Guidance for industry: Preparation of veterinary new drug submissions and abbreviated new drug submissions (new and generic drugs) - Quality requirements: General

G.1 Introduction

This document is intended to provide drug manufacturers (referred to as sponsors hereafter) with guidance on the quality technical requirements for the following submission types for regulatory approval of a veterinary drug in Canada:

New Drug Submission (NDS)
Abbreviated New Drug Submission (ANDS)
Changes to NDS and ANDS: Supplement to a New Drug Submission (SNDS), Supplement to an Abbreviated New Drug Submission (SANDS) and Notifiable Change (NC)

This guidance document replaces:

Part II: Requirements for Manufacturing and Quality Control of Guidance for Industry Preparation of Veterinary New Drug submissions (2007)
Part I, Chemistry and Manufacturing Requirements of Guidance for Industry - Preparation of Veterinary Abbreviated New Drug Submissions - Generic Drugs (2010)

This guidance document:

Provides clarity and consistency in the interpretation of and guidance on the regulatory requirements of the Food and Drug Regulations (FDR)
Reflects feedback received from stakeholders during consultation
Provides guidance to Health Canada staff, so that the rules are followed in a fair, consistent and effective way
Outlines many scenarios and examples, yet it is not intended to cover every possible case (for example, as new technologies and approaches emerge, different considerations may be called for)
Has been written with a view to harmonize with international approaches, such as the International Cooperation on Harmonisation of Technical Requirements for Registration of Veterinary Medicinal Products (VICH) and other regulatory agencies in other countries

As required by subsection C.08.002(2) of the Food and Drug Regulations, a NDS or an ANDS must contain sufficient information and material to allow an assessment of the safety, efficacy, and quality of the new drug.

If you have questions about this guidance document or a particular scenario that may not be covered, contact us: vdd.skmd.so-dgps.dmv.cp@hc-sc.gc.ca

Learn more about clinical and human safety requirements:

Guidance for Industry Preparation of Veterinary New Drug Submissions
Guidance for Industry: Preparation of Veterinary Abbreviated New Drug Submissions (Generic Drugs) – Clinical and Human Safety Requirements

G.2 Scope and application

This guidance document applies to veterinary drugs (pharmaceuticals) consisting of substances of synthetic or semi-synthetic origin. This guidance does not cover the following products:

Veterinary biologics regulated by the Canadian Food Inspection Agency under the Health of Animals Act (e.g. biological vaccines)
Submissions for biotechnological and biological drugs that are filed with VDD under Division 8 of the Food and Drug Regulations, for example:
biotechnological tools are used at any stage during the synthesis of the drug substance(s). For example:
DNA cloning
gene targeting
rDNA technology
biological processes are used during the manufacturing of a veterinary drug product
Note: Sponsors are encouraged to consult the Veterinary Drugs Directorate (VDD) for specifics of the conditions, data requirements and submission classifications.

ICH guidelines Q8 - Q11 apply to medicinal products for human use only. However, the related concepts are also useful in the context of veterinary drug products. We advise sponsors of veterinary drugs submissions to refer to these relevant ICH guidelines.

G.3 Core templates and file structure

A complete Quality Overall Summary (QOS) and Certified Product Information Document (CPID) should be submitted under 1.11 Submission and Product Summary of the drug submission folder.

G.3.1 Quality Overall Summary for NDS/ANDS (i.e. VDD QOS (NDS/ANDS)) Template

Subsection C.08.005.1(1)(c) of the FDR stipulates that all relevant submission types (i.e. NDS, ANDS, SNDS, SANDS, and NC) should include a comprehensive summary of each animal and in vitro study in order to facilitate the assessment of the experimental data.

The VDD QOS (NDS/ANDS) template is a summary that follows the scope and the outline of Part 2: Requirements for Manufacturing and Quality Control of a NDS or an ANDS (see below in section G.3.3). The QOS should include sufficient information from each section to provide the Quality reviewer with an overview of Part 2. The table structure provided in the VDD QOS (NDS/ANDS) template should be used whenever possible; however, modifications can be made as required. Portions of the QOS that are not relevant for the drug submission should indicate "Not Applicable" with an explanatory note/justification and any quantitative tests (e.g. individual and total degradation product tests and assay tests) should include numerical results.

When information in a section has been included in a prior drug submission in its entirety and the information has not changed subsequent to that filing, the relevant section should be cross-referenced. If there are changes to any sections that have been cross-referenced, these should be summarized appropriately.

G.3.2 Certified Product Information Document (CPID)

The CPID constitutes part of the Notice of Compliance (NOC) package and it is recommended to be provided for all relevant submission types (i.e. NDS, ANDS, SNDS, SANDS, and NC). The CPID provides an accurate record of information on the Quality of the drug substance and drug product at the time the NOC is issued. It is a condensed version of the QOS, and a template is available for sponsors to use as an official reference document during the course of post-authorization activities.

For drug submissions with more than one dosage form, information on the different dosage forms should be provided in a separate CPID. For more information on the CPID, refer to Health Canada's (HC's) "Post-Notice of Compliance (NOC) Changes: Guidance for Quality of Veterinary Drug".

G.3.3 Part 2 of an NDS and ANDS preparation

When preparing Part 2 of an NDS and an ANDS, all section headings and numbering as described in section "S. Drug Substance", and section "P. Drug Product" below, should be retained. Sections that are not relevant for the drug submission should indicate "Not Applicable" or "Not Relevant" with an explanatory note/justification.

For subsequent entry (i.e. generic) products

A generic product may be filed as an ANDS when the proposed drug is pharmaceutically equivalent to the Canadian Reference Product (CRP) as defined in section C.08.001.1 of the FDR. Generic drug products meeting all of the following criteria would be eligible for an ANDS:

an acceptable Canadian reference product is available
an identical medicinal ingredient to the CRP
an identical amount of the medicinal ingredient to the CRP
a comparable dosage form to the CRP
the same route of administration to the CRP
conditions of use within those of the CRP

For more information on generic drug product eligibility, including comparable dosage forms, refer to "Guidance for Industry: Preparation of Veterinary Abbreviated New Drug Submissions (Generic Drugs) – Clinical and Human Safety Requirements".

G.4 Structure and content

This guidance contains 3 main sections that describe the various quality requirements that a submission must meet, in addition to appendices. The main sections consists of sections for general information, drug substance, and drug product. When preparing a regulatory submission, sponsors should use the folder structure as outlined in Appendix 2: Index for Part 2, Requirements for manufacturing and quality control.

G. General

This section intends to provide guidance on how to prepare quality documents for an (A)NDS. References to templates are included and guidance is provided on the recommended structure and format in preparing Part 2 of an (A)NDS. It also outlines the relevant provisions in the FDR with respect to generic drugs, including information on ANDS eligibility criteria.

S. Drug substance

This section outlines the technical quality requirements for an (A)NDS and supporting information on the chemistry, manufacturing, and controls for a drug substance.

P. Drug product

The information provided in this section outlines the technical quality requirements for an (A)NDS and supporting information on the chemistry, manufacturing, and controls for a drug product.

A. Appendices

Appendix A includes key definitions used throughout the guidance for reference and additional context.

Appendix B outlines the folder structure for requirements for manufacturing and quality control that aligns with this guidance document, as well as the electronic zip folder structure for filing submissions. Sponsors should use them when preparing an (A)NDS dossier veterinary drug submission (i.e. NDS, ANDS) to help facilitate the review.

Note about guidance documents in general

Guidance documents are meant to provide assistance to industry and health care professionals on how to comply with governing statutes and regulations. They also help to support the implementation of Health Canada mandates and objectives in a manner that is fair, consistent, and effective.

Guidance documents are administrative instruments not having the force of law and, as such, allow for flexibility in approach. Alternate approaches to the principles and practices described in this document may be acceptable provided they are supported by adequate justification. Alternate approaches should be discussed in advance to avoid the possible finding that applicable statutory or regulatory requirements have not been met.

Health Canada reserves the right to request information or material, or define conditions not specifically described in this document, in order to allow the Department to adequately assess the safety, efficacy, or quality of a drug product.

This guidance document should be read in conjunction with the relevant sections of other applicable guidance documents, in addition to relevant statutes and regulations where applicable.

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Date modified:: 2025-03-14

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