Memo to Applicants and Registrants: New Version of the e-Index Builder

Purpose

To communicate to Applicants and Registrants a new version of the e-Index Builder (v.2.8), which includes updates to the PMRA’s Data Code Numbering (DACO) System, as well as the ability to identify document ownership.

Background

The e-Index Builder is the stand-alone tool provided by the PMRA that enables Applicants to prepare an electronic index (e-Index) in XML format. The e-Index describes the purpose of each document using the DACO numbering system, provides the documents’ bibliographic information, as well as whether or not the documents contain Confidential Business Information as defined in the Pest Control Products Act. The tool also allows Applicants to attach electronic versions of documents to the index, which in turn allows the submission of one ZIP package in PRZ format to the PMRA. The PRZ package allows for efficient and accurate ‘consumption’ of the index and attached documents into the PMRA’s internal database.

Identification of Document Owners

Currently, when an e-Index is submitted by an Applicant, all the documents within that e-Index are assumed to be owned by the Applicant, unless otherwise specified. If documents from a Third Party are submitted, a separate e-Index with the Third Party documents is required. The PMRA separates the documents from the Applicant and the Third Party in its internal database, but ‘links’ them to indicate that they are to be used in support of the same submission.

The new version of the e-Index Builder allows the explicit identification of both Applicant and Third Party documents within the same e-Index. This will be accomplished with the addition of two new fields: Third Party Owner and Multiple Owners. These changes will more clearly identify document ownership for both applicants and the PMRA.

Third Party Owner Field

Within the e-Index Builder, the “Third Party Owner” field should be populated with the Third Party’s three-letter company code for all documents owned by a Third Party. This field should be left blank for all documents owned by the Applicant. Please contact the Third Party directly to obtain their relevant three-letter company code.

To receive your company code, please complete  Form 6026: Change in or Request for Registrant Information

Multiple Owners

A document may be owned by multiple parties. In this situation, the ‘Multiple Owners’ field should be selected for that document. Within the document, or in a separate letter, the Applicant should identify the multiple owners of the document.

Effective Date

The new version of the e-Index Builder was released on 13 August 2013. If an older version of the e‑Index Builder is being used, a message will be displayed to notify the user that a new version is available. Updated versions of the e-Index Builder Guidance and the e-Index Builder Tutorialare also available on the e-Index Builder page in the Pesticides and Pest Management portion of the Health Canada website.

Questions

If you have any questions, please contact the Pest Management Regulatory Agency Information Service.

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