bookmarks. Excluded from this check are: literature references in sections 3.3, 4.3, and 5.4; and Health Canada application e-forms. Warning
B45 PDF Protection – Printing Finds all documents where printing is not allowed. New Error
B46 PDF Protection – Content Copying Finds all documents where copying is not allowed. New Error
B47 PDF Content restrictions This rule checks for pdf files that contain JavaScript, dynamic content (e.g., audio, video or special effects), or 3D content. New Error
C - REFERENCED FILES
C05 Naming Syntax This rule is configured to verify that the maximum path length including the first level folder of the regulatory transaction must not exceed 200 characters.  The file names must not exceed a maximum of 64 characters, including the file extension. Revised Error
TIP: File path length character count starts at the application folder and includes the file name.
I: Regulatory Enrolment Process* New

*ONLY for users of the Regulatory Enrolment Process (REP)

I01 Corrupt xml file An XML file will be reported as corrupt if the file cannot be opened because the file is damaged. Error
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