BfArM - Federal Institute for Drugs and Medical Devices

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Demarcation/Borderline questions

According to Section 2 (1) Medicinal Products Act (AMG), medicinal products are substances or preparations made from substances that are intended for use as remedies with properties for the curing, alleviating or preventing of human or animal diseases or disease symptoms (so-called presentation medicinal products), or to restore, correct or influence physiological functions through a pharmacological, immunological or metabolic effect, or to make a medical diagnosis (so-called functional medicinal products).

In recent years, however, more and more product groups have been introduced which, especially for consumers, have comparable properties to medicinal products and are difficult to distinguish from those.

Different legal frameworks apply to medicinal products, foodstuffs (including food supplements and foods for special medical purposes), medical devices, biocides or cosmetic products. For example, products of different product groups can be manufactured from the same herbal raw materials. For consumers or patients, but even for professionals, it is often difficult to recognise the differences or to compare products.

Each product category entails a different market access procedure. Food products are subject to different requirements in terms of quality and labelling standards or benefit-risk assessment than medicinal products. Likewise, different requirements apply to medical devices. Regardless of the classification, however, the required quality and safe use must be guaranteed for all products.

In principle, the local supervisory authorities are responsible for the question of product classification and the question of the obligation to obtain a marketing authorisation as a medicinal product, depending on where the entrepreneur placing the product on the market is based or intends to establish his or her registered office.
The homepage of the Central Authority of the Länder for Health Protection with regard to Medicinal Products and Medical Devices contains the contact details of the local authorities (Landesbehörden):

Central Authority of the Länder for Health Protection with regard to Medicinal Products and Medical Devices

At the request of a competent local authority (Landesbehörde), the competent higher federal authority pursuant to Section 21(4) of the Medicinal Products Act (AMG) decides, independently of a marketing authorisation application pursuant to Section 21(3) AMG or an application for authorisation pursuant to Section 21a(1) or Section 42(2) AMG, inter alia, on the obligation to authorise a medicinal product or the obligation to authorise a clinical trial. This examination also includes the classification of the product subject of the application as a medicinal product. The competent local authority (Landesbehörde) must attach a reasoned statement on the classification of the medicinal product or the clinical trial to the application.

With regard to the demarcation of medical devices, you can find further information under Differentiation and classification.

Joint Commission of Experts on the Classification of Substances

Participants of the 30th meeting on the third appointment period of the Joint Expert Commission on the Classification of Substances
Figure 1: Participants of the 30th meeting on the third appointment period of the Joint Expert Commission on the Classification of Substances (20.02.2019) Source: BfArM

The Joint Expert Commission is intended to provide the competent federal and local authorities (Landesbehörden) with recommendations of an advisory nature in the fulfillment of their statutory duties. As an independent panel with a high level of technical and scientific expertise, it develops catalogues of criteria, decision trees and statements on technical issues relating to the classification of so-called borderline substances that are placed on the market as foods or food ingredients.

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