Regulatory Services > Registration
Borderline Substances Applications
What is a borderline substance?
A healthcare product which does not distinctly fall into a particular area is referred to as a ‘borderline product’. This term is used when a product is not clearly identifiable as a medicine and maybe, for example, a cosmetic or food supplement. For more detailed information about specific borderline products see our page on Borderline Substances.
In the UK, for a particular group of borderline products; nutritional and dermatological products that have been specifically formulated to manage medical conditions, the Advisory Committee on Borderline Substances (ACBS) is responsible for advising on the prescribing of these products. The ACBS reviews applications for borderline substances made by manufacturers. Products approved and recommended by the ACBS are then listed in Part XV of the Drug Tariff.
If you are unsure about your product - CambReg can help
CambReg is highly experienced in this area and has worked on all types of applications
Type 1 applications are for new formulations that have substantiated advantages and where there is no comparable product on the market
Type 2 applications are for formulations that are broadly similar in composition to existing products already on the market.
Type 3 applications are for changes to existing products that have already been approved by the ACBS.