Questions and answers - end of the natural health products unprocessed product licence applications regulations

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Over the past year, Health Canada has been consulting on and rolling out a new approach to natural health products (NHPs). The approach introduces new policies and process improvements to expedite application review and focus evaluation efforts on complex applications.

Ultimately, it provides a stable, predictable regulatory environment.

In August 2010, the Government introduced the Natural Health Products (Unprocessed Product Licence Applications) Regulations (NHP-UPLAR), a temporary set of regulations that allowed lower risk products that meet safety and efficacy requirements to be legally sold (and labelled with exemption numbers (ENs)) while awaiting full review. The NHP-UPLAR was intended to be a temporary measure for dealing with the large number of unprocessed applications that followed the introduction of the Natural Health Products Regulations in 2004.

As planned, NHP-UPLAR will no longer be in effect as of February 2013. These regulations are no longer needed because changes to NHP licensing processes enable the majority of decisions to be made within 180 days or less. This means that no new ENs for NHPs will be issued, and that Health Canada will be transitioning toward the requirement that all NHPs sold in Canada have natural product numbers or NPNs, or Homeopathic Medicine Number (DIN-HM) on the label.

Health Canada has developed a transition plan--using key input from stakeholders--that provides time for companies to make necessary adjustments to business practices and/or phase out products that are not in compliance.

For more information on the implications of the repeal of NHP-UPLAR and the transition plan, please see the following questions and answers.

Questions and answers

• 1. What is the Natural Health Products Unprocessed Product Licence Applications Regulations and why was it introduced?
• 2. Why is the Natural Health Products Unprocessed Product Licence Applications Regulations being repealed?
• 3. What is Health Canada doing to prevent another backlog of applications?
• 4. What happens to natural health products that were issued exemption numbers under the Natural Health Products Unprocessed Product Licence Applications Regulations?
• 5. How can someone determine if a natural health product which was issued an exemption number is now licensed?
• 6. Does the repeal of the Natural Health Products Unprocessed Product Licence Applications Regulations change Canadians' access to natural health products?
• 7. What impact does the new approach have on safety?
• 8. What impact does the repeal of the Natural Health Products Unprocessed Product Licence Applications Regulations have on advertising?

Compliance and enforcement

• 9. Will there be a change to Health Canada's compliance and enforcement approach for natural health products after the repeal of the Natural Health Products Unprocessed Product Licence Applications Regulations?
• 10. What is Health Canada's plan after the repeal of the Natural Health Products Unprocessed Product Licence Applications Regulations?
• 11. What will be the transition period for compliance and enforcement?
• 12. What actions must companies take as a result of the repeal of the Natural Health Products Unprocessed Product Licence Applications Regulations?

1. What is the natural health products unprocessed product licence applications regulations and why was it introduced?

Natural health products (NHPs) are regulated under their own specific regulations, the Natural Health Products Regulations (NHPR), which take into account the unique nature and properties of these products.

These regulations came into effect in 2004 and have been in use ever since. They outline the requirements for the legal sale of NHPs in Canada.

When these regulations came into effect, they captured a large number of products that were already on the market and needed to be licensed. This created an immediate large number of unprocessed applications.

To address this, in August 2010, the Government introduced a temporary set of regulations called the Natural Health Products (Unprocessed Product Licence Applications) Regulations (NHP-UPLAR).

NHP-UPLAR provided a short-term way for products to be legally sold when Health Canada had not completed its licensing decision within 180 days.

2. Why is the natural health products unprocessed product licence applications being repealed?

The natural health products unprocessed products applications regulations (NHP-UPLAR) was always intended as a short-term way for products to be legally sold when Health Canada had not completed its licensing decision within 180 days.

NHP-UPLAR will no longer be needed because the Government has introduced a new approach to the regulation of NHPs which focuses on reducing red tape and increasing consumer access to safe and effective products.

From now on, the expectation is that product licensing decisions will be made in 180 days or less.

The unprocessed applications which NHP-UPLAR was designed to address will be completed by February 2013.

3. What is Health Canada doing to prevent another backlog of applications?

The Government has introduced a new approach to NHPs which provides a stable, predictable regulatory environment.

The new approach introduces new policies and process improvements to expedite application review and focus evaluation efforts on complex applications.

These changes are complemented by newly revised guidance on the requirements and pathways for licensing NHPs. The Department is also developing a new approach to site licensing focused on greater quality assurance for products.

These changes and other ongoing process improvements provide a stable, predictable approach for the efficient processing of applications.

For more information see: A new approach to natural health products.

4. What happens to NHPs that were issued exemption numbers under the natural health products unprocessed product licence applications regulations?

With the repeal of the natural health products unprocessed product applications regulations (NHP-UPLAR) in February 2013, new Exemption Numbers (ENs) will no longer be issued.

Health Canada has a transition plan to enable industry to phase-out products that do not meet the current requirements including products that bear an EN.

5. How can someone determine if a natural health product which was issued an exemption number is now licensed?

Canadians can identify natural health products (NHPs) that have undergone a full assessment for safety, efficacy and quality and been authorized for sale (licensed) in Canada by looking for the Natural Product Number (NPN) or Homeopathic Medicine Number (DIN-HM) on the label.

Canadians can identify NHPs that have been licensed by searching the Licensed Natural Health Products Database.

Canadians can identify NHPs which were issued an Exemption Number (EN) and are now licensedby searching the  Exempted Products Database. A product that had an EN and now is licensed will have the status "Licence Issued" and the NPN or DIN-HM will be provided. These products will also now appear in the Licensed Natural Health Products Database.

The Exempted Products Database will remain operational during the transition phase which means that Canadians may continue to search for products that were issued an EN, although no new products will be added as of the date of the natural health products unprocessed product licence applications regulations (NHP-UPLAR) repeal.

6. Does the repeal of the natural health products unprocessed product licence applications regulations change Canadians' access to natural health products?

The repeal of the natural health products unprocessed product licence applications regulations (NHP-UPLAR) does not change Canadians' access to NHPs. Companies wishing to sell NHPs will continue to apply for licences under the Natural Health Products Regulations.

The difference is that Health Canada is implementing a new approach that provides a stable, predictable regulatory environment. Under this approach, processes have been streamlined and new policies and tools have been introduced.

7. What impact does the new approach have on safety?

Safety remains a top priority. The policies under the new approach do not change the measures in place to protect consumer safety. The level of evidence required to demonstrate safety remains the same, and products will continue to be labelled with required cautionary statements.

Companies are still required to submit reports of serious adverse reactions (ARs). This will not change. Health Canada will continue to collect, monitor, and analyze ARs to NHPs through the Canada Vigilance Program. Health Canada is developing new tools for monitoring NHP ARs in the Canada Vigilance database.

8. What impact does the repeal of the natural health products unprocessed product licence applications regulations have on advertising?

Guidance on the impact of the repeal of the natural health products unprocessed product licence applications regulations (NHP-UPLAR) on advertising will be released shortly.

Compliance and enforcement

9. Will there be a change to Health Canada's compliance and enforcement approach for natural health products after the repeal of the natural health products unprocessed product licence applications regulations?

The end of the natural health products unprocessed product licence applications regulations (NHP-UPLAR) does not signal an immediate change in compliance and enforcement for natural health products (NHPs).

Compliance and enforcement efforts will continue to be risk based. Health Canada's focus will continue to be on those products for which steps have not been taken to bring them into compliance and/or that pose a higher risk to consumers.

However, the expectation is that, following the transition period, all products will have an Natural Product Number (NPN) or Homeopathic Medicine Number (DIN-HM).

10. What is Health Canada's plan for after the repeal of the natural health products unprocessed product licence applications regulations?

Health Canada will provide a transition period - developed using key input from stakeholders - that provides time for companies to make necessary adjustments to business practices and/or to phase-out products that are not in compliance. Health Canada consulted on the transition period during the November 2012 sessions on the New Approach to Natural Health Products (NHPs) held across Canada.

Work will continue with industry to raise awareness of the regulations and how to be in compliance with them.

11. What will be the transition period for compliance and enforcement?

There will be an 18 month transition period.

The first 9 months of the Transition Period (March 1, 2013 - November 30, 2013) will focus on compliance promotion:

• During this time, Health Canada will work to enhance awareness of the Natural Health Products Regulations, so that companies have what they need to understand and comply with the Regulations.

• Companies may use this time to plan and prepare for phasing out of distribution their non-market authorized products.

• Unless a risk to health or additional non-compliances are identified, the following products will be a lower priority for enforcement at all levels of the distribution chain:
  • NHPs that have an active submission number with the Natural Health Products Directorate (NHPD); and
  • Approved NHPs that have undergone minor modifications during the licensing process which are not yet reflected in the current labelling.

During the following 9 months of the Transition Period (December 1, 2013 - August 31, 2014):

• At the retail level only, the phasing out of any non-market authorized product can continue. Products that have an active submission number with the NHPD or products that have undergone minor modifications which are not reflected in the current labelling, will be considered a lower priority for enforcement, unless a risk to health or additional non-compliances are identified; and
• At the importation and manufacturing level, NHPs will be expected to have market authorisation and respect the terms of their market authorisations, including formulation and labelling.

Following the transition period (September 1, 2014), the expectation is that all NHPs will have an NPN or DIN-HM before coming onto the market, and respect the terms of their market authorisation.

12. What actions must companies take as a result of the repeal of the natural health products unprocessed product licence applications regulations?

There will be an 18 month transition period.

During the first 9 months of the Transition Period (March 1, 2013 - November 30, 2013):

• companies should review their product(s) status and supply and should start phasing out products without market authorisation and authorised product with old, non-compliant formulations, labelling or packaging; and
• companies should review their practices and prepare to ensure that only compliant products will be manufactured and imported by the end of the first 9 months of the Transition Period.

During the following 9 months of the Transition Period (December 1, 2013 - August 31, 2014):

• companies can continue to phase out products at the retail level that do not have market authorization, or products with old, non-compliant formulations, labelling or packaging.
• companies must not manufacture or import non-compliant products.

Following the transition period (September 1, 2014):

• companies must only import, manufacture and sell NHPs with a market authorisation and respect the terms of their market authorisation.