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Evidence of Good Manufacturing Practices (GMP) for drug submissions. The goal of this revision is to better align the drug submission screening and review process with the Drug Establishment Licence (DEL) process. This should allow sponsors to make timely drug submissions while still providing adequate assurance of an establishment’s commitment to quality.

This guidance document is intended to provide sponsors with an outline of the chemistry and manufacturing, clinical, and human safety requirements for the filing of the following submission types with the Veterinary Drugs Directorate (VDD): Abbreviated New Drug Submission (ANDS); Changes to ANDS - Supplemental Abbreviated New Drug Submission (SANDS) and Notifiable Change (NC).

This Guidance Document is to be used in the preparation of Veterinary Drug Submissions for presentation to Health Canada. Some sections of this Guidance Document are general in nature. Therefore, this Guidance Document should be used in conjunction with the complete Food and Drugs Act and Regulations, and with specific Health Canada Policies and Guidance Documents applicable to veterinary drugs.

The objective of this guidance document is to outline the procedures that veterinary Master File (MF) holders must follow to file confidential business information (CBI) directly with Health Canada's Veterinary Drugs Directorate (VDD) that is cross-referenced in support of an Applicant's veterinary drug submission (including DIN (Drug Identification Number) applications.)

Division 1A of Part C of the Regulations applies to COVID-19 drugs. A person must hold a drug establishment licence (DEL) authorizing any activities conducted with respect to COVID-19 drugs.

Following several successful joint reviews between Australia, New Zealand and Canada, there has been interest by others within industry to explore this as a model for bringing new veterinary drug products to market. Industry has been keen to understand how to initiate discussions and how the overall process would work. This document is therefore provided as guidance for industry about the joint review process for veterinary drugs.

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.

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

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

The NOC is issued to a manufacturer following the satisfactory review of a submission for a new drug, and signifies compliance with the Food and Drug Regulations. The database is updated nightly and contains NOC information on human drugs from January 1, 1994 to date. It also contains NOC information on Veterinary drugs from September 19, 2000 to date.