.png)
TL;DRMedicinal product (Arzneimittel) is the legal category defined in §2 of the German Medicinal Products Act (AMG) and in Article 1(2) of Directive 2001/83/EC: a substance or preparation of substances that is either presented as having properties for treating or preventing human disease, or that acts on physiological functions by pharmacological, immunological or metabolic means.
The classification is not cosmetic. It decides whether a product needs a marketing authorisation, whether it may be advertised to the public, which authority supervises it, whether it can be dispensed only against a prescription, and whether it enters the reimbursement system at all. Two products with identical ingredients can end up in entirely different regulatory worlds because one of them makes a disease claim on the carton.
§2 Abs. 1 AMG defines medicinal products for human use as substances or preparations of substances in two alternative limbs. The wording is deliberately broad, and either limb on its own is sufficient.
§2 Abs. 2 AMG extends the term to articles that contain a medicinal product or have one applied to their surface and that are intended for permanent or temporary contact with the human body. §2 Abs. 3 AMG then carves out the neighbouring categories: veterinary medicinal products, food (Regulation (EC) No 178/2002), cosmetic products (Regulation (EC) No 1223/2009), tobacco products, biocidal products, medical devices and their accessories under Regulations (EU) 2017/745 and 2017/746, and organs intended for transplantation.
The exclusions in §2 Abs. 3 AMG only work if you can decide which box a product belongs in. For the device borderline the test is the principal mode of action: under Article 2(1) of the Medical Device Regulation (EU) 2017/745, a device is a product that does not achieve its principal intended action by pharmacological, immunological or metabolic means in or on the human body, although it may be assisted in its function by such means. A product acting primarily physically or mechanically is a device; a product whose main effect runs through a pharmacological, immunological or metabolic pathway is a medicinal product. The Commission's MDCG 2022-5 guidance treats this as a case-by-case assessment based on the state of the art, not on the label alone.
| Category | Governing law | Decisive criterion | Market-entry route |
|---|---|---|---|
| Arzneimittel (medicinal product) | §2 AMG, Directive 2001/83/EC | Disease claim (presentation) or pharmacological, immunological or metabolic action (function) | Marketing authorisation before placing on the market (§21 AMG) |
| Medizinprodukt (medical device) | Regulation (EU) 2017/745 (MDR) | Principal intended action is not pharmacological, immunological or metabolic (typically physical or mechanical) | Conformity assessment and CE marking, device identification via UDI |
| Nahrungsergänzungsmittel (food supplement) | LFGB, NemV, Regulation (EC) No 178/2002 | A food intended to supplement the normal diet, a concentrate of nutrients or other substances, marketed in dosed form (§1 NemV) | Notification, no authorisation; disease claims are not permitted |
| Kosmetikum (cosmetic product) | Regulation (EC) No 1223/2009 | Applied externally, intended for cleaning, perfuming, changing appearance, protecting or maintaining condition | Notification via CPNP, responsible person, no authorisation |
| Lebensmittel (food) | Regulation (EC) No 178/2002 | Intended for human consumption as nourishment or enjoyment | General food law, no product-specific authorisation |
The decisive rule for genuinely ambiguous products sits in §2 Abs. 3a AMG: products that, taking account of all their characteristics, can fall under the definition in §2 Abs. 1 and at the same time under one of the categories excluded in §2 Abs. 3, are medicinal products. In other words, in case of doubt medicines law prevails. This transposes the doubt rule of Article 2(2) of Directive 2001/83/EC and is why borderline products such as high-dose vitamin preparations, some wound-care substances and many "substance-based" devices are argued over so intensively.
Classification itself is decided in the first instance by the competent authority of the federal state in which the manufacturer or distributor is established. BfArM decides on the request of a state authority under §21 Abs. 4 AMG. For the food borderline, BfArM and the Federal Office of Consumer Protection and Food Safety (BVL) run a joint expert commission. The device borderline is where the UDI system, not the PZN world, provides the identifier, and the prescription-status question is treated separately under Verschreibungspflicht.
Not every medicinal product needs an authorisation, because the authorisation obligation attaches to a narrower sub-category.
§21 Abs. 1 AMG states the rule that matters commercially: finished medicinal products may only be placed on the market in Germany if they have been authorised by the competent federal higher authority or if the EU has granted a marketing authorisation under Article 3(1) or (2) of Regulation (EC) No 726/2004. That is the bridge to Zulassung (marketing authorisation), and it is also why a Generikum is a finished medicinal product with its own authorisation rather than a copy that rides on someone else's.
For anyone working with article master data, the legal category is a filter, not a footnote. Reimbursement logic, prescription rules, distribution channels, pharmacovigilance duties and even which identifier applies all branch off it. A list of articles that mixes medicinal products with devices and supplements will produce wrong answers to almost every downstream question.
Where this is genuinely useful is the mixed basket: a hospital pharmacy or a wholesaler running a list of PZNs through the platform sees in one pass which items are medicinal products and which are not, instead of inferring it from the product name. Eisbergsuche® runs the same query across the licensed databases in parallel, which is what makes the category visible without switching tools.
One honest limitation: a category flag in article master data reflects how a marketed product has been classified and notified, and it is not a legal determination. For a genuinely borderline product, or for a product not yet on the market, the flag cannot substitute for the decision of the competent state authority or BfArM under §21 Abs. 4 AMG. Treat the data as a fast, reliable orientation for products already in distribution and as a starting point, not an opinion, for the hard cases.
