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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).

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.

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.

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

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.

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.

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.

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

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.

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