Drug OTC Product Licensing
We want to help you get these imperative products to market, ensuring that they meet the necessary safety and effectiveness standards of Health Canada.
We can handle your DIN-labelling standard and Category IV Monograph DIN applications. These are determined by the amount and ingredients in your product. When the dose is higher than an NHPD Monograph- the product may fall into this category which requires a modified DIN application for product license approval. The application still follows the eCTD format. Though, it is modified and shortened to accommodate the lower-risk ingredients in the following product categories.
