Validation rules for regulatory transactions provided to Health Canada in the non-eCTD format
May 13, 2022
Our file number: 22-105657-165
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:
- Guidance Document: Preparation of Regulatory Activities in Non-eCTD format
- Guidance Document: The Regulatory Enrolment Process (REP)
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: 5.1
Effective date: August 1, 2022
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 |
|---|---|---|
| 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 5.1
| 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: Documents: .pdf, .doc, .docx, .xls, .xlsx, .wpd, .ppt, .pptx, *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:
|
|||
| 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:
|
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:
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 |
| 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*
*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. |
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, 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 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. |
Error |
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