Some products are hard to distinguish from medicines, for example products that might be food supplements. These products are called borderline products until their status has been decided.

Usually it is the National Competent Authority that determines whether a product falls within the definition of a medicine. 

The types of products which may fall into the borderline category include:

There is also a borderline between medicinal products and medical devices, both of which have medical purposes. In these cases, it will be the claims being made and the mode of action that will decide which regulatory regime will apply (medicine or device).

This area is complex to navigate but our team have experience working with these types of products and can ensure that you are in compliance with marketing your product.