Natural Health Products Regulations (SOR/2003-196)

56. Every importer who sells a natural health product shall maintain the following records:

• (a) the master production document for the natural health product;

• (b) a list of all ingredients contained in each lot or batch of the natural health product;

• (c) records of any testing conducted in respect of a lot or batch of the natural health product;

• (d) a copy of the specifications for the natural health product;

• (e) a record of each determination made by the importer in accordance with section 52 and the information that supports that determination;

• (f) records containing sufficient information to enable the recall of every lot or batch of the natural health product that has been made available for sale; and

• (g) a copy of the sanitation program in use by the importer.

57. Every distributor shall maintain the following records at the site at which the natural health product is stored:

• (a) records containing sufficient information to enable the recall of every lot or batch of the natural health product that has been made available for sale;

• (b) a list of all natural health products that are being stored at the site; and

• (c) a copy of the sanitation program in use at the site.

58. Every person required under this Part to maintain a record that relates to a lot or batch of a natural health product shall maintain that record for a period of one year following the expiry date of the natural health product to which that record relates.

59. Every natural health product that is intended to be sterile shall be manufactured and packaged

• (a) in a separate and enclosed area;

• (b) under the supervision of a person trained in microbiology; and

• (c) using a method scientifically proven to ensure its sterility.

• 60. (1) Section C.01.064 of the Food and Drug Regulations applies in respect of natural health products except that it shall be read without reference to the words “or parenteral”.

• (2) Section C.01.065 of the Food and Drug Regulations applies in respect of natural health products except that it shall be read without reference to

  • (a) the words “or parenteral”; and

  • (b) the words “or to its common name if there is no proper name”.

• 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.