Questions and Answers on Labelling and Posting Information to the Health Canada Website

November 2010

1. If my product is eligible for the exemption, what will the exemption number look like?
2. Do I have to list my exemption number on my natural health product (NHP) label?
3. What information will be shown in the exempted products database on the Health Canada website?
4. Can I get an exemption number for my product but not have my information posted to the Health Canada website?
5. How long do I have to add the exemption number to my product?
6. Can I add the exemption number to my product as soon as I have sent the forms to Health Canada to opt in to the Natural Health Products (Unprocessed Product Licence Applications) Regulations (NHP-UPLAR)?
7. If I make a change to my exempted natural health product (NHP) which results in changes to the labelling, do I have to make the label changes immediately?

1. If my product is eligible for the exemption, what will the exemption number look like?

Your exemption number will be the prefix "EN" followed by the submission number you were issued by way of a Submission Receipt Acknowledgement Notice or Application Acceptance Letter from NHPD.

2. Do I still have to list my exemption number on my natural health product (NHP) label?

Yes. Exemption numbers must be on NHP labels to allow for clear communication regarding the status of your product with consumers, health professionals and retailers.

3. What information will be shown in the exempted products database on the Health Canada website?

The exemption number, brand name(s) of product, company name, and status of exemption will be shown. The status will read "valid" or "not valid" or "licence issued (8xxxxxxx)":

• Valid - This Exemption Number is in good standing
• Not valid - This Exemption Number is no longer valid
• Licence Issued (8xxxxxxx) - The Exemption Number is no longer valid. The natural health product has been approved by Health Canada and has been issued licence number 8xxxxxxx

4. Can I get an exemption number for my product but not have my information posted to the Health Canada website?

No. The information must be posted to the Health Canada website to allow the NHP stakeholders, including consumers, health professionals and retailers, to know which products have received exemption numbers. This is a requirement for obtaining the exemption.

5. How long do I have to add the exemption number to my product?

Once a company chooses to opt in to the exemption, the exemption number must be added to the product label within a reasonable time period.

6. Can I add the exemption number to my product as soon as I have sent the forms to Health Canada to opt in the Natural Health Products (Unprocessed Product Licence Applications) Regulations (NHP-UPLAR)?

No. The exemption takes effect upon posting of the exemption number, status of exemption, brand name(s) of product, and company name on the Health Canada website.

7. If I make a change to my exempted natural health product (NHP) which results in changes to the labelling, do I have to make the label changes immediately?

An exemption number is granted based on the information provided by the applicant to the Natural Health Product (NHPD) in the PLA form. If an exempt NHP is being marketed, it is required to be consistent with the information for which the exemption number has been granted.

Should the exemption number holder wish to make changes to the exempt product, only those considered to be notifications as outlined in section 12 of the NHPR are acceptable for exempt NHPs. These include changes that do not impact the safety, efficacy and/or quality of the product and include:

• The company information as required by section 5(a) or (b)
• The site information as required by section 22 of the NHPR
• The addition or substitution of a non-medicinal ingredient that does not affect the safety or efficacy of the product
• The brand name of the product
• The common or proper name of any of the medicinal ingredients
• The addition of risk information

If any of the above changes are made to an exempt NHP, exemption number holders should consult NHPD's Post-Licensing Guidance Document for information on how to submit a noitification to NHPD. Rather than referencing the NPN or DIN-HM, the exemption number holder would reference the exemption number. The exemption database would be updated accordingly. It is also possible for applicants to contact their NHPD submission coordinator associated with the PLA with any questions of clarification surrounding these types of changes. This notification should take place as soon as possible, but is required within 60 days of making the change to a marketed exempt NHP.

Changes initiated by the applicant and considered to be amendments as per section 11 of the NHPR are not acceptable for exempt NHPs. These include but are not limited to: changes to the recommended use or purpose, the recommended dose or duration, removal of risk information, changes to product specifications, among others. These changes may have an impact on the safety, efficacy or quality profile of the NHP and may significantly impact the assessment of information for which the exemption number has been granted. Refer to the Post Licensing Guidance Document for more information. An exempt NHP may be subject to compliance and enforcement actions if the product being marketed differs from the PLA for which the exemption number was granted, in relation to any of the changes considered amendments as outlined above.

It is important to note that during the course of the PLA review by the NHPD following assignment of an exemption number, NHPD may request changes to the PLA as part of the licensing process. In some instances, NHPD may request changes that have an impact on the safety, efficacy or quality profile of the NHP. In these cases, if a risk to health is identified with the original exempt NHP and the NHP is being marketed, the marketed NHP may require risk management actions be taken, such as a product recall and relabeling, to come into compliance and be consistent with the new PLA information. These actions are based on the level of risk associated with the marketed product and in accordance with the NHP Compliance and Enforcement Policy.

Labelling of the exemption number on the product label must be done within a reasonable period of time. Health Canada interprets this to mean the lesser of the next label run or 12 months. Compliance with this part is of benefit to the regulated party as well as to consumers to help identify products that have obtained an exemption number. Non-compliance with this section of the NHP-UPLAR is considered to pose a lower risk to health and is a lower priority for compliance and enforcement actions by the HPFBI.