Natural Health Products Regulations (SOR/2003-196)

52. Every manufacturer and every importer shall determine the period of time that, after being packaged for sale, the natural health product will continue to comply with its specifications when

• (a) it is stored under its recommended storage conditions; or

• (b) if it does not have recommended storage conditions, it is stored at room temperature.

53. Every manufacturer who sells a natural health product shall maintain the following records at the site at which the natural health product is manufactured:

• (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 raw material used in the manufacture of the natural health product;

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

• (e) a copy of the specifications for each natural health product that is being manufactured at the site;

• (f) records demonstrating that each lot or batch of the natural health product was manufactured in accordance with the requirements of this Part;

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

• (h) 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;

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

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

54. Every packager who sells a natural health product shall maintain the following records at the site at which the natural health product is packaged:

• (a) records of any testing conducted in respect of the material used to package the natural health product;

• (b) records demonstrating that each lot or batch of the natural health product was packaged in accordance with the requirements of this Part;

• (c) 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;

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

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

55. Every labeller who sells a natural health product shall maintain the following records at the site at which the natural health product is labelled:

• (a) records demonstrating that each lot or batch of the natural health product was labelled in accordance with the requirements of this Part;

• (b) 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;

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

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