Label Review: A Pilot for a More Efficient Process

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.

June 2009

1.0 Purpose

The purpose of this document is to present changes to the label review process designed to improve the efficiency and consistency of the process and to improve the tracking of label changes for both the registrant and the Pest Management Regulatory Agency. 

2.0 Background

The current label process using Adobe Portable Document Format (PDF) was introduced in 2003¹. There are several aspects of this process that affect the ability of the Pest Management Regulatory Agency and the registrants to deal with labels in an efficient and transparent manner. Specifically:

• The label compare of PDF documents is sometimes difficult, particularly with large labels or in cases where text has been moved around;
• Pest Management Regulatory Agency staff spend considerable time identifying changes when verifying text labels because the Pest Management Regulatory Agency has not required registrants to highlight changes in the label;
• It is time consuming for registrants to incorporate the changes annotated on the PDF label into the version created by their word processing software.

The current process requires creation of a text label using word processing software followed by conversion to PDF normal using Adobe Acrobat Professional. A recent Pest Management Regulatory Agency survey of registrants found that a high percentage of companies use Microsoft Word (Word) as their primary word processing software for product labels.

Changes to the label review process were proposed by an industry association and their document was used as the basis for the development of changes presented herein.

3.0 Scope

The changes proposed in this document apply to text labels. Marketplace labels are not affected.

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

4.0 Proposed Changes for Submitting Label Changes

• The preferred format for text labels as proposed in this document is Word. This includes proposed and corrected labels for new or amended registration applications. For applicants/registrants that do not use Word, the Pest Management Regulatory Agency will continue to accept labels in PDF normal format. 

  Note, that once a label is submitted in Word format, all subsequent versions of the label for that application and all subsequent label applications pertaining to the registered product must also be submitted in Word format.

• Labels that are submitted in PDF normal format should be prepared using word processing software (e.g., Word, WordPerfect, OpenOffice, etc), rather than desktop publishing software.
• All label changes made by either the registrant or the Pest Management Regulatory Agency must be annotated in accordance with the standards published as part of this document. For Word standards see Appendix A, and for Adobe Acrobat standards see Appendix B. For registrants there are two new annotation requirements:
  • For amended registration applications, the registrant must annotate the label with the application number of the last approved label (i.e., the label that was used as the basis for amending and submitting the proposed label); and
  • All proposed changes to label text must be highlighted and referenced, either by using 'track changes' in Word or using 'comments and markups' in Adobe Acrobat Professional. (see the Appendices for details).

  This will help the Pest Management Regulatory Agency to more effectively identify and review the submitted label changes and make it easier for registrants and the Pest Management Regulatory Agency to track and manage label changes. 

  
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5.0 Effective Date

Effective immediately, the Pest Management Regulatory Agency is introducing these label changes on a pilot basis for up to one year, after which the effectiveness of the changes will be assessed and the process changes finalized.

Appendix A: Preparing Amended Pest Management Regulatory Agency Labels Using Word

This appendix provides details for preparing Word labels to the Pest Management Regulatory Agency according to the proposed process described in the document "Label Review: A Pilot for a more Efficient Process". The process describes preparing labels in Word 2003, but similar functions are available in earlier versions of Word, Word 2007 and OpenOffice.

A) Track Changes in Word

In order to help in the screening and correction of labels, registrants should use the track changes feature in Word. This feature helps in identifying changes that are made to a document.

To turn on the feature, click 'Tools' > 'Track Changes'. You can also add the track changes button to your toolbar by selecting 'View' > 'Toolbars' > 'Reviewing'. The track changes button () will now appear on your Word toolbar.

Changes are tracked in a variety of ways. Below is a summary of various track changes that you are most likely to encounter while screening or correcting labels.

Track change indication: Any place in the document where a change was made, a vertical bar will be found in the left margin.

Deleted text: Text that is deleted will be identified by a balloon in the right margin of the document with the word "Deleted" and a line connecting the balloon to the portion of the document where the text was deleted. The actual deleted text will be found inside the balloon.

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 about a change by selecting the changed portion and adding a comment. The comment will be found in a shaded bubble in the right margin with the word "Comment".

Changes to the appearance of track changes can be made in the Word 'Options', but the Pest Management Regulatory Agency recommends that applicants keep the default settings in order to remain consistent with the Pest Management Regulatory Agency's settings.

B) The Track Changes Toolbar

The easiest way to work with track changes is to have the Reviewing toolbar available. This is done by clicking 'View', 'Toolbars', 'Reviewing'. The following toolbar will then appear:

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' and is the version that is relevant to all the Word Label guidance documents.

Show Track Changes  : 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. The default is to show all. One of the types that a user may wish to turn off is 'Formatting'.

Previous and Next Track Change  : These two buttons allow the user to automatically navigate among the track changes in a document.

Accepting and Rejecting 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, rejecting all changes in the document, and deleting all the comments in the document.

Insert Comment : This button allows a user to add a comment. The drop-down menu gives additional options, such as editing and deleting comments.

Activating Track Changes : This button activates or deactivates the track changes feature.

Reviewing 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. The figure below lists some of the track changes summary for this document.

Show/Hide markups  : Another button, which is not found on the Reviewing toolbar, is the 'Show/Hide markups' button,. It is found by clicking 'View' button on the menu bar. Instead of accepting or rejecting all the track changes in a document, a user can simply click this button to hide the markups until the user clicks the same button again.

C) Amending Labels

Before amending the label, insert the following in the Header of the document (to access the Header, click 'View', 'Header and Footer'):

[Submission that accepted latest approved label]
[Date of submission of proposed label]

Every deletion and addition made to a label, excluding changes that can be made with a Notification application, will need to be commented upon using track changes by the applicant. Making comments using track changes is described in section A) of this document.

Tracking and commenting on changes helps the Applicant and the Pest Management Regulatory Agency by:

1. Helping the Pest Management Regulatory Agency to identify and review exactly which amendments are being made to the product label.
2. Helping the Pest Management Regulatory Agency and Applicants track and manage when particular changes were made to product labels.

The comments do not need to be detailed, but need at least the following minimum requirements:

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 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 requested from Pest Management Regulatory Agency decision under [submission #] (or) [policy #] (or) etc."
• "Changes in accepted standard statements."

D) Corrected Labels

A corrected version of the Word label will be sent to the Applicant after the Pest Management Regulatory Agency has completed a review of their application. Corrected labels will contain and use track changes. For an explanation of track changes, see section A) of this document.

1. If there is a proposed label amendment (track change on the label) that was not accepted by the Pest Management Regulatory Agency, the following comment will be found where the amendment was proposed "Proposed label [insertion or deletion] was rejected by the Pest Management Regulatory Agency."
2. If there is a proposed label amendment (track change on the label) that was accepted by the Pest Management Regulatory Agency, the following comment will accompany the accepted amendment: "Proposed label [insertion or deletion] was accepted by the Pest Management Regulatory Agency."
3. Any other label amendments requested by the Pest Management Regulatory Agency will be inserted/deleted and will have the accompanying comment: "Pest Management Regulatory Agency requested [insertion or deletion]."

If the applicant is an agreement with the Corrected Pest Management Regulatory Agency label, then no other changes to that label need to be made. However, a French version of the Corrected label will need to be prepared by the applicant and submitted to the Pest Management Regulatory Agency.

If there are any disagreements with the corrected Pest Management Regulatory Agency label, then notify the Pest Management Regulatory Agency. The Pest Management Regulatory Agency will then work with the applicant to generate a final version of the Corrected label. Once a final version is generated, the Pest Management Regulatory Agency will send it to the applicant.

Appendix B - Preparing Labels for Submission to Pest Management Regulatory Agency Using Adobe Acrobat Professional

This appendix provides details for preparing PDF labels to the Pest Management Regulatory Agency according to the proposed process described in the document "Label Review: A Pilot for a more Efficient Process". PDF labels should be created using Adobe Acrobat Professional (henceforth referred to as "Adobe").

A) Comments and Markups in Adobe Acrobat Professional

Adobe uses a variety of tools to help in tracking changes to a document: Many of the buttons presented below are found in the "Comment & Markup" toolbar. This toolbars can be added by selecting 'View' > 'Toolbars', then selecting the appropriate toolbar.

Highlighting (): Text in adobe can be highlighting by clicking this button then scrolling over the text you wish to highlight.

Eg. Part of this sentence was highlighted using the 'Highlight' tool in Adobe.

Sticky Notes (): Text in Adobe can be commented on by clicking this button and then adding comments inside the bubble.

Eg.

Text box (): Text can be added to an Adobe document by clicking this button and typing text in the text box.

Eg.

B) Amending Labels

All amendments using Adobe by the Applicant should be made in red. In order to change the colour of a comment or markup (either a highlight, comment bubble, or text box), right-click on the object, select 'Properties', then make the necessary changes. After making the changes, right-click the object again, and select 'Make Current Properties Default'.

Before amending the label, insert the following in a Text Box (see section A) at the top of the document:

"Last Approved Label: [Submission that accepted latest approved label]"
"Amended label submitted on: [Date of submission of proposed label]"

Every deletion and addition made to a label will need to be identified and commented upon by the applicant. Identifying and commenting on changes help the Applicant and the Pest Management Regulatory Agency by:

• Identifying and reviewing exactly which amendments are being made to the product label.
• Providing the ability to track and manage when particular changes were made to product labels.

To identify and comment on an insertion to the label, begin by highlighting the insertion in red (see section A). Then comment on the insertion using the sticky note tool (see section A).

Eg.

To identify and comment on a deletion to the label, place a sticky note in the location of the deleted text, and write the deleted text in the sticky note. Also comment on the deletion using the same sticky note.

Eg.

The comments in the sticky-notes do not need to be detailed, but need at least the following minimum requirements:

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 requested from Pest Management Regulatory Agency decision under [submission #] (or) [policy #] (or) etc."
• "Changes in accepted standard statements."
• Etc.

Deletions - 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 removal of text."
• Etc.

C) Annotated Labels

An Annotated version of the PDF label will be sent to the Applicant after the Pest Management Regulatory Agency has completed a review of their application. Annotated labels will contain and use the Comment & Markup tools available in Adobe. For an explanation of Comments and Markups, see section A) of this document. All Pest Management Regulatory Agency comments and markups will be in blue.

• If there is a proposed label amendment (a comment or markup on the label) that was not accepted by the Pest Management Regulatory Agency, the following sticky note will be found where the amendment was proposed "Proposed label [insertion or deletion] was rejected by the Pest Management Regulatory Agency."
• If there is a proposed label amendment (a comment or markup on the label) that was accepted by the Pest Management Regulatory Agency, the following comment will accompany the accepted amendment: "Proposed label [insertion or deletion] was accepted by the Pest Management Regulatory Agency."
• Any other label insertions requested by the Pest Management Regulatory Agency will be added as an annotation. Any label deletions requested by the Pest Management Regulatory Agency will be crossed-out text. These changes will also have the accompanying comment: "Pest Management Regulatory Agency requested [insertion or deletion]."

If the applicant is an agreement with the Annotated Pest Management Regulatory Agency label, then English and French Corrected versions of the label will need to be submitted to the Pest Management Regulatory Agency.

If there are any disagreements with the Annotated Pest Management Regulatory Agency label, then notify the Pest Management Regulatory Agency The Pest Management Regulatory Agency will then work with the applicant to generate a final version of the Annotated label. Once a final version is generated, the Pest Management Regulatory Agency will send it to the applicant.

D) Approved Labels

Once the final, Corrected version of the label submitted by the applicant to the Pest Management Regulatory Agency is accepted (see section C), then the applicant will receive an Approved PDF version of the label.