Application for Alternate Sample Retention

 

The Natural Health Products Directorate (NHPD) has changed its name to the Natural and Non-prescription Health Products Directorate (NNHPD) subsequent to its recently expanded mandate to include the oversight of non-prescription and disinfectant drugs in addition to natural health products (NHPs). Please note that we are currently modifying documents to reflect this change.

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This HTML document is not a form. Its purpose is to display the information as found on the form for viewing purposes only. If you wish to use the form, you must use the alternate format below.

For Viewing Purposes Only - Licence applicants must use the available WORD or PDF versions of this form when submitting it to the Natural Health Products Directorate (NHPD).

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Natural Health Products Directorate

  • Health Canada File Number (if known):
  • Company Code (if known):
  • Applicant:
    • Name:
    • Address:
    • Telephone Number:
    • Fax Number:
    • Email:
  • Product:
    • Name:
    • Product Number (if Applicable):
  • Manufacturer:
    • Name:
    • Address:
    • Telephone Number:
    • Fax Number:
    • Email:
  • Site where samples are to be retained:
    • Name:
    • Address:
    • Contact Person:
    • Telephone Number:
    • Fax Number:
    • Email:

Attestation:

We have formally arranged with the storage site to retain sufficient numbers of samples of lots as per storage conditions indicated on the label, with the same container-closure sold in Canada to allow access by all pertinent regulatory authorities including Health Canada.

  • Yes
  • No

We have read and understood Section 61 (1), (2), (3) (see below) under Lot or Batch Samples.

61. (1) Subject to subsection (3), if the Minister has reasonable grounds to believe that a lot or batch of a natural health product made available for sale may result in injury to the health of a purchaser or consumer, the Minister may require the manufacturer, importer or distributor to provide a sample of that lot or batch.

(2) The sample shall be of sufficient quantity to enable a determination of whether the lot or batch of the natural health product complies with the specifications for that natural health product.

(3) The Minister shall not require a sample of a lot or batch referred to in subsection (1) to be provided if more than one year has elapsed since the expiry date of that natural health product.

  • Yes
  • No

Commitment:

We have a written commitment with the responsible person at the storage site that samples will be provided within 48 hours of receiving a request from Health Canada.

  • Signature, Responsible Officer:
  • Title:
  • Emergency Telephone Number:
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