Label Review

2014-04-14 (Updated 2016-09-22)

1.0 Purpose

The purpose of this document is to communicate changes to the label review process including the full implementation of Microsoft (MS) Word documents. Implementation of these changes has been designed to improve the efficiency and consistency of the process and to improve the tracking of label changes for both registrants and the Pest Management Regulatory Agency (PMRA).

2.0 Background on Word Labels

The PMRA has been piloting the receipt and review of labels in MS Word format since June 2009. As a result of this successful pilot, the Agency will only accept labels in MS Word format (.doc or .docx) within the context of any submission for which a label is required.

3.0 Scope

The process outlined in this document applies to text labels. It does not apply to any special PMRA requests for Marketplace labels.

Submission processes as outlined in the Management of Submissions Policy (PRO96-01 - or most recent version) are not affected by the changes proposed in this document.

4.0 Format for Submitting Label Changes

The required format for text labels as outlined in this document is DOC prepared by software such as MS Word or Open Office.  This includes proposed and corrected labels for new or amended registration applications.

All label changes made by either the registrant or the PMRA, to both the English and French label text, must be annotated in accordance with the standards published in Appendix A.

5.0 Specifying a new validity period for product registrations through product amendments not involving a label review

For pest control product amendment applications not involving the submission and review of a pest control product label, (e.g., changes to product specifications) the validity period  will only be extended for a period up to December 31st of the fifth year after the year in which amended registration is granted, provided the registrant attests that no changes have been made to the product label since it was last approved by the PMRA.

In such instances the following statement must be included within the covering letter for the application:

"I, the undersigned, certify on the basis of direct knowledge that no changes have been made to the English or French pest control product label for [insert product name and registration number] since it was last approved by the PMRA"

The PMRA may conduct an audit of product label text for products that have not undergone a recent label review by the PMRA (e.g. in the last 5 years) by requesting the submission of label text during the review of the application for product amendment or under a separate application.

6.0 Category C Applications based on Precedent Registrants

For Category C applications to register a new  product based on more than one precedent registration, applicants must indicate on the proposed label text (using the MS Word  track changes feature) the precedent product (i.e., registration number) upon which a particular portion of text is based.

For Category C label amendments based on more than one precedent registration, applicants must indicate on the proposed label text (using the MS Word  track changes feature) the precedent product (i.e., registration number) upon which a particular portion of amended text is based.

7.0 Effective Date

These process changes will be in effect on April 1, 2013.

8.0 Questions/Contact

Any questions on the new process should be directed to the PMRA Information Service.

Appendix A: Preparing Amended Labels Using Word

This appendix provides details for preparing DOC labels for submission to the PMRA. The process describes preparing labels in MS Word 2010, but similar functions are available in earlier versions of MS Word and Open Office.

A) Track Changes in MS Word

In order to help in the screening and correction of labels, registrants should use the track changes feature in MS Word. This feature helps to identify changes that are made to a document. To turn on the feature, go to the 'Review' ribbon, and select 'Track Changes'.

Changes are tracked in a variety of ways. Below is a summary of the track changes annotations that are most likely to be encountered when screening or correcting labels.

Track change indication:

A vertical bar will be found in the left margin any place in a document where a change was made.

Deleted text:

Text that is deleted will be in a different colour and be struck-through.

Inserted text:

Whenever text is inserted, the inserted text will be underlined and in a different colour.

Format changes:

Any format changes will be identified in a balloon in the right margin with the word "Formatted" and a line connecting to the portion of the text where the format change began.

Comments:

A user can insert a comment by selecting the changed portion and adding a comment by clicking the 'New Comment' button (). The comment will be found in a shaded bubble in the right margin with the word "Comment".

B) The Track Changes Ribbon

The Track changes ribbon (displayed above) has many other buttons that are very useful when reviewing a document.

Activate Track Changes:

This button activates or deactivates the track changes feature. The drop-down menu below it, also allows access to the track changes options, where  a change in setting such as the colour of the track changes, and how balloons are displayed can be made.

Display for Review:

This drop-down menu gives the option as to which version of the document to view: Final showing markup, Final, Original showing markup, and Original. The default version is Final showing markup.

Show Markup:

In the previous section, four types of track changes were described: Insertions, deletions, formatting and comments. This drop-down menu gives the user the option of which of these types of changes to show to others. The default is to show all. One of the types that a user may wish to turn off is 'Formatting'. This button can also be used to choose which track changes from which reviewer  to display or hide, and whether or not  to have 'balloons' displayed on the right side of the document.

Previous and Next Track Change:

These two buttons allow the user to automatically navigate among the track changes in a document. This can be used in place of a visual scan of a document to identify the  track changes.

Accept and Reject Track Changes:

These two buttons allow the user to either accept or reject track changes. Each also has a drop-down menu giving extra options, such as accepting all changes in the document, and rejecting all changes in the document.

Comment buttons:

These buttons allow users to add comments, delete comments, or navigate to the previous or next comments in the document.

Review Pane:

Clicking this button opens up a review pane that gives a summary of the track changes made in the document. Included in that summary is the name of the author that made the change.

C) Submitting Proposed Changes on a Word Label

Whenever an Applicant is submitting a label with proposed changes (via an amendment application or notification), they will first need to insert the following in the Header of the document (to access the Header, double-click the area at the top of the page):

[Submission number under which the latest approved label was issued]
[Date of submission of proposed label]

Applicants must also indicate the proposed label changes (additions, deletions and/or changes - including translation and re-wording) on the submitted English and French label text using the MS Word "track changes" feature. Tracking and commenting on these changes assists the applicant and the PMRA to:

• Identify and review exactly which proposed changes are being requested to the product label.
• Track and manage when particular changes were requested.

Although comments need not be detailed, they should at a minimum contain text such as the following:

Deletion - Comment indicating why the deletion was made, such as:

• "Uses no longer being supported."
• "Changes in accepted standard statements."
• "Text moved to a different portion of the label."
• "Study submitted supporting insertion/removal of text."

Insertions - Comment indicating why the insertion was made, such as:

• "Proposed new use."
• "Text approved under submission [xxxx-xxxx]."
• "Text found on label of product registration number X"
• "Text moved from a different portion of the label."
• "Text insertion/deletion requested from Pest Management Regulatory Agency decision under [submission #] (or) [policy #] (or) etc."
• "Changes in accepted standard statements."

Changes - Comment indicating why the label change was made, such as:

• "Re-wording"
• "New translation"

Finally, Applicants must attest that the only changes that have been made to the currently approved label are those that are indicated on the submitted English and French label text using Track Changes. Applicants must include the following attestation statement in their covering letter:

"I, the undersigned, have compared the currently approved label with the label submitted with this application and have confirmed that no changes have been made to the English or French approved label other than those indicated on the submitted label."

D) Receipt and Posting of the Approved Labels

The PMRA will review only the indicated label text. After the review and decision process, the full label will be posted to the Pesticides and Pest Management portion of Health Canada's website and will become the current label text of record. The applicant will also receive a MS Word version of the approved label from the PMRA.