Questions and Answers on Eligibility and Selling Products without Exemption Numbers

November 2010

1. How do I know if my product is eligible for an exemption number?
2. My product is eligible for an exemption number based on the criteria above. How do I get my exemption number?
3. How do I know when my product will become eligible for an exemption - i.e., for an application that has received a submission number but has not been with the Natural Health Product Directorate (NHPD) for 180 calendar days?
4. How do I know if my product is eligible for an exemption number for an application which has been submitted but has not yet received a submission number?
5. How and when will I know if my product is eligible for an exemption number for applications which have not yet been submitted?
6. If I decide to pre-emptively opt-in to receive an exemption for an application that has not reached the eligibility date, when will the exemption become valid?
7. Do I have to apply for an exemption number after the 180 calendar days has passed?
8. I submitted a product licence application (PLA) but my PLA was withdrawn or refused. Is my product still eligible for an exemption number?
9. When does the clock start for the 180 calendar days?
10. Does the clock start ticking on the 180 calendar days when the Natural Health Products (Unprocessed Product Licence Applications) Regulations (NHP-UPLAR) come into force?
11. If I do not want my product to get an exemption number, can I sell it?
12. My product meets one of the outlined criteria so it is not eligible for an exemption number. When will my product licence application (PLA) be reviewed?

1. How do I know if my product is eligible for an exemption number?

To be eligible for an exemption number:

• a complete product licence application (PLA) must have been submitted as per Section 5 of the Natural Health Products Regulations (NHPR);
• the submitted PLA must not have been withdrawn;
• the PLA must have been with the Natural Health Products Directorate (NHPD) for 180 calendar days without a final licensing decision (i.e., licensed or refused); and
• the product must not meet certain criteria indicating that the product may pose a risk to the health of a purchaser or consumer (sterile NHP for ophthalmic use, makes a Schedule A claim, is recommended for use in children under 12 years of age or for use during pregnancy or breastfeeding, contains prohibited ingredients, or contains an ingredient which has been the subject of a recall or stop sale).

The Natural Health Products (Unprocessed Product Licence Applications) Regulations (NHP-UPLAR) will be repealed 30 months after they come into force; therefore, PLAs submitted less than 180 calendar days before this sunset date would not be eligible, since they could not be in queue for greater than 180 calendar days.

2. My product is eligible for an exemption number based on the criteria above. How do I get my exemption number?

Shortly after the NHP-UPLAR comes into force, Health Canada will send a notice to all product licence applicants which will include instructions on how to apply for an exemption number and will also include the Fax-Back Form which must be used. For all of the products which are eligible on the date the NHP-UPLAR comes into force, the applicant must complete the form provided by Health Canada within 60 days of the coming into force date to opt in or out of this exemption. If you do not respond within 60 days, Health Canada will take this to mean that you do not want your product to be included in the exemption.

3. How do I know when my product will become eligible for an exemption - i.e., for an application that has received a submission number but has not been with the Natural Health Product Directorate (NHPD) for 180 calendar days?

To calculate the date the product becomes eligible for an exemption, you will need to add 180 calendar days to the date you received your submission number, as the 180 day clock starts ticking on the date NHPD has issued a submission number for your application. You will have up to 60 calendar days from the eligibility date to submit a complete Fax-Back Form. The Fax-Back-Form will be available on the NHPD website. If you do not respond within these 60 calendar days, Health Canada will take this to mean that you do not want your product to be included in the exemption. You will have the opportunity to submit a complete Fax-Back Form in advance of the eligibility date in order to pre-emptively opt-in so that if the application does remain at NHPD for 180 calendar days without a final licensing decision, the exemption number would become valid and would automatically be posted on the Health Canada website on the Exempted Products Database on day 180.

4. How do I know if my product is eligible for an exemption number for an application which has been submitted but has not yet received a submission number?

Health Canada will send an Application Acceptance Letter that will contain a submission number. The letter will indicate, if applicable, the date the product is eligible to receive an exemption (180 calendar days from the issuance date of the Application Acceptance Letter). You will be required to submit a completed Fax-Back Form provided by Health Canada on its website, to opt in or out of this exemption. You will have up to 60 calendar days from the eligibility date to respond. If you do not respond within the 60 calendar day time frame, Health Canada will take this to mean that you do not want your product to be included in the exemption.

5. How and when will I know if my product is eligible for an exemption number for applications which have not yet been submitted?

For applications submitted to NHPD during the 30 month period of the NHP-UPLAR, all Application Acceptance Letters will include information regarding:

• if the product is eligible for an exemption;
• what the exemption number would be for that product;
• the date on which the product would be eligible for an exemption;
• what is needed to apply for an exemption
• the fact that a complete Fax-Back Form must be submitted up to 60 calendar days from the eligibility date

Alternatively, applicants can provide a completed Fax-Back Form with new applications in order to pre-emptively opt-in so that if the application does remain at NHPD for 180 calendar days, the exemption number would become valid in the Exempted Products Database automatically on day 180. This Fax-Back-Form will be available on the NHPD website.

6. If I decide to pre-emptively opt-in to receive an exemption for an application that has not reached the eligibility date, when will the exemption become valid?

The exemption becomes valid the day the exemption number for the application is posted on the Health Canada website on the Exempted Products Database. The exemption number would become valid in the database automatically on day 180.

7. Do I have to apply for an exemption number after the 180 calendar days has passed?

To receive an exemption number you need to opt in to the NHP-UPLAR, either pre-emptively, or after the 180 days has passed. You will be required to submit a completed Fax-Back Form provided by Health Canada on its website, to opt in or out of this exemption. You will have up to 60 calendar days from the eligibility date to respond. If you do not respond within the 60 calendar day time frame, Health Canada will take this to mean that you do not want your product to be included in the exemption.

8. I submitted a product licence application (PLA) but my PLA was withdrawn or refused. Is my product still eligible for an exemption number?

No. PLAs which have been withdrawn or refused are not eligible for an exemption number. Only PLAs which have received a submission number and after 180 calendar days of receiving this number are still with Health Canada for a final licensing decision may be subject to the exemption.

9. When does the clock start for the 180 calendar days?

The clock starts after a complete PLA has been submitted to NHPD (i.e., all of the information as required in Section 5 is present) and NHPD has issued a submission number to product licence applicants.

10. Does the clock start ticking on the 180 calendar days when the Natural Health Products (Unprocessed Product Licence Applications) Regulations (NHP-UPLAR) come into force?

No. The clock starts ticking when a complete PLA is submitted (i.e., all of the information in Section 5 is present) and NHPD has issued a submission number to product licence applicants. For example, if a submission number was received on March 1, 2010, and the NHP-UPLAR come into force on September 1, 2010, 180 calendar days will have passed.

11. If I do not want my product to get an exemption number, can I sell it?

If you choose not to get an exemption number, you will need to wait until you get a product licence to sell the product.

12. My product meets one of the outlined criteria so it is not eligible for an exemption number. When will my product licence application (PLA) be reviewed?

NHPD will prioritize those PLAs which are not eligible for an exemption. A risk-based approach to the review of all applications will be used.