When developing a product that requires market authorization, either by way of a DIN (drug identification number) or an NPN (natural product number), product monographs are essential documents provided by Health Canada that layout mandatory label information. These monographs outline key details for products such as the acceptable qualifications for a product to be recognized as a drug product or natural health product based on their active ingredients, labelling requirements for these products, and other information. There are a few monographs that are currently under periodic review with Health Canada and have also recently gone through consultation periods with the public to determine if these proposed revisions will work for the private sector. These monographs include Anti-Dandruff, Medicated Skin Care, and Acne Therapy. Many of the proposed changes to these monographs are set to potentially change the allowable claims for these products and other key labelling requirements. In particular, there could potentially be several changes to the Acne Therapy monograph that could impact products under this category:
Statements to the Effect of…
“Statements to the effect of” has been proposed to be eliminated with the new electronic form submission. The revised monograph could veer off the current path in that instead there will be a list of all acceptable phrases instead of using “statements to the effect of”. There will be a reduction in variability with hopefully less room for mistakes in claims on products.
Doses and Permitted Combinations
The proposed revised monograph features a defined subpopulation. Previously, there was an absence of a subpopulation. In the newly revised monograph, it features the potential for the subpopulation to be defined as strictly “adolescents over 12 years of age and adults”.
The new proposed monograph will feature optional Drug Facts Table examples for both drug and NHP (Product Facts Tables) for acne therapy products.
Equally important in any formulation, non-medicinal ingredients are often ignored in drug and natural health products as there is typically emphasis on the product’s actives instead. Alternatively, to using INCI nomenclature for non-medicinal ingredients, the new proposed monograph states that the non-medicinal ingredients must be present on the current Natural Health Products Ingredients Database (NHPID). The ingredients must also meet the criteria outlined on the database and/or other ingredient databases, such as the Food and Drug Regulations or Canadian Cosmetic Hotlist.
Additional Changes in Language
Directions for use is typically the first section a consumer is drawn to on primary packaging. With the new monograph, there may be wording changes in the Directions for Use for both leave-on and rinse off products. The wording for “Caution/Warning” statements may also be modified. Additionally, products with benzoyl peroxide will most likely require the presence of additional warning statements related to sun exposure and proper sun protection.
The consultation period for the Anti-Dandruff, Medicated Skin Care, and Acne Therapy has recently passed, therefore we now await the final decision on what will officially be present on the newly revised final version of these monographs. According to Health Canada, the next ones on the agenda to be placed under consultation after review are Oral Health, Lozenges, and the Sunscreen Monograph. Stay tuned for more information on those proposed changes.
For more information, please contact Focal Point Research Inc. We are leading North American Regulatory and New Product Consultants for Medical Devices, Natural Health Products, OTC Drugs, Cosmetics, and other consumer products regulated by Health Canada and the U.S. FDA.