Demarcation Between Medicinal Products and Other Product Categories at BfArM

Importance of Correct Product Classification

In Germany, the regulatory pathway and competent authority depend on whether a product qualifies as a medicinal product under the German Medicines Act (AMG) or falls under another regime (e.g., Medical Devices Regulation, Food Law, Cosmetics Regulation, or Biocidal Products Regulation). Misclassification can lead to rejection, delays, or legal issues. BfArM assesses borderline cases and issues decisions on demarcation to clarify the applicable framework. Demarcation - BfArM

Key Criteria for Classification as a Medicinal Product

A product is considered a medicinal product if it:

• Is presented as treating or preventing disease in humans (presentation criterion), or
• Is intended to restore, correct, or modify physiological functions by pharmacological, immunological, or metabolic action (function criterion).

BfArM evaluates both presentation (claims on labelling, advertising, or website) and actual mode of action, even if no therapeutic claims are made.

Common Borderline Areas and Demarcation Examples

Medicinal Products vs. Medical Devices

• Products with primary pharmacological action → Medicinal product (BfArM/PEI).
• Products with principal intended action achieved by physical means → Medical device (BfArM or notified body).
• Borderline: e.g., wound dressings with antimicrobial substances may be classified as devices or medicinal products depending on the main mechanism.

Medicinal Products vs. Food Supplements / Foods for Special Medical Purposes

• Products with nutrient or physiological effect without therapeutic claims → Food / food supplement (BfR or local food authorities).
• Products restoring physiological functions via pharmacological action or presented for disease treatment → Medicinal product.

Medicinal Products vs. Cosmetics

• Products with primary cosmetic purpose (cleaning, perfuming, protecting, etc.) → Cosmetic (BfR).
• Products claiming to treat or prevent skin diseases or exerting pharmacological effects → Medicinal product.

Medicinal Products vs. Biocides

• Products for human therapy or prophylaxis → Medicinal product.
• Products for disinfection or pest control on humans without therapeutic intent → Biocide (UBA).

Application Process for Demarcation Decisions

• Applicants submit a formal request to BfArM with product description, intended use, composition, claims, and mode of action data.
• BfArM provides a binding classification decision (often within months).
• In complex cases, BfArM may consult EMA borderline working group or other authorities.

Correct demarcation ensures appropriate regulatory oversight, safety standards, and market access. BfArM encourages early consultation for borderline products to avoid misclassification risks. Demarcation - BfArM