This guidance document provides source establishments with assistance on how to comply with adverse reaction reporting obligations under the Food and Drugs Act and the Safety of...
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This labelling standard describes the requirements necessary to receive marketing authorization (a Drug Identification Number (DIN) or a Natural Product Number (NPN)) for...
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This Labelling Standard describes the requirements necessary to receive marketing authorization (a Drug Identification Number (DIN)) for single and multiple-ingredient orally...
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To support implementation of the proposed Act, regulations would need to be enacted in a range of areas, such as cannabis product standards and packaging and labelling...
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This document presents the final regulatory decision for the special review of metaldehyde. To comply with this decision, the required label amendments (Appendix II) must be...
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The Framework, Safety and Efficacy and Quality guidance documents apply to sponsors intending to make post approval changes to new drugs (ie. changes to a drug that have...
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Prescription drugs are an increasingly important part of our health care system, helping prevent and cure disease as well as save lives. However, Canada’s drug spending, which...
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