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Licensing, authorizing and manufacturing drug and health products

https://www.canada.ca/en/health-canada/topics/licensing-authorizing-manufacturing-drug-health-products.html

Jun 6, 2016 ...Licensing, authorizing and manufacturing drug and health products Information on drug, medical device or natural health product licence applications, approvals and legal requirements. Services and information Licences, authorizations and registrations for drug and health products Information on applying for licences, drug submission requirements, clinical

Drug and health products

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

Jun 28, 2019 ... consumption, production, selling, licensing, regulations Self-care products Self-care products, cosmetics, over-the-counter drugs, regulating in Canada Natural and non-prescription health products Natural health products, associated guidelines and regulations Licensing, authorizing and manufacturing drug and health products Drug, medical device and natural health

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

Drug and health product review and approval

https://www.canada.ca/en/health-canada/services/drug-health-product-review-approval.html

Oct 2, 2019 ... to evaluate their safety and efficacy. Contributors Health Canada What we are doing Laws and regulations Food and Drugs Act Protecting Canadians from Unsafe Drugs Act (Vanessa's Law) Publications Guidance document on Public Release of Clinical Information Health Canada New Drug Authorizations: 2016 Highlights Reporting adverse reactions to marketed health products

Regulation of non-prescription drugs

https://www.canada.ca/en/health-canada/services/self-care-regulation-non-prescription-drugs.html

Feb 21, 2018 ... take corrective action For more information Recalls and safety alerts Report a health and safety concern How drugs are reviewed in Canada Licensing, authorizing and manufacturing drug and health products

Recall policy for health products

https://www.canada.ca/en/health-canada/services/drugs-health-products/compliance-enforcement/information-health-product/drugs/recall-policy-0016/policy.html

Sep 27, 2019 ... manner, as follows: For drugs The responsible party should notify Health Canada if there is a potential need to recall a distributed product at the time a risk to health is identified. Section C.01.051 of the Food and Drug Regulations requires a manufacturer or importer who commences a recall to submit information to Health Canada "forthwith". This is interpreted

List of Regulatory Agencies for the Purposes of the Proposed Section 61.2 of the Medical Devices Regulations

https://www.canada.ca/en/health-canada/services/drugs-health-products/public-involvement-consultations/medical-devices/proposed-amendment-medical-device-regulations/agencies.html

Sep 24, 2019 ... Switzerland Paul Ehrlich-Institute of Germany Germany Agence nationale de sécurité du médicament et des produits de santé France Health Products Regulatory Authority Ireland National Medical Products Administration China Russian Ministry of Health Russia Ministry of Food and Drug Safety South Korea Medical Products Agency Sweden Medicines and Healthcare Products

Drugs

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

Aug 30, 2019 ...Drugs The maintenance and enhancement of health and safety is a responsibility that is shared between government and industry, consumers, healthcare professionals and their respective associations. Regulated parties that market drugs and medical devices have the primary responsibility for the safety of any product they sell, manufacture, import

Meeting legal requirements for manufacturing drug and health products

https://www.canada.ca/en/health-canada/services/meeting-legal-requirements-manufacturing-drug-health-products.html

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

Foreign Risk Notification, Annual Summary Reports, and Issue-related Analysis of Safety and Effectiveness for Medical Devices - Draft Guidance Document

https://www.canada.ca/en/health-canada/services/drugs-health-products/public-involvement-consultations/medical-devices/proposed-amendment-medical-device-regulations/document.html

Sep 18, 2019 ... or increased serious risk of injury to health related to the use of their medical device and, as a result, has withdrawn the product from the market in one or more countries listed in Appendix A. The device is also authorized for sale in Canada. Examples of non-reportable foreign actions A manufacturer of a medical device authorized for sale in a country listed

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