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Questions and Answers on Submission Numbers

November 2010

1. If I submit a product licence application (PLA) after the Natural Health Products (Unprocessed Product Licence Applications) Regulations (NHP-UPLAR) come into force, will my product get a submission number?
2. What does a submission number under the Natural Health Products Regulations (NHPR) mean?
3. What does it mean - submission numbers will be issued for administrative purposes only?
4. If I submit a product licence application (PLA) after Health Canada starts issuingsubmission numbers for administrative purposes only, can I sell my product before I receive a product licence?
5. A product licence application (PLA) is submitted in May, 2010, the product receives a submission number and is sold under the current Compliance Policy for natural health products (NHP).  What happens when the regulations come into effect? Can the product continue to be sold, or must a stop sale and recall be done until an exemption number is received? Is the submission number no longer valid after the regulations come into force?

1. If I submit a product licence application (PLA) after the Natural Health Products (Unprocessed Product Licence Application) Regulations (NHP-UPLAR) come into force, will my product get a submission number?

Yes. Health Canada will continue issuing submission numbers when the NHP-UPLAR come into force.  However, the submission number will only be issued for administrative purposes - i.e., to track product licence applications. Products that do not have a product licence or an exemption number may be subject to compliance and enforcement action.

2. What does a submission number under the Natural Health Products Regulations (NHPR) mean?

Currently, a submission number is provided to a product licence applicant when it is confirmed that the PLA contains the information set out in section 5 of the NHPR ("licence application"). Unless a risk is identified, under the current Compliance Policy for NHPs Health Canada does not take compliance and enforcement action against products which have received a submission number. As of the coming into force of the NHP-UPLAR, Health Canada will continue to issue submission numbers. However, these submission numbers will be issued for administrative purposes only - i.e., to track product licence applications. Products that do not have a product licence or an exemption number may be subject to compliance and enforcement action.

3. What does it mean - submission numbers will be issued for administrative purposes only?

Under the current Compliance Policy for NHPs, Health Canada does not take compliance and enforcement action against products which have received a submission number unless a risk to health is identified. Once a new Compliance and Enforcement Policy for NHPs is implemented, a product licence or exemption number will be required in order to sell a product; therefore compliance and enforcement action may be taken against any product without a product licence or exemption number.  Health Canada will acknowledge receipt of a complete product licence application submitted to the NHPD by way of an NHPD Application Acceptance Letter containing a submission number.

4. If I submit a product licence application (PLA) after Health Canada starts issuing submission numbers for administrative purposes only, can I sell my product before I receive a product licence?

No. When the new Compliance and Enforcement Policy for NHPs is in place you will need to wait until you get a product licence or an exemption number to sell the product. Once Health Canada starts issuing submission number for administrative purposes only, compliance and enforcement action may be taken against unlicensed products. 

5. A product Licence application (PLA) is submitted in May, 2010, the product receives a submission number and is sold under the current Compliance Policy for Natural Health Products (NHP). What happens when the regulations come into effect? Can the product continue to be sold, or must a stop sale and recall be done until an exemption number is received? Is the submission number no longer valid after the regulations come into force?

The submission number will still be valid once the Natural Health Products (Unprocessed Product Licence Applications) Regulations come into force. The submission number will be used by NHPD as a tracking number for the licence application and if an exemption is granted will form the basis for the EN number.  However, the new Compliance and Enforcement Policy for NHPs, which is proposed to be implemented concurrently with the regulations, will no longer recognize submission numbers as a lower enforcement priority. 

In addition, Health Canada is proposing a phased in approach to the new Compliance and Enforcement Policy for NHPs.  During the first six months (anticipated for August 2010 - Feb 2011) compliance and enforcement in response to unauthorized products (those without an EN, NPN or DIN-HM) will focus on compliance promotion and education.  Regulated parties who make an effort to come into compliance with the product licensing requirements will not be a high priority for enforcement unless their product poses a risk to health. Once the compliance promotion period has elapsed (anticipated February 1, 2011),products without an NPN, DIN-HM or exemption number will be subject to compliance and enforcement activities.  As such, a stop sale and recall would be required, as only products with product licences or exemption numbers could legally be sold.