NNHPD Product Monographs
By: Joanna Chudyk, SENIOR REGULATORY AFFAIRS SPECIALIST, email
Product Monographs are documents published by the Government of Canada containing pre-cleared information describing the properties, claims, indications, and conditions of use of a product. They also contain other ingredient information that may be necessary for the optimal, safe, and effective use of the product.
If your product meets the conditions of use in the monograph then you are permitted to attest to it for safety, efficacy, and quality. It’s not often that Health Canada provides simplified regulatory pathways, so if a monograph is available for you to use, we want to help you take advantage of that opportunity.
What product categories have monographs?
Monographs exist for both Natural Health Products (NHPs) and prescription and non-prescription drugs that require Drug Identification Numbers (DINs).
These categories encompass a wide range of products including:
- homeopathic medicines
- multi-vitamins and minerals
- hard surface disinfectants
- acne products.
In some cases, 1 monograph can apply to both NHPs and DINs through the self-care framework.
Some examples include:
| NHP Only Monograph | NHP and DIN Monograph | DIN Only Monograph |
| Multivitamin and Mineral Monograph | Acne Therapy Monograph
| Disinfectant Monograph
|
Types of Monographs
There are two types of monographs:
- single ingredient monographs; or
- product monographs
Single-ingredient monographs are specific to individual ingredients, for example, Ashwagandha. Product monographs on the other hand are for a broad product type (Disinfectant Monograph), with unique finished product specifications or a group of ingredients (Antioxidant Monograph).
A single ingredient can also appear on multiple monographs. For example, amino acids like L-Arginine appears on both the single ingredient monograph for L-Arginine as well as the product monograph for Workout Supplements.
The full list of Health Canada’s Natural and Non-prescription Health Product Directorate (NNHPD) monographs can be accessed through the Natural and Non-prescription Health Product Ingredient Database (NNHPID). Drug monographs are found in the Drug Product Database (DPD).
When can a monograph be used?
To determine if attesting to a monograph is acceptable for your product you must compare the ingredient specifications to the detailed information in the monograph such as plant parts, preparations, solvents, and doses of the ingredient. To compliantly attest to a monograph the ingredient or product must match the parameters declared.
What are the benefits of a monograph?
The monographs play a vital role in the classification of your product, directly impacting the data necessary to submit and the timelines for approval. For the NNHPD, if a product complies with one or more monographs, then the submission class will be Class I or II. No additional information regarding safety/efficacy is required to be compiled by the applicant to support the product, the approval timelines are shorter, and once cost recovery is implemented the cost will be significantly less than a Class III submission. Moreover, with the new monograph validation service that exists for the web Product License Application (PLA) form when completed online, Class I’s can be validated in real-time resulting in a lower risk of refusal. For more assistance with Product License Application (PLAs), you can visit the user guide web page here.
For DINs that fully comply with a monograph, a Labelling Standards submission type can be selected where no clinical or non-clinical data or chemistry and manufacturing data is required. Labelling Standard submissions also cost less and have a significantly lower service standard when compared to full review submissions (60 days vs 210 days).
When filing to receive market authorization from NNHPD (Natural Product Number (NPN)) or the DPD (Drug Identification Number (DIN)), following a product monograph allows for a simpler submission and an expedited review time.
What responsibilities do license holders have when a monograph is updated?
Periodically, the Natural and Non-prescription Health Product Directorate (NNHPD) will publish revisions to monographs and announce them on the “What’s New” page in the Natural and Non-prescription Health Product Ingredient Database (NNHPID). It is the responsibility of the license holder to file amendments or notifications for any affected products within 3 years of the changes, or at the next label run (whichever comes first).
How Dell Tech Can Help with NNHPD and Other Monographs
Dell Tech’s Regulatory Affairs team assists with ingredient review, label compliance, submission and liaison with Health Canada for natural health products, as well as over-the-counter drugs. Whether your natural health product meets the NNHPD monograph requirements or not, we can help you navigate the complex natural health products regulations.
If you need assistance in keeping up with monograph updates or you’re curious about the flexibilities that exist for drugs and natural health products, contact Dell Tech today!
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