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This guide is for anyone working with drugs or natural health products. It will help facilitate understanding and compliance with sections of the Food and Drugs Act (the Act), the Food and Drug Regulations (FDR) and Natural Health Products Regulations (NHPR) that relate to recalls.

In Canada, natural health products and foods are regulated under the Food and Drugs Act (FDA) and its associated regulations. Products that meet the definition of a "natural health product" (NHP) as set out in the Natural Health Products Regulations (NHPR) are subject to the FDA as it applies to drugs and to the NHPR. Products that are foods as defined in the FDA are subject to the FDA as it applies to foods and to Parts A, B and D of the Food and Drug Regulations (FDR). It is important to note that the provisions of the FDR do not apply to products classified as NHPs except where such provisions are incorporated by reference into the NHPR, as per section 3 of the NHPR.

This guidance provides information relating to the interpretation and enforcement of section 3 and Schedule A to the Food and Drugs Act (FDA), as well as sections A.01.067 and A.01.068 of the Food and Drug Regulations (FDR) and sections 103.2 and 103.3 of the Natural Health Products Regulations (NHPR) (which exempt natural health products (NHPs) and nonprescription drugs from the FDA's general prohibition on labelling and advertising of preventative claims for the diseases listed in Schedule A).

An antiseptic product is considered to be one that inactivates, reduces, prevents or arrests growth of microorganisms with the inherent intent to mitigate or prevent disease. This includes antiseptic products whether they are regulated under the Food and Drug Regulations (FDR) or the Natural Health Products Regulations (NHPR). This guidance document provides recommendations regarding the information considered necessary by Health Canada in order to support these types of claims.

This guide is for companies in the drug manufacturing industry. It will help to facilitate understanding and compliance with Part C, Division 1A of the Food and Drug Regulations (FDR) with regards to drug establishment licence (DEL) requirements.

Health Canada is issuing this notice to clinical trial sponsors to clarify key obligations under the Food and Drug Regulations (FDR) for various types of cannabis-based clinical research.

In Canada, natural health products (NHP's) fall under the Natural Health Products Regulations of the Food and Drugs Act. These Regulations came into effect on January 1, 2004. Several guidance documents have been created to provide industry with clear guidelines on how to comply with the Regulations.

Importing and exporting health products is regulated under the Food and Drugs Act and its associated Regulations. Some health products may also have additional restrictions placed on them by other Acts and Regulations.

These guidelines are meant to help companies in the drug manufacturing industry and health care professionals understand how to comply with regulations, specifically drug establishment licence (DEL) requirements in Part C, Division 1A of the FDR.

Before a drug is authorized for sale in Canada, it must be issued a DIN in accordance with the Food and Drug Regulations. Also in accordance with the Food and Drug Regulations, a manufacturer of a drug must annually, before October 1, notify Health Canada that the drug is still on the market and that all the information previously provided pertaining to the drug is correct. The Health Products and Food Branch (HPFB) commits to service delivery standard of 120 calendar days, from the receipt of annual notification, to update the Drug Product Database (DPD).