As part of a federal initiative to address the opioid crisis, the Regulations Amending the Food and Drug Regulations (Opioids) came into force on 23 April 2018 (for further details please see "Health Canada update"). The regulations add post-market oversight of prescription opioids.
The minister of health can now impose terms and conditions on the market authorisation for listed opioids (ie, 'Class B' opioids, set out in Part B of the Health Canada List of Opioids). As explained in the Regulatory Impact Analysis Statement, following the regulatory change Health Canada will require the drug sponsor or authorisation holder of a listed opioid to develop a risk management plan for the product, which it must keep updated throughout the product's lifecycle. The risk-management plan will include risk-monitoring activities and risk-minimisation measures relating to the product.
The amendments also introduce a mandatory warning sticker and patient information handout for 'Class A' opioids (as set out in Part A of the List of Opioids, which is presently identical to the Part B list). Aimed at better informing patients about the safe use and risks of opioids, the amendments require pharmacists or practitioners to place the warning sticker on the drug's packaging and provide the handout to the patient when the drug is dispensed. These provisions will not come into force until 23 October 2018.
Health Canada has published information on the new regulations, including industry guidance on the risk-management plan and questions and answers for pharmacists and practitioners on the sticker and handout requirements.
For further information on this topic please contact Lynn Ing at Smart & Biggar/Fetherstonhaugh by telephone (+1 416 593 5514) or email ([email protected]). The Smart & Biggar/Fetherstonhaugh website can be accessed at www.smart-biggar.ca.
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