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Qs & As -- Veterinary Natural Health Products
Questions
- What is the issue?
- What is Health Canada doing to address this?
- How does VDD define vNHPs?
- What is the current status of vNHPs?
- Why does Health Canada regulate vNHPs as "drugs"when they are natural, and therefore safe?
- Are there any risks involved in giving an unapproved vNHP to my pet?
- Can human NHPs that have market authorization (indicated by a natural health product number, or NPN) be marketed for veterinary use?
- Do I need a market authorization before marketing my vNHP in Canada?
- Can I import vNHPs authorized in another country into Canada, even if I have not obtained a market authorization in Canada?
- What do I need to provide Health Canada with to obtain a market authorization?
- How can I stay informed about this issue?
Answers
More and more, people are turning to natural health products for themselves and for their animals as an alternative to conventional medication to prevent or treat diseases and conditions. As such, there is a need for these products to be adequately regulated to ensure their quality, efficacy and safety. Unlike Human Natural Health Products, which have their own set of regulations, Veterinary Natural Health Products (vNHPs) currently fall under the Food and Drugs Regulations which is causing confusion for consumers and industry. The vast majority of vNHPs are classified as "New Drugs', for which the current data requirements for authorization for sale in Canada are not appropriate.
2. What is Health Canada doing to address this?
Health Canada's Veterinary Drugs Directorate (VDD) is developing a strategy that will take into consideration the unique aspects of vNHPs. There are several steps to be taken as part of this long-term solution, such as consultation with stakeholders.
All vNHPs are considered drugs under the Food and Drug Regulations. A definition will need to be established to develop a strategy for vNHPs. Health Canada will be consulting with stakeholders on a proposed definition.
4. What is the current status of vNHPs?
Most vNHPs are considered to be new drugs, and are subject to Division 8 requirements of the Food and Drug Regulations. In other words, a New Drug Submission, supported by adequate safety, efficacy and quality data, must be filed for a thorough evaluation by Health Canada scientists.
5. Why does Health Canada regulate vNHPs as "drugs"when they are natural, and therefore safe?
The belief that "natural products" are always safe is a misconception. Some substances found in nature could be toxic, for example, arsenic. Food derived from animals (e.g., meat, milk, eggs) may potentially contain residues of a vNHP administered to the animal. As well, since drugs are given to animals which could enter the human food chain, the drugs may also have implications for human health. Since natural products are not necessarily safe, they are regulated to protect the health of animals, and of humans who consume food derived from treated animals.
6. Are there any risks involved in giving an unapproved vNHP to my pet?
There may be risks associated with the use of unapproved vNHPs because scientific evaluation for safety, efficacy and quality has not been conducted.
7. Can human NHPs that have market authorization (indicated by a natural health product number, or NPN) be marketed for veterinary use?
No. The market authorization provided by the NHP Regulations only applies to human NHPs; it does not apply to products for use in animals. Veterinary NHPs are subject to the requirements of the Food and Drug Regulations, and are given a different type of market authorization known as a Drug Identification Number (DIN).
8. Do I need a market authorization before marketing my vNHP in Canada?
Yes. All drugs including vNHPs must have market authorization before they can be sold in Canada. For a drug product to be imported for sale, sold or advertised in Canada, it must have a valid Drug Identification Number (DIN) according to the Food and Drug Regulations.
9. Can I import vNHPs authorized in another country into Canada, even if I have not obtained a market authorization in Canada?
No. The sale of all products in Canada must be authorized by Health Canada, irrespective of whether they have been approved in another country. For a drug product to be imported for sale, sold or advertised in Canada, it must have a valid Drug Identification Number (DIN) according to the Food and Drug Regulations. The Canadian importer assumes responsibility for the compliance of any drug product imported into Canada.
10. What do I need to provide Health Canada with to obtain a market authorization?
Currently, most vNHPs are considered new drugs, and therefore need to meet the requirements of Division 8 in the Regulations, and obtain a Notice of Compliance and a Drug Identification Number (DIN) to obtain market authorization. Information on how to prepare and submit an application can be found at www.hc-sc.gc.ca/dhp-mps/vet/applic-demande/index-eng.php. Some vNHPs could also be classified as Not New Drugs under certain circumstances, i.e., if a similar product has been approved for sale in Canada for a significant period of time.
11. How can I stay informed about this issue?
As new information becomes available, it will posted on VDD's Website.
