CRED 8 Presentations

03/07/2024

Borderline Products

Medicinal Product

• EU Regulatory basis: EC Directive 2001/83/EC as amended • A medicinal product is: • any substance or combination of substances presented as having properties of preventing or treating disease • any substance or combination of substances that may be used by or administered to with a view to restoring, correcting or modifying a physiological function by exerting a pharmacological, immunological or metabolic action, or making a medical diagnosis • Some products are hard to distinguish from medicines, for example products that might be medical devices, cosmetics, food supplements or biocidal products. These products are called borderline products until their status has been decided and are treated on a case by case basis

• European Regulation(EC) No 1924/2006

• Harmonised rules for health and/or nutritional claims on foodstuffs, based on nutrient profile • Meant to ensure clarity, accuracy and substantiation • Pending questions remains for Probiotics and Herbals • Enforcement at the discretion of individual MSs

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The Organisation for Professionals in Regulatory Affairs

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Borderline Products

Decision Tree for Borderline Classification

Medicinal Product

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Drug / device Combination products

Pharmacological, immunological or metabolic ?

Medical Devices

Substance(s) &/OR products for treatment, prevention, monitoring, diagnosis of disease OR injury/handicap OR investigation, replacement or modification of anatomy, OR control of conception ?

Nutraceuticals

Cosmeceuticals

Food

Cosmetic/Device

ingested orally?

Nutricosmetics

Cosmetics

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