Borderline Products

Some products can be difficult to determine whether they are a medicine or not, for example, cosmetics, food supplements and nutraceuticals.  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 refer to our regulatory services pages for further information or contact us with your specific regulatory compliance requirements.