Application for Alternate Sample Retention

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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

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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

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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