NNHPD released the version 4.2.0 of the web-based Natural Health Product Licence Application (web PLA) form on May 10, 2021. The new feature in this version enables the validation of 31 additional monographs.
Please share your experiences with this new version with your CA Regulatory team at regulatory@cosmeticsalliance.ca.
Below is a summary of features and fixes that are new to version 4.2.0:
- New recommended use or purpose feature allows user to add medicinal ingredients to traditional claims,
- Fixed medicinal ingredient source information save function,
- Fixed Quantity Crude Equivalent unit of measure save function when a range is provided,
- New restricted list of solvents by application class based on International Council for Harmonisation solvent classifications,
- New conditional field added to the risk information section when there is Iron in the product to support compliance with safety requirements when the package contains more than the equivalent of 250 mg of elemental iron. New feature in recommended dosage section allows user to identify specific recommended uses by subpopulation,
- General form style and formatting fixes,
- Fixed medicinal ingredient “additional quantity” form-level validation,
- Increased field length for medicinal ingredient quantity,
- Fixed frequency field validation (numerical characters only),
- Revised calculations table to include quantity fresh equivalent and quantity dry equivalent values,
- New dosage form-driven validation for non-medicinal ingredient requirements,
- New percentage conversions to enable dose and dosage calculations for validation,
- More specific validation error messaging.
Validation of the following 31 monographs have been enabled with version 4.2.0:
- Arnica
- Benzocaine
- Bilberry – Buccal
- Cayenne – Capsicum annuum – Topical
- Cod Liver Oil
- Cognitive function products
- Deglycyrrhizinated licorice – Buccal
- Deglycyrrhizinated licorice – Oral
- Devil’s Claw
- Diaper Rash Products
- Elder – Sambucus
- Feverfew
- First aid antiseptics
- Goldenseal – Oral
- Grape Seed Extract
- Green Coffee Bean Extract
- Green Tea Extracts
- Holy Basil – Ocimum Tenuliflorum – Leaf
- Laxatives, Carbon Dioxide-Releasing
- Marshmallow – Althaea Officinalis – Leaf
- Marshmallow – Althaea officinalis – Root
- Medicated vapours
- Pancreatic Enzymes
- Poria – Wolfiporia extensa
- Propolis – Buccal
- Rhodiola – Rhodiola rosea
- Sage – Salvia officinalis – Oral
- Saw palmetto, liposterolic extract
- Serrapeptase
- Skullcap
- Whey products
The list of validation-supported monographs can be found on the web PLA landing page. Applicants may begin using the web PLA form version 4.2.0 exclusively for all new product licence applications when attesting to validation-supported monographs.
The NNHPD will maintain access to version 3 of the form until all of its monographs can be populated and/or validated using version 4. For specific inquiries or to report technical issues or errors with the NHP Online System (e.g., web forms/databases), please email: hc.nhp.initiative-psn.sc@canada.ca.
