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NHPD

Natural and Non-prescription Health Products Directorate · nnhpd · natural health products directorate · natural and non-prescription health products directorate

In short

The Health Canada directorate that licenses Natural Health Products, Site Licences and enforces Part 3 NHP GMP.

The Natural and Non-prescription Health Products Directorate (NNHPD, originally the Natural Health Products Directorate / NHPD) is the Health Canada branch responsible for the pre-market and post-market regulation of Natural Health Products under the Natural Health Products Regulations (SOR/2003-196). NNHPD issues Product Licences (NPN, DIN-HM), issues Site Licences for manufacturers, packagers, labellers and importers, maintains the public monographs that drive Compendial (Class I) and Traditional (Class II) submissions, and inspects Canadian sites for Part 3 GMP compliance through the Health Canada inspectorate using guidance document GUI-0048.

The directorate's posture is a three-class risk pyramid. Class I monograph-matched submissions clear in 60 days because NNHPD has already pre-decided the safety/efficacy question through the monograph. Class II traditional-use submissions in 90 days. Class III non-traditional submissions through full evidence review in 210 days or more. NNHPD operates the Licensed Natural Health Products Database (LNHPD) and the Licensed Site Database — both public, both checked by buyers and partners before commercial relationships are formed.

In V5 the NNHPD-issued NPN and Site Licence form the spine of the Canadian regulatory record: licence renewal dates, Quality Assurance Report (QAR) currency, monograph references for compendial products, and the GUI-0048 inspection history all sit on one SKU and site spine, so a renewal lapse or a monograph update does not silently put a saleable product out of compliance.

Regulatory anchors
  • NHPR SOR/2003-196
  • Health Canada GUI-0048
Where this term comes up
Dietary Supplements
How V5 handles it
Document control — one version in force, every change signed and explained.
Draft the next revision while the current one stays in use, approve it under your sign-off route, and track training on it — with the history kept.
QMS — quality records next to the work they concern.
Deviations, corrective actions and quality review sit in the same system as production, so each quality record references the work order, step and lot it concerns.
Related terms
NPN
Software that covers NHPD
V5 Ultimate (GMP)
V5 Ultimate is a full-lifecycle GMP platform for US and international manufacturers — cGMP under 21 CFR 210/211, EU GMP Parts…
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