Interim Notification Pilot Program for Low-Risk Veterinary Health Products (LRVHPs) - Frequently Asked Questions

1. What is the Interim Notification Program?

This is a voluntary program in which a notifier applies for a Notification Number with a third party Program Administrator, North American Compendiums (NAC). If the product meets the relevant conditions established by Health Canada, a notification number would be issued. For the purpose of the Interim Notification Program (INP), Health Canada considers a notifier as being a person interested in importing or manufacturing a Low-risk Veterinary Health Product (LRVHP) for sale in Canada.

Health Canada would not normally seek to prevent the importation, manufacture or sale of products duly notified through the program unless a health risk is identified.

2. When will this program come into effect?

North American Compendiums will start accepting Notification Applications on February 6, 2012 and will start issuing Notification Numbers as of March 19^th, 2012.

3. What products are included in the Interim Notification Program?

Low-risk Veterinary Health Products covered under this Program are products such as oral and topical products for use in cats, dogs and horses not intended for food that meet specific safety criteria. Medicinal ingredients of the product must be listed on the List of Substances established by Health Canada. Examples of admissible substances include pre-identified vitamins, minerals and botanicals among others.

4. Does this program apply to veterinary health products used on any animal?

No, the scope of the program is limited to LRVHPs used in dogs, cats and horses not intended for food.

5. What is the purpose of this Notification Program?

This Program is a pilot project that is a temporary measure intended to assess the effectiveness of a streamlined approach to oversee LRVHPs with a view to informing the development of a new veterinary drugs framework.

The Program will also provide information needed for the development of a new regulatory approach for low-risk veterinary health products, as recommended by the external Expert Advisory Committee on Veterinary Natural Health Products (EAC-vNHPs).

6. How would the program work?

The notifier would have to complete an application form and provide information such as his or her coordinates and that of the manufacturer, location of manufacturing site(s) and information such as details about the product. It is the responsibility of the notifier to ensure that the product meets all the conditions set out by Health Canada and will attest to this on the application form. The notifier would also have to comply with post market regulatory requirements (e.g. reporting of adverse events, change of manufacturing site, etc). A product-specific notification number is issued when all requirements are met.

7. How much will it cost to get a notification number?

The program will be funded by charging reasonable fees for processing the notifications. The fees will be charged to the notifier by the third party Program Administrator. Information about the fees related to the INP is available at:  North American Compendiums.

8. Will a list of products that have been assigned notification numbers be available to the public?

Yes, a list of products that have been assigned notification numbers and their labelling information will be available online via a public website which is available at:  North American Compendiums.

9. Will a duly notified product be allowed for sale in Canada?

A notification number does not constitute market authorization under the Food and Drugs Act and Regulations. However, Health Canada would not normally seek to prevent the importation, manufacture or sale of products duly notified through the program unless a health risk is identified.

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

10. Will a feed manufacturer be able to add a product that has been assigned a notification number to a commercial horse feed?

No. Medicated feeds must meet the requirements of the Feeds Act and Regulations. Nothing in this Program would affect the enforcement of the Feeds Act and Regulations or other legislation under the responsibility of the Canadian Food Inspection Agency (CFIA). The CFIA will continue to take action against non-compliant products when appropriate.

11. What is the List of Substances and when will it be established?

Substances appearing on the List of Substances and deemed admissible have been evaluated by Health Canada and are considered to be of minimal concern, i.e. they are not expected to present a significant risk to the health of humans or animals when used in cats, dogs and horses not intended for food when the conditions associated with them are respected. The List has been developed based on generally accepted scientific and traditional knowledge and is in line with similar lists in other jurisdictions. The list is available at:  North American Compendiums. The List will be updated on a regular basis.

12. What risk mitigation measures will be in place to ensure that the products which receive a notification number pose a low risk, are of good quality and have a reasonable expectation of effectiveness?

Health Canada's primary consideration in implementing this Program is always to protect public health, and any doubt with regard to the safety of a product would exclude it from the Notification Program.

• The Program is limited to products containing active (medicinal) ingredients on the List of Substances identified by Health Canada as being a low risk substance when used under certain conditions.
• Only general health claims will be allowed, such as "has a role in maintaining healthy cartilage". Specific treatment claims such as "for the treatment of osteoarthritis" will not be permitted.
• The notifier will attest compliance to the Good Manufacturing Practices requirements for LRVHPs that are very similar to those outlined in the Natural Health Products Regulations which applies to Natural Health Products used in humans.
• The notifier will attest that there is objective and credible evidence to support a reasonable expectation of effectiveness.
• The notifier must report adverse events to the Third Party Administrator.
• The Program allows the product to be traced back to the manufacturer so that corrective action can be taken in an efficient manner as soon as a problem is revealed, for example, if a recall is required

13. As a manufacturer, why would I participate in this program?

Products that have not been issued a notification number as part of the INP or that have not obtained a valid Drug Identification Number (DIN) and/or a Notice of Compliance (NOC), will be considered non-compliant products and may be subject to compliance and enforcement actions as per Health Canada's Compliance and Enforcement Policy (POL-0001).

Health Canada would not normally seek to prevent the importation, manufacture or sale of products duly notified through the program unless a health risk is identified.

In addition, this project allows for opportunities to educate the members of the industry on important issues such as quality controls and Good Manufacturing Practices, most of which will likely be similar to the future amendments to improve the regulation of LRVHPs.

14. What if the product I am manufacturing contains active (medicinal) ingredients that are not on the List of Admissible Substances, can I still sell it?

No, products that have not been issued a notification number as part of the INP or that have not obtained a valid Drug Identification Number (DIN) and/or a Notice of Compliance (NOC), will be considered non-compliant products and may be subject to compliance and enforcement actions as per Health Canada's Compliance and Enforcement Policy (POL-0001).

15. What happens if a product arrives at the border prior to March 19^th, 2012 and has not yet received a notification number or a drug identification number (DIN)?

Products arriving at the border which are referred to Health Canada for an admissibility determination will be refused entry into Canada if they have not received a DIN. Products with a notification number issued as of March 19^th, 2012, will be allowed entry into Canada.

16. What happens if a product arrives at the border on or after March 19^th, 2012 and has not yet received a notification number or a drug identification number (DIN)?

Products arriving at the border which are referred to Health Canada for an admissibility determination will be refused entry into Canada if they have not received a notification number or a DIN.

17. If my product currently has a Drug Identification Number (DIN) and my company holds an Establishment License, is my product eligible for the notification program?

Any company whose products meet the conditions of the notification program may apply to the program.

18. Can substances be added to the List of Substances?

Health Canada will periodically review the List to determine if any changes are required.

19. What if I have a complaint about a product?

Information about how to file a complaint is available on the following websites:

• How to Submit a Trade Complaint
• How to Submit a Consumer Complaint

20. Where can I obtain additional information about the program?

For more information please contact:

 North American Compendiums
45 Erb St East (Back Entrance)
Waterloo, ON  N2J 1L7
Toll Free 877-203-3313
Phone 519-746-8258
Fax 866-685-1521