Food and Drug Regulations — 8
8 The Regulations are amended by adding the following after section C.01.625: Risk Management Plans C.01.700 For the purposes of sections C.01.703 and C.01.704, existing risk management plan means the most recent risk management plan for a drug that the drug’s manufacturer has provided to the Minister under these Regulations. C.01.701 (1) A risk management plan for a drug that the drug’s manufacturer provides to the Minister under these Regulations must, taking into account the Canadian context, contain sufficient information to enable the Minister to identify and characterize the risks associated with the drug and to conclude that the plan, if implemented, would prevent or reduce those risks or address uncertainties associated with the drug and must include (a) a description of the drug and the uses of the drug; (b) a detailed description of the risks associated with the drug and the uncertainties relating to those risks; (c) a detailed description of the measures that the manufacturer intends to take to address those uncertainties and monitor the situation with respect to them; (d) a detailed description of the measures that the manufacturer intends to take to prevent or reduce those risks; (e) a detailed description of how the manufacturer intends to evaluate the effectiveness of the measures referred to in paragraph (d); and (f) a summary of the plan’s contents in English and French. (2) Despite paragraph (1)(f), for the purposes of subsection C.01.014.1(4), paragraph C.08.002(2)(p), subparagraph C.08.002.01(2)(b)(xi), paragraph C.08.002.1(2)(a.1) and subsection C.08.003(3.2), the manufacturer may initially provide the summary of the risk management plan in either English or French if the manufacturer then provides a summary of the plan in the other language before the document that sets out the drug identification number assigned for the drug is issued under subsection C.01.014.2(1) or the notice of compliance is issued under section C.08.004 or C.08.004.01. C.01.702 (1) The Minister may request that the manufacturer of a drug for human use for which a drug identification number has been assigned and not been cancelled provide the Minister, within a period specified by the Minister that is reasonable in the circumstances, with a risk management plan for the drug that meets the requirements set out in section C.01.701, if (a) a risk management plan for the drug has not yet been provided to the Minister; and (b) the Minister has reasonable grounds to believe that (i) there is a significant degree of uncertainty respecting the risks associated with the drug, or (ii) the drug presents a serious risk of injury to human health that warrants that measures, other than labelling, be taken to reduce the probability or severity of such an injury. (2) The manufacturer must provide the risk management plan within the specified period. C.01.703 In cases where there is already an existing risk management plan, the manufacturer of a drug for human use for which a drug identification number has been assigned and not been cancelled must, as soon as feasible, provide the Minister with an updated risk management plan for the drug that meets the requirements set out in section C.01.701 if (a) the risks associated with the drug, or the uncertainties relating to those risks, are significantly different than those that are described in the existing risk management plan; or (b) the measures that the manufacturer intends to take to prevent or reduce the risks associated with the drug, or to address the uncertainties relating to those risks and to monitor the situation with respect to those uncertainties, are significantly different than those that are described in the existing risk management plan. C.01.704 (1) In cases where there is already an existing risk management plan, the Minister may request that the manufacturer of a drug for human use for which a drug identification number has been assigned and not been cancelled provide the Minister, w