Validation rules for regulatory transactions provided to Health Canada in the non-eCTD format

March 1, 2024
Our file number: 23-112118-833

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.

Version of the non-eCTD validation rules: 5.2
Effective date: May 1, 2024

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

Revision Table:

Date Version Summary of Changes
May 1, 2024 5.2

Added Master File (MF) XML file to A08, I06, I08 and I10
A03a - Changed size limit for other files
A03b - Changed size limit for other files
B49 - Added searchable documents
I09 - Changed dash to underscore
I11 - Added version of the RT XML and MF XML files

August 1, 2022 5.1 A08 – Added new valid file extensions
I08 – Added lower case letter "f" followed by 7 digits

Health Canada non-eCTD format Validation Rules version 5.2

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 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 500MB. 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 500MB. 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:

Documents: .pdf, .doc, .docx, .xls, .xlsx, .wpd, .ppt, .pptx
Images: .png, .gif, .svg, .jpg, .jpeg, .tif, .tiff, .bmp
Audio/Video: .wav, .mp3, .mp4, .wmv, .mov, .mpg, .mpeg
Coding Language: .xml*
Data: .dat, .inf, .txt, .sas, .xpt, .sdax, .edpdp, .wsp, .epr, .pnf, .psf

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

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).
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.

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."

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.

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.

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.

Error
B49 Searchable documents Document contains images only and is not text searchable Warning
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).

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 (REP) and XML files
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 or MF file with the top level folder (Dossier ID folder)

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

Error
I08 Dossier ID naming convention

Checks the Dossier ID field in the RT or MF XML file. It must be one of the lower case letters "p", "d", "m", "v", "c" followed by 6 digits, or lower case letter "f" followed by 7 digits.

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

Element values for "product_name" and "company_id" must not be empty.

Error
I10 Presence of the RT or MF file

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

Error
I11 Version of the RT XML and MF XML files

Checks the software_version element value of the Regulatory Transaction (RT) and Master File (MF) XML files.

For the latest versions of the RT and MF XML files accepted by Health Canada refer to:

REP Summary Table - for Human Use Drugs (pharmaceutical, biologic and radiopharmaceutical), disinfectants, veterinary drugs and medical devices

Filling submissions electronically - for master files

Error

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