Medicinal Product Guide.pdf

The Medicines and Healthcare products Regulatory Agency (MHRA) regulates medicinal products for human use in the UK. A product's regulatory status may not be immediately obvious, and the MHRA decides whether a product is a medicine or not on a case-by-case basis.

Key Definitions

A medicinal product is defined as any substance or combination of substances presented as having properties for treating or preventing disease in human beings.
Disease is defined as any condition that impairs normal tissue or organ function.

Determining Medicinal Product Status

The MHRA considers the following factors when determining a product's status:
The product's presentation, including labeling and advertising
The product's ingredients and their intended use
The product's claimed benefits and any supporting evidence

Borderline Products

Products on the borderline between medicinal products and other categories, such as food supplements or cosmetics, may require careful consideration. The MHRA provides guidance on specific product types, including:
Herbal medicinal products
Homeopathic medicinal products
Topical anesthetics
Weight loss products
Nitrous oxide

Regulations and Enforcement

The MHRA enforces regulations related to medicinal products, including:
The Human Medicines Regulations 2012
The Food Information to Consumers Regulation
The General Product Safety Directive

Claims and Advertising

Claims made for a product must be supported by evidence, and advertising must comply with regulations. The MHRA provides guidance on:
Claims to treat or prevent disease
Claims to "maintain" health
Cosmetic claims
* Food claims

Seeking Guidance

If a product's status is unclear, the MHRA can provide guidance and support. The agency's Medicines Borderline Section can assist with determining a product's regulatory status, and Appendix 3 provides information on the statutory determination procedure.