Application for the Inspection of Confidential Test Data

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Instructions

Instruction 1

Submitter

The person identified on the form will be the one permitted to inspect the confidential test data in the Reading Room. The name and address listed on the application form must match the information identified on the affidavit or statutory declaration. Only one person should be identified per application.

Return to instruction 1 referrer

Instruction 1.1

Affiliation

Indicate and identify your affiliation to any media group, pesticide manufacturer or other organization. If you are not associated with an organization, please identify yourself as a member of the public. Check only one.

The registrant who provided the data will be notified after an application to inspect the data has been approved by the PMRA. The identity of the applicant will remain confidential; however, the person’s affiliation will be shared with the registrant. If it is possible to identify an individual based on the name of the affiliation, then only the type of affiliation will be provided to the registrant.

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Instruction 2

Inspection

Indicate whether or not you are requesting access to inspect test data in the Reading Room on behalf of another person or organization. If so, identify the client or organization you represent.

If you have already confirmed your affiliation to an organization in section 1, then specify that you wish to inspect the data for your own use.

Return to instruction 2 referrer

Instruction 2.1

Purpose of Inspection

Indicate the purpose for your request to inspect the test data. The response provided here must match the purpose described in the affidavit or statutory declaration.

The PMRA will prioritize applications to inspect data with the possibility of filing a notice of objection. Such applications will only apply to recent major regulatory decisions, where the 60-day reconsideration period is still open. As long as the application to inspect confidential test data is received well in advance of the reconsideration closing date, Health Canada will attempt to schedule the Reading Room visit within 15 days of receiving the application. The 60-day reconsideration period is established by legislation and will not be extended. For more information on the reconsideration of decision process, consult the Fact Sheet Getting Involved in Canada’s Pesticide Regulatory Process.

Return to instruction 2.1 referrer

Instruction 3

Confidential Test Data to be Inspected

The data supporting a registration decision made under the new Act (after 28 June 2006) are available for inspection in the Reading Room. After a registration decision is finalized, the Evaluation Report is published in the Public Registry which provides a reference to all the relevant studies supporting the decision.

Identify which studies you want to inspect during your Reading Room visit, using the criteria provided.

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Instruction 3.a

Product information

Identify the active ingredient (name and/or registration number) or the end-use product (name and/or registration number) related to the data you want to inspect.

Return to instruction 3.A referrer

Instruction 3.b

Study information

If possible, use the criteria outlined below to refine the query. Refer to the evaluation report for a list of relevant studies supporting a registration decision.

Return to instruction 3.B referrer

Instruction 3.b.1

Study type

All of the studies submitted when registering a product can be arranged into four disciplines: chemistry, human health, environment or efficacy. You may, for example, choose to inspect all human health toxicology studies.

Return to instruction 3.B.1 referrer

Instruction 3.b.2

Pest Management Regulatory Agency (PMRA) document number

The evaluation report will provide a unique identifier number to every study.

Return to instruction 3.B.2 referrer

Instruction 3.b.3

Study title

The title of each study will be referenced in the Evaluation Report (e.g., acute oral toxicity test in the rat).

Return to instruction 3.B.3 referrer

Instruction 3.b.4

Data code (DACO)

DACOs are numeric codes used to identify individual scientific studies (e.g., DACO 4.6.1—Acute Oral Toxicology Study).
DACO tables are the list of data requirements for the registration of a product.
DACO tables for use-site categories are available on the PMRA website at: Use Site Category (DACO Tables)

Return to instruction 3.B.4 referrer

Instruction 4

Attachments

Attach any files you wish to include with the online form.

Note:

A completed affidavit or statutory declaration must be submitted along with this application. Please include a completed affidavit or statutory declaration as an attachment.

Return to instruction 4 referrer

1. Submitter^{Instruction 1}

First name (required)

Last name (required)

Address

City

Country

Other country (required)

Province

State

Region

Postal code / Zip

Telephone (including area code)

Telephone (including country code)

Email address (required)

Confirm your email address (required)

Affiliation (required) ^{Instruction 1.1}

Describe selected affiliation (required)

2. Inspection^{Instruction 2}

Representation (required)

Describe selected Representation (required)

Purpose of inspection (required) ^{Instruction 2.1}

Other purpose of inspection (required)

3. Confidential test data to be inspected^{Instruction 3}

A. Product information^{Instruction 3.A}

Product information (required)

Registration number (digits only) (required)

Product name (required)

Active ingredient (maximum of 500 characters) (required)
{{500-confidentialData.activeIngredients.length}}

B. Study information^{Instruction 3.B}

Provide at least one of the fields in the "B. Study information" section (required)

Study type ^{Instruction 3.B.1}

Pest Management Regulatory Agency (PMRA) document number ^{Instruction 3.B.2}

Study title ^{Instruction 3.B.3}

Data code (DACO) ^{Instruction 3.B.4}

If unable to identify the test data according to criteria listed above, provide a description in your own words (maximum of 2,000 characters)
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4. Attachments^{Instruction 4}

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Add any additional attachments you wish to include in the online form.

I have read, understood and agree with the Privacy notice statement (required)Privacy notice statement

I have read, understood and agree with the Security notice (required)Security notice

I have attached a completed affidavit or statutory declaration with this form. (required)

Application for the Inspection of Confidential Test Data

Privacy notice statement

Security notice: Up to Protected B only

Instructions

1. SubmitterInstruction 1

2. InspectionInstruction 2

3. Confidential test data to be inspectedInstruction 3

4. AttachmentsInstruction 4

1. Submitter^{Instruction 1}

2. Inspection^{Instruction 2}

3. Confidential test data to be inspected^{Instruction 3}

4. Attachments^{Instruction 4}