NHP Management of Applications Policy Updates
By: Sarah Calder, Regulatory Affairs Specialist, email
In late April, the Natural and Non-Prescription Health Products Directorate took part in a series of webinars informing industry of the updates and ongoing challenges facing the NNHPD.
The webinars included material on the newly released Management of Applications Policy and a review of the current challenges with natural health product (NHP) licence applications.
The most significant update was the revision of some of NNHPD’s service standards for the regulatory screening and assessment of applications. The current service standards for the review of NHP applications by classification are:
- Class I = 60 calendar days
- Class II = 90 calendar days
- Class III = 210 calendar days
Additional points of interest include:
- New requirement for the web-based product licence application form – Applicants must first register their company with NNHPD and will receive a 5-digit code which must be used to submit a product licence application.
- As of June 1, 2019 – paper and scanned product licence applications will no longer be accepted, by the NNHPD.
- Fall 2019 – the only acceptable means of filing for a Natural Product Number (NPN) will be the new web-based product licence application form.
- Monograph updates – Licencees which attest to monographs are required to align products when changes to those monographs occur. Licence holders have 3 years, until the next label run, or any other post-licensing change to bring their products into line.
Need help on understanding the new requirements for natural health product licence applications or are you struggling with the classification of your natural health product?