SPECIAL ALERT: NHP Compliance and Enforcement Transition: Phase I ending December 1, 2013

November 8, 2013 By

dicentra Special Alert

November 8, 2013

Phase I of the NHP Compliance and Enforcement transition period is ending December 1, 2013. Companies have been advised to ensure that they are familiar with and in compliance with the Regulations.

In order to legally sell natural health products (NHPs) in Canada, you must have an NPN. However, there is currently an NHP compliance and enforcement “transition period” that allows products that have not received their market authorizations to be sold without being subject to enforcement actions.

From now until December 1, 2013 the Inspectorate will allow manufacturers, packagers, labellers, and importers of NHPs to sell their products without taking enforcement action if it meets the following criteria:

  • The product has a submission number (indicating that you filed a product license application)
  • The product is manufactured and/or imported through a Site Licensed facility
  • The product is not considered high risk (examples of high risk products are those indicated for children or pregnant women, or products that contain ingredients that have been the subject of recalls in the past)

As of December 1, 2013, all manufactured and imported products should have their NPNs and may be subject to enforcement action if they do not. From December 1, 2013 to September 1, 2014, products without an NPN can continue to be distributed and/or sold at retail without an NPN if they meet the above criteria. After September 2014, all products on the market must have an NPN in order to be legally sold.

As we are nearing the December 1 deadline it is advisable to manufacture, package, label and import your NHPs such that they meet the above criteria. While the Inspectorate has assured the industry that there has been no change in their NHP Compliance and Enforcement Policy and enforcement will continue to be risk based, they have indicated that actions will be focused on all activities including the supply chain. Additionally, enforcement will be based on whether a company has tried to come into compliance (i.e. do they have an application in queue for assessment).

dicentra can assist you with filing your product license applications, site license applications and conduct label reviews to ensure you are in compliance with the regulations. Additionally, to help ensure a smooth process at the border dicentra offers importation services through their site license.

dicentra provides sought-after regulatory and scientific guidance on product and marketing compliance, quality assurance, research and development, new ingredient assessments and overall regulatory strategies for health-related products sold in North American marketplaces. We can be reached at 1-866-647-3279 or info@dicentra.com.