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EU Medicinal Product (MAA)

Many companies in the nicotine industry with NGPs are looking at alternative routes to bring their products to market. The medicinal product route is a well-defined and pre-existing process that allows your product to be marketed as a cessation aid. The benefits of obtaining a medicinal product license for your product are detailed below.

NGPs
Increase product strength and capacity

Consumers who are looking for a new product to help them quit smoking often fail because the cessation aide doesn’t deliver the level of nicotine they are used to. With increased strength, your vaping product can deliver enough satisfaction to start the cessation process. An increase in capacity allows the consumer to use your product with less refill. 

Increase consumer confidence

Many consumers have either not tried vaping products because of their concerns for safety or they have tried a vaping product and found it to be ineffective. By obtaining a medicinal product license, you will gain consumer’s confidence in the delivery of a high-quality vaping product.

Consumer confidence
Advertising and promotion
Advertising and promotion

When a vaping product is licensed as a medicinal product, all advertising routes are allowed because of the health and cessation claims that can be applied. In addition, a medicinal licensed vaping product can be made available on prescription.

Gain consumer's confidence in the delivery of a high-quality vaping product.

TPD vs MAA Comparison Chart

Download our free comprasion chart to see the key differences between TPD and Medical Product authorisation for your ENDS products

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Howe we deliver
How We Deliver

Most companies who decide to go down the Medicinal Product route are unfamiliar with the drug product submission process. Our team of highly qualified and experienced scientists and regulatory consultants guide you through the process. We manage all aspects of compiling the CTD (Common Technical Document) as well as post-marketing approval support. You will have a dedicated Project Manager who delivers effective communication and has a strong track record of meeting project deadlines. Combined with our regulatory consultancy, we help you reduce the lead time in getting your product to market by designing your strategy appropriately to minimize rework and satisfy the regulators.

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