- Instruction 1
Create New XML
Creates a new package.
A new e-Index may be created by choosing the desired Data Numbering System from one of the three choices available, either PMRA (Pest Management Regulatory Agency), OECD (Organization of Economic Cooperation and Development) or EPA (US Environmental Protection Agency).
EPA OPP & OPPTS codes are both included in the EPA Data Numbering System.
In both the OECD and EPA data numbering systems, PMRA DACOs have been added where necessary to identify unique PMRA information (e.g., PMRA application forms).
Select one of the following to continue : PMRA, OECD,EPA,Cancel
The package size limit is 245MB.
Load XML
Loads data from a previously saved XML file. To activate this button, first click the 'Create New XML' button. After clicking 'Create New XML' make sure to select the same data numbering system (PMRA, OECD or EPA) as is found in the XML file you are loading.
Save XML
Downloads the current progress to an XML file that can be loaded in the future. Do not submit this file to PMRA.
Note: Uploaded documents will not be preserved in the saved draft if the total size of the package exceeds 10MB. Documents will need to be reuploaded before exporting the package.
Export Package
Creates a PRZ file for submission to the PMRA.
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- Instruction 2
Add New Record
Creates a new record in the package to which a document and data can be assigned.
Delete Record
Deletes the selected record and all its data.
Copy Record
Copies the selected records data.
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- Instruction 3
Select the document you wish to edit.
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- Instruction 4
Select “Yes” if you are cross referencing a study previously submitted to the PMRA or being submitted under another e-Index as part of a group of applications, e.g., a Technical and associated End Use Products.
The Confidential Business Information and Applicant DER fields will be deactivated since these were addressed when the file was originally submitted to the PMRA.
Select “No” to upload a new file to be associated with this record.
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- Instruction 5
The PMRA document number is a unique number assigned by the PMRA to the document upon receipt into our document management system. This field is only available for a cross reference record.
Indicate this document’s PMRA document number under which it was originally submitted.
If you do not have this information, submit a cross-reference request to pmra-arla.data@hc-sc.gc.ca and provide them the application or registration number. They will provide you with a list of the documents and their associated PMRA document number.
Note: You may not assign a Data Code beginning with 0. or 1. to a cross-referenced document.
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- Instruction 6
Data Numbering Code(s)
The Data Numbering Code(s) field contains a list of data numbering codes specific to the Data Numbering System chosen to create the e-Index file.
Certain documents are required to be submitted to the PMRA in order to fulfill the requirements of the application. These documents are identified using a data numbering code.
Select all data numbering codes that correspond to the requirements that the document is fulfilling.
For DACOs beginning with 0. or 1., you can only have one code selected per document, as these types of documents cannot be combined with any other code.
Available
Lists available Data Numbering Codes to select from.
Selected
Lists selected Data Numbering Codes assigned to the record.
Add Selected
Add all the selected Data Numbering Codes in the Available list and copies it to the Selected List.
Remove Selected
Removes the selected Data Numbering Codes from the Selected list.
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- Instruction 7
The complete title of the document being submitted. This title can be the study title of the document, or when no formal title exists it may be a brief description of the document. The title may match the data numbering code description, e.g., “30 Day Rat Oncology Study”.,
For studies and other scientific data, please provide a sufficiently descriptive and non-ambiguous title.
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- Instruction 8
The name(s) of the author(s) of the report being submitted. Mandatory for studies and other scientific data.
Use Council of Science Editors (CSE) citation style
Ex. One Author: Doe J, Multiple Authors: Doe J, Simpson B, More than 10 authors: List first 10, followed by et al
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- Instruction 9
The date which appears on the report, or when it was completed. Mandatory for studies and other scientific data. If only the month and year is available, then select the first day of that month and the corresponding year. If only the year is available, then select January 1st of that particular year.
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- Instruction 10
The total number of pages in the document. This field is restricted to numeric characters. In the case of an electronic document, indicate the count of pages if the document were printed.
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- Instruction 11
Indicate whether the document is publicly available. This includes Websites, physical publications, studies published in scientific journals, etc., regardless if they are behind a pay wall. Indicating yes confirms that the document does not contain confidential information and the author name(s) may be released.
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- Instruction 12
Select where the document is published. E.g., is it published in a journal article or on a website?
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- Instruction 13
Name of the journal publication
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- Instruction 14
The specific volume number or the range of volume numbers covered by the document being submitted. The Parent document and CBI Reference document of a CBI document pair are NOT considered volumes of the same document, and do not require a value in this field.
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- Instruction 15
Document issue number
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- Instruction 16
Document page number range, if found in a paper journal
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- Instruction 17
The website name
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- Instruction 18
The URL to the document
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- Instruction 19
Website Access Date
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- Instruction 20
This field is auto-completed based on input in other fields.
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- Instruction 21
Company report number
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- Instruction 22
The full legal name of the laboratory where the study was conducted. Abbreviations are not acceptable.
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- Instruction 23
The name of the city where the study was conducted.
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- Instruction 24
The name of the country where the lab is located.
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- Instruction 25
The unique lab report number that is associated with the study. The test data and segregated Confidential Business Information (CBI) of a CBI reference pair must have identical lab report number values.
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- Instruction 26
The operational standards under which the study was performed.
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- Instruction 27
US Environmental Protection Agency Master Record Identification Number (MRID).
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- Instruction 28
An Applicant DER is an applicant-supplied Data Evaluation Record (DER).
This is created by downloading and completing an Evaluation Template from the PMRA Website.
The Applicant DER and corresponding test data document must have identical values in the Document
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- Instruction 29
Indicate if the entire document is Confidential Business Information (CBI) as defined in the PMRA guidance document.
If two documents are being submitted as the non-CBI (parent document) and CBI (CBI reference document) components of a document pair, all of the Document data must be identical except for the CBI - Yes/No value (i.e. Parent Document marked CBI ‘No’ and CBI Reference Document marked CBI ‘Yes’)
The test data and segregated CBI of a CBI document pair must have identical Lab Report No. values. The Lab Report value is used to establish the document relationship in the PMRA document management system.
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- Instruction 30
Select 'Yes' if the document is owned by a party separate from the Applicant. If the document is owned jointly by the applicant and a 3rd party company, select No
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- Instruction 31
The three-letter company code of the owner of the document. This code can be obtained from the 3rd Party. If the 3rd Party does not have a company code, they can contact pmra.reg.contacts-titu.arla@hc-sc.gc.ca to create a code. Use TBD as a last resort.
Note: Inputting an incorrect code could result in delays with your application.
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- Instruction 32
Indicate if the document is owned jointly by multiple companies. Either by multiple 3rd party owners or jointly with the applicant.
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- Instruction 33
Used to associate related documents.
The Applicant DER and corresponding test data document must have identical values in the “Document group” field.
The Document group value is used to establish a relationship between documents in that group when entered into the PMRA document management system.
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- Instruction 34
This field can be used to include any extra information which needs to be submitted with the document.
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- Instruction 35
Validate Record
Checks that all mandatory fields are provided and that all fields contain valid inputs.
Exit
Exit the builder. Do not forget to save your work using the Save XML record before exiting the application.
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