As Health Canada shifts to a proactive phase of enforcement of the Natural Health Products Regulations, it is important for natural health product (NHP) licence holders to ensure they have policies in place to monitor, assess and report adverse reactions to their products.
Many companies forget or are unaware that once they have been issued an NHP product licence, they are required to report known adverse reactions involving their products in accordance with the Natural Health Products Regulations. Reporting requirements vary depending on the type of adverse reaction:
Adverse reaction—a noxious and unintended response to an NHP that occurs at any recommended dose. This type of reaction must be recorded, analyzed and summarized in an annual report that does not need to be submitted to Health Canada unless requested. The Minister can request a copy of this report at any time by providing 30 days’ notice.
Serious adverse reaction—an adverse reaction to an NHP that occurs at any dose and which requires in-patient hospitalization or a prolongation of existing hospitalization, causes congenital malformation, results in persistent or significant disability or incapacity, is life-threatening or results in death. This type of reaction must be recorded, analyzed and reported to Health Canada within 15 days after the product licence holder becomes aware of it.
Serious unexpected adverse reaction—a serious adverse reaction whose nature, severity or frequency is either not identified or not consistent with the product’s labelling. A serious adverse reaction that results in death should be considered unexpected unless the product labelling specifically states that product use may be associated with a fatal outcome. This type of reaction must be recorded, analyzed and reported to Health Canada within 15 days after the product licence holder becomes aware of it, even if it occurs outside of Canada.
Every product licence holder should have written procedures in place for the receipt, evaluation and reporting of all types of adverse reactions. In addition, Health Canada guidance states that product licence holders are expected to exercise due diligence in collecting information regarding adverse reactions, including monitoring consumer reports and screening worldwide scientific literature related to the ingredients, dosage and safety of their products. While this type of constant monitoring is not obligatory, Health Canada policy recommends it for product licence holders. Adequate procedures should be in place to ensure that sufficient details about any adverse reaction are properly collected and retained to enable follow-up and investigation of the incident. Health Canada recommends that reports be readily accessible and retained for a minimum of 25 years from the date they are created.
Regardless of similar procedures adopted by retailers, manufacturers or distributors, the product licence holder is ultimately responsible for regulatory reporting. Ensuring that up-to-date policies are established and communicated can minimize the potential for inadequate information retention and delays in the sharing of key facts related to adverse reactions.