Importance of Discontinuing Natural Health Product Licences for Site Licence Holders 

The site licensing process for Natural Health Products has seen Health Canada making regular improvements to their review process and expectations. This affects the comments and questions Health Canada provides in response to any GMP documents submitted to them, as well as the responsibilities they expect Quality Assurance Persons to fulfill when maintaining a site licence for Natural Health Products. 

What are some recent changes Health Canada has made? 

One improvement Health Canada has made is to their Natural Health Product database, which now allows for listing the ‘market status’ of a product licence and includes this information in the NHP database. 

They are asking Quality Assurance (QA) Persons to pay attention to the market status of the product licences they currently work with or for which they act as the product licence holder. If there is a specific NPN or formulation they are no longer working with, Health Canada asks that updates be sent in the form of a discontinuation request. This can be seen as a routine responsibility a QA Person must perform in maintaining GMP and GDP. It also benefits site licence holders, as it encourages companies to ensure their documents and templates are kept up to date. 

Who can submit a discontinuation request? 

The request must come only from the Senior Official of the company, or someone formally acting on their behalf with an approved Designated Party Authorization (DPA). Any requests from unauthorized personnel will not be processed. To ensure the process goes smoothly, requests should be submitted from the Senior Official’s email address as registered with Health Canada. 

The request must include specific information and be sent via email to the NNHPD Client Service Unit at: nnhpd-dpsnso@hc-sc.gc.ca 

Your letter must be on official company letterhead, signed and dated by the Senior Official, and must include: 

• The list of NPN(s) or DIN-HM(s) you wish to discontinue. 

• The associated submission number(s). 

• The brand name(s) under which those products are licensed. 

NNHPD will aim to process the request within 15 calendar days and will update the Health Canada Licensed Natural Health Products Database (LNHPD) status from “Active” to “Discontinued.” Once a licence is discontinued, it cannot be reactivated. To sell the product again in the future, a new licence application will be required. 

For any product licences that are out of date or obsolete, going through this process allows Health Canada to prioritize their focus on active product licences and formulations. 

Why is this important for site licence holders? 

It is important for site licence holders to maintain an updated list of the products they work with. This will demonstrate to Health Canada that the Quality Assurance Persons at your company are keeping up to date with the documentation requirements needed to show compliance. Additionally, it will provide a clear internal resource that can be referenced whenever regulatory questions arise. 

Taking steps to maintain the Quality Management System at your company will ensure that the only documents being used and updated are those related to active product licences. 

Dell Tech holds a site licence to act as your importer of record for Natural Health Products. Contact us today for more information about importation, site licensing, and quality assurance. 

DELL TECH HAS PROVIDED PROFESSIONAL, CONFIDENTIAL CONSULTING SERVICES TO THE SPECIALTY CHEMICAL INDUSTRY IN CANADA, THE USA, EUROPE AND ASIA FOR THE LAST 40 YEARS.