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

December 16, 2020
Our file number: 17-108289-287

Health Canada has updated the validation rules for regulatory transactions submitted in the non-eCTD format. These rules are built in accordance with the information provided in the following documents:

The purpose of the validation rules is to help ensure Sponsors provide a valid electronic transaction to Health Canada, and reduce errors and follow-up with Sponsors. Sponsors are encouraged to use a commercially available tool to validate their regulatory transactions in non-eCTD format, prior to filing them to Health Canada.

Health Canada validates each regulatory transaction as it is received. If the validation fails due to one or more errors detected, a Validation Report describing each error will be emailed to the sponsor as a .pdf file attachment.

Beginning November 1, 2020, Health Canada will be using the non-eCTD validation rules version 5.0.

Should you have any questions regarding the content of this document, please email us at hc.ereview.sc@canada.ca.

Health Canada non-eCTD format Validation Rules version 5.0

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. 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, .xml*.

*Applies only to regulatory transaction (rt-*.xml), product information (pi-*.xml) and application information (ai-*.xml) files provided as part of the Regulatory Enrolment Process (REP).

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 references an attached template located via http or https
  4. Document is empty
Note: This rule applies only to Word version 2007 or later (.docx). Revised
Error
A10 Duplicate Transaction

This rule compares the content of the transaction received with the content of the previous transaction in the same dossier to ensure they are not the same.

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.
  2. Appears to have zero number of pages.
  3. Appears to be an application form, but the form content cannot be read.
  4. The document contains additional data (more than 1024 characters) after the last %%EOF (End Of File).

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 Health Canada application 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. Error
B46 PDF Protection – Content Copying Finds all documents where copying is not allowed. Error
B47 PDF Content restrictions

This rule checks for pdf files that contain  dynamic content (e.g., audio, video or special effects), or 3D content. Health Canada application forms are excluded from this check regardless of their location.

 Revised

Error
B48 PDF Content restrictions

This rule checks for PDF files that contain JavaScript. Health Canada application forms are excluded from this check regardless of their location.

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. Since non-eCTD transactions do not have sequence numbers, the second level folder must not be a sequence folder named nnnn (four digits).

Revised

Error
TIP: File path length character count starts at the application folder and includes the file name. The correct structure path for non-eCTD transaction is x123456\m1.
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
I06 Comparison of the RT file with the top level folder (Dossier ID folder)

Compares the value in the Dossier ID field in the RT file with the top-level folder.

New

Error
I08 Dossier ID naming convention

Checks the Dossier ID field in the RT XML file. It must be one of the lower case letters "p", "d", "m", "v", "c" followed by 6 digits.

New

Error
I09 Product Name and company ID in the RT XML file

Element values for "product-name" and "company_id" must not be empty.

New

Error
I10 Presence of the RT file

Checks that the transaction has a valid RT XML file based on the root elements TRANSACTION_ENROL or DEVICE_TRANSACTION_ENROL. Error will also be reported if more than one RT is found in the transaction.

New

Error
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