Drug OTC Product Licensing

Group 574@2x

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

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Group 474
CosMog
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CosMog
CosMog

YOU CAN COUNT ON US TO HELP WITH THAT.

Let us deal with the government, so you dont have to!