Guidance document : labelling of pharmaceutical drugs for human use.: H164-385/2024E-PDF

"Labelling of Pharmaceutical Drugs for Human Use replaces the Health Canada guidance document Labelling of Drugs for Human Use. This guidance document came into effect in 1989, was subsequently revised in 1991, and has since been removed from circulation by Health Canada because much of its content was deemed to be out-of-date. The purpose of this document is to provide guidance to sponsors to facilitate compliance with the labelling requirements pursuant to sections 3, 9, and 10 of the Food and Drugs Act as well as related provisions of the Food and Drug Regulations, the Controlled Drugs and Substances Act, and its related Regulations including the Narcotic Control Regulations, Parts G and J of the Food and Drug Regulations and the Benzodiazepines and Other Targeted Substances Regulations. This guidance should be used in conjunction with any other relevant Health Canada guidelines, policies and technical documents. Adherence to this guidance is expected to support the safe and effective use of drugs by health care professionals, patients and consumers. …"--Introduction, page 1.

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