Natural Health Products Regulations (SOR/2003-196)

• 45. (1) Every natural health product shall be manufactured, packaged, labelled and stored in premises that are designed, constructed and maintained in a manner that permits the activity to be conducted under sanitary conditions, and in particular that

  • (a) permits the premises to be kept clean and orderly;

  • (b) permits the effective cleaning of all surfaces in the premises;

  • (c) permits the natural health product to be stored or processed appropriately;

  • (d) prevents the contamination of the natural health product; and

  • (e) prevents the addition of an extraneous substance to the natural health product.

• (2) Every natural health product shall be stored under conditions that will maintain the quality and safety of the natural health product.

46. Every natural health product shall be manufactured, packaged, labelled and stored using equipment that is designed, constructed, maintained, operated and arranged in a manner that

• (a) permits the effective cleaning of its surfaces;

• (b) permits it to function in accordance with its intended use;

• (c) prevents it from contaminating the natural health product; and

• (d) prevents it from adding an extraneous substance to the natural health product.

47. Every natural health product shall be manufactured, packaged, labelled and stored by personnel who are qualified by education, training or experience to perform their respective tasks.

48. Every natural health product shall be manufactured, packaged, labelled and stored in accordance with a sanitation program that sets out

• (a) procedures for effectively cleaning the premises in which the activity is conducted;

• (b) procedures for effectively cleaning the equipment used in the activity;

• (c) procedures for handling any substance used in the activity; and

• (d) all requirements, in respect of the health, the hygienic behaviour and the clothing of the personnel who are involved in the activity, that are necessary to ensure that the activity is conducted in sanitary conditions.

49. Every natural health product shall be manufactured, packaged, labelled and stored in accordance with standard operating procedures that are designed to ensure that the activity is conducted in accordance with the requirements of this Part.

50. Every manufacturer, packager, labeller, importer and distributor shall establish and maintain a system of control that permits the rapid and complete recall of every lot or batch of the natural health product that has been made available for sale.

• 51. (1) Every manufacturer, packager, labeller, importer and distributor shall

  • (a) have a quality assurance person who

    • (i) is responsible for assuring the quality of the natural health product before it is made available for sale, and

    • (ii) has the training, experience and technical knowledge relating to the activity conducted and the requirements of this Part; and

  • (b) investigate and record every complaint received in respect of the quality of the natural health product and, if necessary, take corrective action.

• (2) Every natural health product shall be manufactured, packaged and labelled using only material that, prior to its use in the activity, has been approved for that use by a quality assurance person.

• (3) Every natural health product shall be manufactured, packaged, labelled and stored using methods and procedures that, prior to their implementation, have been approved by a quality assurance person.

• (4) Every lot or batch of a natural health product shall be approved by a quality assurance person before it is made available for sale.

• (5) Every natural health product that is sold and subsequently returned to its manufacturer, packager, labeller, importer or distributor, as the case may be, shall be approved by a quality assurance person before that natural health product may be made available for resale.