Validation rules for regulatory transactions in non-eCTD format

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*, .html**

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.

** Applies to biocide application form.

• 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.

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

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.

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."

Finds all documents with an owner password set, excluding Health Canada application forms regardless of their location in the folder structure.

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.

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

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).

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

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", "q" followed by 6 digits, or lower case letter "f" followed by 7 digits.

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

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.

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