Natural Health Products Management of Applications Policy: Overview
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Purpose
This document outlines the:
- responsibilities and expectations of applicants throughout the product licence application (PLA) and post-licensing processes in accordance with the Natural Health Products Regulations (NHPR)
- processes applied by the Natural and Non-prescription Health Products Directorate (NNHPD) to the lifecycle of applications – from pre-submission to post-licensing
Scope
This document applies to all classes of NHP applications, including new applications and changes made after a product has been licensed (amendments and notifications).
It is designed to help applicants and licence holders navigate the application and post-licensing process and should be used alongside the relevant guidance documents linked throughout this document.
Exclusions
This document does not apply to:
- site licence applications for NHPs
- clinical trial applications for NHPs
- applications for foods, other health products including drugs (prescription and non-prescription), medical devices, biologic and genetic therapies, and veterinary drugs.
Site licensing
To manufacture, label, package, and/or import an NHP, a site licence is required. For details on the site licensing process, refer to the Site Licensing Guidance Document.
Note about guidance documents in general
Guidance documents provide assistance to industry on how to comply with governing statutes and regulations. They also provide guidance to Health Canada staff on how mandates and objectives should be met fairly, consistently and effectively.
Guidance documents are administrative, not legal, instruments. This means that flexibility can be applied. However, to be acceptable, alternate approaches to the principles and practices described in this document must be supported by adequate justification. They should be discussed in advance with the relevant program area to avoid the possible finding that applicable statutory or regulatory requirements have not been met.
As always, Health Canada reserves the right to request information or material, or define conditions not specifically described in this document, to help us adequately assess the safety, efficacy and/or quality of a natural health product. We are committed to ensuring that such requests are justifiable and that decisions are clearly documented.
This document should be read along with the relevant sections of the regulations and other applicable guidance documents.