The legal dispute concerns the distinction between substance-based medical devices and medicinal products.

The claimant manufactures the nasal spray "..." and places it on the market as a medical device. According to the package information leaflet, each 1.0 g of solution contains 25.00 mg... (...), 0.25 mg aloe vera gel, ... as well as water. The January 2011 package information leaflet states, among other things, that the preparation was suitable for use with irritation of the nasal mucosa caused by viral rhinitis. It also soothed irritation of the nasal mucosa and supported its regeneration during a cold. In a package information leaflet dated September 2011, the product is described as, among other things, supporting the treatment of colds.

By notice of 16 January 2014, the Federal Institute for Drugs and Medical Devices (BfArM, Bundesinstitut für Arzneimittel und Medizinprodukte, hereinafter Federal Institute) declared in accordance with section 21 (4) of the Medicinal Products Act (AMG, Arzneimittelgesetz), that the preparation is a medicinal product requiring marketing authorisation. It fulfilled the requisite conditions to be qualified as a medicinal product by function pursuant to section 2 (1) no. 2 (a) AMG. The principal intended action of the preparation was achieved by pharmacological means with the ingredients ... and .... In addition, the product was also a medicinal product by presentation within the meaning of section 2 (1) no. 1 AMG. The claimant's objection directed against the notice was rejected.

The action and an appeal on points of fact and law by the claimant remained likewise unsuccessful. 

By decision of 20 May 2021 (3 C 19.19), the Senate suspended the proceedings and referred questions to the Court of Justice of the European Union (CJEU, hereinafter Court of Justice) for a preliminary ruling on the delimitation of medical devices and medicinal products. The Court of Justice ruled by judgment of 19 January 2023 (C-495/21 and C-496/21).

9 The admissible appeal on points of law is without merit and is therefore to be dismissed (section 144 (2) of the Code of Administrative Court Procedure (VwGO, Verwaltungsgerichtsordnung)). The contested judgment is not based on a breach of federal law (section 137 (1) no. 1 VwGO). Taking the factual findings established by the Court of Appeal as a basis (section 137 (2) VwGO), the admissible action is unfounded. The contested notice of 16 January 2014 in the form of the objection notice of 14 October 2014 is lawful and does not violate the claimant's rights (section 113 (1) first sentence VwGO).

10 1. As the Higher Administrative Court (Oberverwaltungsgericht) also held, the legal basis for the contested notice is section 21 (4) first sentence AMG in the version applicable when the administrative procedure was concluded (see Federal Administrative Court (BVerwG, Bundesverwaltungsgericht), judgments of 24 October 2019 - 3 C 4.18 - Rulings of the Federal Administrative Court (BVerwGE, Entscheidungen des Bundesverwaltungsgerichts) 167, 1, para. 12 and of 17 September 2021 - 3 C 20.20 - BVerwGE 173, 262 para. 13) in the version of the amending act of 27 March 2014 (Federal Law Gazette (BGBl., Bundesgesetzblatt) I p. 261). Accordingly, the Federal Institute, as the competent higher federal authority pursuant to section 77 (1) AMG and at the request of a competent state authority decides, among other things, on the required marketing authorisation for a medicinal product.

11 2. The Court of Appeal found, without breaching the law subject to an appeal on points of law, that the nasal spray manufactured and distributed by the claimant is a medicinal product requiring marketing authorisation. On the basis of its factual findings, the Court's classification of the nasal spray as a medicinal product by presentation (a), that is not excluded from the application of the Medicinal Products Act under section 2 (3) no. 7 AMG (b), does not give rise to any significant concerns.

12 a) The Higher Administrative Court, without breaching the law, held that the nasal spray is a medicinal product by presentation within the meaning of section 2 (1) no. 1 AMG.

13 aa) Provisions on medicinal products by presentation can be found both in the Medicinal Products Act as well as in Directive 2001/83/EC on the Community code relating to medicinal products for human use (OJ L 311 p. 67) in the relevant version of Directive 2012/26/EU of 25 October 2012 (OJ L 299 p. 1). The definitions in the Medicinal Products Act are to be interpreted in the light of the requirements stipulated by EU law (see BVerwG, judgment of 17 September 2021 - 3 C 20.20 - BVerwGE 173, 262, para. 18). The term medicinal product by presentation within the meaning of section 2 (1) no. 1 AMG and article 1 no. 2 (a) of Directive 2001/83/EC covers substances and combinations of substances that are intended for use in or on the human body and are presented as having properties for treating, alleviating or preventing human diseases or disease symptoms.

14 bb) The Higher Administrative Court has also correctly held that the category of medicinal product by presentation, as defined, is applicable when a product is distributed as a medical device. In the preliminary ruling procedure, the Court of Justice ruled that a product distributed as a medical device may also be a medicinal product by presentation (CJEU, judgment of 19 January 2023 - C-495/21 [ECLI:EU:C:2023:34] and C-496/21 - para. 49). The claimant's objection that, contrary to the system, this imposed the burden of proof for the existence of a medical device on it, is irrelevant. The Court of Justice has clarified that a manufacturer wishing to market a product as a medical device must demonstrate that it fulfils the conditions for being considered such a product (see CJEU, judgment of 19 January 2023 - C-495/21 and C-496/21 - para. 38).

15 cc) The Higher Administrative Court's assumption that the nasal spray manufactured by the claimant is presented as having properties for treating or alleviating or preventing human diseases or disease symptoms does not give rise to concerns.

16 (1) The standard applied by the Court of Appeal, according to which a product is presented as having properties for treating or alleviating or preventing human diseases or disease symptoms if it is either expressly indicated as such or whenever any averagely well-informed consumer gains the impression, which, provided it is definite, may even result from implication, that the product in questions does, having regard to its presentation, have the properties for treating or alleviating or preventing human diseases, is in line with the case-law of the Court of Justice (CJEU, judgment of 15 November 2007 - C-319/05 (ECLI:EU:C:2007:678) - para. 44, 46; confirmed by judgment of 19 January 2023 ‌- C-495/21 and C-496/21 - para. 45 et seq.) and the deciding Senate (see BVerwG, judgment of 17 September 2021 - 3 C 20.20 - BVerwGE 173, 262 para. 20). The same applies to the requirement to carry out an overall assessment as held by the Higher Administrative Court (see CJEU, judgment of 19 January 2023 - C-495/21 and C-496/21 - para. 48; BVerwG, judgment of 17 September 2021 - 3 C 20.20 - ‌BVerwGE 173, 262 para. 20). In its preliminary ruling, the Court of Justice also confirmed that, in the context of this overall assessment, the presentation of the product, the references to interactions with medicinal products and to adverse effects, as well as the pharmacy-only distribution, may be used as relevant criteria (see CJEU, judgment of 19 January 2023 - C-495/21 and C-496/21 - para. 48). It did not take up the criterion of the claiming of a specific medicinal effect addressed in the decision to request a preliminary ruling, thus making it clear that this is not relevant to affirming the existence of a medicinal product by presentation in distinction from a medical device.

17 (2) On the basis of these standards, the factual findings of the Higher Administrative Court, which are not contested by procedural complaints and are thus binding on the Court deciding on appeals on points of law pursuant to section 137 (2) VwGO, support the classification of the claimant's nasal spray as a medicinal product by presentation. The Court of Appeal found that the instructions for use dated January 2011 initially indicated the preparation as a medical device and then described it as a "rhinologic agent/astringent" suitable for use with irritation of the nasal mucosa caused by viral rhinitis. A viral rhinitis was a pathological condition, especially during an acute cold, which could be treated with medicinal nasal sprays; the same applied to irritation of the nasal mucosa caused by rhinitis. The instruction for use also referred to "interactions" with other products and "adverse effects", which were similar to the information on risks and side effects in package information leaflets that consumers of medicinal products were familiar with. The instruction for use concluded with the statement "Pharmacy-only medical device". This form of distribution is familiar to consumers of medicinal products, while pure salt water or sea water preparations were also available in chemist's shops. In the instructions for use dated September 2011, the preparation was also described as a means "for the supportive treatment of colds" and "for the treatment of colds".

18 On this basis, the Higher Administrative Court's assumption that the claimant made a clear reference to diseases in the instructions for use and assigns its product the purpose of alleviating the symptoms of the disease, leading the averagely well-informed consumer to get the impression that the product is intended to treat or alleviate a disease like a medicinal product, does not give rise to concerns. This also applies to the assessment that, from a consumer perspective, the pharmacy-only requirement and the reference to interactions and adverse effects suggested the existence of a medicinal product.

19 b) The Higher Administrative Court also ruled without breach of federal law that the claimant's nasal spray is not exempt from the application of the Medicinal Products Act pursuant to section 2 (3) no. 7 AMG.

20 aa) According to this provision, medical devices and accessories for medical devices within the meaning of section 3 of the Medical Devices Act (MPG, Medizinproduktegesetz) are not medicinal products, unless they act as in-vivo diagnostics, which is not the case here. According to section 3 no. 1 (a) MPG in the relevant version of the Act for the Further Development of the Financial Structure and Quality in Statutory Health Insurance (GKV-FQWG, GKV-Finanzstruktur- und Qualitäts-Weiterentwicklungsgesetz) of 21 July 2014 (BGBl. I p. 1133), medical devices are, among other things, all substances and combinations of substances that are intended by the manufacturer to be applied to human beings by means of their functions for the purpose of detecting, preventing, monitoring, treating or alleviating diseases and whose principal intended action in or on the human body is achieved neither by means of pharmacological or immunological action nor by metabolism, but whose mode of action may be assisted in its function by such means. The wording of the provision thus corresponds to the wording of article 1 (2) (a) of Directive 93/42/EEC concerning medical devices (OJ L 169 p. 1) in the version amended by Directive 2007/47/EC (OJ L 247 p. 21). According to article 1 (5) (c) of Directive 93/42/EEC, the decision as to whether a product falls within the scope of the Medicinal Products Directive 2001/83/EC or that of the provisions applicable to medical devices is to be made in particular on the basis of the principal mode of action of the product. This corresponds to the provision set out in section 2 (5) no. 1 MPG. In its judgment in the preliminary ruling procedure, the Court of Justice made it clear that, despite the wording "in particular", the mode of action is the decisive criterion for the distinction between medical devices and medicinal products. In the absence of scientific knowledge that would make it possible to establish that the principal intended action in or on the human body is not achieved by pharmacological, immunological or metabolic means, a product may not be classified as a medical device (see CJEU, judgment of 19 January 2023 - C-495/21 and C-496/21 - para. 40 et seq.).

21 bb) The Court of Appeal held, without violation of federal law, that it is not possible to established that the principal intended action of the claimant's product is achieved by non-pharmacological means.

22 (1) The Higher Administrative Court held that a pharmacological effect may be considered not only if a substance is absorbed by the human body and thus interacts with the body's own molecules, but also if it remains on the surface of, for example, the mucosa and reacts with other cell molecules present there. Non-receptor-mediated modes of action could also be covered by the term pharmacological effect, provided that the substance has a significant influence on the physiological functions of the human body and influences them in a targeted manner (...).

23 The Senate may decide that this interpretation is compatible with the law subject to an appeal on points of law without referring the matter back to the Court of Justice. It is true that it left unanswered the first question in the decision to request a preliminary ruling, which concerned the concept of pharmacological effect. However, the fact that - contrary to what the claimant submits - the concept of pharmacological effect may also cover non-receptor-mediated modes of action can be affirmed on the basis of the Court's previous case-law. In proceedings concerning a mouthwash solution, it ruled that the pharmacological effect of a substance may not only be assumed to exist if there is an interaction between the molecules of that substance and a human cellular constituent, but that an interaction between that substance and any cellular constituent present within the user's organism is sufficient (CJEU, judgment of 6 September 2012 - C-308/11 [ECLI:EU:C:2012:548] - para. 31 et seqq.); the Court of Appeal made reference thereto. Had the Court intended to limit that case-law in constellations such as in the present case, one would have expected a statement to that effect in its preliminary ruling.

24 (2) In factual terms, the Higher Administrative Court, in dealing with the expert reports and opinions submitted by the claimant, stated that the mode of action of the nasal spray remained unclear. There was a lack of scientific evidence for the (physical) modes of action of the product as alleged by the claimant. The assumptions made by Dr S., commissioned by her, were based exclusively on theoretical reaction possibilities due to chemical properties of the active substance. There was no scientific evidence, neither for the development of a mechanical barrier over the nasal mucosa nor for a shrinkage of the nasal mucosa. The defendant countered the claimant's assumptions with findings from scientific literature. In addition to the modes of action of her product as alleged by the claimant, it is also possible that the ingredient [...] reacts with protein molecules in the membrane of cells in the nasal mucosa, thereby denaturing them and affecting the structure and function of the cell membrane. However, it is not clear whether this mechanism of action is actually triggered; the specialist literature presented in this regard is of an older date. The expert reports submitted by the claimant did not refute the defendant's assumptions; the study by... GmbH even showed a certain cell-damaging effect of the preparation. There was no indication of other scientific data that could provide clear information on the mode of action of the product. In such a situation, it is not the task of the administrative courts to conduct further investigations, which would amount to conducting a clinical study.

25 The claimant does not successfully challenge these findings of the Higher Administrative Court with his submissions in the appeal proceedings on points of law.

26 (a) The procedural complaint asserting that the Higher Administrative Court breached section 86 (1) VwGO, since it did not obtain any (further) expert report is irrelevant. The claimant did not formally file an application to take evidence in the oral hearing before the Court of Appeal. Her submissions also fail to show that the Court should have undertaken further investigations on its own initiative without being prompted to do so. The claimant already fails to present any specific factual claim for which evidence should have been taken, and fails to show how a further expert report, beyond the expert reports and statements submitted during the proceedings, could have contributed to the clarification of the facts. This also applies insofar as the claimant assumes that the Court would have had to consult an expert to analyse the study of the... GmbH. Insofar as the claimant complains that the Higher Administrative Court did not include the files from the post-marketing authorisation procedure concerning comparable products of the claimant, she also fails to submit the findings that should have resulted from this.

27 (b) Nor is there any recognisable breach of the Court's duty to provide information under section 86 (3) VwGO. There is no obligation on the court to inform the parties of the intended assessment of the subject matter of the proceedings (see BVerwG, decision of 14 October 2004 - 6 B 6.04 - (...) para. 88 with further references). Accordingly, contrary to what the claimant asserts, the Court of Appeal was neither required to point out that it would uphold the defendant's objections nor to indicate what evidence it considered the claimant should have provided.

28 (c) Insofar as the claimant argues that the Court of Appeal should not have considered the defendant's objections as being suitable to undermine the expert reports she had submitted, she is in fact challenging the Court's own assessment of the evidence. The submissions in the appeal on points of law fail to show the existence of significant shortcomings in the assessment of evidence pursuant to section 108 (1) first sentence VwGO, which requires that the court responsible for finding the facts has departed from the scope of evaluation available to it in determining the facts by applying the principle of free assessment of evidence, in particular by disregarding the laws of logic, legal rules on evidence or general principles of experience, or by an objectively arbitrary assessment of the facts or the assessment of the facts contrary to the files (see BVerwG, judgment of 2 March 2022 - 6 C 7.20 - BVerwGE 175, 76 para. 40). The fact that a different outcome of the assessment of evidence might have been possible, is not sufficient for such a breach. In particular, the Higher Administrative Court did not, as the claimant argues, place excessive demands on the production of evidence for the existence of the non-pharmacological effect. It did not accept the mere presumption of a pharmacological effect as sufficient to find that a non-pharmacological mode of action was not provable, but, among other things, relied on the fact that the study by... GmbH submitted by the claimant showed a certain cell-damaging effect of the preparation, which spoke in favour of the cell denaturation asserted by the defendant. In the proceedings, the claimant did not submit any other explanation for the observed cell-damaging effect. In addition, the Court of Appeal stated that, according to the statements of the claimant's expert, Dr S., the denaturation assumed by the defendant could not be ruled out. Insofar as he assumed that a direct reaction of the... released from the depot with membrane-bound proteins of the nasal mucosa was improbable because the soluble proteins of the nasal secretion were present in such a quantity that the active substance only entered into a bond leading to protein precipitation with these, or that the nasal secretion spatially prevented a direct interaction with the nasal mucosa, this was a mere hypothesis. The fact that the Higher Administrative Court did not want to follow this hypothesis without scientific confirmation does not constitute an overstretching of the requirements for producing evidence.

29 (3) The fact that, based on this, the Court of Appeal assumed that one of the modes of action of the nasal spray that are possible according to the Court's factual findings - the denaturation of cells of the nasal mucosa - would have to be qualified as pharmacological, does not give rise to concerns. In factual terms, it established that substances increasing the permeability of the cell membrane are recognised as non-receptor-mediated medicinal substances. The reverse mechanism discussed here, namely a reduction in the permeability of the cell membrane due to protein denaturation, i.e. a sealing and shrinking of the nasal mucosa, did not constitute a significantly different influence on the functional conditions of the human body. The denaturation of membrane proteins signified an interference with the secondary structure (spatial arrangement) of the proteins, which lead to a change or loss of their biological functions. Since membrane proteins played a crucial role in almost all cellular functions, a loss or a change in the biological function could cause significant and difficult-to-predict effects and consequences (...). The claimant did not challenge these factual findings with procedural complaints. The Higher Administrative Court's conclusion that these consequences justify the assumption of the existence of a pharmacological effect does not give rise to any objections within the scope of the appeal on points of law.

30 cc) If the Higher Administrative Court thus assumed without legal error that a non-pharmacological effect of the nasal spray cannot be established, it then also assumed, in accordance with the law that is subject to an appeal on points of law, that the non-provability of this condition precludes the recognition as a medical device and thus works to the detriment of the claimant.

31 This distribution of the burden of proof was confirmed by the Court of Justice in the preliminary ruling procedure (see CJEU, judgment of 19 January 2023 - C-495/21 and C-496/21 - para. 38). The appliation of this distribution also does not lead to disproportionate interference with the free movement of goods and with the fundamental rights of the manufacturers (articles 16, 17 of the Charter of Fundamental Rights of the European Union (CFR); articles 12, 14 of the Basic Law (GG, Grundgesetz)). Insofar as the scope of protection of these provisions are even open to challenge, the interference is in any case proportionate. The application of medicinal products law to products for which the manufacturer cannot prove a non-pharmacological effect, as follows from the distribution of the burden of proof described above, serves health protection. The use of the medicinal products law regime is also suitable for promoting this purpose. This follows, on the one hand, from the consideration that products which achieve their principal intended action not by pharmacological, immunological or metabolic means are less dangerous than medicinal products (see CJEU, judgment of 19 January 2023 - C-495/21 and C-496/21 - para. 39). However, being less dangerous can only be assumed if it is certain that the product in question has no modes of action associated with an increased risk potential. On the other hand, the application of medicinal products law ensures that no products reach the market that consumers, based on their presentation as medicinal products, attribute a corresponding efficacy to, but whose mode of action is unknown and has not been verified in an authorisation procedure under medicinal products law (see CJEU, judgment of 19 January 2023 - C-495/21 and C-496/21 - para. 42). There is nothing to indicate the existence of a less severe, equally suitable means. The application of medicinal products law is also appropriate. This makes a significant contribution to promoting health protection, which overrides the economic interests of the manufacturers.

32 3. Insofar as the claimant argues that a comparable product from another manufacturer is being distributed as a medical device without being objected to by the authorities, she cannot derive any rights for herself from this alleged unequal treatment, regardless of the lack of factual findings in this regard, since there is no right to equal treatment in the case of wrongdoing.