ECLI:EU:C:2026:485

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OPINION OF ADVOCATE GENERAL

SZPUNAR

delivered on 11 June 2026 (1)

Case C‑354/25 [Waisrinter] (i)

R. SpA

Bundesrepublik Deutschland,

joined party:

A. AG

(Request for a preliminary ruling from the Bundesverwaltungsgericht (Federal Administrative Court, Germany))

( Reference for a preliminary ruling – Medicinal products for human use – Free movement of goods – Article 34 TFEU – Directive 2001/83/EC – Title V – Article 63(3) – Labelling requirements – Language – Exemptions )

I. Introduction

1. The present request for a preliminary ruling from the Bundesverwaltungsgericht (Federal Administrative Court, Germany) concerns the question of where the line should be drawn between the free movement of medicinal products and the protection of patients by means of labelling rules. It revolves around a simple question: when a parallel importer cannot relabel a product without damaging its immediate packaging, must the label still be subject to national language requirements under Directive 2001/83/EC (2)?

II. Legal framework

A. European Union law

2. Article 63(1) and (3) of Directive 2001/83 is worded as follows:

‘1. The particulars for labelling listed in Articles 54, 59 and 62 shall appear in an official language or official languages of the Member State where the medicinal product is placed on the market, as specified, for the purposes of this Directive, by that Member State.

…

3. Where the medicinal product is not intended to be delivered directly to the patient, or where there are severe problems in respect of the availability of the medicinal product, the competent authorities may, subject to measures they consider necessary to safeguard human health, grant an exemption to the obligation that certain particulars should appear on the labelling and in the package leaflet. They may also grant a full or partial exemption to the obligation that the labelling and the package leaflet must be in an official language or official languages of the Member State where the medicinal product is placed on the market, as specified, for the purposes of this Directive, by that Member State.’

B. German law

3. Under Paragraph 10(1) of the Gesetz über den Verkehr mit Arzneimitteln (Arzneimittelgesetz – AMG) (German Law on Medicinal Products; ‘the AMG’), finished products may only be placed on the market under the AMG if certain mandatory particulars are affixed in German on the containers and, where applicable, on the outer packaging, in a manner whereby they are comprehensible to the public. Those particulars are, at least, the name of the medicinal product followed by an indication of its strength and pharmaceutical form and, where applicable, a statement that it is intended for infants, children or adults (unless that information is already included in its name), the batch identification (with the abbreviation ‘Ch.-B.’ if the medicinal product is placed on the market in batches, or with the date of manufacture if the medicinal product cannot be placed on the market in batches), the content by weight, nominal volume or number of units, the method of administration, and the expiry date with the words ‘use by’.

4. The third sentence of Paragraph 10(8) of the AMG contains a shorter list of mandatory particulars for, inter alia, containers with a nominal volume not exceeding 10 ml.

III. Facts, procedure and questions referred

5. R. SpA is a company incorporated under Italian law which holds the marketing authorisation issued by the competent authorities of the Federal Republic of Germany for a prescription-only medicinal product indicated for the treatment of advanced prostate cancer (‘the reference medicinal product’).

6. That medicinal product is supplied as a solution for injection, marketed in two thermoplastic trays, each sealed with a plastic film and containing one syringe, with both trays enclosed in a cardboard box. One of the syringes contains a solvent and the other an active substance in powder form.

7. To prepare the solution for injection, the syringes are screwed together and the liquid from the first syringe is injected into the second. The reference medicinal product is single-use only and, according to the information in the package leaflet, the solution for injection must be prepared and used immediately after the trays are opened.

8. In 2009, A. AG applied to the Bundesinstitut für Arzneimittel und Medizinprodukte (Federal Institute for Drugs and Medical Devices, Germany; ‘the BfArM’) for marketing authorisation for a medicinal product to be imported into Germany from Italy, in parallel to the reference medicinal product. That competent authority granted that application in July 2010.

9. In 2012, A. additionally declared its intention to import that product, in parallel to the reference medicinal product, into Germany from Poland and Romania. In July 2014, that company applied to the BfArM for renewal of the marketing authorisation for that medicinal product, again in parallel to the reference medicinal product.

10. By decision of 8 September 2014 (‘the contested decision’), the BfArM renewed its authorisation for the parallel import of that medicinal product, subject, however, to a clarification regarding the information to be included on the syringe containers. In particular, it was specified that, because opening the thermoplastic trays affects the stability of the medicinal product, the parallel importer must not open them in order to label the syringes as required by Paragraph 10(8) of the AMG.

11. Nevertheless, in order to ensure that the medicinal product and the two syringes could reliably be identified, the contested decision required the parallel importer, using documented samples, to verify that, in principle, at least the following were indicated on the labelling, in Roman characters: the name of the medicinal product and its strength; the letter A or B on the syringe, enabling the two syringes to be clearly distinguished from each other; the batch identification; and the expiry date of the medicinal product.

12. As the Bundesverwaltungsgericht (Federal Administrative Court), the referring court, states, the syringes bore no information in German. The former holder of the German marketing authorisation, R.’s predecessor in title (‘the original holder’), therefore lodged an objection against the contested decision, which the BfArM rejected by decision of 22 May 2015.

13. The original holder subsequently brought an action before the Verwaltungsgericht (Administrative Court, Germany), alleging non-compliance with the labelling requirements laid down in the third sentence of Paragraph 10(8) of the AMG.

14. That action was declared inadmissible on the ground that R. lacked standing to bring proceedings, since it had not suffered any breach of its rights as a result of the alleged infringements of the German provisions on the labelling of medicinal products. An appeal was lodged against that judgment before the Oberverwaltungsgericht (Higher Administrative Court, Germany). R., which had in the meantime acquired the marketing authorisation from the original holder, resumed the appeal proceedings.

15. By judgment of 14 December 2021, that court dismissed the appeal against the judgment at first instance, declaring it admissible but unfounded. It considered that it was not necessary to address the question of whether the contested decision was unlawful on the ground of non-compliance with the labelling requirements since it did not affect the applicant’s rights; the labelling requirements set out in Paragraph 10(1) and the third sentence of Paragraph 10(8) of the AMG, and in Article 55(3) of Directive 2001/83, were not intended to protect the holder of the marketing authorisation for the reference medicinal product in the Member State of importation, but solely to inform and protect patients.

16. R. then lodged an appeal on a point of law (Revision) before the referring court. In that appeal, it argues, in particular, that the contested decision is unlawful and infringes its rights, in so far as that decision granted a renewal of the marketing authorisation for the medicinal product imported from Italy, Poland and Romania even though the labelling of that product does not comply with the requirements set out in the third sentence of Paragraph 10(8) of the AMG.

17. The Federal Republic of Germany, supported by A., the parallel importer, considers that the contested decision is lawful. According to that Member State, the BfArM was entitled, in the interests of the free movement of goods, to allow the parallel importer, in exceptional and justified cases and notwithstanding the requirements laid down in Paragraph 10(8) of the AMG, not to affix information in German on the immediate packaging. That is particularly so where, as in the present instance, opening the thermoplastic trays affects the stability of the medicinal product.

18. The referring court states that the alleged breach of the national labelling requirements, namely those laid down in Paragraph 10(1) and the third sentence of Paragraph 10(8) of the AMG, would render the renewal of the marketing authorisation for a parallel-imported medicinal product unlawful only if those requirements apply to such products. Since those national provisions transpose Article 54, Article 55(3) and Article 63(1) of Directive 2001/83, the referring court seeks, first of all, to ascertain whether those provisions of the directive are applicable to a marketing authorisation for a parallel-imported medicinal product or the renewal of such an authorisation.

19. If those provisions are applicable, then in order to determine whether a competent authority (in this case, the BfArM) is justified, first, in completely exempting a parallel importer from the obligation to include certain particulars on the immediate packaging and, secondly, in exempting that parallel importer from the obligation, in respect of certain of those particulars and certain other particulars, to label the immediate packaging in the language of the Member State of importation (in this case, German), the referring court raises a second question, concerning both the scope of Article 63(3) of Directive 2001/83, which has not been transposed into national law, and its direct effect. According to that court, given that the BfArM has granted a complete exemption from the obligation to include certain particulars, that exemption could have its basis in the first sentence of that provision. The exemption from the use of the German language for the other particulars could consequently be based on the second sentence of that provision.

20. If, however, those provisions are not applicable, the referring court asks the Court of Justice whether it is consistent with the rules on the free movement of goods, contained in Articles 34 and 36 TFEU, to require a parallel importer of medicinal products for human use to label the immediate packaging with certain minimum particulars in the language of the Member State of importation, where such labelling would affect the stability of that medicinal product.

21. It is against that background that, by order of 20 March 2025, received at the Registry of the Court of Justice on 27 May 2025, the Bundesverwaltungsgericht (Federal Administrative Court) decided to stay the proceedings and to refer the following questions to the Court of Justice for a preliminary ruling:

‘(1) Do the labelling requirements laid down in [Article 54, Article 55(3) and Article 63(1)] of [Directive 2001/83] apply to a medicinal product for which a marketing authorisation has been issued in a Member State and the importation of which into another Member State constitutes a parallel import in relation to a medicinal product already covered by a marketing authorisation in that second Member State?

(2) Must Article 63(3) of [Directive 2001/83] be interpreted as meaning that a medicinal product is not intended to be delivered directly to the patient if it is classified as a medicinal product subject to medical prescription?

(3) Does Article 63(3) of [Directive 2001/83] have direct effect, meaning that an operator wishing to import into Germany a medicinal product from another Member State may rely on that provision before the German courts against the defendant[, the] Federal Republic of Germany[,] which has not transposed that provision into national law or has not transposed it fully?

(4) Do Articles 34 and 36 TFEU preclude provisions of national and … EU law, which require the labelling of immediate packaging with certain minimum particulars in the language of the Member State of importation, [from] being applied to a medicinal product imported in parallel, if it is not possible to relabel the immediate packaging of the medicinal product imported in parallel in order to comply with those labelling requirements because of a significant impairment to its shelf life which would result from this?’

22. Written observations have been submitted by R., the BfArM, A. and the European Commission. R., A., the German Government and the Commission attended the hearing, which was held on 19 March 2026.

IV. Assessment

A. Preliminary remarks

1. Rationale of Directive 2001/83

23. Directive 2001/83 is a classic example of a harmonising measure in the domain of the internal market, as clearly illustrated by the recitals of that directive. It started from the premiss that, while the essential aim of any rules governing the production, distribution and use of medicinal products is to safeguard public health, (3) that objective must be attained by means which will not hinder the development of the pharmaceutical industry or trade in medicinal products within the European Union. (4) Before Directive 2001/83 was adopted, trade in medicinal products within the European Union was hindered by disparities between certain national provisions relating to medicinal products, (5) and such disparities directly affected the functioning of the internal market. (6) In order to remove those hindrances, it was decided to approximate the relevant provisions. (7)

24. The legal basis for doing so was Article 114 TFEU, under which, (8) in order to achieve the objectives set out in Article 26 TFEU, the EU legislature, under the ordinary legislative procedure, (9) can adopt harmonising measures ‘which have as their object the establishment and functioning of the internal market’. The Court of Justice understands that provision as requiring the harmonising measures ‘genuinely’ to ‘improve’ the conditions for the establishment and functioning of the internal market. (10)

25. Harmonising measures seek to align national levels of protection (in the present case, of health) with an EU level of protection; that is precisely the purpose of harmonisation. The rationale of the harmonisation of national provisions on the labelling of medicinal products is therefore that a level playing field must be created for economic operators to be able to trade freely, obviously within the confines of the rules adopted by the EU legislature. The level of protection at EU level, for its part, must be high, as is apparent from Article 114(3) TFEU. (11)

26. Medicinal products are products unlike any others, and the specific characteristics of the market for such products requires that public health be taken into account at all stages. Accordingly, recital 2 of Directive 2001/83 confirms that the essential aim pursued by that directive is to safeguard public health.

2. Title V of Directive 2001/83: rules on labelling and package leaflets

27. It is against the foregoing that the rules on labelling and package leaflets contained in Title V of Directive 2001/83 are to be examined.

28. Title V of Directive 2001/83 governs labelling and package leaflets. The provisions it contains are intended to ensure that essential information about a medicinal product is supplied in a standardised and intelligible form. The overall structure of Title V reflects a balance between uniformity and adaptability: the directive specifies mandatory particulars, but leaves Member States a certain amount of room to determine language rules and, in defined situations, exemptions.

29. Article 54 of Directive 2001/83 sets out the mandatory particulars that must appear on the outer packaging or, if there is no outer packaging, on the immediate packaging. Those particulars are listed exhaustively and include, inter alia, the name of the product; its strength and pharmaceutical form; the active substance; the content by weight, volume or number; the method of administration and, if necessary, the route of administration; the expiry date; special storage precautions; warnings; the marketing authorisation holder; the batch number; and, in specified circumstances, instructions for use. The provision is intended to ensure immediate identification of the product and to reduce the risk of misuse.

30. Under Article 55(3) of Directive 2001/83, a number of particulars, at least, must appear on small immediate packaging units on which the particulars laid down in Articles 54 and 62 thereof cannot be displayed.

31. Article 63 of that directive governs the language regime for the information required by Title V. Its core rule, contained in the first paragraph, is that the particulars on the labelling and in the package leaflet must appear in an official language or official languages of the Member State in which the medicinal product is marketed. The provision also allows for more than one language, provided the same information is given in each.

32. Language requirements are inherently linked to the public health objective of Directive 2001/83, because, if it is to be useful, package information must be understood by patients and healthcare professionals alike.

33. Article 63(3) of Directive 2001/83 then states that where the medicinal product is not intended to be delivered directly to the patient, or where there are severe problems in respect of the availability of the medicinal product, the competent authorities may, subject to measures they consider necessary to safeguard human health, grant an exemption to the obligation that certain particulars should appear on the labelling and in the package leaflet. They may also grant a full or partial exemption to the obligation that the labelling and the package leaflet must be in an official language or official languages of the Member State where the medicinal product is placed on the market, as specified, for the purposes of the directive, by that Member State.

34. The key point at issue in the present case is the relationship between the two sentences in Article 63(3) of Directive 2001/83.

35. The referring court’s questions appear to rest on the premiss, (12) with which R. agrees, that a Member State can rely on the second sentence of that provision, that is to say, it can grant an exemption to the obligation that the labelling must be in an official language of the Member State where the medicinal product is placed on the market, only if the requirements of the first sentence of that provision are fulfilled (the medicinal product is not intended to be delivered directly to the patient or there are severe problems in respect of the availability of the product).

36. I do not share that view and concur in that respect with the observations submitted by the Commission and by the German Government. My position is the result of an analysis of that provision, of its wording, the context in which it occurs and the objectives pursued by the act of which it forms part. (13)

37. First, looking at the wording of the second sentence of Article 63(3) of Directive 2001/83, the use of the term ‘also’ indicates that that provision is a stand-alone clause in the sense that it can be resorted to in addition to, or further to, the provision in the first sentence of that paragraph. Were that not the case, the term ‘also’ would be devoid of legal meaning.

38. Secondly, it is not only the structure of Article 63(3) of Directive 2001/83, but also its spirit and purpose that support the interpretation that, under the second sentence of that article, Member States may, without any further conditions, provide that national authorities can, in exceptional cases, grant an exemption from the labelling requirement, provided that compliance with the general objective of public health protection pursued by that directive is observed. In order to reconcile free movement of pharmaceutical products and the protection of public health, the competent authorities of the Member States must enjoy the necessary flexibility as regards language requirements. The case under consideration is a perfect illustration: if an exemption were not granted, there would be no parallel import of the product in question, since the immediate packaging would have to be destroyed. That situation would run directly counter to the fundamental principle of the free movement of goods.

39. Thirdly, the legislative history of Article 63(3) of Directive 2001/83 supports my interpretation.

40. That provision has been amended a number of times over the years and its wording and the context in which it operates have undergone a degree of evolution.

41. Initially, Member States had no general competence to grant derogations from the language requirement. Indeed, there was only one sentence which provided for the possibility of an exemption from the obligation both that certain particulars should appear on the leaflet and that the leaflet (14) must be in the official language or languages of the Member State, for products not intended to be delivered to patients for self-administration. (15)That wording was amended in 2004 to refer to products not intended to be directly delivered to the patient. (16)

42. In 2010, Article 63(3) of Directive 2001/83 was split into two sentences: the first sentence referred only to the particulars to be included on the labelling and the package leaflet. Here, another possibility for the granting of an exemption was added: ‘where there are severe problems in respect of the availability of the medicinal product’. At the same time, the second sentence of that provision allowed the competent authorities to grant a full or partial exemption from the obligation that the labelling and the package leaflet must be in the official language or languages of the Member State in which the medicinal product is placed on the market. (17)

43. That division into two sentences indicates to me that the particulars that must appear on the labelling are exhaustively regulated by the first sentence, while the second sentence contains all the conditions for exemptions from language requirements. In addition, that provision is, in my view, an indication of an evolution, in the sense that, with a more integrated internal market, Member States have become more confident as regards waiving language requirements in specific circumstances.

44. Article 63(3) of Directive 2001/83 thus provides for two distinct and independent situations in which a competent authority may to a certain extent disapply the labelling requirements for medicinal products.

45. Expressed in the terminology and according to the logic of the internal market, Article 63(1) of Directive 2001/83, by establishing requirements in relation to language, constitutes a restriction on the free movement of medicinal products. Article 63(3) of that directive somewhat relaxes that restriction by allowing the competent authorities of the Member States to reduce the labelling requirements, which in turn fosters and facilitates the free movement of medicinal products. That provision does not allow Member States to introduce additional requirements and, consequently, to create new restrictions on the free movement of medicinal products.

46. The foregoing means that Article 63 of Directive 2001/83 seeks to resolve, within the ambit of Title V, the tension that underlies the entire instrument, namely the need to facilitate trade in medicinal products while ensuring a high level of protection of public health. Importantly, where the competent authorities of the Member States are empowered to grant exemptions, they must be guided by both of those objectives. In other words, an exemption – which by its very nature will often facilitate intra-EU trade – must at all times remain anchored in, and justified by, the public health objective pursued by Directive 2001/83. Article 63 of that directive thus provides a particularly clear illustration of the balance to be struck between the interests of trade and those of public health protection. In my view, such an interpretation of Article 63(3) of that directive is also necessary to ensure that the provision remains compatible with the fundamental principle of the free movement of goods under Article 34 et seq. TFEU.

47. In other words, and relying on the terminology of the German Government, Article 63(3) of Directive 2001/83 should be labelled (18) an Öffnungsklausel, an ‘opening-up clause’: with respect to the situations described in that provision, the EU legislature does not have the final and all-encompassing answer. It is for Member States to apply that provision, in line with the overall rationale of that directive and the FEU Treaty. In that context, it is the free movement of goods under Article 34 et seq. TFEU which must be respected.

48. Finally, it should be stressed that, under Article 63(3) of Directive 2001/83, it is the competent authorities of the Member States (as opposed to Member States in general) that may grant an exemption. That implies to me that Member States may not decline to transpose that provision into their national law, thereby never conferring power on the authorities to derogate from the general language requirements laid down in Article 63(1) thereof. (19)

3. The phenomenon of parallel imports

49. The present case invites the Court to revisit a perennial tension at the heart of the internal market: how to reconcile the free movement of goods with the protection of public health and of industrial property in the pharmaceutical sector. Specifically, the Court is asked to clarify the extent to which the harmonised rules on the labelling and packaging of medicinal products, as set out in Title V of Directive 2001/83, apply to the activities of parallel importers.

50. Parallel trade in medicinal products is a direct consequence of the price disparities that persist across Member States, often resulting from divergent national social security and pricing policies. While such trade promotes price competition between economic operators, which is an objective consistent with the establishment of an internal market, (20) it operates within a highly regulated environment where Member States typically invoke patient safety. Overall, in EU law, parallel imports of medicinal products constitute a ‘desirable phenomenon’. (21)

51. That brings us to the questions of the case under consideration, a defining feature of which is that it is not the Member State in question – the Federal Republic of Germany – which is seeking to prevent a parallel import of a medicinal product, but the holder of the marketing authorisation itself.

B. First question

52. By its first question, the referring court seeks, in essence, to ascertain whether the labelling requirements laid down in Article 54, Article 55(3) and Article 63(1) of Directive 2001/83 apply to a medicinal product for which a marketing authorisation has been issued in a Member State and where its importation into another Member State constitutes a parallel import in relation to a medicinal product already covered by a marketing authorisation in that second Member State.

53. It is my contention that the answer to the question is ‘yes’: the labelling requirements of Directive 2001/83 apply to parallel importers.

54. A parallel import of a medicinal product occurs when a medicinal product lawfully placed on the market in one Member State is imported into another Member State by an operator other than the holder of the marketing authorisation, when the imported product is sufficiently similar to a product already authorised in the Member State of importation for it to be marketed there under a simplified parallel-import procedure rather than a completely new marketing authorisation.

55. The Court has held that a situation in which a medicinal product covered by a marketing authorisation in one Member State is imported into another Member State, in which an essentially similar medicinal product is already the subject of a marketing authorisation, constitutes a parallel import of a medicinal product. (22)

56. Parallel imports of medicinal products are only marginally regulated by Directive 2001/83, for the simple reason that that directive applies, in accordance with Article 2(1) thereof, ‘to medicinal products for human use intended to be placed on the market in Member States’. (23)

57. The Court has accordingly and consistently held that ‘Directive 2001/83 cannot apply to a medicinal product covered by a marketing authorisation in one Member State which is being imported into another Member State as a parallel import of a medicinal product already covered by a marketing authorisation in that other Member State, because the imported medicinal product cannot, in such a case, be regarded as being placed on the market for the first time in the Member State of importation. Such a situation therefore falls under the provisions of the FEU Treaty on the free movement of goods’. (24)

58. A word of caution is needed at this stage. I find it inconceivable that the Court, in the passage cited in the preceding point and contrary to what might be an intuitive reading of ‘Directive 2001/83 cannot apply to’, intended to mean that parallel imports, in all circumstances, fall outside the entire body of provisions of Directive 2001/83. If they did, then under Article 76(3) of that directive, the notification requirement of a distributor, which imports a medicinal product from another Member State but is not the holder of the marketing authorisation, would be meaningless.

59. Instead, and in line with the observations of both the Commission and of A., as well as with those of the German Government, I understand that passage as referring primarily to the provisions of Directive 2001/83 on marketing authorisations. (25)

60. As a consequence, it is my view that the traditional methods of interpretation can be relied on to assess whether the labelling requirements of that directive apply to parallel imports. Here, I would make the following observations.

61. First, as regards the wording of the provisions contained in Title V of Directive 2001/83, there is nothing to suggest that those provisions do not apply to parallel imports. Indeed, the provisions of that title refer to ‘medicinal products’ throughout, without any further specification as to their origin or marketing authorisation.

62. Secondly, the purpose of Directive 2001/83, which, according to recital 2, includes the protection of public health, implies to me that the provisions of that directive that are intended to prevent parallel imports of medicinal products from creating an additional risk to public health are applicable to the parallel imports in question. A parallel import should thus, in principle, meet the same requirements as an authorised medicinal product, including as regards the information on its safe use that appears on the packaging.

63. Thirdly, I endorse the interpretation proposed by the referring court (26) to the effect that the Court’s case-law on the application of the labelling requirements in Directive 2001/82/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to veterinary medicinal products (27) to parallel imports of veterinary medicinal products can be transposed to Directive 2001/83. The Court has held that, in the event of the parallel import of a veterinary medicinal product, the provisions of Directive 2001/82 concerning the procedure for issuing a marketing authorisation do not apply; that is not true of the other provisions of that directive. There is nothing to justify the non-application of those stringent provisions, concerning in particular possession, dispensing, labelling and information leaflets and pharmacovigilance, which form part of the coherent system of measures put into place by that directive in order to ensure a high level of protection of public health in cases of parallel imports. On the contrary, if those provisions did not apply in such cases, there would be a risk that the operators in the veterinary medicinal product sector would circumvent the obligations laid down in Directive 2001/82 by importing those medicinal products in parallel. (28)

64. What is necessary to protect animals should a fortiori be necessary as regards humans.

65. Parallel imports of pharmaceutical products thus occupy a hybrid space. In some instances, they are governed by the provisions of Directive 2001/83, whereas in others they are subject to the rules on the free movement of goods under Article 34 et seq. TFEU.

66. My proposed reply to the first question is therefore that the labelling requirements laid down in Article 54, Article 55(3) and Article 63(1) of Directive 2001/83 apply to a medicinal product for which a marketing authorisation has been issued in a Member State and the importation of which into another Member State constitutes a parallel import in relation to a medicinal product already covered by a marketing authorisation in that second Member State.

C. Second question

67. By its second question, the referring court asks, in essence, whether Article 63(3) of Directive 2001/83 must be interpreted as meaning that a medicinal product is not intended to be supplied directly to the patient, within the meaning of that provision, where it is subject to a medical prescription.

68. The referring court seeks to determine to what extent, in relation to the parallel import of a medicinal product, Article 63(3) of Directive 2001/83 permits the competent authority, by means of an administrative decision, to limit the labelling requirements to the name of the medicinal product, the batch number and the expiry date.

69. I would state at the outset that the referring court seems to consider that even though Article 63(3) of Directive 2001/83 has not been transposed into national law, (29) the Court’s interpretation is needed so that it can determine the scope of that provision, before it, (30) in the context of the third question, addresses the issue of the direct effect of that provision.

70. As a consequence of the analysis I have set out above, the second question is hypothetical, because the referring court will not need a reply to that question in order to decide the case before it. That is so because, as detailed above, the two sentences of Article 63(3) of Directive 2001/83 constitute independent grounds for granting exemptions.

71. Nevertheless, for the sake of completeness, I shall briefly address the referring court’s question, to which I believe the answer should be ‘no’: direct supply to a patient is quite different from the question of a medical prescription.

72. A ‘medicinal prescription’ is defined in Article 1(19) of Directive 2001/83 as any such prescription issued by a professional person qualified to do so. (31) By contrast, there is no legal definition of the concept of ‘direct delivery to the patient’.

73. In addition, it is specified in Article 54(n) of Directive 2001/83 that the labelling of a medicinal product which is not subject to a prescription must include an indication of its intended use. Had the intention been to do the same in Article 63(3) of that directive, the legislature should have used the same wording, particularly since that provision merely derogates from Article 54 thereof. However, it did not do so.

74. As a consequence, I consider that Article 63(3) of Directive 2001/83 must not be interpreted as meaning that a medicinal product is not intended to be supplied directly to the patient, within the meaning of that provision, where it is subject to a medical prescription.

D. Third question

75. By its third question, the referring court seeks, in essence, to ascertain whether Article 63(3) of Directive 2001/83 has direct effect, in the sense that an economic operator wishing to import a medicinal product into a Member State from another Member State may rely on that provision before the national courts.

76. The referring court specifies that it needs to ascertain whether A., the intervener in the main proceedings, can rely on the provision in question against the Federal Republic of Germany, the defendant in the main proceedings. (32)

77. The answer to that question is ‘no’.

78. According to settled case-law, whenever the provisions of a directive appear, so far as their subject matter is concerned, to be unconditional and sufficiently precise, they may be relied upon before the national courts by individuals against the Member State where the Member State has failed to implement the directive in domestic law within the period prescribed or where it has failed to implement the directive correctly. (33)

79. As has been seen above, Article 63 of Directive 2001/83 provides for the possibility for the competent authorities of a Member State to adopt measures. That provision is therefore subject to a condition that further measures must be granted by a Member State for its implementation. The wording of Article 63(3) of that directive (34) leaves no doubt in that respect.

80. My proposed reply to the third question referred is therefore that Article 63(3) of Directive 2001/83 does not have direct effect. An economic operator wishing to import a medicinal product into a Member State from another Member State cannot rely on that provision before the national courts against the first Member State.

E. Fourth question

81. By its fourth question, the referring court enquires whether Articles 34 and 36 TFEU must be interpreted as precluding the application of national legislation which requires the labelling of the immediate packaging of a medicinal product for human use imported by means of parallel trade to include certain information in the language of the Member State of importation, where relabelling would substantially affect the stability of that medicinal product.

82. On the basis of my analysis above, I shall be rather brief at this stage in setting out the reasons why I believe the answer is ‘yes’.

83. At the outset, it should be recalled that, as a consequence of the application of the second sentence of Article 63(3) of Directive 2001/83, Articles 34 and 36 TFEU are applicable to the main proceedings in the sense that an exemption granted under the former provision must be in conformity with the latter two provisions.

84. National legislation such as that at issue in the main proceedings, which requires labelling in the language of a Member State, without exception, including where relabelling is not possible without compromising the safety of the medicinal product, constitutes a measure having equivalent effect to a quantitative restriction within the meaning of Article 34 TFEU.

85. Such a restriction may be justified on grounds of public health protection, but it must in any event be necessary and proportionate. It is for the referring court to examine whether that is the case here. On the basis of the information at our disposal, it is fair to assume, however, that the legislation in question, which does not provide for any exceptions, does not meet the proportionality test.

86. As correctly observed by the Commission, the de facto impossibility of importing medicines into Germany in parallel is not necessary for the protection of public health, since the labelling on the outer packaging and the package leaflet are both available in German. The German legislation would therefore have the effect that parallel imports of medicinal products into Germany are impossible, which is, however, not necessary in all cases in order to ensure the effective protection of health.

87. I accordingly propose that the reply to the fourth question referred be that Articles 34 and 36 TFEU must be interpreted as precluding the application of national legislation which requires the labelling of the immediate packaging of a medicinal product for human use imported by means of parallel trade to include certain information in the language of the Member State of importation, where relabelling would substantially affect the stability of that medicinal product.

V. Conclusion

88. In the light of the foregoing considerations, I propose that the Court answer the questions referred by the Bundesverwaltungsgericht (Federal Administrative Court, Germany) as follows:

(1) Article 54, Article 55(3) and Article 63(1) of Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to medicinal products for human use, as amended by Directive 2012/26/EU of the European Parliament and of the Council of 25 October 2012,

must be interpreted as meaning that the labelling requirements contained in those provisions apply to a medicinal product for which a marketing authorisation has been issued in a Member State and the importation of which into another Member State constitutes a parallel import in relation to a medicinal product already covered by a marketing authorisation in that second Member State.

(2) Article 63(3) of Directive 2001/83

must be interpreted as not having direct effect. An economic operator wishing to import a medicinal product into a Member State from another Member State cannot rely on that provision before the national courts against the first Member State.

(3) Articles 34 and 36 TFEU

must be interpreted as precluding the application of national legislation which requires the labelling of the immediate packaging of a medicinal product for human use imported by means of parallel trade to include certain information in the language of the Member State of importation, where relabelling would substantially affect the stability of that medicinal product.

1 Original language: English.

i The name of the present case is a fictitious name. It does not correspond to the real name of any party to the proceedings.

2 Directive of the European Parliament and of the Council of 6 November 2001 on the Community code relating to medicinal products for human use (OJ 2001 L 311, p. 67), amended by Directive 2012/26/EU of the European Parliament and of the Council of 25 October 2012 (OJ 2012 L 299, p. 1; ‘Directive 2001/83’).

3 See recital 2 of Directive 2001/83.

4 See recital 3 of Directive 2001/83.

5 Those provisions exclude substances or combinations of substances which are foods, animal feeding-stuffs or toilet preparations.

6 See recital 4 of Directive 2001/83.

7 See recital 5 of Directive 2001/83. See, also, judgment of 8 November 2007, Gintec (C‑374/05, EU:C:2007:654, paragraph 19).

8 See Article 114(1) TFEU.

9 The legislature must also consult the European Economic and Social Committee.

10 See judgments of 5 October 2000, Germany v Parliament and Council (C‑376/98, EU:C:2000:544, paragraph 83 et seq.); of 12 December 2006, Germany v Parliament and Council (C‑380/03, EU:C:2006:772, paragraph 24); of 8 June 2010, Vodafone and Others (C‑58/08, EU:C:2010:321, paragraph 32 and the case-law cited); and of 3 September 2015, Inuit Tapiriit Kanatami and Others v Commission (C‑398/13 P, EU:C:2015:535, paragraph 26 and the case-law cited).

11 Pursuant to that provision, the Commission, in its proposals concerning health, safety and environmental and consumer protection, is to take as a base a high level of protection, taking account in particular of any new development based on scientific facts. Within their respective powers, the Parliament and the Council will also seek to achieve that objective.

12 See paragraph 21 of the request for a preliminary ruling.

13 I rely on the Court’s standard approach of interpretation. See, by way of example, judgments of 17 November 1983, Merck (292/82, EU:C:1983:335, paragraph 12), and of 5 March 2026, Erdrich Umformtechnik (C‑828/24, EU:C:2026:154, paragraph 24).

14 No mention was initially made to the labelling.

15 According to Article 63(3) of Directive 2001/83, in its original 2001 version, ‘the competent authorities may exempt labels and package leaflets for specific medicinal products from the obligation that certain particulars shall appear and that the leaflet must be in the official language or languages of the Member State where the product is placed on the market, when the product is not intended to be delivered to the patient for self-administration.’

16 See Article 1, point 48, of Directive 2004/27/EC of the European Parliament and of the Council of 31 March 2004 amending Directive 2001/83 (OJ 2004 L 136, p. 34). Article 63(3) of Directive 2001/83 came to read: ‘When the product is not intended to be delivered directly to the patient, the competent authorities may grant an exemption to the obligation that certain particulars should appear on the labelling and in the package leaflet and that the leaflet must be in the official language or languages of the Member State in which the product is placed on the market.’

17 See Article 1, point 19, of Directive 2010/84/EU of the European Parliament and of the Council of 15 December 2010 amending, as regards pharmacovigilance, Directive 2001/83 (OJ 2010 L 348, p. 74), pursuant to which Article 63(3) was replaced by the following: ‘When the medicinal product is not intended to be delivered directly to the patient, or where there are severe problems in respect of the availability of the medicinal product, the competent authorities may, subject to measures they consider necessary to safeguard human health, grant an exemption to the obligation that certain particulars should appear on the labelling and in the package leaflet. They may also grant a full or partial exemption to the obligation that the labelling and the package leaflet must be in the official language or languages of the Member State in which the medicinal product is placed on the market.’

18 Pun intended.

19 See also, by analogy, judgment of 21 December 2023, Infraestruturas de Portugal and Futrifer Indústrias Ferroviárias (C‑66/22, EU:C:2023:1016, paragraphs 50 to 58, in particular paragraph 53).

20 See, to that effect, Opinion of Advocate General Geelhoed in Ferring (C‑172/00, EU:C:2002:86, point 44).

21 As stated in the Opinion of Advocate General Geelhoed in Ferring (C‑172/00, EU:C:2002:86, point 45).

22 See judgment of 25 November 2021, Delfarma (C‑488/20, EU:C:2021:956, paragraph 29).

23 Emphasis added.

24 See, by way of example, judgments of 3 July 2019, Delfarma (C‑387/18, EU:C:2019:556, paragraph 19), and of 8 October 2020, kohlpharma (C‑602/19, EU:C:2020:804, paragraph 25). The same applies equally to the precursor to Directive 2001/83; see judgment of 16 December 1999, Rhône-Poulenc Rorer and May & Baker (C‑94/98, EU:C:1999:614, paragraph 27).

25 Indeed, in its judgment of 12 November 1996, Smith & Nephew and Primecrown (C‑201/94, EU:C:1996:432, paragraph 21), the Court, with respect to the precursor to Directive 2001/83, referred specifically to the procedure for issuing marketing authorisations.

26 See paragraph 14 of the request for a preliminary ruling.

27 OJ 2001 L 311, p. 1.

28 See judgment of 27 October 2016, Audace and Others (C‑114/15, EU:C:2016:813, paragraph 56).

29 That court refers to a partial transposition of that provision by Paragraph 10(1a) of the AMG in 2020, and therefore prior to the contested decision.

30 That is to say: the referring court.

31 Article 71 of Directive 2001/83 specifies the situations in which medicinal products must be subject to a medical prescription.

32 See paragraph 25 of the request for a preliminary ruling.

33 See, by way of example, judgments of 1 July 2010, Gassmayr (C‑194/08, EU:C:2010:386, paragraph 45 and the case-law cited), and of 10 December 2020, Golfclub Schloss Igling (C‑488/18, EU:C:2020:1013, paragraph 26).

34 ‘the competent authorities may …’. Emphasis added.

Opinion of Advocate General Szpunar delivered on 11 June 2026.###

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