Interim Notification Program for Low-risk Veterinary Health Products: Questions and Answers

1. What is the Interim Notification Program?
2. What products are included in the Notification Program?
3. Does this program apply to veterinary health products used on any animal?
4. What is the purpose of this Notification Program?
5. How would the program work?
6. How much will it cost to get a notification number?
7. Will a list of products that have been assigned notification numbers be available to the public?
8. Will a duly notified product be allowed for sale in Canada?
9. Will a feed manufacturer be able to add a product that has been assigned a notification number to a commercial horse feed?
10. What is the List of Admissible substances and when will it be established?
11. What risk mitigation measures will be in place to ensure that the products which receive a notification number are safe, of good quality and have a reasonable expectation of effectiveness?
12. When will this program come into effect?
13. As a manufacturer, why would I participate in this program?
14. What if the product I am manufacturing contains medicinal ingredients that are not on the List of Admissible Substances, can I still sell it?
15. What happens if a product arrives at the border and does not have a notification number or a drug identification number (DIN)?
16. 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?
17. Can substances be added to the List of Admissible Substances?

1. What is the Interim Notification Program?

This is a voluntary temporary program in which a sponsor applies for a Notification Number with a third party Program Administrator. If the product meets the relevant conditions established by Health Canada, a notification number would be issued. For the purpose of the Interim Notification Project, 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 requirements related to the importation, manufacture, or sale of these veterinary drugs and would not normally seek to prevent its marketing in Canada, unless a health risk is identified.

2. What products are included in the 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 Admissible Substances established by Health Canada. Examples of admissible substances include pre-identified vitamins, minerals and botanicals among others.

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

No, the scope of the program is limited to low-risk veterinary health products intended for dogs, cats and horses not intended for food.

4. What is the purpose of this Notification Program?

The Interim Notification Program would allow Health Canada to gain knowledge of the volume and characteristics of these products, as well as establish a method to trace manufacturers of these products and take corrective action, should post-market surveillance reveal a problem.

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 EAC-vNHP and under consideration by Health Canada.

5. How would the program work?

The sponsor 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 sponsor to ensure that the product meets all the conditions set out by Health Canada and will attest to this on the application form. The sponsor 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.

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

The program would be funded by charging reasonable fees for processing the notifications. There will be a fee charged to the sponsor by the third party Program Administrator. The fee structure is to reflect resource requirements and is under development.

7. 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.

8. 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, but for products that meet all the conditions of the Program and have been assigned a notification number by the Program Administrator, Health Canada will not prioritize the enforcement of the requirements relating to the manufacturing, importation or sale of low-risk veterinary health products, and will not normally seek to prevent the importation, manufacturing or sale of such products, unless a particular risk is identified.

Health Canada will 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.

9. 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 for horses 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.

10. What is the List of Admissible substances and when will it be established?

Substances listed have been evaluated by Health Canada and are considered to be of minimal concern, i.e. they are not expected to cause adverse events 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 will be updated on a regular basis.

11. What risk mitigation measures will be in place to ensure that the products which receive a notification number are safe, 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 medicinal ingredients on the List of Admissible 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 sponsor will attest compliance to the Good Manufacturing Practice requirements specified by the Natural Health Products Regulations for human Natural Health Products, as defined in those Regulations.
• The sponsor will attest that there is objective and credible evidence to support a reasonable expectation of effectiveness
• The sponsor must report adverse events
• 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

12. When will this program come into effect?

Subject to the feedback received through the consultation, it is anticipated that the Program will be in effect during the summer / fall of 2011.

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

If your product meets all of the conditions of the Program and has been assigned a notification number by the Program Administrator, Health Canada will not prioritize the enforcement of the requirements related to the importation, manufacturing or sale of the product, and will not normally seek to prevent the importation, manufacturing or sale of such products unless a particular 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 low-risk veterinary health products.

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

If a product that falls outside the scope of the Program is sold without a market authorization (Drug Identification Number, Notice of Compliance) in Canada, it is subject to compliance and enforcement action under the Food and Drugs Act and Regulations. Health Canada will take enforcement action in whatever manner deemed appropriate, should it have reasons to believe that a product does not fall within the conditions of the Notification Program (e.g. unauthorized health claim), or that it is unsafe or may cause the public to be deceived.

15. What happens if a product arrives at the border and does not have 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.

16. 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.

17. Can substances be added to the List of Admissible Substances?

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