Are NHP regulations confusing you?

Q: Do I need a product licence (NPN) to launch my product in the Canadian market even if I have applied with Health Canada and have not heard anything for the past two years?
A: If you have filed a product licence application, and your application has been in queue for two years, you would have received notification that your product has become eligible for an Exemption Number (EN). The trick is you have to complete a form and send it to Health Canada to opt-in for the Exemption Number. If you have not done so, as per Health Canada, you will have to wait for your licence before you can market your product in Canada.

Q: How long does it take to be granted a Natural Product Number (NPN)?
A: If you’re filing a compendial application, the turnaround time at Health Canada is 60 days from the time you receive acknowledgment of your submission. On the other hand, if your submission is non-compendial (e.g. multiple combination ingredients), the turnaround time could be months, and even years.

Q: Can I import a natural health product into Canada without a Site Licence?
A: As per the Natural Health Products Regulations, product and site licences are required before a natural health product can be marketed in Canada.

Q: Does my natural health product have to meet any testing requirements?
A: Yes. All natural health products must comply with the specifications approved by Health Canada for the licensed product. Specification requirements include: product purity, quantity and identity of the medicinal ingredients, potency if applicable, and testing methods. In addition, they must undergo a stability study to determine the expiry date of the product.

Q: Is my label and/or packaging subject to specific requirements?
A: Yes. Bilingual packaging is mandatory in Canada. Also, to ensure consumer safety, your product label must carry proper risk information, disclose the amounts of each active ingredient and – in some instances – may be subject to packaging security features, i.e., child proof resistance. In addition, product information and claims should not be misleading. Health Canada’s mandate is to provide access to safe NHPs and allow consumers to make informed choices.

Q: Is there any compliance enforcement on natural health products conducted by Health Canada at the wholesale or retail level?
A: There is no official enforcement at this time. Initially Health Canada had set a date of March 1, 2011 to begin enforcing the regulations. This has since been postponed until further notice by Health Canada.

Q: What does "no official enforcement" mean?
A: Currently, Health Canada has adopted a risk-based approach enforcement only (meaning it will target high risk products). Enforcement actions will be undertaken by Health Canada when necessary, particularly when the regulated party is unable or unwilling to comply with regulatory requirements, with or without market authorization. Compliance and enforcement activities include rejection/ cancellation of EN/NPN, request for removal of products from the shelves, re-labeling, stop sale/stop importation and product recall.

Q: What happens if my submission is refused by Health Canada?
A: If the product has been granted an Exemption Number, it will be suspended and, as per NHPR/UPLARs, the product cannot be legally sold in Canada. A request for reconsideration can be filed within 30 days of the submission being refused.

Q: Who needs a site licence?
A: Manufacturers, packagers, labellers and importers of NHPS must have a valid Site Licence. Distributors are not required to carry a Site Licence to distribute NHPs, however, they must demonstrate that they meet GMP requirements.

Q: What is the extent of the UPLARs?
A: The Unprocessed Products Licence Applications Regulation came into effect in August of 2010. The first stage is a compliance promotion transition period to be followed by a full compliance and enforcement phase. The UPLARs will be removed after 30 months.

Bernie Desgagnés is founder and president of Source Nutraceutical, which offers everything a company needs to successfully launch a food, pharmaceutical (drug and medical device), natural health product, organic product, dietary supplement, or cosmetic product into the Canadian market. For more information, please go to www.sourcenutra.ca