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New regulations governing post-market oversight over opioids

Part of a federal initiative to address the opioid crisis, the Regulations Amending the Food and Drug Regulations (Opioids), which add post-market oversight over prescription opioids, came into force on April 23, 2018. We previously reported on the proposed regulations.

The Minister of Health can now impose terms and conditions on the market authorization for listed opioids (“Class B” opioids, set out in Part B of a List of Opioids). As explained in the Regulatory Impact Analysis Statement, the regulatory change contemplates that Health Canada will require a risk management plan (RMP) to be developed by the opioid drug sponsor or authorization holder and updated throughout the product’s life cycle. An RMP would include risk-monitoring activities and risk-minimization measures relating to the product. 

The amendments also introduce a mandatory warning sticker and patient information handout (for “Class A” opioids, set out in Part A of the List of Opioids, 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 provide the warning sticker on the drug’s packaging and to provide the handout to the patient at the time the drug is dispensed.  These provisions will not come into force until October 23, 2018.      

Health Canada has published information on the new regulations, including Guidance for industry on the RMPs and Questions and Answers for pharmacists and practitioners on the sticker and handout requirements.