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Medicinal Products Act · Chapter 1 · Purpose of the Act, definitions, scope
Section 3

Definition of substance

§ 3 AMG · Stoffbegriff

Arzneimittelgesetz (AMG) – Gesetz über den Verkehr mit Arzneimitteln · German text as of 29 October 2026 · translation edited by Alexander Baranov

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Substances within the meaning of this Act are

Stoffe im Sinne dieses Gesetzes sind

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1. chemical elements and chemical compounds as well as their naturally occurring mixtures and solutions,

1. chemische Elemente und chemische Verbindungen sowie deren natürlich vorkommende Gemische und Lösungen,

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2. plants, parts of plants, plant constituents, algae, fungi and lichens, in a processed or unprocessed state,

2. Pflanzen, Pflanzenteile, Pflanzenbestandteile, Algen, Pilze und Flechten in bearbeitetem oder unbearbeitetem Zustand,

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3. animal bodies, including those of living animals, as well as body parts, body constituents and metabolic products of humans or animals, in a processed or unprocessed state,

3. Tierkörper, auch lebender Tiere, sowie Körperteile, -bestandteile und Stoffwechselprodukte von Mensch oder Tier in bearbeitetem oder unbearbeitetem Zustand,

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4. micro-organisms, including viruses, as well as their constituents or metabolic products.

4. Mikroorganismen einschließlich Viren sowie deren Bestandteile oder Stoffwechselprodukte.

Does § 3 AMG affect your product?

Background: Pharma market access in Germany · Four routes to a German marketing authorisation. We explain what this provision means for your launch, price and timeline — fixed price, in writing.

Unofficial translation for information only. Only the German text is legally binding. German text: consolidated version from gesetze-im-internet.de, retrieved 29 October 2026. Where German statutes use “soll”, “shall” denotes an obligation that admits exceptions in atypical cases. Not legal advice.