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<!DOCTYPE html><!--[if lt IE 9]>
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<title>Regulatory Enrolment Process (REP) Template Revision History</title>
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<h1 property="name" id="wb-cont">Regulatory Enrolment Process (REP) Template Revision History</h1>
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<p>Health Canada has updated the Regulatory Enrolment Process (REP) templates to reflect process changes and improvements. Refer to the Guidance Document: Regulatory Enrolment Process (REP) – Drugs for Human and Veterinary Use and Disinfectants for more information on the templates.</p>
<p>In order to access the most up-to-date version of the template, please be reminded to delete your cache frequently and “refresh” the template links on your web browser prior to each use.</p>
<p>Should you have any questions regarding the content of this document, please contact <a href="mailto:[email protected]" lang="en">[email protected]</a>.</p>
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<h3>May 3, 2021 Release</h3>
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<div>
<table class="col-md-12">
<tr>
<th class="col-md-3">Template</th>
<th class="col-md-9">Change</th>
</tr>
<tr>
<td class="col-md-3">Company (CO) Template
</td>
<td class="col-md-9">
<ul>
<li>Added “Reason for Filing” field. Refer to instruction on CO template for more information.</li>
<li>Removed importer company role and importer contact role Refer to section 3 of the REP guidance document for more information.</li>
<li>Updated instructions for various fields.</li>
<li>Revised “Country” picklist.</li>
</ul>
</td>
</tr>
<tr>
<td class="col-md-3">Regulatory Transaction (RT) Template
</td>
<td class="col-md-9">
<ul>
<li>Updated picklist option for “Dossier Type”, “Regulatory Activity Lead”, “Regulatory Activity Types” and “Associated Transaction Descriptions” to incorporate veterinary drugs.</li>
<li>Updated instructions for various fields to include veterinary drugs.</li>
<li>Updated instructions for various fields and added further descriptions for fields.</li>
</ul>
</td>
</tr>
<tr>
<td class="col-md-3">Product Information (PI) Template
</td>
<td class="col-md-9">
<ul>
<li>Resolved bugs</li>
<li>Added option for proprietary information under the formulation section and revised associated requirements for non-medicinal ingredient. Refer to section 5 of the REP guidance document for more information.</li>
<li>Revised “Calculated as Base” picklist to include the option “ingredient is not a salt”.</li>
<li>Updated instructions for various fields.</li>
<li>Removed HC6-024 prefix from “Dossier Identifier” field.</li>
<li>Removed Importer Company Identifier” field.</li>
<li>Updated instructions for various fields specific to veterinary drugs.</li>
<li>Revised “Country” picklist.</li>
</ul>
</td>
</tr>
<tr>
<td class="col-md-3">Stylesheet Package
</td>
<td class="col-md-9">
<ul>
<li>New CO and PI version 4.2 stylesheets to match changes to REP CO and PI templates.</li>
</ul>
</td>
</tr>
</table>
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<dt>Date modified: 2021-05-03</dt>
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