Validation Rules for Transactions Containing the Regulatory Enrollment Process (REP) Company XML File

October 22, 2020
Our file number: 20-114830-58

Health Canada has developed a set of validation rules for the submission of the Regulatory Enrollment Process (REP) Company (CO) XML file. These rules are built in accordance with the company enrolment information provided in the Guidance Document: The Regulatory Enrolment Process (REP).

The purpose of this document is to inform sponsors of the validation rules Health Canada will be using in order to assist sponsors in providing a valid electronic transaction to Health Canada via the CESG. Awareness and use of the validation rules to correctly submit a REP transaction will reduce errors and additional follow-up with sponsors. Sponsors are encouraged to use a commercially available tool to validate the REP transaction containing the draft CO XML file prior to sending it to Health Canada.

Health Canada validates each regulatory transaction as it is received. If the validation fails due to errors detected, a Validation Report describing the errors will be sent to the sponsor in a.zip format.

Important Note: These rules are only for the transaction containing the draft CO XML file and must not to be used for regulatory transactions containing other REP files or regulatory documents submitted for review.

Beginning October 1, 2020, Health Canada will be using the Company XML validation rules version 1.0.

Should you have any questions regarding this document, please contact hc.ereview.sc@canada.ca.

REP CO Transaction Validation Rules version 1.0
ID # Rule Name Rule Description Severity
01 Naming convention of the top level folder

Checks the three first digits of the top level folder name.

The first three digits of the top level folder name must be "rep" using lower case letters, followed by the <company name>

Example: repCompanyX.

An error will be reported if the folder name does not start with "rep".

Error
02 Existence of the CO XML file

Checks the number of the CO XML files contained within the top level folder.
There must be only one CO XML file in the folder.
The identification of the CO XML file is based on one of the following root elements:

  • COMPANY_ENROL (example: draftrepco-0-1.xml)
  • DEVICE_COMPANY_ENROL (example: draftrepcom-0-1-.xml)

An error will be reported if there is more than one CO XML file in the folder.

Error
03 Additional files

Checks for the additional files received with the CO XML file. The identification of additional file(s) is based on the following root elements:

  • COMPANY_ENROL - Additional files will not be accepted
  • DEVICE_COMPANY_ENROL - Additional file(s) with.pdf extension will be accepted. Additional files with other extensions will not be accepted.

An error will be reported if there is/are any additional file(s) with the CO XML file containing COMPANY_ENROL in the root element.

An error will be reported if there is/are additional file(s) with file extension(s) other than.pdf with the CO XML containing DEVICE_COMPANY_ENROL in the root element.

Error
04 Validation of CO XML file content

Checks for the presence of the following elements of the CO XML file.
The CO XML file with root element: COMPANY_ENROL, must include an address_record element with manufacturer element value set to "Y" and company_name element value not empty.

Example: <address_record>
<address_id>1</address_id>
<manufacturer>Y</manufacturer>

<company_name>companyname</company_name>

</address_record>

The CO XML file with root element: DEVICE_COMPANY_ENROL, must include an address element with company_name element value not empty.

Example: <address>
<company_name>companyname</company_name>

</address>

An error will be reported if any of the elements are missing.

Error
05 Naming Syntax Checks that the maximum path length, including the top level folder, of the regulatory transaction does not exceed 200 characters. Each file name must not exceed a maximum of 64 characters, including the file extension.
An error will be reported if the path length exceeds 200 characters.
Error
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