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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

Import and Export Policy for Health Products under the Food and Drugs Act and its Regulations (POL-0060)

Oct 30, 2019 ... meet the relevant requirements of the Food and Drugs Act and its Regulations. Such requirements include, among others, ensuring that products exported are not adulterated, manufactured in unsanitary conditions or manufactured, sold or advertised in a manner that is false or misleading. 5.3.1 Health products fabricated to a Canadian market authorized formulation

Guidance Document - Human-Use Antiseptic Drugs

Nov 15, 2019 ... (e.g.) mucous membranes, catheter insertion, etc.). Applicants seeking authorization for such products should request a presubmission meeting to discuss appropriate supporting data. Further, the guidance does not apply to hard surface disinfectants (see Health Canada's Guidance Document: Disinfectant Drugs for more information). The guidance will outline

Guidance Document: Risk Classification Guide for Licensed Dealers of Controlled Substances’ Inspection Observations (CS-GD-017)

Dec 6, 2019 ... and legal references. Tip: Suggestions that can help people comply with the regulations. 3. Overview Under the authority of section 31 of the CDSA, Health Canada inspects licensed dealers that conduct activities with controlled substances, such as produce, package, import, export, sell or send, transport or deliver to assess their compliance with the CDSA and its

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

Apr 3, 2019 ... they are intended to be used. Important: Key or cautionary information for people to know. Information: Supplementary information like quotes and legal references. About this document 1. Purpose Health Canada inspects buildings where drugs are fabricated, packaged/labelled, tested, imported, distributed, or wholesaled against requirements for good manufacturing practices

Inspection approach for blood establishments (POL-0039)

Jul 19, 2019 ... Regulations. Health Canada’s regulatory oversight was limited to submissions from manufacturers of drugs derived from blood, inspections of blood product manufacturing plants, and plasmapheresis collection centres operated by the Red Cross and private corporations. In 1989, regulatory oversight was expanded to include all “blood” further encompassing most

Guidance on the regulations respecting flavoured purified alcohol

Jul 22, 2019 ... alcohol products. You can access the text of the regulations and accompanying documentation. This document provides further guidance to support industry compliance with the regulations. 2.0 Oversight of alcohol 2.1 Federal government At the federal level, Health Canada regulates alcohol under the regulations for food, through the Food and Drugs Act (FDA

Promotion of health and charitable registration

Jul 15, 2019 ... purposes include: conducting research into causes and possible treatmentsFootnote 57 of [specify condition] and making the results publicly availableFootnote 58 conducting clinical trials of drugs or natural health products 91. Organizations conducting research should see Policy statement CPS-029 for information on the legal and administrative requirements

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

Aug 20, 2019 .... No such clinical trial drugs should be imported prior to the NOL issuance and the NOL should accompany the package at the time of the importation. If 30 days have passed and no NOL was obtained, specific requests to import clinical trial drugs should be directed to the Health Product Border Compliance Program at the following generic email account:

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