VICH Guidelines Adopted by Canada

In this section you will find VICH guidance documents related to technical requirements for veterinary drug submissions adopted by Canada.

Foreword

These guidelines have been developed by the responsible VICH Expert Working Groups. The VICH Steering Committee has endorsed these guidelines and they have already been accepted by the regulatory bodies of the European Union, Japan and USA.

In adopting these VICH guidelines, Government of Canada endorses the principles and practices described therein. These documents should be read in conjunction with the relevant sections of other applicable guidelines.

Guidelines are meant to provide assistance to industry and health care professionals on how to comply with Government of Canada's policies and governing statutes and regulations. They also serve to provide review and compliance guidance to Government of Canada staff, thereby ensuring that the policies and guidelines are implemented in a fair, consistent and effective manner.

Guidelines are administrative tools that do not have the force of law and, as such, some flexibility in approach is allowed. Alternative approaches to the principles and practices described in these documents may be acceptable provided they are supported by adequate scientific justification. Alternative approaches should be discussed in advance to avoid the possible determination through evaluations that applicable statutory or regulatory requirements have not been met.

It is important to note that Government of Canada reserves the right to request information or material, or define conditions not specifically described in these guidelines, in order to allow the evaluators to adequately assess the safety, efficacy or quality of a veterinary drug. Government of Canada is committed to ensuring that such requests are justifiable and that decisions are clearly documented.

Guidelines

Please refer to the VICH website under the tab "Guidelines" for the official final text of the adopted guidelines listed below.

GL 1 - Validation of Analytical Procedures: Definition and Terminology

Date Adopted by VDD: 2003/11/01
Effective Date: 2003/11/01
VICH Canada Coordinating Secretariat, Veterinary Drugs Directorate, HPFB, Health Canada

GL 2 - Validation of Analytical Procedures: Methodology

Date Adopted by VDD: 2003/11/01
Effective Date: 2003/11/01
VICH Canada Coordinating Secretariat, Veterinary Drugs Directorate, HPFB, Health Canada

GL 3 - Stability Testing of New Veterinary Drug Substances and Medicinal Products

Date Adopted by VDD: 2003/11/01
Effective Date: 2003/11/01
Revised Date: 2007/01/25
VICH Canada Coordinating Secretariat, Veterinary Drugs Directorate, HPFB, Health Canada

GL 4 - Stability Testing for New Veterinary Dosage Forms

Date Adopted by VDD: 2003/11/01
Effective Date: 2003/11/01
VICH Canada Coordinating Secretariat, Veterinary Drugs Directorate, HPFB, Health Canada

GL 5 - Stability Testing: Photostability Testing of New Veterinary Drug Substances and Medicinal Products

Date Adopted by VDD: 2003/11/01
Effective Date: 2003/11/01
VICH Canada Coordinating Secretariat, Veterinary Drugs Directorate, HPFB, Health Canada

GL 7 - Efficacy of Anthelmintics: General Requirements

Date Adopted by VDD: 2003/11/01
Effective Date: 2003/11/01
VICH Canada Coordinating Secretariat, Veterinary Drugs Directorate, HPFB, Health Canada

PLEASE NOTE
The use of arithmetic (AIcon) and geometric (GIcon) means for the evaluation of anthelmintic effectiveness.

In Canada, as a general rule, we are of the opinion that either AIcon or GIcon can be used when adequate infection has been confirmed in the control group and when substantial parasite elimination (greater/lesser than 90%) has been determined in the treated group; under such conditions, it is expected that the results will be similar, regardless of the method. However, under certain circumstances (e.g., evaluation of effectiveness against dose-limiting parasites), we consider that the AIcon is preferable as it reflects a more stringent estimation of effectiveness.

GL 8 - Stability Testing for Medicated Premixes

Date Adopted by VDD: 2003/11/01
Effective Date: 2003/11/01
VICH Canada Coordinating Secretariat, Veterinary Drugs Directorate, HPFB, Health Canada

GL 10 - Impurities in New Veterinary Drug Substances

Date Adopted by VDD: 2003/11/01
Effective Date: 2003/11/01
Revised Date: 2007/01/25
VICH Canada Coordinating Secretariat, Veterinary Drugs Directorate, HPFB, Health Canada

GL 11 - Impurities in New Veterinary Medicinal Products

Date Adopted by VDD: 2003/11/01
Effective Date: 2003/11/01
Revised Date: 2007/01/25
VICH Canada Coordinating Secretariat, Veterinary Drugs Directorate, HPFB, Health Canada

GL 12 - Efficacy of Anthelmintics: Specific Recommendations for Bovines

Date Adopted by VDD: 2003/11/01
Effective Date: 2003/11/01
VICH Canada Coordinating Secretariat, Veterinary Drugs Directorate, HPFB, Health Canada

PLEASE NOTE
The use of arithmetic (AIcon) and geometric (GIcon) means for the evaluation of anthelmintic effectiveness.

In Canada, as a general rule, we are of the opinion that either AIcon or GIcon can be used when adequate infection has been confirmed in the control group and when substantial parasite elimination (greater/lesser than 90%) has been determined in the treated group; under such conditions, it is expected that the results will be similar, regardless of the method. However, under certain circumstances (e.g., evaluation of effectiveness against dose-limiting parasites), we consider that the AIcon is preferable as it reflects a more stringent estimation of effectiveness.

GL 13 - Efficacy of Anthelmintics: Specific Recommendations for Ovines

Date Adopted by VDD: 2003/11/01
Effective Date: 2003/11/01
VICH Canada Coordinating Secretariat, Veterinary Drugs Directorate, HPFB, Health Canada

PLEASE NOTE
The use of arithmetic (AIcon) and geometric (GIcon) means for the evaluation of anthelmintic effectiveness.

In Canada, as a general rule, we are of the opinion that either AIcon or GIcon can be used when adequate infection has been confirmed in the control group and when substantial parasite elimination (greater/lesser than 90%) has been determined in the treated group; under such conditions, it is expected that the results will be similar, regardless of the method. However, under certain circumstances (e.g., evaluation of effectiveness against dose-limiting parasites), we consider that the AIcon is preferable as it reflects a more stringent estimation of effectiveness.

GL 14 - Efficacy of Anthelmintics: Specific Recommendations for Caprines

Date Adopted by VDD: 2003/11/01
Effective Date: 2003/11/01
VICH Canada Coordinating Secretariat, Veterinary Drugs Directorate, HPFB, Health Canada

PLEASE NOTE
The use of arithmetic (AIcon) and geometric (GIcon) means for the evaluation of anthelmintic effectiveness.

In Canada, as a general rule, we are of the opinion that either AIcon or GIcon can be used when adequate infection has been confirmed in the control group and when substantial parasite elimination (greater/lesser than 90%) has been determined in the treated group; under such conditions, it is expected that the results will be similar, regardless of the method. However, under certain circumstances (e.g., evaluation of effectiveness against dose-limiting parasites), we consider that the AIcon is preferable as it reflects a more stringent estimation of effectiveness.

GL 15 - Efficacy of Anthelmintics: Specific Recommendations for Equines

Date Adopted by VDD: 2003/11/01
Effective Date: 2003/11/01
VICH Canada Coordinating Secretariat, Veterinary Drugs Directorate, HPFB, Health Canada

PLEASE NOTE
The use of arithmetic (AIcon) and geometric (GIcon) means for the evaluation of anthelmintic effectiveness.

In Canada, as a general rule, we are of the opinion that either AIcon or GIcon can be used when adequate infection has been confirmed in the control group and when substantial parasite elimination (greater/lesser than 90%) has been determined in the treated group; under such conditions, it is expected that the results will be similar, regardless of the method. However, under certain circumstances (e.g., evaluation of effectiveness against dose-limiting parasites), we consider that the AIcon is preferable as it reflects a more stringent estimation of effectiveness.

GL 16 - Efficacy of Anthelmintics: Specific Recommendations for Porcines

Date Adopted by VDD: 2003/11/01
Effective Date: 2003/11/01
VICH Canada Coordinating Secretariat, Veterinary Drugs Directorate, HPFB, Health Canada

PLEASE NOTE
The use of arithmetic (AIcon) and geometric (GIcon) means for the evaluation of anthelmintic effectiveness.

In Canada, as a general rule, we are of the opinion that either AIcon or GIcon can be used when adequate infection has been confirmed in the control group and when substantial parasite elimination (greater/lesser than 90%) has been determined in the treated group; under such conditions, it is expected that the results will be similar, regardless of the method. However, under certain circumstances (e.g., evaluation of effectiveness against dose-limiting parasites), we consider that the AIcon is preferable as it reflects a more stringent estimation of effectiveness.

GL 17 - Stability Testing of New Biotechnological / Biological Veterinary Medicinal Products

Date Adopted by VDD: 2003/11/01
Effective Date: 2003/11/01
VICH Canada Coordinating Secretariat, Veterinary Drugs Directorate, HPFB, Health Canada

GL 18 - Impurities: Residual Solvents in New Veterinary Medicinal Products, Active Substances and Excipients

Date Adopted by VDD: 2003/11/01
Effective Date: 2003/11/01
Revised date: 2011/07/20
VICH Canada Coordinating Secretariat, Veterinary Drugs Directorate, HPFB, Health Canada

GL 19 - Efficacy of Anthelmintics: Specific Recommendations for Canines

Date Adopted by VDD: 2003/11/01
Effective Date: 2003/11/01
VICH Canada Coordinating Secretariat, Veterinary Drugs Directorate, HPFB, Health Canada

PLEASE NOTE
The use of arithmetic (AIcon) and geometric (GIcon) means for the evaluation of anthelmintic effectiveness.

In Canada, as a general rule, we are of the opinion that either AIcon or GIcon can be used when adequate infection has been confirmed in the control group and when substantial parasite elimination (greater/lesser than 90%) has been determined in the treated group; under such conditions, it is expected that the results will be similar, regardless of the method. However, under certain circumstances (e.g., evaluation of effectiveness against dose-limiting parasites), we consider that the AIcon is preferable as it reflects a more stringent estimation of effectiveness.

GL 20 - Efficacy of Anthelmintics: Specific Recommendations for Felines

Date Adopted by VDD: 2003/11/01
Effective Date: 2003/11/01
VICH Canada Coordinating Secretariat, Veterinary Drugs Directorate, HPFB, Health Canada

PLEASE NOTE
The use of arithmetic (AIcon) and geometric (GIcon) means for the evaluation of anthelmintic effectiveness.

In Canada, as a general rule, we are of the opinion that either AIcon or GIcon can be used when adequate infection has been confirmed in the control group and when substantial parasite elimination (greater/lesser than 90%) has been determined in the treated group; under such conditions, it is expected that the results will be similar, regardless of the method. However, under certain circumstances (e.g., evaluation of effectiveness against dose-limiting parasites), we consider that the AIcon is preferable as it reflects a more stringent estimation of effectiveness.

GL 21 - Efficacy of Anthelmintics: Specific Recommendations for Poultry - Gallus Gallus

Date Adopted by VDD: 2003/11/01
Effective Date: 2003/11/01
VICH Canada Coordinating Secretariat, Veterinary Drugs Directorate, HPFB, Health Canada

PLEASE NOTE
The use of arithmetic (AIcon) and geometric (GIcon) means for the evaluation of anthelmintic effectiveness.

In Canada, as a general rule, we are of the opinion that either AIcon or GIcon can be used when adequate infection has been confirmed in the control group and when substantial parasite elimination (greater/lesser than 90%) has been determined in the treated group; under such conditions, it is expected that the results will be similar, regardless of the method. However, under certain circumstances (e.g., evaluation of effectiveness against dose-limiting parasites), we consider that the AIcon is preferable as it reflects a more stringent estimation of effectiveness.

GL 22 - Studies to Evaluate the Safety of Residues of Veterinary Drugs in Human Food: Reproduction Testing

Date Adopted by VDD: 2003/11/01
Effective Date: 2003/11/01
Revised Date: 2004/06/02
VICH Canada Coordinating Secretariat, Veterinary Drugs Directorate, HPFB, Health Canada

GL 23 - Studies to Evaluate the Safety of Residues of Veterinary Drugs in Human Food: Genotoxicity Testing

Date Adopted by VDD: 2003/11/01
Effective Date: 2003/11/01
Revised Date: 2014/11/20
VICH Canada Coordinating Secretariat, Veterinary Drugs Directorate, HPFB, Health Canada

GL 24 - Pharmacovigilance of Veterinary Medicinal Products: Management of Adverse Event Reports (AERs)

Date Adopted by VDD: 2009/07/13
Effective Date: 2010/01/13
VICH Canada Coordinating Secretariat, Veterinary Drugs Directorate, HPFB, Health Canada

GL 25 - Testing of Residual Formaldehyde

Date Adopted by CFIA: 2003/11/01
Effective Date: 2003/11/01
VICH Canada Coordinating Secretariat, Veterinary Drugs Directorate, HPFB, Health Canada

GL 26 - Testing of Residual Moisture

Date Adopted by CFIA: 2003/11/01
Effective Date: 2003/11/01
VICH Canada Coordinating Secretariat, Veterinary Drugs Directorate, HPFB, Health Canada

GL 28 - Studies to Evaluate the Safety of Residues of Veterinary Drugs in Human Food: Carcinogenicity Testing

Date Adopted by VDD: 2005/07/01
Effective Date: 2005/07/01
VICH Canada Coordinating Secretariat, Veterinary Drugs Directorate, HPFB, Health Canada

GL 29 - Pharmacovigilance of Veterinary Medicinal Products - Management of Periodic Summary Update Reports

Date Adopted by VDD: 2009/07/13
Effective Date: 2010/01/13
VICH Canada Coordinating Secretariat, Veterinary Drugs Directorate, HPFB, Health Canada

GL 31 - Studies to evaluate the safety of residues of Veterinary Drugs in Human Food: Repeat-Dose (90 Days) Toxicity Testing

Date Adopted by VDD: 2003/11/01
Effective Date: 2003/11/01
Revised Date: 2004/06/02
VICH Canada Coordinating Secretariat, Veterinary Drugs Directorate, HPFB, Health Canada

GL 32 - Studies to Evaluate the Safety of Residues of Veterinary Drugs in Human Food: Developmental Toxicity Testing

Date Adopted by VDD: 2003/11/01
Effective Date: 2003/11/01
Revised Date: 2004/06/02
VICH Canada Coordinating Secretariat, Veterinary Drugs Directorate, HPFB, Health Canada

GL 33 - Studies to evaluate the safety of residues of Veterinary Drugs in Human Food: General Approach to Testing

Date Adopted by VDD: 2003/11/01
Effective Date: 2003/11/01
Revised Date: 2004/06/02
VICH Canada Coordinating Secretariat, Veterinary Drugs Directorate, HPFB, Health Canada

GL 36 - Studies to Evaluate the Safety of residues of veterinary drugs in human food: General Approach to Establish a Microbiological acceptable daily intake (ADI)

Date Adopted by VDD: 2004/10/01
Effective Date: 2004/10/01
Revised date: 2019/07/04
VICH Canada Coordinating Secretariat, Veterinary Drugs Directorate, HPFB, Health Canada

GL 37 - Guidance for Industry: Studies to Evaluate the Safety of residues of veterinary drugs in human food: Repeat-Dose Chronic toxicity testing

Date Adopted by VDD: 2004/10/01
Effective Date: 2004/10/01
VICH Canada Coordinating Secretariat, Veterinary Drugs Directorate, HPFB, Health Canada

GL 43 - Target Animal Safety - Pharmaceuticals: Target Animal Safety for Veterinary Pharmaceutical Products

Date Adopted by VDD: 2008/11/05
Effective Date: 2009/07/01
VICH Canada Coordinating Secretariat, Veterinary Drugs Directorate, HPFB, Health Canada

GL 45 - Quality - Bracketing and matrixing designs for stability testing of new veterinary drug substances and medicinal products

Date Adopted by VDD: 2011/02/09
Effective Date: 2011/08/01
VICH Canada Coordinating Secretariat, Veterinary Drugs Directorate, HPFB, Health Canada

GL 46 - Studies to evaluate the metabolism and residue kinetics of veterinary drugs in food-producing animals: Metabolism study to determine the quantity and identify the nature of residues

Date Adopted by VDD: 2011/03/16
Effective Date: 2011/09/01
VICH Canada Coordinating Secretariat, Veterinary Drugs Directorate, HPFB, Health Canada

GL 47 - Studies to evaluate the metabolism and residue kinetics of veterinary drugs in food-producing animals: Comparative metabolism studies in laboratory animals

Date Adopted by VDD: 2011/03/16
Effective Date: 2011/09/01
VICH Canada Coordinating Secretariat, Veterinary Drugs Directorate, HPFB, Health Canada

GL 48 - Studies to evaluate the metabolism and residue kinetics of veterinary drugs in food-producing animals: Marker residue depletion studies to establish product withdrawal periods

Date Adopted by VDD: 2011/03/16
Effective Date: 2011/09/01
Revised Date: 2015/02/05
VICH Canada Coordinating Secretariat, Veterinary Drugs Directorate, HPFB, Health Canada

GL 49 - Studies to evaluate the metabolism and residue kinetics of veterinary drugs in food-producing animals: Validation of analytical methods used in residue depletion studies

Date Adopted by VDD: 2011/03/16
Effective Date: 2011/09/01
Revised Date: 2015/02/05
VICH Canada Coordinating Secretariat, Veterinary Drugs Directorate, HPFB, Health Canada

GL 50 - Harmonisation of Criteria to Waive Target Animal Batch Safety Testing for Inactivated Vaccines for Veterinary Use

Date Adopted by CFIA: 2018/02/16
Effective Date: 2018/02/16
VICH Canada Coordinating Secretariat, Veterinary Drugs Directorate, HPFB, Health Canada

GL 51 - Statistical evaluation of stability data

Date Adopted by VDD: 2013/04/03
Effective Date: 2014/03/01
VICH Canada Coordinating Secretariat, Veterinary Drugs Directorate, HPFB, Health Canada

GL 52 - Blood Level Bioequivalence Study

Date Adopted by VDD: 2015/09/24
Effective Date: 2016/03/24
VICH Canada Coordinating Secretariat, Veterinary Drugs Directorate, HPFB, Health Canada

GL 53 - Electronic exchange of documents: electronic file format

Date Adopted by VDD: 2015/04/30
Effective Date: 2015/10/30
VICH Canada Coordinating Secretariat, Veterinary Drugs Directorate, HPFB, Health Canada

GL 54 - Studies to Evaluate the Safety of Residues of Veterinary Drugs in Human Food: General Approach to Establish an Acute Reference Dose (ARfD)

Date Adopted by VDD: 2017/01/05
Effective Date: 2017/07/05
VICH Canada Coordinating Secretariat, Veterinary Drugs Directorate, HPFB, Health Canada

GL 55 - Harmonisation of Criteria to Waive Target Animal Batch Safety Testing for Live Vaccines for Veterinary Use

Date Adopted by CFIA: 2018/02/16
Effective Date: 2018/02/16
VICH Canada Coordinating Secretariat, Veterinary Drugs Directorate, HPFB, Health Canada

GL 56 - Studies to evaluate the Metabolism and Residue Kinetics of Veterinary Drugs in Food-producing Species: Study Design Recommendations for Residue Studies in Honey for establishing MRLs and Withdrawal Periods

Date Adopted by VDD: 2018/07/19
Effective Date: 2019/01/18
VICH Canada Coordinating Secretariat, Veterinary Drugs Directorate, HPFB, Health Canada

GL 57 - Studies to evaluate the Metabolism and Residue Kinetics of veterinary drugs in food-producing species: Marker Residue Depletion studies to establish product withdrawal periods in aquatic species

Date Adopted by VDD: 2019/07/04
Effective Date: 2020/01/03
VICH Canada Coordinating Secretariat, Veterinary Drugs Directorate, HPFB, Health Canada

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