About 402 search results for "guidelines for drug tests to be waived"

PMPRB Draft Guidelines Consultation

https://www.canada.ca/en/patented-medicine-prices-review/services/consultations/draft-guidelines.html

Dec 9, 2019 ... it can continue to ensure they are protected from excessively priced patented drugs. Draft Guidelines PMPRB Guidelines 2019 PDF version (1.4 MB) Table of Contents I. Preface II. Interpretation III. Legal Framework IV. Filing Requirements Pertaining to Price Reviews V. Price Review Process A. Price Review Process for Non-Grandfathered Patented Medicines 1. Step 1

Guidance on Drug Establishment Licences and Associated Fees (GUI-0002)

https://www.canada.ca/en/health-canada/services/drugs-health-products/compliance-enforcement/establishment-licences/directives-guidance-documents-policies/guidance-drug-establishment-licences-drug-establishment-licensing-fees-0002/document.html

Oct 30, 2019 ... to Biologicals for Veterinary Use Inclusions Third Party Performing Testing Required by Part C, Division 2 of the Food and Drug Regulations Sterilization of Raw Materials including Packaging Material Medical Gas Trans-Filling and Curbside Filling Export Combination Products Prohibition and Interpretation Prohibition Exception - Test Exception – Package/Label

Fees for the Review of Human and Veterinary Drug Establishment Licence Applications

https://www.canada.ca/en/health-canada/services/drugs-health-products/funding-fees/review-drug-establishment-licence.html

Nov 25, 2019 ... activities with respect to drugs - fabricate, import, distribute, wholesale, package/label, and test. Health Canada has charged fees since 1995 to recover some of the costs associated with the regulatory oversight of these activities. This document provides guidance on how the fees for the review of an application for a DEL will be administered, as stipulated

Guidance Document : Post-Notice of Compliance (NOC) Changes: Quality Document

https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/applications-submissions/guidance-documents/post-notice-compliance-changes/quality-document/guidance.html

Aug 1, 2019 ... by design 3.8 Consistency lot testing 3.9 On-site evaluation (OSE) 3.10 Multiple changes 3.11 Interchangeable pharmacopoeial texts 4. Appendices Appendix 1: Quality Post-NOC Changes (human pharmaceuticals) 3.2.S Drug substance 3.2.S.1 General information 1. Change in the name of the drug substance 3.2.S.2 Manufacture 2. Replacement or addition of a manufacturing

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 ..., pregnancy tests, defibrillators, infusion pumps, bacteria and drug test kits, hyperbaric oxygen therapy chambers, implants, insulin pumps and cardiac pacemakers, glucose testing systems, embolectomy and occlusion catheters, balloon thermodilution catheters, blood catheters, central venous catheter kits, aneurysm clips, excimer laser and intraocular lens) Device

2.7 - Chapter 2 - Data Requirements for Single Ingredient Approval and Feed Registration - Animals - Canadian Food Inspection Agency

https://inspection.gc.ca/animals/feeds/regulatory-guidance/rg-1/chapter-2/eng/1329298059609/1329298179464?chap=7

Jun 18, 2019 ... in the database by comparing peer reviewed publications supporting the classification of the proteins as allergens or putative allergens following predetermined guidelines. Drug: Includes any substance or mixture of substances manufactured, sold or represented for use in the diagnosis, treatment, mitigation or prevention of a disease, disorder, abnormal physical state

2.7 - Chapter 2 - Data Requirements for Single Ingredient Approval and Feed Registration - Animals - Canadian Food Inspection Agency

https://www.inspection.gc.ca/animals/feeds/regulatory-guidance/rg-1/chapter-2/eng/1329298059609/1329298179464?chap=7

Jun 18, 2019 ... in the database by comparing peer reviewed publications supporting the classification of the proteins as allergens or putative allergens following predetermined guidelines. Drug: Includes any substance or mixture of substances manufactured, sold or represented for use in the diagnosis, treatment, mitigation or prevention of a disease, disorder, abnormal physical state

New substances: guidelines for organisms

https://www.canada.ca/en/environment-climate-change/services/managing-pollution/evaluating-new-substances/biotechnology-living-organisms/guidelines.html

Aug 20, 2019 ... to new substances that are chemicals, biochemicals, polymers and biopolymers can be found in the Guidelines for the Notification and Testing of New Substances: Chemicals and Polymers, Version 2005. 1.1 The Canadian Environmental Protection Act, 1999 The Canadian Environmental Protection Act, 1999 (CEPA 1999), promulgated in 1988 and amended in 1999, provides

Chapter 2 - Data Requirements for Single Ingredient Approval and Feed Registration - Animals - Canadian Food Inspection Agency

https://inspection.gc.ca/animals/feeds/regulatory-guidance/rg-1/chapter-2/eng/1329298059609/1329298179464?chap=0

Jun 18, 2019 ... and Impurities A) Name and Synonyms The chemical name and synonyms of all ingredients should be listed. Resources CEPA "Guidelines for the Notification and Testing of New Substances: Chemicals and Polymers" (Appendix 5) Chemical Abstracts Services (CAS) Registry International Union of Pure and Applied Chemistry (IUPAC) Combined Chemical Dictionary B) Contaminants

Chapter 2 - Data Requirements for Single Ingredient Approval and Feed Registration - Animals - Canadian Food Inspection Agency

https://www.inspection.gc.ca/animals/feeds/regulatory-guidance/rg-1/chapter-2/eng/1329298059609/1329298179464?chap=0

Jun 18, 2019 ... and Impurities A) Name and Synonyms The chemical name and synonyms of all ingredients should be listed. Resources CEPA "Guidelines for the Notification and Testing of New Substances: Chemicals and Polymers" (Appendix 5) Chemical Abstracts Services (CAS) Registry International Union of Pure and Applied Chemistry (IUPAC) Combined Chemical Dictionary B) Contaminants

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