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Questions and Answers on Regulatory Requirements for Products with Exemption Numbers

November 2010

1. Does a product with an exemption number have to be manufactured according to good manufacturing practices?
2. Which sections of the Natural Health Products Regulations (NHPR) does a product with an exemption number have to meet?
3. Do I have to provide site information for my products with exemption numbers, since Section 22 of the Natural Health Products Regulations (NHPR) does not apply?
4. Do I have to report adverse reactions to my products with exemption numbers?
5. Do I have to report recalls for my products with exemption numbers?
6. If my licence application for a product with an exemption number is refused, what does that mean?
7. How long is my exemption number valid?
8. If my product received an exemption number, and then a classification decision was made such that my product was no longer considered to be an Natural Health Product (NHP), what happens to my exemption number?

1. Does a product with an exemption number have to be manufactured according to good manufacturing practices?

Yes. A product with an exemption number must meet Part 3 (Good Manufacturing Practices) of the NHPR.

2. Which sections of the Natural Health Products Regulations (NHPR) does a product with an exemption number have to meet?

A product with an exemption number must meet all of the provisions within the NHPR with the exception of the following:

• Section 11 (amendment)
• Section 13 (fundamental change)
• Section 18(1)(b) (suspension and cancellation)
• Section 22 (site information)
• Paragraph 62(c) (product number)
• Subparagraph 93(1)(a)(ii) (product number)
• Subparagraph 94(1)(a)(vii) (product number)

3. Do I have to provide site information for my products with exemption numbers, since Section 22 of the Natural Health Products Regulations (NHPR) does not apply?

Yes. Section 5 of the Natural Health Products (Unprocessed Product Licence Applications) Regulations (NHP-UPLAR) states that the information required by Section 22 of the NHPR must be provided:

1. for products already for sale at the coming into force of the regulations - if requested by Health Canada; and
2. for new products (i.e., not yet for sale as of the coming into force of the regulations) - before sale of the NHP

4. Do I have to report adverse reactions to my products with exemption numbers?

Yes. Section 24 (reaction reporting) applies to products with exemption numbers.

5. Do I have to report recalls for my products with exemption numbers?

Yes. The regulations require that all recalls be reported similar to s. 62 of the NHPR.

6. If my licence application for a product with an exemption number is refused, what does that mean?

It means that your product licence application is refused, your exemption number is no longer valid and you will no longer be allowed to sell your product.

7. How long is my exemption number valid?

Your exemption number is no longer valid once your PLA is licensed, refused or withdrawn, the EN is suspended or cancelled or 30 months from the date of the coming into force of the regulation, whichever is sooner.

8. If my product received an exemption number, and then a classification decision was made such that my product was no longer considered to be a Natural Health Product (NHP), what happens to my exemption number?

Your exemption number would no longer be valid. The classification of your product would determine which if any regulatory requirements apply, for example, the Food and Drug Regulations.