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

July 28, 2017
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.

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

Health Canada “Non-eCTD Electronic-Only” Validation Rules
“Non-eCTD Electronic-only” - Profile 4.2

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 transaction. A warning will be generated for PDF files between 150 MB and 200 MB. A warning will be generated for other files (excluding SAS XPT) between 100 MB and 200MB.

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.

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:

  • Cannot be opened because it is damaged or the encryption is too strong.
  • Appears to have zero number of pages.
  • 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.”

Therefore, the document has no valid XFA XML data.

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

This rule is configured to detect documents with an owner password enabled. This excludes Health Canada application e-forms with XFA.

Error

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

C - REFERENCED FILES

C05

Naming Syntax

This rule is configured to verify if all file and folder names are using the correct syntax, as recommended by the International Council for Harmonisation (ICH) (lower case letters, digits, hyphens) and that they do not exceed the maximum character length of 200 for all file paths.

Error

TIP: File path length character count starts at the application folder and includes the file name.

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