New Application Management Policy

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Dear stakeholders,

The Application Management Policy outlines the way in which Product Licence Applications for natural health products are submitted in accordance with the Natural Health Products Regulations. The policy also outlines the responsibilities and expectations for natural health product applicants before and throughout the application review process. In addition, the policy outlines the proposed performance targets for the management of all types of product licence applications.

In May and June 2010, this policy was presented to stakeholders as part of the Natural Health Products Program Workshops held in various cities across Canada.

This policy is attached and applies to all product licence applications received after today’s date.  The policy will be published on the NHPD website as soon as possible. Any questions regarding this policy can be directed towards your Submission Coordinator or PLA.info.DLMM@hc-sc.gc.ca

Contents of the Application Management Policy:

  • Requirements for applicants before filing a Product Licence Application
  • How to file a Product Licence Application
  • Communicating with NHPD
  • Pre-submission meetings
  • Administrative processing of applications
  • Initial assessment of applications
  • Full assessment of applications (including Information Request Notices)
  • Refusal and Withdrawal Letters
  • Reviewer’s Reports
  • Unsolicited Information
  • Re-filed Applications
  • Requests for Reconsideration
  • Proposed Performance targets for all application types

Respectfully,

The Natural Health Products Directorate

Health Canada