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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)
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.