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|