Food and Drug Regulations — C.11.002
C.11.002 (1) In order to address an actual, imminent or potential emergency, event or incident affecting public health or the health of members of the Canadian Armed Forces, a public health official may, on application to the Minister, obtain an authorization that permits a drug manufacturer to sell a specified quantity of a drug to the public health official, for immediate use or stockpiling or both. (2) The application must (a) set out the name of the public health official and include information setting out how they may be contacted at any time; (b) set out the name of the manufacturer and include information setting out how they may be contacted at any time; (c) describe the emergency, event or incident; (d) state whether the drug is for immediate use or stockpiling or both; (e) describe the use of the drug that is intended to address the emergency, event or incident; (f) set out the civic address of the place to which the drug is to be shipped by the manufacturer; (g) set out the following information about the drug: (i) its brand name, if any, and either its proper name, common name and chemical name or its identifying name, code, number or mark, (ii) its medicinal ingredients, (iii) its strength, (iv) its dosage form, (v) the recommended dosage for the use described under paragraph (e), (vi) its recommended route of administration, (vii) the indications that have been approved by any foreign regulatory authority, if applicable, (viii) its contraindications, (ix) a summary of its safety profile, and (x) the recommended storage conditions for the drug; (h) specify the quantity of the drug required to address the emergency, event or incident; (i) include a statement by the public health official, accompanied by supporting information or documents, attesting that (i) there is an actual, imminent or potential emergency, event or incident affecting public health or the health of the members of the Canadian Armed Forces that is likely to result, in humans, in a serious or life-threatening disease, disorder or abnormal physical state, (ii) immediate action is or would likely be required to diagnose, treat, mitigate or prevent the disease, disorder or abnormal physical state or its symptoms, (iii) conventional therapies, if any, have failed, are unsuitable or are unavailable in Canada at the time the application is made, and (iv) the known and potential benefits associated with the use of the drug described under paragraph (e) outweigh the known and potential risks associated with that use; (j) include any information or document available to the public health official concerning the safety, efficacy and quality of the drug in respect of the use described under paragraph (e), including information published in a medical or scientific journal; and (k) set out the following information, if known by the public health official: (i) the names of the foreign regulatory authorities that have authorized the sale of the drug in their jurisdictions for the same use as that described under paragraph (e), (ii) the names of the foreign regulatory authorities that have received an application for authorization to sell the drug in their jurisdictions for the use described under paragraph (e) but that have not yet made a decision in respect of that application at the time the public health official makes the application under subsection (1), and (iii) the names of the foreign regulatory authorities that have refused to authorize the sale of the drug in their jurisdictions for any use, as well as the reason for the refusal. (3) The public health official must provide the Minister with any additional information or document that the Minister determines is necessary for the purpose of reviewing the application, by the date specified by the Minister. SOR/2023-18, s. 4