Borderline Products

Some products can be difficult to determine whether they are a medicine or not, for example, cosmetics, food supplements, nutraceuticals and medical devices.  These are known as 'borderline products'. 

A product which is used solely as a disinfectant, food or drink isn't usually considered to be a medicine and therefore, doesn't require a Product Licence to be sold in the UK.  In addition, dietary supplements which contain known substances such as vitamins and minerals are not classed as a medicine but they are regulated by food safety and food labelling legislation.  If, however, any of these products make a medical claim or contain a pharmacologically active substance then it will be defined as a medicinal product and therefore, require a Product Licence.

If there is any uncertainty about whether or not a product is a medicine, it is always best to ask a regulatory professional or the appropriate Regulatory Body who can advise on the product's status.

Please contact us with your specific regulatory compliance requirements.  We look forward to working with you.