Electronic Pesticide Regulatory System (e-PRS)
The Electronic Pesticide Regulatory System, dubbed e-PRS, offers a new approach to information management and will enable the Pest Management Regulatory Agency (PMRA) to continue the evolution from a completely paper-based system to a sophisticated system using information technology.
The electronic system will transform pesticide regulation in Canada by allowing companies to conduct secure web-based transactions when submitting applications and to provide essential health and environmental data to the PMRA more quickly using the Internet and the Government of Canada's On-Line secure channel service.
e-PRS will also strengthen the PMRA's ability to process, review and report to the public on pesticide information as required under the new Pest Control Products Act. Efficiencies gained through electronic information management processes are key to the Agency's commitment to modernizing the registration system and in particular electronic delivery on the transparency requirements of the 2002 Pest Control Products Act.
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e-PRS System Requirements
To access and conduct transactions on the e-PRS, you will require the following suggested settings*:
- IBM compatible PC
- 1.3 GHz - Pentium III Processor
- 256 MB of RAM
- Windows 2000 Professional
- Internet Explorer 6.0 or Netscape Navigator 7.2
- Mac computer running OS 10.4
In addition to the above settings, the browsers must have the following features:
- Support for SSL 3.0 - 128 bit encryption
- Cookies enabled
- The Sun Java Virtual machine (JVM) 1.4.2_03 or later running
The Java Virtual Machine can be downloaded on the Java website. Select "Free Java Download" on the Java homepage to start the download process.
* Disclaimer: The configurations listed are the environment in which the e-PRS was developed and tested. Other systems may be compatible.
Compiling and Submitting Documents
Although numerous PMRA Directives and Guidance Documents give specific instructions as to how to submit documents to the PMRA, we ask that Applicants and Registrants instead begin with the guidance detailed below for document compilation and submission.
Step 1: Compiling a PRZ (PMRA Regulatory Zip) file using the e-Index Builder
Applicants and Registrants must create an e-Index in PRZ format using the e-Index Builder of the documents they are submitting, and, if electronic versions are available, package that set of documents into the e-Index.
Once the PRZ file is created, please name it according to the application type or according to the documents being submitted. If a submission number has been assigned to the application, then include that number in the PRZ file name.
- Application for new product - "Pest-Cure Category A Application.prz"
- Application for product amendment - "PCP.99999 Category B Application.prz"
- Response to PMRA deficiency letter - "1995-0001 Deficiency Response.prz"
- Submission of corrected labels - "1995-0001 Corrected Labels.prz"
Step 2: Submitting the PRZ file to the PMRA
Applicants and Registrants must submit PRZ files and any paper documents (where electronic versions were not packaged using the e-Index Builder) to the PMRA using one of the following three methods listed below.
1. e-PRS Secure Web Portal
The e-PRS Secure Web Portal is an Internet Portal available through the Health Canada web site where Applicants and Registrants can send the compiled PRZ file quickly and securely to the PMRA. Please note that the Secure Web Portal can only by used when electronic documents are being submitted on the PRZ file. If some documents are not available in electronic format, then the Mail option must be used. If documents are being sent through the Secure Web Portal, any fees owed must be paid by credit card.
PRZ files burned onto a CD/DVD and any paper documents indexed in the PRZ file can be mailed to the PMRA.
Applicants and Registrants can send compiled PRZ files by email to the Submission and Information Management Division. If documents are being sent using email, any fees owed must be paid by credit card.
The Submission and Information Management Division's email account is designed to accept files in PRZ format from Applicants and Registrants for PMRA applications.
The Central E-mail has the advantages of accepting electronic files, and allows quick transmission of documents, however, the following caveats/restrictions must be taken into account:
- The Central E-mail is not secure. As such, any files lost or intercepted during transmission from the Applicant or Registrant is not the responsibility of the PMRA.
- The total size of the documents sent via the Central E-mail cannot exceed 5MB. If they do, then the PMRA will not receive the documents and an error message will be e-mailed back to the sender. No further notification of the rejected transmission will be sent from the PMRA.
- Specific keywords need to be included in the subject line of the e-mail. A list of these keywords and when to use them is detailed in the section below.
A better method of submitting electronic files to the PMRA is to use the e-PRS Secure Web Portal. This secure channel accepts files up to 250 MB in size, and Applicants / Registrants can specify clearly what is being sent to the PMRA.
Key Terms in Subject Line
Please note that the system uses the keywords criteria for accepting e-mails. If an applicable keyword is not included in the subject line, the system will automatically return the e-mail to the sender. These keywords include the following:
- If a new application is being submitted, the application type should be identified in the subject line. Also, please ensure that the keyword 'PRZ' is included in the subject line, to correspond to the PRZ file being submitted. For example: [Pest product name] [Application Type].PRZ
- If a submission number has been assigned, list the submission number within the e-mail subject line and the PRZ file. A list of the terms describing these documents is found in the table below.
Document Type and Applicable Keywords
- Corrected Labels applicable keywords: Label, labels, etiquette, etiquettes, étiquette, étiquettes (if sending proposed labels, please indicate this in the subject line or email)
- Corrected Statement of Product Specifications applicable keywords: specification, specifications, sps, spsf, spécification, spécifications, fdsp, dsp
- Notifications applicable keywords: notify, notification
- Discontinuations applicable keywords: discontinuation
- Incident Reports applicable keywords: Incident, IR
- Other applicable keywords: PRZ
- The email should reference only one submission number - there should be no bundling of submissions into a single e-mail. Also, please do not forward a hard copy or other electronic versions of the document. An automatic acknowledgement will be forwarded to the applicant upon receipt.
- Please do not include any extra information in the e-mail body. Any information related to the submission or documents should be captured within another document, which should then be indexed and attached to the PRZ. This ensures that the document and its information is automatically loaded into our database, and, as such, will be viewed by the requisite PMRA officers.
In all three methods, if a submission number has already been assigned that is related to the documents being submitted, that number should be included on the CD/DVD if sending by mail, or in the subject line if submitting by e-mail. The Secure Web Portal has a specific field where that number must be input.
Third party submissions: If there is information being submitted by a Third Party, please have the Third Party indicate which document(s) they are submitting in a cover letter, and list that cover letter under Data Numbering Code 0.8.1 in the e-Index Builder. While compiling the document(s) in the e-Index Builder, the Third Party must designate themselves as the Document Owner by entering their company code in the Third Party Owner field. If the code is unknown, they must contact the PMRA to obtain it.
Confidential Business Information Designation and Segregation: Please refer to regulatory directives Confidential Business Information Designation and Segregation Part 1: Submission of Test Data and Confidential Business Information Designation and Segregation Part 2: Previously Provided Test Data for guidance on the designation and segregation of Confidential Business Information.
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