Borderline Products

Regulatory Context

Most human medicines are clearly identifiable as such and are subject to European Union (EU) marketing authorisation procedures. However, there are some products where it is not so easy to distinguish a medicine from, for example, cosmetics, medical devices, biocides, food supplements, herbal products. These are known as borderline products.


Current issues in this Sector

Difficult to Determine Status
The person or company marketing a product has a responsibility to do so in accordance with the law. However, the status of many products on the “borderline” between medicinal products and cosmetics, medical devices, biocides, food supplements or herbal products can be very difficult to determine and in some cases, has led to requests for clarification of applicable EU law about the borderline to the European Court of Justice.

Product Claims
Information on the Internet about a borderline product and its uses is not excluded from the definition of the term ‘advertising’. Many companies bring borderline products within the definition of a medicinal product by making direct or implied claims on the internet which cause the product to fall within the definition of a medicinal product.


Difficulties to be avoided

Incorrect classification of a product by a company can result in non-compliance with the applicable EU legislation. Risk of incorrect classification of a product can be minimised by a thorough review of ingredients, labelling, permitted claims (including those on the internet and product brochures), intended use, primary mode of action, similar licensed or registered products on the market and registration requirements of the product before launch onto the EU market. Advice may also be sought from the classification committee of the relevant competent authority.

Differences Between Member States
Within the EU it is difficult to get a clear understanding of the interpretation of the legislation relating to borderline products in each Member State, with the result that a food supplement product which is compliant in one country may not necessarily be considered a food supplement or compliant with the legislation of another country.  Therefore, it is important that local requirements are identified in advance by personnel familiar with the localised interpretation of the legislation.

The most efficient route for your regulatory approval

Real Regulatory has up-to-date knowledge in key areas relating to borderline legislation and can assist you in dealing with current issues in product classification and in anticipating costly delays your route to market might encounter. Whether you need help with filing submissions, regulatory strategy, compliance issues, regulatory intelligence or commercialisation our highly experienced team of consultants can ensure you follow the most efficient route to regulatory approval.

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