Drug OTC Product Licensing

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 for the lower-risk ingredients in the following product categories.
The Category IV Monographs include:
• Acne Therapy | • Sunscreen Monograph | • Medicated Skin Care Products |
• Diaper Rash Products | • Anti-Dandruff Products | • Antiseptic Skin Cleansers |
• Athletes Foot Treatment | •Throat lozenges | • Disinfectants |