Proposed Interim Notification Program: Low-risk Veterinary Health Products

Table of Contents

• Executive Summary
• 1. Purpose
• 2. Background
• 3. Scope
• 4. Roles
• 5. Qualification Process
• 6. Handling of Notification
• 7. Eligible Products
• 8. Feeds for Horses
• 9. Risk Management and Enforcement
• 10. For More Information
• Appendix A: Criteria for Notifiable Products

Executive Summary

Health Canada, in cooperation with the Canadian Animal Health Institute (CAHI), has developed a proposed Interim Notification Program for low-risk veterinary health products (LRVHPs) used in cats, dogs, and horses that are not intended for food. The proposed Interim Notification Program applies to LRVHPs, such as homeopathic preparations, botanicals, vitamins and minerals.

Health Canada considers the Interim Notification Program to be a temporary measure pending the amendment to the drug regulations to improve the regulation of low-risk veterinary health products.

On a voluntary basis, a sponsor could apply for a notification number with the Program Administrator. If the product meets the conditions described in Appendix A, Criteria for Notifiable Products, a notification number may be issued. For the purpose of the Interim Notification Program, Health Canada considers a sponsor as being a person interested in importing or manufacturing a LRVHP for sale in Canada.

With regard to such a duly notified product, Health Canada would not prioritize the enforcement of the regulatory requirements related to the importation, manufacture, or sale of veterinary drugs and would not normally seek to prevent its marketing in Canada, unless a health risk is identified.

The Interim Notification Program would be administered by a third-party Program Administrator operating independently from CAHI. The review of the notifications would be conducted on a fee-for-service basis by the Program Administrator. Health Canada's role would be to set various standards, establish a List of Admissible Substances, issue guidance documents (e.g. on what health claims would be allowed), and audit the program.

1. Purpose

This document describes a proposed Interim Notification Program for low-risk veterinary health products (LRVHPs) used in cats, dogs, and horses that are not intended for food.

2. Background

There is an increasing demand for veterinary health products, such as vitamins, minerals, homeopathic preparations, and botanicals.

The Interim Notification Program is being developed in cooperation with the Canadian Animal Health Institute (CAHI), a trade association that represents companies that develop, manufacture, and distribute animal health products. The proposed program is consistent with recommendations made to Health Canada by the Expert Advisory Committee on Veterinary Natural Health Products (EAC-vNHP) regarding the regulation of low-risk products.

The following considerations were taken into account during the development of the proposed program:

• The mandate of Health Canada's Veterinary Drugs Directorate (VDD) is to protect human and animal health and the safety of Canada's food supply. In support of this objective, the VDD sets standards and promotes the safe use of veterinary drugs administered to animals in Canada.
• As Health Canada intends to develop new risk-based regulations to control the importation, manufacture, or sale of veterinary drugs, this program would serve as an interim measure.
• The Interim Notification Program will provide information needed for the development of a new regulatory approach for low-risk veterinary health products, as recommended by the external EAC-vNHP and under consideration by Health Canada.
• Some of these products may be currently on the market without authorization for sale, in which case, the quality, safety, and efficacy of such products are unknown to Health Canada.
• The majority of these products are classified as "new drugs" as defined in the Food and Drugs Regulations. Therefore, persons seeking market authorization are required to provide substantial data to obtain market authorization. Health Canada is aware that some members of the industry face challenges in meeting certain current regulatory requirements for these products.
• While these LRVHPs may meet the definition of a new drug, Health Canada considers it unlikely that a product satisfying all applicable requirements, as outlined in Appendix A, could present a significant risk to the health of humans or animals.

3. Scope

The Interim Notification Program is a voluntary program in which sponsors apply for a notification number with a third party Program Administrator. For the purpose of the Interim Notification Program, Health Canada considers a sponsor as being a person interested in importing or manufacturing a LRVHP for sale in Canada.

The Program is intended for products used in dogs, cats, and horses that are not intended for food. The Program would be accessible to all manufacturers or importers.

4. Roles

The role of Health Canada would be to work in cooperation with CAHI to design and implement the program. Health Canada would set the standards for inclusion of products in the program. Health Canada would develop and maintain a List of Admissible Substances and develop guidance documents for industry in such areas as labelling, reporting adverse events, and acceptable health claims. Health Canada would also audit the Program Administrator and evaluate the program to ensure that the public is adequately protected against health risks and deception.

The role of CAHI would be to work in cooperation with Health Canada to design and implement the program. Once the program is operational, CAHI would work independently from the Program Administrator to educate program participants on issues such as quality control and Good Manufacturing Practices. To protect confidentiality and avoid any appearance of preferential treatment, CAHI would not be involved nor be able to intervene in any way in the handling of any particular notification under the Interim Notification Program.

The Program Administrator would be a third party operating independently from CAHI. The role of the Program Administrator would be to process the notifications and, if the LRVHP meets the standards for program eligibility, to issue a unique, product-specific notification number. The Program Administrator will inform Health Canada each time a notification application has been reviewed and a decision has been made, regardless of what the outcome is, e.g. issuance or refusal of a notification number.

The role of the sponsor would be to complete a notification form and provide the required information about the product.

5. Qualification Process

To qualify for the Interim Notification Program, a sponsor would have to complete a notification form to provide information about the product, including the following information:

• The coordinates of the Canadian representative who will be responsible for providing any information requested by Health Canada concerning the product;
• Information to clearly identify the product;
• Information necessary to determine whether the product is eligible for the program, including a list of medicinal and non-medicinal ingredients;
• General health claims that will be made for the product, to ensure that no prohibited specific therapeutic health claim is made;
• Information about the manufacturer and the location of manufacturing sites; and
• Information necessary to ensure traceability to the manufacturer and facilitate corrective action, should post-market surveillance reveal a problem.

The sponsor will also have to attest that:

• Objective and credible evidence exists that demonstrates that the product is safe;
• Objective and credible evidence exists to support a reasonable expectation of effectiveness;
• Quality control systems will comply with the Good Manufacturing Practices (GMP) requirements of the Natural Health Products Regulations for human natural health products;
• The product meets all the conditions described in Appendix A, Criteria for Notifiable Products;
• Conditions of the program, including those relating to health claims, will be met;
• Product labelling information and any other information supplied to users will match the information provided on the notification form (e.g., health claims made for the product);
• Post-market regulatory requirements (e.g. reporting of adverse events or recalls) will be complied with; and
• They will inform the Program Administrator of any relevant change (e.g., change in manufacturing site).

If the product meets the relevant conditions established by Health Canada, the Program Administrator may issue a notification number.

The Interim Notification Program will operate on a cost recovery basis. The fee charged to sponsors by the Program Administrator will be fixed, based on the cost required to process the notification applications.

6. Handling of Notification

Health Canada will have online access to all relevant information on products for which a notification number has been issued under the Interim Notification Program. Health Canada will also have complete and timely access to all information contained in the notification forms as well as the files of the Program Administrator. The information collected about the notified products would further allow for traceability to the manufacturer and facilitate corrective action, should post-market surveillance reveal a problem.

In assessing the admissibility of a notification, the Program Administrator would act independently from any organization representing the industry. The information provided by the sponsor in the notification form would be considered confidential.

A list of products that have been assigned notification numbers under the Interim Notification Program would be made available to the public via a public website. The list would include the labelling information provided in the notification form by the sponsor.

7. Eligible Products

The proposed Interim Notification Program concerns veterinary drugs in so far as they are subject to the Food and Drugs Act, as administered by Health Canada. It is intended for products containing pre-identified substances, such as homeopathic preparations, botanicals, vitamins, minerals, and other veterinary products, provided that these products meet the conditions of Appendix A, Criteria for Notifiable Products.

Only products with general health claims would be eligible for the Interim Notification Program. Specific therapeutic claims (claims to diagnose, prevent, treat, or cure a disease or abnormal physiological condition) would not be allowed. For example, a product could carry the claim that it "may help in the improvement of joint health and function," but not that it is "for the treatment of osteoarthritis."

8. Feeds for Horses

The issuance of a notification number under the proposed program would not exclude the product from the application of the Feeds Act and Regulations, which apply to horses but not to dogs and cats. This is particularly relevant in the case of mixed feeds for horses that must meet the requirements of the Feeds Act and Regulations. The program would not affect the enforcement of any legislation for which the Canadian Food Inspection Agency (CFIA) is responsible. The CFIA will continue to take action against non-compliant products when appropriate.

The program only concerns products to be used on horses not intended for food. However, to address the possibility that a horse could be slaughtered for food even though this may not have been anticipated at the time the product was administered, the label would refer to European standards with respect to withdrawal times.

9. Risk Management and Enforcement

Given the Interim Notification Program's safeguards, Health Canada considers it unlikely that a product satisfying all applicable requirements could present a significant risk to the health of humans or animals. Consequently, in the case of a product that meets all conditions of the Interim Notification Program and has been assigned a notification number by the Program Administrator, Health Canada would not prioritize the enforcement of the regulatory requirements related to the importation, manufacture, or sale of veterinary drugs and would not normally seek to prevent the importation, manufacture, or sale of such a product, unless a health risk is identified.

Health Canada will continue to take enforcement action should it have reasons to believe that a product does not fall within the conditions of the Interim Notification Program (e.g. unauthorized health claim), or that it is unsafe or may cause the public to be deceived.

10. For More Information

For additional information on the proposed Interim Notification Program, please send your questions by e‑mail to vNHP-PSNv_consultations@hc-sc.gc.ca .

Appendix A: Criteria for Notifiable Products

The proposed Interim Notification Program is intended for homeopathic preparations, botanicals, vitamins, minerals, and other veterinary drugs that meet the following conditions:

• The product is for use only on dogs, cats, or horses that are not intended for food.
• All medicinal ingredients are listed in and meet the conditions of the List of Admissible Substances established by Health Canada.
• All non-medicinal ingredients are listed in and meet the conditions of the list of non-medicinal ingredients established by Health Canada.
• The product is not to be used on pregnant or lactating animals.
• With respect to horses, the product is not to be mixed with feeds by a feed manufacturer in circumstances where the Feeds Regulations would apply.

Exclusions

Health Canada, at its sole discretion, can exclude any product from the application of the Interim Notification Program. Products belonging to the categories described below are excluded.

Products delivered through the following routes of administration are excluded from the program:

• Implants;
• Injectable;
• Inhalation;
• Intra-mammary;
• Intra-uterine;
• Ophthalmic; and
• Transdermal patches.

The following product types are excluded from the program:

• Chemically synthesized antibiotics and hormones, except for plants and whole herb extracts with antimicrobial or mild hormonal activity;
• General anesthetics-drug involving loss of consciousness; and
• Tranquilizers, except for products having mild calming effects.

The following designated substances are excluded from the program:

• Radiopharmaceuticals listed in Schedule C of the Food and Drugs Act;
• Biological products, including drugs obtained by recombinant DNA procedures, listed in Schedule D of the Food and Drugs Act, except in homeopathic medicines;
• Prescription substances listed in Schedule F of the Food and Drug Regulations, except in homeopathic medicines;
• Substances covered under the Controlled Drugs and Substances Act; and
• Products used in relation to a reportable disease listed in the Health of Animals Act.