Food and Drugs Act — F-27 30
ducts (1.2) Without limiting the power conferred by any other subsection of this section, the Governor in Council may make regulations (a) respecting the issuance of authorizations — including licences — that authorize, as the case may be, the import, sale, advertisement, manufacture, preparation, preservation, packaging, labelling, storage or testing of a therapeutic product, and the amendment, suspension and revocation of such authorizations; (b) authorizing the Minister to impose terms and conditions on authorizations referred to in paragraph (a), including existing authorizations, and to amend those terms and conditions; (b.1) requiring the Minister to ensure that decisions with regard to the issuance, amendment, suspension and revocation of authorizations referred to in paragraph (a), and to the imposition and amendment of terms and conditions in respect of those authorizations, along with the reasons for those decisions, are publicly available; (b.2) specifying provisions of the regulations that are excluded from the exemption provided for in section 21.94 or 21.96; (c) requiring holders of a therapeutic product authorization that authorizes the import or sale of a therapeutic product for a clinical trial, or former holders of such an authorization, to provide the Minister, after the trial 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safety information that the holders or former holders receive or become aware of about the therapeutic product; (c.1) [Repealed, 2019, c. 29, s. 172] (d) requiring holders of a therapeutic product authorization to provide the Minister with information, in respect of any serious risk of injury to human health, that the holders receive or become aware of and that is relevant to the safety of the therapeutic product to which the authorization relates, regarding (i) risks that have been communicated outside Canada, and the manner of the communication, (ii) changes that have taken place to labelling outside Canada, and (iii) recalls, reassessments and suspensions or revocations of authorizations, including licences, in respect of a therapeutic product, that have taken place outside Canada; (d.01) requiring holders of a therapeutic product authorization to provide the Minister with information, in respect of any serious risk to the environment, that the holders receive or become aware of and that is relevant to the therapeutic product to which the authorization relates, regarding (i) risks that have been communicated outside Canada, and the manner of the communication, (ii) changes that have taken place to labelling outside Canada, and (iii) recalls, reassessments and suspensions or revocations of authorizations, including licences, in respect of a therapeutic product, that have taken place outside Canada; (d.1) specifying the business information obtained under this Act in relation to an authorization under paragraph (a) that is not confidential business information, or the circumstances in which business information obtained under this Act in relation to such an authorization ceases to be confidential business information; (d.2) authorizing the Minister to disclose, without notifying the person to whose business or affairs the information relates or obtaining their consent, business information that, under regulations made under paragraph (d.1), (i) is not confidential business information, or (ii) has ceased to be confidential business information; (e) respecting modifications of labels and modifications and replacements of packages referred to in sections 21.2 and 21.302; (f) respecting the recall of a therapeutic product or the sale of a therapeutic product that is the subject of a recall; (f.1) respecting assessments referred 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