Presentation medicinal product: Administrative Court of Schwerin classifies hoof care product as medicinal product and confirms marketing ban

The Administrative Court of Schwerin has ruled: Even a hoof care product without pharmacological effect can be classified as a veterinary medicinal product subject to authorisation – solely by virtue of its presentation and advertising. Manufacturers should urgently review their product communications to avoid marketing bans and sanctions.

The Administrative Court of Schwerin had to decide on the lawfulness of a manufacturing and marketing ban imposed by the competent authority for a hoof care product that had been distributed without veterinary medicinal product authorisation. The case was particularly striking because the product demonstrably contained no pharmacologically active ingredients – yet the court nonetheless considered it a veterinary medicinal product subject to authorisation. The decisive factor was the legal classification as a so-called presentation medicinal product.

What was at issue?

The claimant had a product with the designation "M." manufactured in his private kitchen, which was distributed in 500g plastic pots with screw caps and package inserts. On the front was the notice "Highly effective hoof care product in support of therapeutic treatment for bacterial hoof diseases such as e.g. Mortellaro". The website was also crystal clear: Under headlines such as "Mortellaro – a worldwide problem for cattle farmers now solved!" and "In almost 100% of cases the bacterial hoof disease did not recur", rapid healing successes were promised and detailed "treatment procedures" were presented.

The competent supervisory authority became aware of this offer and requested an assessment from the Federal Office for Consumer Protection and Food Safety (BVL). The BVL classified the product – with reference to an earlier expert opinion from the State Institute for Health and Work North Rhine-Westphalia – as a presentation medicinal product subject to authorisation. No authorisation under the EU Regulation 2019/6 which has been directly applicable since 2022 was in place. The competent authority then prohibited manufacture, marketing and supply of the product by invoking § 76 Abs. 1 TAMG and threatened a penalty payment of 5,000 euros.

The claimant argued that it was a pure care product without pharmacological effect and refused to accept the classification as a medicinal product.

Legal framework

The Animal Medicinal Products Act (TAMG) refers in § 2 Abs. 1 for the definition of veterinary medicinal products to the definitions in the EU Regulation 2019/6. This distinguishes between functional medicinal products (Art. 4 Nr. 1 Buchst. b, c), which actually have pharmacological, immunological or metabolic effects, and presentation medicinal products (Art. 4 Nr. 1 Buchst. a). The latter are already to be classified as veterinary medicinal products if – from the perspective of the average informed consumer – they are attributed properties for the treatment or prevention of animal diseases.

What is essential: The actual efficacy of the hoof care product plays no role in the classification as a presentation medicinal product. What matters is the impression conveyed by presentation, designation and advertising. This "subjective impression" is intended to prevent consumers from being misled by suggested therapeutic effects.

The decision of the Administrative Court of Schwerin (Judgment of 25.06.2025 – 3 A 1709/24)

The court followed the authority's reasoning. In the court's view, "M." met all characteristics of a presentation medicinal product.

Already the product presentation with medicinal product-typical packaging, the use of terms such as "highly effective" and "therapeutic treatment" as well as the reference to a specific animal disease – Mortellaro disease (Dermatitis digitalis) – gave the impression that the hoof care product served the treatment and prevention of this disease. This impression was reinforced by experience reports and the presentation of application schemes that closely resembled the structure of package inserts of approved medicinal products.

The court made clear that it is irrelevant whether the hoof care product actually has a therapeutic effect. Even the undisputed absence of pharmacologically active substances does not change the classification. The very concept of a presentation medicinal product in Art. 4 Nr. 1 Buchst. a EU-VO 2019/6 is deliberately drafted so broadly to also capture such products that give the appearance of a medicinal product solely through their presentation.

Classification as an animal cosmetic product (§ 3 Abs. 2 Nr. 1 TAMG) was ruled out because the product was not intended exclusively for care or cleansing, but was clearly aimed by its advertising at the treatment of a disease.

Distinction from other decisions concerning presentation medicinal products

The Administrative Court of Schwerin explicitly distinguishes itself from a decision of the Administrative Court of Osnabrück from 2013. There, a hoof care and stable treatment product was not classified as a presentation medicinal product because the description was factually neutral and contained no concrete healing promises or disease designations. The difference thus lies not in the composition of the products, but in the manner of their presentation: While in Osnabrück the presentation was purely care-oriented, in Schwerin the therapeutic effect was at the centre of the advertising.

At the same time, the judgment follows the line of the Federal Administrative Court (Judgment of 20.11.2014 – 3 C 25.13) and the Court of Justice of the European Union (Judgment of 15.11.2007 – C-319/05), according to which the mere impression of a therapeutic effect is sufficient to classify a product as a medicinal product. Both courts emphasise that this broad concept is necessary to prevent circumvention of the authorisation requirement.

Implications for manufacturers and retailers

The decision makes clear that in veterinary medicinal product law it is not solely the ingredients, but above all the overall external presentation of the product that is in focus. The use of a disease designation or the promise of certain treatment successes alone can turn a purported care product into a veterinary medicinal product subject to authorisation – with serious consequences: Without authorisation, immediate marketing bans, substantial penalty payments and in cases of repetition even criminal consequences threaten.

Companies in the field of animal care products must therefore carefully review their marketing and packaging design. Statements that even indirectly suggest a therapeutic or preventive effect carry the risk of intervention by authorities. Prior legal review is therefore urgently recommended.

Conclusion

The Administrative Court of Schwerin confirms the far-reaching significance of the presentation medicinal product concept. What matters is not whether a product works, but whether it appears to work. Anyone who makes reference to specific animal diseases in advertising or packaging or suggests healing successes quickly moves into the area of medicinal product law authorisation requirements. Manufacturers and retailers should not underestimate this – and should design their product communications accordingly restrainedly.

The decision demonstrates: The distinction between authorisation-free care product and authorisation-required presentation medicinal product requires detailed knowledge of national and European veterinary medicinal product law as well as the relevant case law. AVANTCORE Lawyers in Stuttgart is a law firm highly specialised in this field and can provide legally secure advice already in product development and advertising design, thus preventing costly marketing bans, penalty payments, competition law disputes and reputational damage.