By: Ashleigh Hampton, MSc, Scientific & Regulatory Affairs Associate
January 23, 2012

You’ve developed an innovative natural health product, compiled the full submission for a Product License Application and thought you were almost at approval when you receive a Notice of Refusal (NR) for the application. You think this isn’t possible – there was nothing wrong with the submission and it is possibly that you are correct. It is important to note that not all refusals are justified and that you are able to request that the Natural Health Products Directorate (NHPD) re-evaluate a decision made on an application or amendment to a license.

The NHPD has a team of highly qualified scientific evaluators to review your files. Occasionally, the evaluators may interpret the provided information incorrectly and thus, issue an unjustified NR outlining the potential deficiencies on which the regulatory decision was based. When this happens, the NHPD allows us to file a request for reconsideration of decision so they can re-evaluate the provided evidence in a new light and make a final regulatory decision.

The request for reconsideration of decision must be filed in writing within 30 calendar days from the date the NHPD issued the NR. Upon receipt of the request for reconsideration, the NHPD will issue an acknowledgement letter indicating that you will have 20 calendar days to submit a detailed document outlining your rationale as to why the refusal is unjustified. It is important to note that only originally provided material (i.e. in the submission and in the response(s) to Information Request Notice(s)) can be referenced in the request for reconsideration of decision. Newly provided evidence submitted along with the request will not be accepted.

A new reviewer will review the reconsideration package and corresponding file and come to a final regulatory decision which will be approved by the Director General. If the NHPD agrees that the refusal was not justified, the application will receive a reinstatement notice or a product license. However, if the NHPD agrees that the refusal was in fact in order, then a final NR will be issued to the applicant.

It is important to note that if your product held a valid Exemption Number (EN) at the time the refusal was issued, the EN will not be valid during the reconsideration process. The EN will become valid once a reinstatement notice has been issued.

dicentra offers a full range of scientific support to help you determine whether your NR is in fact justified. Our team of experts can assist you in compiling a reconsideration package and successfully have your application reinstated into the queue and/or licensed. If you have any questions or concerns about your applications and/or newly issued NRs please contact our experts at dicentra.

For additional information on the NHPD’s reconsideration process please refer to the following Guidance Document:

Reconsideration Process – available at:

http://www.hc-sc.gc.ca/dhp-mps/prodnatur/legislation/docs/reconsid-eng.php.
Released October 2008.

dicentra provides regulatory and scientific solutions for accelerated business growth. We specialize in the areas of natural health products, dietary supplements, foods, cosmetics and OTCs. We can be reached at 1-866-647-3279 or at dicentra.com