Formatting an Application, Electronic Submission Process (e-PRS and e-Index Builder) and the new Secure Channel

Help on accessing alternative formats, such as Portable Document Format (PDF), Microsoft Word and PowerPoint (PPT) files, can be obtained in the alternate format help section.

Christopher Pollard
Section Head, Quality Systems Section
Submission and Information Management Division Registration Directorate

Primary References

• DIR2003-01, Organizing and Formatting a Complete Submission for Pest Control Products
• DIR2006-05, Requirements for Submitting Data Index, Documents and Forms
• Website DACO Tables:
  • Home: Applicants and Registrants: USC DACO Tables
• E-Index Builder Documentation:
  • Home: Applicants and Registrants: e-PRS: e-Index Builder

Old System

The old system was paper-based...

New System

...while the new system is electronic-based

E-Index Builder - The Tool

• Software available from PMRA website
  • Home: Applicants and Registrants: e-PRS: e-Index Builder
• MANDATORY since June 15, 2006
• Allows you to create an e-Index
  • SAVES index as XML file
  • Describes each document being sent to PMRA
  • Captures mandatory information (DACO, CBI)
• Allows you to create a PRZ file
  • FINALIZES the index and attached files into a PRZ
  • Contains the index AND digital files
  • Needed for automated processing

E-Index Builder - Interface

The e-Index Builder interface deals with lists of documents, data codes, cross references, confidential business information, APP DER, document details and links to fil

E-Index Builder - Mandatory Fields -Data Codes

• E-Index Builder supports the data coding systems of OECD, PMRA and EPA.
• Each document MUST have at least one code assigned. One document MAY have multiple codes.

Data Part	Type of Information	Data Part	Type of Information
0	Administrative -Forms, Cover Letters	7	Residue
1	Label	8	Environmental Chemistry/Fate
2	Chemistry -Technical Class	9	Environmental Toxicology
3	Chemistry -Non-Technical Class	10	Value
4	Toxicology	12.5	Foreign Reviews
5	Exposure	12.7	Comprehensive Data Summaries
6	Metabolism

E-Index Builder - Mandatory Fields -Data Codes

The most recent update of the e-Index Builder includes new PMRA Data Codes for LABELS:

Old Code	Old Description	New Code	New Description
1.1	Proposed Label	1.1.1	Proposed Label - English
		1.1.2	Proposed Label - French
1.2	Corrected Label	1.2.1	Corrected label - English
		1.2.2	Corrected label -French

E-Index Builder - Mandatory Fields - XRef/AppDER

• Cross Reference: To be used ONLY when a document is already with the PMRA.
• Applicant DER
  • If the document is an Evaluation Template downloaded from the PMRA website, indicate "YES".
  • These templates capture specific data components and record the reviewer's conclusions and rationales that are based on each data set.

E-Index Builder - Mandatory Fields - CBI

• CBI: For an applicant-created Index, the options are Yes/No.
  • Indicate if the entire document is CBI or not.
• CBI: For a "CBI Index" provided by PMRA for historic data, the options are:
  • Yes - The entire document is CBI
  • No - The entire document is not CBI
  • Partial - Part of the document is CBI and the extraction is attached
  • Request Copy - It is our document -we don't have a copy
  • No Authority - This is not our document, contact info for the proper authority is attached

E-Index Builder - Common Issues

• Each application requires a new PRZ file.
• Each response requires a new PRZ file.
• Create a new PRZ if you change to your index.
• Send the PRZ, not the XML.
• Avoid symbols in Index and file name:
  • . º, ©, ®, =, <, >.
• Cross Reference ONLY data already with PMRA.
• One document per row in the E-Index Builder.

E-Index Builder - EXTRAS

• PRINT YOUR INDEX
  • If you wish to view, print or create a PDF of your index, you can use the "Style Sheet".
    • Home: Applicants and Registrants: e-PRS: e-Index Builder: XSL Stylesheet
  • Place the "XSL" style sheet in the same folder as your XML index, and open your index with Internet Explorer.
  • Open the XML file with Internet Explorer and print.
• MERGE YOUR INDEX
  • If you wish to add one index to another, use the File/Import function.
  • Useful when different people work on different parts of the index.
• DATA CODE LISTS
  • Text files with all approved Data Codes are on the Web
  • Useful for doing key word searches when you are unsure of which code to use
• PMRA English: www.pmra-arla.gc.ca/english/appregis/lists/dacocodes_en_CA.properties
• PMRA French: www.pmra-arla.gc.ca/francais/appregis/lists/dacocodes_fr_CA.properties
• EPA: www.pmra-arla.gc.ca/english/appregis/lists/epacodes_en_CA.properties
• OECD: www.pmra-arla.gc.ca/english/appregis/lists/oecdcodes_en_CA.properties

e-PRS Secure Web Portal

• The e-PRS Secure Web Portal (SWP) is a secure website
  • Uses Government On-Line Secure Channel
• SWP allows you to send your PRZ files directly to the PMRA via the Internet
• SWP allows you to authorize other users to act on your behalf
• Available for Enrolment
  • Home : Applicants and Registrants : e-PRS : Enrolment Package
• Currently in Pilot
• More robust training sessions will follow