Food and Drugs Act — F-27 30
Regulations 30 (1) The Governor in Council may make regulations for carrying the purposes and provisions of this Act into effect, and, in particular, but without restricting the generality of the foregoing, may make regulations (a) declaring that any food or drug or class of food or drugs is adulterated if any prescribed substance or class of substances is present therein or has been added thereto or extracted or omitted therefrom; (a.01) declaring that any drug is adulterated if the Minister believes that a prescribed substance contained in that drug presents a serious risk to the environment; (a.1) respecting consultations in respect of orders referred to in section 2.4; (b) respecting (i) the labelling and packaging and the offering, exposing and advertising for sale of food, drugs, cosmetics and devices, (ii) the size, dimensions, fill and other specifications of packages of food, drugs, cosmetics and devices, (iii) the sale or the conditions of sale of any food, drug, cosmetic or device, and (iv) the use of any substance as an ingredient in any food, drug, cosmetic or device, to prevent the purchaser or consumer thereof from being deceived or misled in respect of the design, construction, performance, intended use, quantity, character, value, composition, merit or safety thereof, or to prevent injury to the health of the purchaser or consumer; (b.01) respecting, for the purposes of managing risks to the environment, any of the following: (i) the labelling and packaging and the offering, exposing and advertising for sale of food, drugs, cosmetics and devices, (ii) the size, dimensions, fill and other specifications of packages of food, drugs, cosmetics and devices, (iii) the sale or the conditions of sale of any food, drug, cosmetic or device, and (iv) the use of any substance as an ingredient in any food, drug, cosmetic or device; (b.1) respecting the conduct of clinical trials; (b.2) respecting the issuance of authorizations referred to in section 3.1 and the amendment, suspension and revocation of those authorizations; (b.3) authorizing the Minister to impose terms and conditions on authorizations referred to in section 3.1, including existing authorizations, and to amend those terms and conditions; (b.4) requiring the Minister to ensure that decisions with regard to the issuance, amendment, suspension and revocation of authorizations referred to in section 3.1, and to the imposition and amendment of terms and conditions referred to in paragraph (b.3), along with the reasons for those decisions, are publicly available; (b.5) requiring holders of an authorization referred to in section 3.1, or former holders of such an authorization, to provide the Minister, after the clinical trial to which the authorization relates is completed or discontinued or, if the authorization is suspended or revoked, after the suspension or revocation, with safety information that the holders or former holders receive or become aware of about the drug, device or food for a special dietary purpose that is or was the subject of the clinical trial; (c) prescribing standards of composition, strength, potency, purity, quality or other property of any article of food, drug, cosmetic or device; (d) respecting the importation of food, drugs, cosmetics and devices — including any importation that is solely for the purpose of export — in order to ensure compliance with the provisions of this Act and the regulations; (e) respecting the method of manufacture, preparation, preserving, packaging, storing and testing of any food, drug, cosmetic or device in the interest of, or for the prevention of injury to, the health of the purchaser or consumer or to manage risks to the environment; (f) requiring persons that sell food, drugs, cosmetics or devices, or persons that import them solely for the purpose of export, to maintain any records, reports, electronic data or other documents that the Governor in Council considers necessary for the purposes of this Act;