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Licence, authorization and registration forms for drug and health products

https://www.canada.ca/en/health-canada/services/licences-authorizations-registrations-drug-health-products/licence-authorization-registration-forms-drug-health-products.html

Aug 24, 2016 ...Licence, authorization and registration forms for drug and health products Guidance documents for drug, medical device, natural health product and site licensing. Also find blood establishment, donor semen, cell, tissue and organ registration information. Services and information License an establishment or site for drugs or health products Guidance

Licences, authorizations and registrations for drug and health products

https://www.canada.ca/en/health-canada/services/licences-authorizations-registrations-drug-health-products.html

Oct 15, 2019 .... Drug and health product fees and submission requirements Information on complying with regulations, and drug submission fees and amendments. Licence, authorization and registration forms for drug and health products Guidance documents for drug, medical device, natural health product and site licensing. Also find blood establishment, donor semen, cell, tissue

Guidance Document on the Import Requirements for Health Products under the Food and Drugs Act and its Regulations (GUI-0084)

https://www.canada.ca/en/health-canada/services/drugs-health-products/compliance-enforcement/importation-exportation/guidance-document-import-requirements-health-products-under-food-drugs-act-regulations-0084.html

Nov 15, 2019 ... the Natural Health Products Regulations. Marketing authorization: A legal document issued by Health Canada authorizing the sale of a drug or a device based on the health and safety requirements of the Food and Drugs Act and its Regulations. The marketing authorization may be in the form of a Drug Identification Number (DIN), a device licence for classes II, III and IV

Health Product InfoWatch – November 2019

https://www.canada.ca/en/health-canada/services/drugs-health-products/medeffect-canada/health-product-infowatch/health-product-infowatch-november-2019.html

Nov 27, 2019 ... easily out of their carrier tube. Advisory - EpiPen and EpiPen Jr (epinephrine) Foreign health products These foreign health products have been found by regulators in the United States, Singapore, Australia and Hong Kong to contain undeclared drug ingredients, which may pose serious health risks. These products are not authorized for sale in Canada and have

Cannabis Regulations

https://laws.justice.gc.ca/eng/regulations/SOR-2018-144/FullText.html

Oct 17, 2019 .... (instrument) drug drug has the same meaning as in section 2 of the Food and Drugs Act, but excludes cannabis that is (a) a natural health product to which the Natural Health Products Regulations apply; or (b) manufactured or sold — within the meaning of section 2 of the Food and Drugs Act — and is not represented, for use in  (i) the diagnosis, treatment, mitigation

Blood for transfusion or for use in the manufacture of a drug

https://www.canada.ca/en/health-canada/services/drugs-health-products/compliance-enforcement/information-health-product/blood-donor.html

Jul 19, 2019 ... inspections" page or browse inspections results in the Drug and Health Product Inspection Database. The Blood Regulations The Blood Regulations under the Food and Drugs Act (Act) came into force on October 23, 2014. Before this, blood and blood components were regulated under the Food and Drug Regulations. The Blood Regulations consolidate the specific requirements

Guidance Document: Fees for the Review of Medical Device Licence Applications

https://www.canada.ca/en/health-canada/services/drugs-health-products/medical-devices/application-information/guidance-documents/fees-review-medical-device-licence-applications-2019/document.html

Nov 8, 2019 ... with the product outweigh the risks. Health Canada has charged industry fees for these pre-market regulatory activities since 1998 in order to recover some of the associated costs. 1.1 Objective This document provides guidance on how fees for the review of medical device applications will be administered in accordance with the Food and Drugs Act and as stipulated

Health products containing cannabis or for use with cannabis: Guidance for the Cannabis Act, the Food and Drugs Act, and related regulations

https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/applications-submissions/guidance-documents/guidance-cannabis-act-food-and-drugs-act-related-regulations/document.html

Jul 15, 2019 ... Act & FDA) No restrictions on product classes that may be approved under FDA (e.g., dosage forms for prescription drugs) Practioner oversight Pre-market review for safety, efficacy and quality under FDA Manufacturing subject to quality and security requirements under the FDA and Cannabis Act Can make health claims, if authorized 1.4 Scope and Application

Industry Medical Device Report Form

https://health.canada.ca/en/health-canada/services/drugs-health-products/compliance-enforcement/problem-reporting/medical-device-industry.html

Nov 25, 2019 ...Industry Medical Device Report Form Privacy Notice Statement Provision of the information requested on this form is voluntary. Personal information is collected under the authority of the Food and Drugs Act and the Privacy Act for the purpose of delivering national compliance and enforcement activities of health products under the Health Canada mandate

Destruction of narcotics, controlled and restricted drugs and targeted substances by licensed dealers – Guidance document

https://www.canada.ca/en/health-canada/services/health-concerns/controlled-substances-precursor-chemicals/controlled-substances/compliance-monitoring/compliance-monitoring-controlled-substances/destruction.html

Sep 6, 2019 ... Loss or Theft Annex A: Definitions Annex B: Contact Information 1.0 Introduction The Controlled Drugs and Substances Act (CDSA) provides for the control of substances that can alter mental processes and that may produce harm to health and to society when diverted or misused. Except as authorized under its related regulations or via an exemption issued under

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