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Meeting legal requirements for manufacturing drug and health products

Sep 28, 2018 ...Meeting legal requirements for manufacturing drug and health products Information on importing, exporting, manufacturing, licensing, producing and monitoring drug and medical health products. Services and information Importing and exporting drug and health products Find requirements, policies and guidance documents related to importing and exporting health

Licensing, authorizing and manufacturing drug and health products

Jun 6, 2016 ... trials and selling veterinarian drugs. Drug and health product review and approval Information on the approval process for drugs, medical devices, natural health products and homeopathic medicine. Includes drug pricing and drug approval decisions. Meeting legal requirements for manufacturing drug and health products Information on importing, exporting

Designated Devices Registry Guidance Document

Jan 17, 2019 ... the device with Health Canada. Legitimate users are required to register any designated device they wish to import with Health Canada. Legitimate users are required to provide the registration number and proof/confirmation of the registration at the border upon importation of the designated device. Registration is not onerous; the burden on legitimate manufacturers

Importing and registering pill presses (designated devices)

Dec 20, 2018 ... Directorate Health Canada 161 Goldenrod Driveway, AL0300B Ottawa ON K1A 0K9 Health Canada’s service hours are Monday to Friday from 8 am to 6 pm (Eastern time). They are closed on statutory holidays. Information and services Canada Drugs and Substance Strategy Related guides and help Registration Form for Importation of Designated Devices Step-by-Step Guide

Guidance Document: Part C, Division 5 of the Food and Drug Regulations “Drugs for Clinical Trials Involving Human Subjects” (GUI-0100)

Aug 20, 2019 ... to the chemistry and manufacturing information that does not affect the quality or safety of the drug, other than a change for which an amendment is required by section C.05.008; and (b) a change to the protocol that does not alter the risk to the health of a clinical trial subject, other than a change for which an amendment is required by section C.05.008. Interpretation

Guidance on the regulations respecting flavoured purified alcohol

Jul 22, 2019 ... on Standardized Alcoholic Beverages 3.4 Labelling requirements 3.5 Acceptable Variation Between Alcohol on Label and Measured Value 4.0 Additional Information Appendix A - Tips on How to Help Identify Flavoured Purified Beverages 1.0 Purpose and scope Health Canada has amended the Food and Drug Regulations (FDR) to restrict the amount of alcohol in flavoured purified

Reducing Youth Access and Appeal of Vaping Products: Potential Regulatory Measures

Aug 20, 2019 ... regulations apply to vaping products that make a health claim, including those that contain nicotine (e.g., for smoking cessation) or any other drugs as defined by the FDA. Any vaping products that meet this description and are authorized for sale under the FDA are also subject to the TVPA unless explicitly excluded by regulations (i.e., Regulations Excluding Certain

Health Canada 2017–2018 Departmental Results Report

Aug 14, 2019 ... cigarettes to protect young Canadians from inducements to tobacco use. As of October 2017, Health Canada prohibited the manufacture and sale of cigarettes, blunt wraps and most cigars that contain menthol, and prohibited the promotion of menthol on the packaging of these tobacco products. Health Canada identified 49 planned Regulatory Transparency and Openness

Cannabidiol (CBD), and industrial hemp

Aug 13, 2019 ... exceptions, are listed on the Prescription Drug List. If you wish to manufacture and sell a health product containing CBD that makes a health claim, you require approval for the product as a prescription drug under the Food and Drug Regulations. CBD in natural health products, veterinary health products and cosmetics Only limited parts of cannabis or hemp plants may

Vaping product regulation

Jul 31, 2019 ... to confirm the product meets safety, efficacy and quality requirements. A valid site licence from Health Canada is also required before a vaping product in Canada can be: labelled imported packaged manufactured Notice: Implications of the Tobacco and Vaping Products Act for the Health Products Regulated Under the Food and Drugs Act Contact: Therapeutic Products

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