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Inspection Guide for Licensed Dealers of Controlled Substances

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

Dec 6, 2019 ... at the destruction. Records keeping J.01.078 A licensed dealer must record the following information concerning any restricted drug that they destroy at the site specified in their licence: (a) the municipal address of the place of destruction; (b) the name, form and quantity of the restricted drug and, if applicable, the brand name and quantity of the product containing

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

Supplementary Information Tables 2017-2018 : Health Canada

https://www.canada.ca/en/health-canada/corporate/transparency/corporate-management-reporting/departmental-performance-reports/2017-18-supplementary-information-tables/page-5-2017-18-supplementary-information-tables1.html

Aug 28, 2019 ...Supplementary Information Tables 2017-2018 : Health Canada Previous Page Table of Contents Fees Fees for Right to Sell Drugs Fees for the Examination of a Drug Submission (Pharmaceuticals and Biologic Products) Fees for the Examination of Medical Device License Applications Fee for Right to Sell a Licensed Class II, III or IV Medical Device Veterinary Drug

Medical Devices Regulations

https://laws.justice.gc.ca/eng/regulations/SOR-98-282/FullText.html

Dec 16, 2019 ... Medical Devices Regulations SOR/98-282 FOOD AND DRUGS ACT Registration 1998-05-07 Medical Devices Regulations P.C. 1998-783 1998-05-07 His Excellency the Governor General in Council, on the recommendation of the Minister of Health, pursuant to subsections 3(3), 30(1) and 37(1)Footnote a of the Food and Drugs Act, hereby makes the annexed Medical Devices

Narcotic Control Regulations

https://laws.justice.gc.ca/eng/regulations/C.R.C.,_c._1041/nifnev.html

Dec 9, 2019 ... of an authorization from a practitioner that a stated amount of the drug be dispensed for a person who is or will be named in the authorization; or (b) cocaine (benzoylmethylecgonine) or any of its salts or any drug that is not in dosage form that contains such a substance, unless the cocaine, salt or drug is to be compounded by a pharmacist in accordance

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

Benzodiazepines and Other Targeted Substances Regulations

https://laws.justice.gc.ca/eng/regulations/SOR-2000-217/nifnev.html

Dec 9, 2019 ... of the Food and Drug Regulations; (g) if the licence is requested in order to produce a targeted substance other than a product or compound that contains a targeted substance, (i) the specified name of the targeted substance, (ii) the quantity that the applicant expects to produce under their licence and the period during which that quantity would be produced

2017-2018 Report on Fees

https://www.canada.ca/en/health-canada/corporate/about-health-canada/reports-publications/fees-report-2017-18.html

Mar 21, 2019 ... that the withdrawal period(s) for each species falls within the conditions of use for the Canadian reference product. 2,900 2,963.80 Not applicable Chemistry and manufacturing data for a non-compendial medicinal ingredient of a drug. 4,840 4,946.48 Not applicable Chemistry and manufacturing data to support a single dosage form. 4,840 4,946.48 Not applicable Documentation

Fees in Respect of Drugs and Medical Devices Regulations

https://laws.justice.gc.ca/eng/regulations/SOR-2011-79/FullText.html

Dec 9, 2019 ...) The purpose of these Regulations is also to remit, in whole or in part, certain of those fees. Application Marginal note:Non-application 3 These Regulations do not apply in respect of (a) a drug that is for veterinary use only; (b) a drug that is a natural health product; (c) a drug that is the subject of an extraordinary use new drug submission filed under section C

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

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