Food and Drugs Act — F-27 30
erred to in section 21.31, and the provision of the results of the assessments to the Minister; (f.2) requiring the Minister to ensure that decisions with regard to the making of orders under section 21.31, along with the reasons for those decisions, are publicly available; (f.3) respecting the compilation of information, the conducting of tests and studies and the monitoring that are referred to in paragraphs 21.32(a) and 21.33(a), and the provision to the Minister of the information or results referred to in paragraphs 21.32(b) and 21.33(b); (g) prescribing anything that is to be prescribed under section 21.71; (h) defining serious adverse drug reaction and medical device incident for the purposes of this Act; (i) respecting the provision by health care institutions referred to in section 21.8 to the Minister of information referred to in that section; and (j) prescribing anything that is to be prescribed under section 21.8. Consideration of existing information management systems (1.3) Before recommending to the Governor in Council that a regulation be made under paragraph (1.2)(i) or (j), the Minister shall take into account existing information management systems, with a view to not recommending the making of regulations that would impose unnecessary administrative burdens. Regulations — preventing or alleviating shortages (1.4) Without limiting the power conferred by any other subsection of this section, the Governor in Council may make any regulations that the Governor in Council considers necessary for the purpose of preventing shortages of therapeutic products or foods for a special dietary purpose in Canada or alleviating those shortages or their effects, in order to protect human health. Regulations — animal testing (1.5) Without limiting the power conferred by any other subsection of this section, the Governor in Council may make any regulations that the Governor in Council considers necessary for the purpose of preventing, in respect of cosmetics, the conduct of a test on an animal that could cause pain, suffering or injury, whether physical or mental, to the animal, or preventing the purchaser or consumer of a cosmetic from being deceived or misled in respect of whether the cosmetic was tested on animals. Regulations respecting drugs manufactured outside Canada (2) Without limiting the power conferred by any other subsection of this section, the Governor in Council may make such regulations governing, regulating or prohibiting (a) the importation into Canada of any drug or class of drugs manufactured outside Canada, or (b) the distribution or sale in Canada, or the offering, exposing or having in possession for sale in Canada, of any drug or class of drugs manufactured outside Canada, as the Governor in Council deems necessary for the protection of the public in relation to the safety and quality of any such drug or class of drugs. Regulations — Canada–United States–Mexico Agreement and WTO Agreement (3) Without limiting the power conferred by any other subsection of this section, the Governor in Council may make any regulations that the Governor in Council considers necessary for the purpose of implementing, in relation to drugs, Articles 20.48 and 20.49 of the Canada–United States–Mexico Agreement or paragraph 3 of Article 39 of the Agreement on Trade-related Aspects of Intellectual Property Rights set out in Annex 1C to the WTO Agreement. Definitions (4) In subsection (3), Canada–United States–Mexico Agreement has the meaning assigned by the definition Agreement in section 2 of the Canada–United States–Mexico Agreement Implementation Act ; ( Accord Canada–États-Unis–Mexique ) North American Free Trade Agreement [Repealed, 2020, c. 1, s. 58] WTO Agreement has the meaning given to the word Agreement by subsection 2(1) of the World Trade Organization Agreement Implementation Act . ( Accord sur l’OMC ) Regulations to implement General Council Decision (5) Without limiting the power conferred by any other subsectio