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Drug and medical device highlights 2018: Helping you maintain and improve your health

https://www.canada.ca/en/health-canada/services/publications/drugs-health-products/drug-medical-device-highlights-2018.html

Jun 27, 2019 ... products, and products produced through biotechnology. Biosimilars A biologic drug that enters the market subsequent to a previously authorized biologic drug in Canada with a demonstrated similarity to the previously authorized biologic drug. Extraordinary use new drug Health Canada recognizes that there are circumstances in which manufacturers cannot reasonably

Travel advice and advisories for France

https://travel.gc.ca/destinations/france

Aug 14, 2019 ... must be accompanied by at least one parent. Children travelling without at least one parent must be in possession of an authorization to leave the country signed by one of the parents, as well as a photocopy of the signing parent’s identification. More information and a copy of the authorization to leave the country form - French administration service

GST/HST Information for Non-Profit Organizations

https://www.canada.ca/en/revenue-agency/services/forms-publications/publications/rc4081/gst-hst-information-non-profit-organizations.html

Apr 3, 2019 ..., see Guide RC4022, General Information for GST/HST Registrants. It has basic information on charging, collecting, and remitting the GST/HST. GST/HST and Quebec In Quebec, Revenu Québec generally administers the GST/HST. If the physical location of your business is in Quebec, you have to file your returns with Revenu Québec using its forms, unless you

Reporting Adverse Reactions to Marketed Health Products - Guidance Document for Industry

https://www.canada.ca/en/health-canada/services/drugs-health-products/reports-publications/medeffect-canada/reporting-adverse-reactions-marketed-health-products-guidance-industry/guidance-document.html

May 17, 2019 ...-Market AR Reporting Requirements to MHPD 1 Introduction 1.1 Scope This guidance document provides market authorization holders (MAHs) with assistance on how to comply with the Food and Drugs Act, the Food and Drug Regulations, and the Natural Health Products Regulations with respect to reporting adverse reactions (ARs) to marketed health products, but excluding

Compliance and enforcement policy for health products (POL-0001)

https://www.canada.ca/en/health-canada/services/drugs-health-products/compliance-enforcement/good-manufacturing-practices/policies-standards/compliance-enforcement-policy-0001.html

May 7, 2019 ... under the Act has clearly defined responsibilities for the safety, efficacy and quality of health products imported or sold in Canada. Other parties may also be subject to the Act although they may not require an authorization from Health Canada to perform certain activities. For example, while wholesalers of non-prescription drugs and active pharmaceutical

Operational procedure: Implementation of Memorandum of Understanding with samplers for the delivery of the Canadian Shellfish Sanitation Program - Canadian Food Inspection Agency

http://www.inspection.gc.ca/food/compliance-continuum/guidance-for-inspectors/sip/main-page/eng/1542739573232/1542739655742

Jul 25, 2019 ... products, environment, water and ice. The guidance below should be used whenever inspection staff use non-CFIA samplers for the collection of shellfish samples. 2.0 Authorities Safe Food for Canadians Act (SFCA) Safe Food for Canadians Regulations (SFCR) Food and Drugs Act (FDA) Food and Drug Regulations (FDR) The inspection powers, control actions and enforcement

What to consider before applying for a Safe Food for Canadians licence - Canadian Food Inspection Agency

http://www.inspection.gc.ca/food/requirements/licensing/obtain-a-licence/eng/1543359915240/1543360663242

Jun 13, 2019 ...) There are many food businesses that already held a valid permission issued by the CFIA, in the form of a registration or licence, before the SFCR came into force on January 15, 2019. These include those listed below, as previously issued under the authorities of these acts: Canada Agricultural Products Act Cheese import licence Dairy establishment registration Fresh

What to consider before applying for a Safe Food for Canadians licence - Canadian Food Inspection Agency

http://www.inspection.gc.ca/food/requirements-and-guidance/food-licensing/obtain-a-licence/eng/1543359915240/1543360663242

Jun 13, 2019 ... issued licence or registration (permission) There are many food businesses that already held a valid permission issued by the CFIA, in the form of a registration or licence, before the SFCR came into force on January 15, 2019. These include those listed below, as previously issued under the authorities of these acts: Canada Agricultural Products Act Cheese import

Applications for Medical Device Investigational Testing Authorizations Guidance Document

https://www.canada.ca/en/health-canada/services/drugs-health-products/medical-devices/application-information/guidance-documents/investigational-testing-authorizations-guidance/guidance-document.html

May 2, 2019 ... study 2.3.3.2 Devices used in drug clinical trials (pharmaceuticals and biologics) 2.3.3.3 Combination products and joint reviews 2.3.4 Organization of an ITA Application 2.3.5 Requirements of an ITA application 2.3.6 The investigational testing authorization 2.4 Responsibilities of manufacturers and importers 2.4.1 Advertising 2.4.2 Quality management system

Good manufacturing practices inspection policy for drug establishments (POL-0011)

https://www.canada.ca/en/health-canada/services/drugs-health-products/compliance-enforcement/good-manufacturing-practices/policies-standards/inspection-policy-canadian-drug-establishments.html

Apr 3, 2019 .... Canadians rely on drugs produced from both domestic and foreign manufacturers through complex global supply chains involving both raw materials and finished dosage forms. A high percentage of health products are imported into Canada, with many products containing ingredients from other countries. To facilitate uniform application of these requirements and help

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