Determining Whether a Borderline Product Is a Medicine in the UK

1. Introduction

In the UK, some products fall into a regulatory grey area between medicines and other regulated categories such as cosmetics, foods, food supplements, medical devices, or consumer products. These are commonly referred to as borderline products. Correct classification is essential because products that meet the legal definition of a medicinal product must comply with medicines legislation and obtain a marketing authorisation before being placed on the market.
Source: Borderline products: how to tell if your product is a medicine

2. Legal definition of a medicinal product

Under UK law, a product is considered a medicine if it meets either of the following criteria:

• It is presented as treating or preventing disease in human beings (the presentation test), or
• It is intended to restore, correct, or modify a physiological function by exerting a pharmacological, immunological, or metabolic action (the function test).

If either test is met, the product is legally classified as a medicine, regardless of how it is described by the manufacturer.
Source: Borderline products: how to tell if your product is a medicine

3. The presentation test

The presentation test focuses on how the product is marketed and perceived. Factors considered include:

• Claims on labels, packaging, or instructions
• Advertising materials, websites, and social media content
• Implied claims, testimonials, or references to medical conditions

Even indirect or suggestive claims (for example, implying treatment of anxiety, pain, infection, or inflammation) may cause a product to be classified as a medicine.
Source: Borderline products: how to tell if your product is a medicine

4. The function test

The function test assesses whether the product’s ingredients or mode of action indicate that it modifies physiological functions through pharmacological, immunological, or metabolic means. This assessment considers:

• Active substances and their known effects
• Strength, dosage, and route of administration
• Scientific and medical evidence regarding mechanism of action

A product may be classified as a medicine under the function test even if no medicinal claims are made.
Source: Borderline products: how to tell if your product is a medicine

5. Common borderline product categories

Products frequently assessed as borderline include:

• Herbal and traditional products
• Vitamins, minerals, and food supplements
• Cosmetics with therapeutic or physiological claims
• Medical devices with ancillary medicinal action

Each product is assessed case by case, and classification depends on the totality of evidence rather than a single factor.
Source: Borderline products: how to tell if your product is a medicine

6. MHRA role and borderline advice

The Medicines and Healthcare products Regulatory Agency (MHRA) is responsible for determining whether a product is a medicine. Businesses may seek borderline advice from the MHRA when classification is uncertain. MHRA decisions are based on legislation, case law, and published regulatory guidance.
Source: Borderline products: how to tell if your product is a medicine

7. Regulatory consequences of classification

If a product is classified as a medicine:

• A marketing authorisation is required before supply
• Manufacturing, distribution, and advertising are strictly regulated
• Non-compliance may result in enforcement action

Correct classification at an early stage helps avoid regulatory delays and compliance risks.
Source: Borderline products: how to tell if your product is a medicine