An update from NNHPD – Release of new web PLA form version 4Published on June 22, 2020
Author: Bhavesh Patel
Quick Facts about Natural Health Products in Canada:
- Health Canada regulates natural health products (NHPs) so that Canadians can have confidence that the products they use are safe, effective and of high quality.
- Health Canada is committed to regulating NHPs under the Natural Health Products Regulations, which means NHPs are not subject to non-prescription and prescription drug requirements.
- Labels are an important tool to assist Canadians in making informed health choices when selecting and using NHPs.
- Health Canada is proposing amendments to the Natural Health Products Regulations, to make NHP product labels easier to read and understand. These proposed changes support consumers in selecting and safely using NHPs.
The Natural and Non-prescription Health Products Directorate (NNHPD) has introduced the release of version 4 of the web-based Natural Health Product Licence Application (web PLA) form.
NHP License Application web-based Form overview:
- The web-based Product Licence Application (web PLA) form is the main component of any natural health product licence submission package. It is designed to be completed online and saved at any time to your workstation. Through an active internet connection, the web PLA form searches and populates data from the Natural Health Products Ingredients Database (NHPID).
- Version 4 or greater includes new features and functions including in-form real-time validation of compendial (class I) applications, enabled by the Natural and Non-prescription Health Products Directorate (NNHPD)'s new monograph validation service.
- Each page of the form also includes links to specific sections of this user guide for quick access to information on how to successfully complete the web PLA form.
This new version builds on the successes of version 3 and includes several new features and functions, most notably, an in-form compendial (class I) validation. Supported by the NNHPD’s new monograph validation engine, compendial (class I) applications are validated prior to finalization to ensure that the product, as it is represented in the form, fully complies with the specified monograph.
Below is a summary of what is new and improved with version 4:
- Compendial (class I) monograph validation
- New Class I-III identification field and related form restrictions
- More precise population of monograph information
- New standard dosage unit information section
- Enhanced ingredient logic and form functions for the medicinal ingredient sections
- New dose and dosage calculations table
- Improved sub-population section with new fields and form flow
- Built-in guidance at each step of the way for users
Currently, 159 monographs are validation-ready, with dozens more soon to follow. The list of validation-supported monographs can be found on the web PLA landing page. Given that the full suite of monographs is not yet validation-ready, applicants will still have access and be able to use web form 3.0 while work continues on the remaining monographs. At this point, our estimate is that web form 3.0 will remain until January 2021.
Applicants may begin using the web PLA form version 4 for all new product licence applications including class II and/or III submissions, as well as homeopathic submissions. The NNHPD will continue to accept submissions using the ePLA pdf form given current limitations with the Amendment and Notification form. For clarity, the pdf form should not be used for new product applications, as either web form 3.0 or 4.0 will be usable for all new product applications. As of today, the pdf form will only be accepted for amendments or notifications for existing product licences.
While version 4.0 of the web form represents significant progress, it is important to note that:
- The validation engine will not validate that an application package is complete, as other documents are needed beyond the form (such as finished product specifications or a designated party authorization form).
- There is certain information in the form that will not be validated electronically, specifically brand name, non-medicinal ingredients and quality information. These will continue to be verified by NNHPD staff.
- Once the form is complete, applicants will still need to submit their complete submission package through ePost.
During the first week of July, NNHPD is planning to host webinars for associations and licence holders. More details will follow by email in the coming weeks.
This major system modernization initiative aimed to bring significant improvement in users’ experience with our NHP application system, program efficiencies in managing and processing these applications, and improve our ability to meet our performance standards thereby providing greater predictability to industry. For Canadians, it will ensure that licensed NHPs continue to meet all safety and efficacy requirements. This system was built in a way that provides scalability. As such, it will serve as the foundation to support the implementation of the simplified pathways for non-prescription drugs, as proposed under the Self-Care Framework.
Health Canada’s website has been updated with information on the NHP Online System available at: https://www.canada.ca/en/health-canada/services/drugs-health-products/natural-non-prescription/applications-submissions/online-solution.html. From this page, you will be able to access information about our electronic tools. Updates to the “Frequently Asked Questions” web page will be web published in the coming week. In the interim, this information is available in the attached document: Natural Health Products Online System: Additional Information.
As for questions related to product licensing, any questions regarding the new web form can be submitted to our Client Services team via email (firstname.lastname@example.org). To facilitate triaging and timely responses from NNHPD, please include a subject line that clearly indicates the inquiry is related to the new web form.
Health Canada: What's new: Natural and non-prescription health products, June 2020:
Health Canada: Natural Health Products:
Pragmatic Clinical Trials: Testing Treatments in the Real-World
What is a Pragmatic Clinical Trial? Clinical trials can be designed to be either pragmatic or explanatory. Explanatory trials are designed to find out whether a treatment...
The FDA Announces Proposed Rule: Nonprescription Drug Product with an Additional Condition for Nonprescription Use – June 28, 2022
The FDA is announcing the availability of the proposed rule Nonprescription Drug Product with an Additional Condition for Nonprescription Use (Docket No. FDA-2021-N-0862)....