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Found 10 records similar to Guidance to apply for a Manufacturer’s Certificate to Export licenced medical devices from Canada (GUI-0097)

Federal

This document clarifies the requirements to be met for the issuance of a Certificate of a Pharmaceutical Product (CPP) or a certificate of Good Manufacturing Practices (GMP) and describes the procedure for their request.

Last Updated: Dec. 29, 2021
Date Published: May 18, 2017
Organization: Health Canada
Formats: HTML
Keywords:  pharmaceutical product, Certificate of Pharmaceutical-Product, CPP, good-manufacturing-practice, certificate of Good-Manufacturing-Practices, GMP, GUI-0024
Provincial

Dollar value of sales of goods manufactured by Canadian establishments in the manufacturing sector. For this indicator seasonally adjusted estimates are shown, unless otherwise indicated.

Last Updated: Jun. 27, 2018
Date Published: May 13, 2015
Organization: Government of Alberta
Formats: XML JSON CSV XLS
Keywords:  Manufacturing, Manufacturing Shipments, Shipments
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

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

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

This notice outlines the safety and effectiveness requirements for closed system devices that decontaminate medical devices using ultraviolet (UV) radiation. The notice is for manufacturers using an interim order (IO) authorization or medical device licence application.

Last Updated: Jan. 6, 2021
Date Published: Nov. 6, 2020
Organization: Health Canada
Formats: HTML
Keywords:  COVID-19, pandemic, UV, ultraviolet radiation, UV decontamination devices, decontaminate medical devices, closed system devices, notice to manufacturers
Provincial

Get statistical data on food beverage and tobacco manufacturing sector for Ontario. Data includes: * revenue from goods manufactured * total revenue * total cost of energy * water utility * vehicle fuel, cost of materials and supplies Statistical data are compiled to serve as a source of agriculture and food statistics for the province of Ontario. Data are prepared primarily by Statistics and Economics staff of the Ministry of Agriculture, Food and Rural Affairs, in co-operation with the Agriculture Division of Statistics Canada and various government departments and farm marketing boards.

Last Updated: Jul. 21, 2022
Date Published: Jan. 11, 2020
Organization: Government of Ontario
Formats: XLSX HTML
Keywords:  Manufacturing Industries, Agriculture and Food, Economy and Business, Business and economy
Federal

GMPs are manufacturing guidelines which are used to ensure product quality control and an effective approach to risk management. These guidelines set out standards for product manufacturing, testing, storage, handling and distribution, to ensure that each step of manufacturing is acceptable for quality and safety of the product.

Last Updated: Mar. 1, 2021
Date Published: Oct. 29, 2019
Organization: Health Canada
Formats: HTML
Keywords:  Cosmetics, health risk, guidance document, Good Manufacturing Practices, GMPs, manufacturing guidelines, cosmetic products, product quality control, risk management
Federal

COVID-19 drugs must be manufactured under good manufacturing practices (GMP) conditions. These conditions must be in line with the international requirements outlined in the International Council for Harmonization Q7A guideline and with applicable Health Canada's guidance.

Last Updated: Jul. 28, 2022
Date Published: Oct. 29, 2021
Organization: Health Canada
Formats: HTML
Keywords:  COVID-19, COVID-19 drugs, market authorization requirements, drug manufactured, sold, regulatory process, manufacturing requirements, quality requirements
Federal

Health Canada’s Veterinary Drugs Directorate (VDD) is clarifying the expectations for the information about Good Manufacturing Practices (GMP) status that should accompany veterinary drug submissions.

Last Updated: Jul. 8, 2021
Date Published: Feb. 16, 2021
Organization: Health Canada
Formats: HTML
Keywords:  Notice, submission filing recommendations, veterinary drugs, good manufacturing practices, drug establishment licences
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