On February 14th, 2018, the NNHPD held a one-day technical session in Ottawa seeking input from the Health Products Associations’ members about updates to the Natural Health Products’ Management of Applications Policy (NHP MAP) that the NNHPD was suggesting. There are six areas of the NHP MAP that the NNHPD are intending to revise, with the aim of the technical session being to help the industry understand what these changes are, to receive feedback from industry on what barriers may arise and the impact the implementation of these updates may have.
- The first topic brought forward by the NNHPD related to post-licensing (Amendment/Notification) application requirements for Class 1 applications. The current policy for Class 1 applications is when the changes being made fall within monograph parameters that the application was attesting to, no amendments or notifications were required, as the product license would already be authorized as it contained the statement “as authorized in the NNHPD monograph(s) to which the applicant attested”. However, the NNHPD was finding that without these amendments and notifications, they had incorrect or out-of-date contact information and that there was a high level of attestation failures relating to the licensing condition. Thus, the NNHPD is proposing that all Class 1 applications require amendments and notifications (as outlined in the NHP Regulations) to notify Health Canada of any post-licensing changes being made, including contact information updates. The future web-based PLA Notification will be utilized for these post-licensing changes and is expected to be released when the revised NHP MAP is finalized.
- The second topic discussed how the NNHPD has been having to issue a high volume of Information Request Notices (IRNs) within a single application, how they rarely exercise their right to refuse applications via the issuance of “Rejection Notices”, and the high number of attestation failures for Class 1 applications. The proposed changes by the NNHPD to address these inefficiencies included having a comprehensive list of refusal criteria and application deficiencies (with “Rejection Notices” being renamed “Notices of Refusal”). As well, the NNHPD is aiming to limit the number of IRNs issued to a maximum of two per application and instead of allowing only two business days to respond, allowing for responses within five business days.
- Timeline service standards for Product Licensing and “Statements to the Effects of” (STTEO) were the third topics discussed. Currently, the timelines for review are 10 days for Class 1 applications, 30 days for Class 2 applications and 210 days for Class 3 applications. The NNHPD has found that there is a high failure rate with the attestation process which necessitates a manual screening process for Class 1 applications. A major source of the attestation failures is the subjective nature of the STTEO phrases. In addition, the lack of a quality control process prior to licensing meant inaccurate licenses were being issued. The changes that Health Canada proposed were to eliminate STTEO phrases in Class 1 applications, the introduction of a quality control function to ensure product licenses are free of administrative error and to necessitate revised review timelines with Class 1 applications now having a 60 day standard (with an internal target of 30 days) and Class 2 applications having a 90 day standard (with an internal target of 45 days).
- The fourth topic discussed the results of Health Canada’s Compliance Monitoring Project and the issues uncovered at the NHP manufacturing and importing sites that were monitored. As a result, the NNHPD has an interest to once again assess quality at the pre-market stage to prevent quality issues down the line. The NNHPD’s brainstorming is at the preliminary stages; they asked for guidance from the attending industry associations on what role(s) they played and their thoughts on the NNHPD’s previous pre-market approval process.
- The fifth topic discussed was the electronic system improvements that the NNHPD is aiming to have implemented in 2018 with a PLA Notification Form launching in the Spring of 2018 and the web-based PLA form launching in August 2018. While currently the use of the ePLA is not mandatory, after a short transition period, the new forms will become mandatory and the NNHPD will only receive electronic applications going forward.
- The sixth and final topic discussed was the NNHPD’s goal to clarify the requirements, processes and service standards for specialized processes such as Master Files, Access Letters, Natural Product Number (NPN) transfers, company mergers, the addition of ingredients to the NHP Ingredient Database (NHPID), requesting updates about the status of applications, and submitting Product License Correction Requests. The NNHPD has confirmed that these processes will align with the upcoming mandatory electronic tools when they become functional.
This technical session was of great benefit for the NNHPD to understand the perspective of the industry and the impact of their suggested revisions to the Management of PLAs for NHPs. The NNHPD is now evaluating the feedback received and applying it to prepare a draft policy to provide all stakeholders. The current timeline is for the NNHPD to have this draft policy out for public consultation with a 30-day written feedback period (though a longer feedback period was suggested by attending stakeholders) at the end of April 2018 followed by the anticipated final policy in September 2018.
dicentra is a professional consulting firm that specializes in addressing all matters related to safety, quality and compliance for all product categories in the life sciences and food industries. We can be reached at 1-866-647-3279 or email@example.com. dicentra’s extensive expertise in the realm of natural health products (NHP’s) stems from 16 years of experience in the industry where strong foundations and relations were built both with parties in the industry as well as with regulatory agencies such as Health Canada. With these sustained relationships and knowledge gleamed from them, dicentra has been very successful in licensing even the most challenging of natural health products and ensuring that sites that manufacture them are up to regulatory standard. dicentra can assist with the product and site licensing of your natural health product to ensure that it can be sold in the Canadian market compliantly.