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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.
Important note
Some of the following hyperlinks are to sites of organizations or other entities that are not subject to the 
Official Languages Act. The material found there is therefore in the language(s) used by the sites in question.
Guidelines
GL 1 - Validation of Analytical Procedures: Definition and Terminology (PDF Version - 71 K)
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 (PDF Version - 94 K)
Date Adopted by VDD: 2003/11/01
Effective Date: 2003/11/01
VICH Canada Coordinating Secretariat, Veterinary Drugs Directorate, HPFB, Health Canada
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 (PDF Version - 103 K)
Date Adopted by VDD: 2003/11/01
Effective Date: 2003/11/01
VICH Canada Coordinating Secretariat, Veterinary Drugs Directorate, HPFB, Health Canada
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 (PDF Version - 34 K)
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 (A
) and geometric (G) means for the evaluation of anthelmintic effectiveness.
In Canada, as a general rule, we are of the opinion that either A or G 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 A is preferable as it reflects a more stringent estimation of effectiveness.
GL 8 - Stability Testing for Medicated Premixes (PDF Version - 98 K)
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 (PDF Version - 211 K)
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 (PDF Version - 170 K)
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 (PDF Version - 131 K)
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 (A) and geometric (G) means for the evaluation of anthelmintic effectiveness.
In Canada, as a general rule, we are of the opinion that either A or G 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 A is preferable as it reflects a more stringent estimation of effectiveness.
GL 13 - Efficacy of Anthelmintics: Specific Recommendations for Ovines (PDF Version - 109 K)
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 (A) and geometric (G) means for the evaluation of anthelmintic effectiveness.
In Canada, as a general rule, we are of the opinion that either A or G 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 A is preferable as it reflects a more stringent estimation of effectiveness.
GL 14 - Efficacy of Anthelmintics: Specific Recommendations for Caprines (PDF Version - 137 K)
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 (A) and geometric (G) means for the evaluation of anthelmintic effectiveness.
In Canada, as a general rule, we are of the opinion that either A or G 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 A is preferable as it reflects a more stringent estimation of effectiveness.
GL 15 - Efficacy of Anthelmintics: Specific Recommendations for Equines (PDF Version - 146 K)
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 (A) and geometric (G) means for the evaluation of anthelmintic effectiveness.
In Canada, as a general rule, we are of the opinion that either A or G 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 A is preferable as it reflects a more stringent estimation of effectiveness.
GL 16 - Efficacy of Anthelmintics: Specific Recommendations for Porcines (PDF Version - 145 K)
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 (A) and geometric (G) means for the evaluation of anthelmintic effectiveness.
In Canada, as a general rule, we are of the opinion that either A or G 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 A is preferable as it reflects a more stringent estimation of effectiveness.
Date Adopted by VDD: 2003/11/01
Effective Date: 2003/11/01
VICH Canada Coordinating Secretariat, Veterinary Drugs Directorate, HPFB, Health Canada
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 (PDF Version - 155 K)
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 (A) and geometric (G) means for the evaluation of anthelmintic effectiveness.
In Canada, as a general rule, we are of the opinion that either A or G 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 A is preferable as it reflects a more stringent estimation of effectiveness.
GL 20 - Efficacy of Anthelmintics: Specific Recommendations for Felines (PDF Version - 138 K)
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 (A) and geometric (G) means for the evaluation of anthelmintic effectiveness.
In Canada, as a general rule, we are of the opinion that either A or G 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 A is preferable as it reflects a more stringent estimation of effectiveness.
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 (A) and geometric (G) means for the evaluation of anthelmintic effectiveness.
In Canada, as a general rule, we are of the opinion that either A or G 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 A is preferable as it reflects a more stringent estimation of effectiveness.
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
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
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
Date Adopted by VDD: 2005/07/01
Effective Date: 2005/07/01
VICH Canada Coordinating Secretariat, Veterinary Drugs Directorate, HPFB, Health Canada
Date Adopted by VDD: 2009/07/13
Effective Date: 2010/01/13
VICH Canada Coordinating Secretariat, Veterinary Drugs Directorate, HPFB, Health Canada
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
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
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
Date Adopted by VDD: 2004/10/01
Effective Date: 2004/10/01
VICH Canada Coordinating Secretariat, Veterinary Drugs Directorate, HPFB, Health Canada
Date Adopted by VDD: 2004/10/01
Effective Date: 2004/10/01
VICH Canada Coordinating Secretariat, Veterinary Drugs Directorate, HPFB, Health Canada
Date Adopted by VDD: 2008/11/05
Effective Date: 2009/07/01
VICH Canada Coordinating Secretariat, Veterinary Drugs Directorate, HPFB, Health Canada
Date Adopted by VDD: 2011/02/09
Effective Date: 2011/08/01
VICH Canada Coordinating Secretariat, Veterinary Drugs Directorate, HPFB, Health Canada
Date Adopted by VDD: 2011/03/16
Effective Date: 2011/09/01
VICH Canada Coordinating Secretariat, Veterinary Drugs Directorate, HPFB, Health Canada
Date Adopted by VDD: 2011/03/16
Effective Date: 2011/09/01
VICH Canada Coordinating Secretariat, Veterinary Drugs Directorate, HPFB, Health Canada
Date Adopted by VDD: 2011/03/16
Effective Date: 2011/09/01
VICH Canada Coordinating Secretariat, Veterinary Drugs Directorate, HPFB, Health Canada
Date Adopted by VDD: 2011/03/16
Effective Date: 2011/09/01
VICH Canada Coordinating Secretariat, Veterinary Drugs Directorate, HPFB, Health Canada
