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 Pilot Program (INPP), 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 notified within the program and would not normally seek to prevent the importation, manufacture, or sale of such a product, unless a health risk is identified.
2. What products are eligible for the Interim Notification Pilot Program?
The INPP originally included low-risk Veterinary Health Products such as oral and topical products for use in cats, dogs and horses not intended for food that meet specific safety criteria.
Building on the success of the INPP, the scope has been expanded to a limited group of low risk veterinary health products (LRVHPs) including oral Calcium supplements and udder creams and lotions for dairy cattle. These products present minimal risk to animals and food safety and are important tools to maintain animal health and welfare.
Medicinal ingredients of the product must be listed on the List of Admissible Substances (List) established by Health Canada. Examples of admissible substances include pre-identified vitamins, minerals and botanicals among others.
3. When did program come into effect?
North American Compendiums started accepting Notification Applications on February 6, 2012 and issued Notification Numbers as of March 19th, 2012.
4. 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).
5. How does the program work?
The notifier needs to complete an application form and provide information such as his or her contact information and that of the manufacturer, location of manufacturing site(s) and 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 needs 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 does it cost to get a notification number?
The program is funded by charging reasonable fees for processing the notifications. The fees are charged to the notifier by the third party Program Administrator. Information about the fees related to the INPP is available at: North American Compendiums.
7. Is a list of products that have been assigned notification numbers available to the public?
Yes, a list of products that have been assigned notification numbers and their labelling information is available at: North American Compendiums.
8. Is a notified product 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 notified through the program unless a health risk is identified.
Health Canada may take appropriate enforcement action, should it have reason to believe that a product does not meet the conditions of the notification program (e.g. unauthorized claim), or that it is unsafe or may cause the public to be deceived.
9. Is a feed manufacturer permitted to add a product that has been assigned a notification number to a commercial livestock feed?
No, at this time products that have been assigned a notification number cannot be added to livestock feeds. 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 only veterinary products that may be used in medicated feeds are veterinary drugs with Drug Identification Numbers (DINs) when feeds are manufactured according the Compendium of Medicating Ingredient Brochures and/or as per a veterinary prescription. The CFIA will continue to take action against non-compliant products when appropriate.
10. What is the List of Admissible Substances?
Substances appearing on the List of Admissible 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 is updated on a regular basis.
11. What risk mitigation measures are 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 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 Admissible Substances identified by Health Canada as being a low risk substance when used under certain conditions.
- Only general health claims are allowed, such as "has a role in maintaining healthy cartilage". Specific treatment claims such as "for the treatment of osteoarthritis" are not 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 serious 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.
12. As a manufacturer, why would I participate in this program?
Products that have not been issued a notification number as part of the INPP 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.
13. 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 INPP or that have not obtained a valid Drug Identification Number (DIN) and/or a Notice of Compliance (NOC), are considered non-compliant products and may be subject to compliance and enforcement actions as per Health Canada's Compliance and Enforcement Policy (POL-0001).
14. What happens if a product arrives at the border on or after March 19th, 2012 and has not yet received a notification number?
Products arriving at the border without a notification number could be refused entry into Canada.
15. 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.
16. Can substances be added to the List of Substances?
Health Canada will periodically review the List to determine if any changes are required.
17. What if I have a complaint about a product?
Information about how to file a complaint is available on the following websites:
18. Where can I obtain additional information about the program?
For more information please contact:
North American Compendiums
P.O. Box 39
Hensall, Ontario N0M 1X0
Toll-Free Number: 1-888-328-6228
Telephone Number: 1-519-489-6014
Fax Number: 519-263-2936
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