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Found 10 records similar to Guidance document on the application for a certificate of a pharmaceutical product and good manufacturing practice certificate (GUI-0024)

Federal

This document is a guide for companies in Canada who want to obtain a Manufacturer's Certificate to Export licensed medical devices from Canada (MCE).

Last Updated: Apr. 26, 2021
Date Published: Mar. 19, 2021
Organization: Health Canada
Formats: HTML
Keywords:  Guidance, a Manufacturer’s Certificate to Export, licenced medical devices, GUI-0097
Federal

Drugs intended for use in clinical trials in Canada are regulated under Division 5 of Part C of the Food and Drug Regulations. Section C.05.010(j) requires the sponsor to ensure that drugs for use in clinical trials are manufactured, handled and stored in accordance with the applicable Good Manufacturing Practices requirements referred to in Divisions 2 to 4, except for Sections C.02.019, C.02.025 and C.02.026. Sponsors of clinical trials shall ensure that imported drugs are fabricated and packaged/labelled in accordance with these requirements.

Last Updated: Jun. 7, 2022
Date Published: Nov. 16, 2020
Organization: Health Canada
Formats: HTML
Keywords:  good manufacturing practices, guidance document, drugs-used in clinical-trials, GUI-0036
Federal

These guidelines interpret the requirements for good manufacturing practices (GMP) in Part C, Division 2 of the Regulations. Guidance documents like this one are meant to help industry and health care professionals understand how to comply with regulations. They also provide guidance to Health Canada staff, so that the rules are enforced in a fair, consistent and effective way across Canada.

Last Updated: Jul. 7, 2021
Date Published: Aug. 28, 2020
Organization: Health Canada
Formats: HTML
Keywords:  Good manufacturing practices, guide, drug products, GUI-0001, requirements for good manufacturing practices, Part C, Division 2 of the Regulations, industry, health care professionals
Federal

Health Canada is pleased to announce the fourth publication of the Guidance Document: Certificates of Supplementary Protection.

Last Updated: Dec. 29, 2021
Date Published: May 18, 2018
Organization: Health Canada
Formats: HTML
Keywords:  certificates of supplementary-protection, guidance document, certificates-supplementary-protection regulations, CSP Regulations
Federal

This guidance document pertains to Part 3 of the Natural Health Product Regulations (the Regulations) and is intended for manufacturers, packagers, labellers, importers, and distributors of natural health products (NHPs) for sale in Canada.

Last Updated: Sep. 9, 2021
Date Published: Jul. 22, 2020
Organization: Health Canada
Formats: HTML
Keywords:  Natural health products, NHPs, good manufacturing practices, Natural Health Product Regulations, Part 3 of the Regulations, manufacturers, packagers, labellers, importers
Federal

A Railway Operating Certificate is an official document issued by Transport Canada, under the authority of the Railway Safety Act, to authorize a railway company or local railway company to operate in Canada. Companies apply for a Railway Operating Certificate by completing an application form and submitting it to Transport Canada. Below is a list of railway companies and local railway companies that have been issued a Railway Operating Certificate. Since January 1, 2015, new companies must obtain a Railway Operating Certificate prior to commencing operations in Canada.

Last Updated: Mar. 9, 2021
Date Published: Mar. 8, 2021
Organization: Transport Canada
Formats: PDF other
Keywords:  Railway, Operating Certificates, Railway Safety Act, Railway Compagnies
Federal

These guidelines address the completion of the Medical Certificate of Death where a patient has received medical assistance in dying, to facilitate the identification of cases of medically-assisted deaths and to encourage consistency in approaches across provinces and territories.

Last Updated: Nov. 5, 2021
Date Published: Apr. 7, 2017
Organization: Health Canada
Formats: HTML
Keywords:  death certificates, medical certificate of death, medical assistance in dying, medically-assisted deaths
Federal

Good manufacturing practices (GMP) ensure that drugs meet the quality standards appropriate to their intended use before they are sold.

Last Updated: Aug. 28, 2020
Date Published: Aug. 8, 2020
Organization: Health Canada
Formats: HTML
Keywords:  COVID-19 pandemic, Good Manufacturing Practices, quality standards.
Federal

Good manufacturing practices (GMP) ensure that drugs meet the quality standards appropriate to their intended use before they are sold.

Last Updated: Jun. 7, 2022
Date Published: Feb. 11, 2022
Organization: Health Canada
Formats: HTML
Keywords:  Good manufacturing practices, COVID-19, quality standards, intended use
Federal

A Certificate of Registration is issued to manufacturers of Transport Canada specification cylinders or tubes who meet the requirements of the Canadian Standards Association, Standard CSA B339. The manufacturer's registered mark indicated on the Certificate of Registration is included in the permanent marking of each cylinder or tube. A Certificate of Registration is valid for a period of five years.

Last Updated: Oct. 4, 2018
Date Published: Nov. 1, 2016
Organization: Transport Canada
Formats: CSV TXT
Keywords:  Cylinder, tube, manufacture, CSA B339, application, registration, certificate, renewal, database
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