Tips to Speed your NHP Product License Applications and Save You Money

Author: Louise Vinnai, B.Sc. Hons.

We are now in the process of preparing NHP product licence applications for many of our clients, and have discovered that most are missing key information that could speed the application process and save them money in consulting fees.

What is this key information? More often than not, it is simply the list of ingredients and detailed information about each. For a non-compendial submission, here’s what is required.

For each product, you will need to provide:

• Product Name
• Trade Name (Brand Name)
• Any additional names you may be considering for marketing purposes.
• A copy of the specifications for each product.
• The text of each proposed product label.
• Recommended conditions of use of the product.

For each medicinal ingredient, separated by product, you will need:

• Proper Name and Common Name: Latin binomial name for plants, proper chemical name for isolates.
• Amount (quantity per dosage unit) and purpose of each ingredient.
• Source information (e.g. Echinacea purpurea – aerial plant parts). You cannot say simply Siberian Ginseng powder, for example.
• The purity or potency associated with the ingredient and any associated standard (e.g. USP grade).
• If the ingredient is an extract you must supply several pieces of information, including the crude to extract ratio and the extraction method.
• If the ingredient is from animal tissue, the information necessary to fill out an Animal Tissue Form must be collected.
• Specify whether any ingredient is synthetically manufactured.

For each Non-medicinal ingredient, you will need essentially the same information as medicinal ingredients unless they are on the NHP Non-Medicinal Ingredient List and used as specified.

Finally, you must provide evidence of Safety, Efficacy and Quality for each product. NHP producers who seek consulting help with any of these issues can shorten the time required to assemble their product licence applications if the ingredient information described above is complete and well organized. Your consultant will thank you and you will save on consulting fees.