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Licence, authorization and registration forms for drug and health products

https://www.canada.ca/en/health-canada/services/licences-authorizations-registrations-drug-health-products/licence-authorization-registration-forms-drug-health-products.html

Aug 24, 2016 ...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 and organ registration information. Services and information License an establishment or site for drugs or health products Guidance

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

2018-2019 Report on Fees

https://www.canada.ca/en/health-canada/corporate/about-health-canada/reports-publications/report-fees-2018-2019.html

Dec 17, 2019 ... that Health Canada had the authority to charge in fiscal year 2018 to 2019 that are set by any of the following: act regulation fees notice A fee grouping is a grouping of all of the fees that a department has the authority to charge for activities relating to a single business line, directorate or program. Fees for the Right to Sell Drugs: totals for fiscal year 2018

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 ... the Natural Health Products Regulations. Marketing authorization: A legal document issued by Health Canada authorizing the sale of a drug or a device based on the health and safety requirements of the Food and Drugs Act and its Regulations. The marketing authorization may be in the form of a Drug Identification Number (DIN), a device licence for classes II, III and IV

Cannabis Regulations

https://laws.justice.gc.ca/eng/regulations/SOR-2018-144/FullText.html

Dec 9, 2019 .... (instrument) drug drug has the same meaning as in section 2 of the Food and Drugs Act, but excludes cannabis that is (a) a natural health product to which the Natural Health Products Regulations apply; or (b) manufactured or sold — within the meaning of section 2 of the Food and Drugs Act — and is not represented, for use in  (i) the diagnosis, treatment, mitigation

Guidance Document: Reporting Loss or Theft of Controlled Substances and Precursors (CS-GD-005)

https://www.canada.ca/en/health-canada/services/publications/healthy-living/loss-theft-controlled-substances-precursors.html

Dec 20, 2019 ... discovery dates or incident types, multiple reports should be submitted. Only one incident of loss or theft should be reported per report form. Multiple reportable incidents captured on a single report form will not be accepted. Important: Forged prescriptions are only considered thefts if a drug product containing a controlled substance or a precursor is actually

Blood for transfusion or for use in the manufacture of a drug

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

Jul 19, 2019 ... inspections" page or browse inspections results in the Drug and Health Product Inspection Database. The Blood Regulations The Blood Regulations under the Food and Drugs Act (Act) came into force on October 23, 2014. Before this, blood and blood components were regulated under the Food and Drug Regulations. The Blood Regulations consolidate the specific requirements

Health Product InfoWatch – November 2019

https://www.canada.ca/en/health-canada/services/drugs-health-products/medeffect-canada/health-product-infowatch/health-product-infowatch-november-2019.html

Nov 27, 2019 ... easily out of their carrier tube. Advisory - EpiPen and EpiPen Jr (epinephrine) Foreign health products These foreign health products have been found by regulators in the United States, Singapore, Australia and Hong Kong to contain undeclared drug ingredients, which may pose serious health risks. These products are not authorized for sale in Canada and have

Food and Drug Regulations

https://laws.justice.gc.ca/eng/regulations/C.R.C.,_c._870/nifnev.html

Dec 16, 2019 ... in this section exempts such a drug from the requirements of Part C. Definition of agricultural implant (2) In this section, agricultural implant means a product that is presented in a form suitable to allow sustained release of an active ingredient over a certain period of time and that is intended for insertion under the skin of a food-producing animal for the purpose

Precursor Control Regulations

https://laws.justice.gc.ca/eng/regulations/SOR-2002-359/FullText.html

Dec 9, 2019 ... of producing a controlled substance unless the person is the holder of (a) a licence issued under section G.02.007 or J.01.015 of the Food and Drug Regulations, section 17.1 of the Benzodiazepines and Other Targeted Substances Regulations or section 10.1 of the Narcotic Control Regulations that authorizes the production of the substance; or (b) an exemption issued

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