Almirall Judgment on Pharmacy-Prepared Medicinal Products

Almirall (Medicinal products for human use - Medicinal products prepared in a pharmacy in accordance with the prescriptions of a pharmacopoeia and intended to be supplied directly to the patients served by the pharmacy in question - Judgment) [2026] EUECJ C-589/24 (19 March 2026)

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  Almirall (Medicinal products for human use - Medicinal products prepared in a pharmacy in accordance with the prescriptions of a pharmacopoeia and intended to be supplied directly to the patients served by the pharmacy in question - Judgment) [2026] EUECJ C-589/24 (19 March 2026)

URL: https://www.bailii.org/eu/cases/EUECJ/2026/C58924.html
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[2026] EUECJ C-589/24,

EU:C:2026:217,

ECLI:EU:C:2026:217 | | |
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Provisional text

JUDGMENT OF THE COURT (Fourth Chamber)

19 March 2026 (*)

( Reference for a preliminary ruling - Medicinal products for human use - Directive 2001/83/EC - Scope - Article 2(1) - Medicinal products prepared industrially or manufactured by a method involving an industrial process - Article 3(2) - Medicinal products prepared in a pharmacy in accordance with the prescriptions of a pharmacopoeia and intended to be supplied directly to the patients served by the pharmacy in question - Exclusion from the directive's scope - National regulation subjecting the latter medicinal products to an authorisation requirement on the basis of a numerical criterion )

In Case C‑589/24,

REQUEST for a preliminary ruling under Article 267 TFEU from the Hoge Raad der Nederlanden (Supreme Court of the Netherlands), made by decision of 6 September 2024, received at the Court on 11 September 2024, in the proceedings

Almirall BV,

Almirall SA

v

Infinity Pharma BV,

Pharmaline BV,

THE COURT (Fourth Chamber),

composed of I. Jarukaitis, President of the Chamber, M. Condinanzi, N. Jääskinen, R. Frendo (Rapporteur) and A. Kornezov, Judges,

Advocate General: M. Szpunar,

Registrar: A. Calot Escobar,

having regard to the written procedure,

after considering the observations submitted on behalf of:

–        Almirall BV and Almirall SA, by C.I. de Geus, N.U.N. Kien, M.O. Meulenbelt and I.L.N. Timp, advocaten,

–        Infinity Pharma BV and Pharmaline BV, by T. van Malssen, A.J.H.W.M. Versteeg and T.G. Wouda, advocaten,

–        the Netherlands Government, by E.M.M. Besselink and M.K. Bulterman, acting as Agents,

–        the Estonian Government, by M. Kriisa, acting as Agent,

–        Ireland, by M. Browne, Chief State Solicitor, S. Finnegan and A. Joyce, acting as Agents, and by S. Aherne, Barrister-at-Law, and N.J. Travers, Senior Counsel,

–        the Greek Government, by Z. Chatzipavlou, V. Karra and S. Trekli, acting as Agents,

–        the Polish Government, by B. Majczyna and D. Lutostańska, acting as Agents,

–        the European Commission, by E. Mathieu, A. Spina and G. Wils, acting as Agents,

after hearing the Opinion of the Advocate General at the sitting on 9 October 2025,

gives the following

Judgment

1 This request for a preliminary ruling concerns the interpretation of Article 3(2), Article 6 and Article 40(2) 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 (OJ 2001 L 311, p. 67), as amended by Regulation (EC) No 1394/2007 of the European Parliament and of the Council of 13 November 2007 (OJ 2007 L 324, p. 121) ('Directive 2001/83').

2 The request has been made in proceedings between, on the one hand, the pharmaceutical companies Almirall BV and Almirall SA ('Almirall') and, on the other hand, the dispensing pharmacies Infinity BV and Pharmaline BV, concerning the prohibition on the latter pharmacies to prepare or supply medicinal products in excess of a certain quantity.

Legal context

European Union law

3 Recitals 2, 4, 5 and 14 of Directive 2001/83 state:

'(2)      The essential aim of any rules governing the production, distribution and use of medicinal products must be to safeguard public health.

…

(4)      Trade in medicinal products within the [European Union] is hindered by disparities between certain national provisions, in particular between provisions relating to medicinal products (excluding substances or combinations of substances which are foods, animal feeding-stuffs or toilet preparations), and such disparities directly affect the functioning of the internal market.

(5)      Such hindrances must accordingly be removed; whereas this entails approximation of the relevant provisions.

…

(14)      This Directive represents an important step towards achievement of the objective of the free movement of medicinal products. Further measures may abolish any remaining barriers to the free movement of proprietary medicinal products will be necessary in the light of experience gained, particularly in the … Committee for Proprietary Medicinal Products.'

4 Articles 2, 3 and 5 of that directive come under Title II thereof, entitled 'Scope'.

5 Article 2(1) of that directive provides:

'This Directive shall apply to medicinal products for human use intended to be placed on the market in Member States and either prepared industrially or manufactured by a method involving an industrial process.'

6 Under Article 3(1) and (2) of that directive:

'This Directive shall not apply to:

1.      Any medicinal product prepared in a pharmacy in accordance with a medical prescription for an individual patient (commonly known as the magistral formula).

2.      Any medicinal product which is prepared in a pharmacy in accordance with the prescriptions of a pharmacopoeia and is intended to be supplied directly to the patients served by the pharmacy in question (commonly known as the officinal formula).'

7 Article 5 of Directive 2001/83 sets out certain cases in which a Member State may allow the distribution of unauthorised medicinal products.

8 Article 6 of Directive 2001/83 forms part of Chapter 1 of that directive, entitled 'Marketing authorisation', which appears in Title III of that directive, entitled 'Placing on the market'. Paragraph 1 of that article provides:

'No medicinal product may be placed on the market of a Member State unless a marketing authorisation has been issued by the competent authorities of that Member State in accordance with this Directive or an authorisation has been granted in accordance with Regulation (EC) No 726/2004 [of the European Parliament and of the Council of 31 March 2004 laying down Community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European Medicines Agency (OJ 2004 L 136, p. 1)], read in conjunction with Regulation (EC) No 1901/2006 of the European Parliament and of the Council of 12 December 2006 on medicinal products for paediatric use [(OJ 2006 L 378, p. 1)] and Regulation (EC) No 1394/2007.'

9 Article 40(1) and (2) of that directive, which appears in Title IV thereof, entitled 'Manufacture and importation', provides:

'1.      Member States shall take all appropriate measures to ensure that the manufacture of the medicinal products within their territory is subject to the holding of an authorisation. This manufacturing authorisation shall be required no[t]withstanding that the medicinal products manufactured are intended for export.

…

2.      The authorisation referred to in paragraph 1 shall be required for both total and partial manufacture, and for the various processes of dividing up, packaging or presentation.

However, such authorisation shall not be required for preparation, dividing up, changes in packaging or presentation where these processes are carried out, solely for retail supply, by pharmacists in dispensing pharmacies or by persons legally authorised in the Member States to carry out such processes.'

Netherlands law

10 Article 18(1) and (5) of the Geneesmiddelenwet (Law on medicinal products) of 8 February 2007 (Stb. 2007, No 93), as amended by the Law of 7 November 2011 (Stb. 2011, No 572) ('the Law on medicinal products') provides:

'1.      It is prohibited to prepare or import medicinal products intended for research without authorisation from [the minister van Medische Zorg en Sport (Netherlands Minister for Medical Care and Sport, “the Minister”)]. It is also prohibited to prepare, import, store, offer for sale, deliver or export or otherwise supply within or outside the territory of the Netherlands, or to engage in selling wholesale, medicinal products other than those referred to in the first sentence without authorisation from the Minister …

…

5.      The second sentence of the first paragraph does not apply to the preparation of medicinal products on a small scale for dispensing in pharmacies by or on behalf of a pharmacist or general practitioner [authorised to prepare medicinal products] and to the storage or sale of medicinal products by them.

…'

11 Article 40(1) to (3) of that law provides:

'1.            It is prohibited to place a medicinal product on the market without a European Union marketing authorisation granted under [Regulation No 726/2004] or under that regulation in conjunction with Regulation No 1394/2007, or by the European Medicines Agency, granted under this chapter.

2.      It is prohibited to store, offer for sale, sell, supply, make available, import, export or otherwise bring into or out of the Netherlands a medicinal product that has not been granted a marketing authorisation.

3.      The prohibition referred to in the first or second paragraph shall not apply to:

(a)      medicinal products prepared and supplied on a small scale by or on behalf of a pharmacist or general practitioner [authorised to prepare medicinal products], in his or her dispensary;

…'

The dispute in the main proceedings and the questions referred for a preliminary ruling

12 Almirall is an international pharmaceutical company which produces and distributes the medicinal product Skilarence, used for the treatment of psoriasis. Almirall has a marketing authorisation and a manufacturing authorisation for Skilarence, issued in accordance with Articles 18 and 40 of the Law on medicinal products. That medicinal product, the active substance of which is dimethyl fumarate, has been available on the Netherlands market since 1 July 2008.

13 Until December 2021, Infinity, a dispensing pharmacy established in the Netherlands, prepared, at its premises, the medicinal product Psorinovo, also intended for the treatment of psoriasis and containing the same active substance. Pharmaline, which is a sister company of Infinity to which Infinity sold its assets, has been preparing the medicinal product Psorinovo in its pharmacy since 1 January 2021. Infinity and Pharmaline do not have marketing and manufacturing authorisations for that medicinal product.

14 On 8 April 2019, the Minister sent a letter to the Tweede Kamer der Staten-Generaal (Netherlands House of Representatives) in which he stated that medicinal products prepared and supplied by or on behalf of a pharmacist or general practitioner are exempt from the requirement to obtain authorisation under certain conditions, including the condition that the preparation must be intended for retail supply or supply in small quantities. That condition is considered to be satisfied when the number of different patients to whom the medicinal product is supplied each month does not exceed 50 in the case of long-term use of the medicinal product ('the numerical criterion').

15 Being of the view that Infinity's preparation and supply of the medicinal product Psorinovo did not fulfil that numerical criterion, Almirall brought civil proceedings against Infinity, in which the rechtbank Oost-Brabant (District Court, Oost-Brabant, Netherlands) ordered Infinity, by a provisionally enforceable judgment of 8 September 2021, to cease preparing medicinal products for supplying individually unless that supply remained within the limits of 50 different patients per month in the event of long-term use of the medicinal product.

16 Almirall also brought interlocutory proceedings before the rechtbank Overijssel (District Court, Overijssel, Netherlands) seeking the same injunction against Pharmaline. By judgment of 15 December 2021, that court prohibited Pharmaline, with effect from 1 January 2022, from preparing or supplying the medicinal product Psorinovo, or any other pharmaceutical preparation the active ingredient of which is dimethyl fumarate, for supplying individually in excess of the numerical criterion.

17 Pharmaline and Infinity appealed against the judgments referred to in paragraphs 15 and 16 of this judgment before the Gerechtshof Arnhem-Leeuwarden (Court of Appeal, Arnhem-Leeuwarden, Netherlands). By judgment of 15 November 2022, that court, first, imposed on Infinity the same prohibition as that imposed by the rechtbank Oost-Brabant (District Court, Oost-Brabant), which is no longer at issue before the referring court.

18 Second, the Gerechtshof Arnhem-Leeuwarden (Court of Appeal, Arnhem-Leeuwarden) imposed on Pharmaline a less extensive prohibition than that imposed by the court of first instance. Specifically, Pharmaline was prohibited, with immediate effect, from preparing or supplying the medicinal product Psorinovo or any pharmaceutical preparation containing the same active substance, intended to be dispensed individually in accordance with the officinal formula, once the numerical criterion had been reached. However, that court specified that this prohibition applies only when that medicinal product or pharmaceutical preparation is not compliant with the pharmacopoeia or is not supplied directly to customers of Pharmaline's pharmacy. In that regard, that court considered, first of all, that the purpose of the Law on medicinal products is, inter alia, to implement Directive 2001/83 and that it must therefore be interpreted in accordance with that directive. Next, it held that the preparation and supply of the medicinal product Psorinovo by Pharmaline satisfied the conditions laid down in Article 3(2) of that directive, with the result that that medicinal product comes within the scope of the concept 'officinal formula' within the meaning of that provision. Lastly, that court took the view that that provision of the directive did not impose a quantitative condition such as that laid down by the national law in question or a numerical criterion such as that established by the Minister, with the result that that condition and that criterion could not be taken into consideration. Thus, Pharmaline is authorised to dispense the medicinal product in question in its pharmacy without being required to comply with that criterion.

19 Almirall lodged an appeal on a point of law against that judgment before the Hoge Raad der Nederlanden (Supreme Court of the Netherlands), which is the referring court. In support of its appeal, Almirall argues that the numerical criterion must be taken into account in the assessment of Article 3(2) of Directive 2001/83. Indeed, that provision, which defines the scope of that directive, does not contain exhaustive conditions which, if satisfied, would prevent Member States from laying down additional conditions or specifying the rule that authorisation is not necessary for the supply of medicinal products on a small scale. Consequently, if the conditions laid down in that provision are satisfied, that directive does not apply, with the result that the sovereignty of the Member States is not limited and an interpretation of the national provisions concerned in conformity with that directive is not required. Furthermore, in its view, the condition laid down in Article 3(2) of Directive 2001/83, according to which the medicinal products are intended to be supplied directly to the patients served by the pharmacy, has an inherent quantitative aspect.

20 The referring court asks whether Article 3(2) of Directive 2001/83 must be interpreted as meaning that that directive does not apply when a medicinal product satisfies the conditions laid down by that provision, with the result that Member States are free to make the manufacture or supply of such a medicinal product subject to the obligation to obtain an authorisation under national law.

21 That court states that, in order to answer that question, it is necessary to ascertain whether Directive 2001/83, or at least Article 3(2) thereof, provides for full harmonisation, since, in the case of minimum harmonisation, the application of a quantitative criterion such as the numerical criterion, in addition to the qualitative conditions laid down in Article 3(2) of that directive, could be compatible with that directive.

22 In addition, that court asks whether the second subparagraph of Article 40(2) of Directive 2001/83, which contains the expression ' voor verstrekking in het klein ' (for retail supply or supply in small quantities) in the Dutch-language version of the exception provided for in that second subparagraph of Article 40(2), is relevant to the interpretation of Article 3(2) of that directive. If it is, it could be inferred from that expression, which necessarily implies a quantitative aspect, that the numerical criterion supplements the definition set out in Article 3(2) and that the national legislature is authorised to lay down a quantitative condition when implementing that directive. In that regard, however, it could be inferred from the English- ('solely for retail supply'), French- (' uniquement en vue de la déliverance au detail ') and Italian-language (' soltanto per la fornitura al dettaglio ') versions of that second subparagraph of Article 40(2) that that provision aims to exempt from the authorisation requirement certain processes carried out by pharmacists in their retail activities and therefore presupposes compliance with a qualitative condition.

23 In those circumstances, the Hoge Raad der Nederlanden (Supreme Court of the Netherlands) decided to stay the proceedings and to refer the following questions to the Court of Justice for a preliminary ruling:

'(1)      Does a directive-compliant interpretation of [Article] 18(5) and [Article] 40(3) of the [Law on medicinal products], in the light of the provisions of Article 3(2) of [Directive 2001/83], reconcile the fact that the assessment of one of the exceptions to the authorisation requirement laid down in national law is also based on a quantitative measure that has been concretised by a numerical criterion?

(2)      Are the national authorities free to subject a medicinal product that falls under Article 3(2) of [Directive 2001/83], whereby the authorisation requirements regulated in Articles 6 and 40 of the same directive do not apply, to a national authorisation requirement on the basis of a quantitative condition regulated by national law and concretised by a numerical criterion?

(3)      Is it relevant to the answer to Questions 1 and 2 whether [Directive 2001/83] provides for full harmonisation for the parts relevant to this case and, if so, does it provide for full harmonisation?

(4)      To what extent is it relevant to the answers to Questions 1 and 2 that, according to the Dutch-language version, the exception set out in the second sentence of Article 40(2) of [Directive 2001/83] applies to ' verstrekking in het klein ' [(meaning 'retail supply' or 'supply in small quantities')] or, according to the English-, French- and Italian-language versions of the directive, appears to relate to a number of operations performed by the pharmacist in the context of retail?'

Consideration of the questions referred

Admissibility

24 In the first place, Almirall disputes the findings of fact made by the referring court and the legal classification of the activity carried out by Pharmaline and Infinity in the light of Article 3(2) of Directive 2001/83 adopted by that court and submits that, given the actual circumstances of the dispute in the main proceedings, the questions referred are hypothetical.

25 In that regard, it should be borne in mind that under the division of jurisdiction between the Court of Justice and the national courts, the Court must take into account the factual and legal context of the questions referred for a preliminary ruling as set out in the order for reference. Therefore, since the referring court has defined the factual and legislative context of the questions it is asking, it is not for the Court to verify the accuracy of those questions (judgment of 29 June 2023, International Protection Appeals Tribunal and Others (Attack in Pakistan), C‑756/21, EU:C:2023:523, paragraphs 37 and 38 and the case-law cited).

26 In the second place, Infinity submits that the second and third questions referred by the referring court are hypothetical. Only the concept of 'on a small scale' is provided for in the national legislation, and that concept should be interpreted as meaning 'intended to be supplied directly to the patients served by the pharmacy in question', in accordance with Article 3(2) of Directive 2001/83. There is no other quantitative condition laid down by the Netherlands legislation.

27 In that regard, it must be noted that, according to settled case-law, in the context of cooperation between the Court and national courts established in Article 267 TFEU, it is solely for the national court before which the dispute has been brought, and which must assume responsibility for the subsequent judicial decision, to determine, in the light of the particular circumstances of the case in the main proceedings, the relevance of the questions which it submits to the Court. Where the questions referred concern the interpretation or validity of a rule of EU law, the Court is in principle required to give a ruling. It follows that a question referred for a preliminary ruling concerning EU law enjoys a presumption of relevance. The Court may refuse to rule on such a question only where it is quite obvious that the interpretation of EU law that is sought bears no relation to the actual facts of the main action or its purpose, where the problem is hypothetical, or where the Court does not have before it the factual or legal material necessary to give a useful answer to the questions submitted to it (judgments of 13 July 2000, Idéal tourisme, C‑36/99, EU:C:2000:405, paragraph 20, and of 20 March 2025, Arce, C‑365/23, EU:C:2025:192, paragraph 38 and the case-law cited).

28 In the present case, it is not obvious that the interpretation of EU law sought bears no relation to the actual facts of the main action or its purpose, or that the problem is hypothetical. It is apparent from the order for reference that the referring court is uncertain as to the scope of Article 3(2) of Directive 2001/83 in the context of a dispute which concerns, inter alia, the interpretation of national legislation in conformity with that directive and, more specifically, the extent to which a quantitative criterion may be adopted in national law where the conditions for the application of that article are satisfied.

29 It follows that the questions referred by the referring court are admissible.

Substance

30 As a preliminary point, it should be noted that Almirall criticises the referring court for having incorrectly formulated the questions referred for a preliminary ruling and suggests, in its written observations, that those questions be reformulated and additional questions which have not been raised by the referring court be answered.

31 Suffice it to recall in this regard that, according to settled case-law, it is for the national courts alone, before which the proceedings are pending and which must assume responsibility for the judgment to be given, to determine, having regard to the particular features of each case, both the need for a preliminary ruling to enable them to give judgment and the relevance of the questions which they refer to the Court. In particular, it is for the national court alone to determine and formulate such questions. The parties to the main proceedings may not change their tenor. Consequently, the Court cannot grant a request that the questions be reformulated in the terms which a party to the main proceedings indicates (judgment of 7 June 2018, Scotch Whisky Association, C‑44/17, EU:C:2018:415, paragraph 22 and the case-law cited).

32 By its questions, which it is appropriate to examine together, the referring court asks, in essence, whether Article 3(2) of Directive 2001/83 must be interpreted as precluding national legislation which provides that the preparation of medicinal products in a pharmacy in accordance with the prescriptions of a pharmacopoeia and intended to be supplied directly to the patients served by the pharmacy in question is subject to a national authorisation requirement in cases where that preparation does not satisfy the condition that the medicinal products concerned must be intended for retail supply or supply in small quantities, that condition being expressed, in practice, in the form of a specific numerical criterion. In that context, the referring court also asks whether, in order to answer those questions, the following are relevant: first, the level of harmonisation effected by that directive and, second, the fact that the second subparagraph of Article 40(2) of that directive contains the expression 'retail supply', which could also be understood, in its Dutch-language version, as referring to the supply of medicinal products in small quantities.

33 In that regard, first of all, it should be noted that Article 2(1) and Article 3(1) and (2) of Directive 2001/83 are in Title II thereof, which defines the scope of that directive.

34 It follows from the wording of those provisions that Article 2(1) of Directive 2001/83 makes a positive determination of the scope of that directive, by providing that it is to apply to medicinal products for human use intended to be placed on the market in Member States and either prepared industrially or manufactured by a method involving an industrial process, while Article 3(1) and (2) of that directive provides for certain cases in which that directive does not apply. It follows that, in order to come within the scope of Directive 2001/83, the product in question, first, must satisfy the conditions laid down in Article 2(1) of that directive and, second, must not come within one of the cases expressly provided for in Article 3 of that directive (see, to that effect, judgments of 26 October 2016, Hecht-Pharma, C‑276/15, EU:C:2016:801, paragraph 29, and of 21 November 2018, Novartis Farma, C‑29/17, EU:C:2018:931, paragraph 55 and the case-law cited).

35 It is therefore the industrial character of the production of a medical product which determines whether that product comes within the scope of Directive 2001/83, bearing in mind that the EU legislature specifically specified that medicinal products prepared in a pharmacy in accordance with the conditions set out in Article 3 of that directive are expressly excluded from its scope (judgment of 21 November 2018, Novartis Farma, C‑29/17, EU:C:2018:931, paragraph 56).

36 Thus, pursuant to Article 3(2) of Directive 2001/83, that directive does not apply to 'any medicinal product which is prepared in a pharmacy in accordance with the prescriptions of a pharmacopoeia and is intended to be supplied directly to the patients served by the pharmacy in question (commonly known as the officinal formula)'. It is clear from the wording of that provision that its application is subject to the fulfilment of a set of conditions concerning the medicinal products in question. Those products must be prepared 'in a pharmacy', 'in accordance with the prescriptions of a pharmacopoeia' and be 'intended to be supplied directly to the patients served by the pharmacy in question'. Those conditions are cumulative, with the result that that provision cannot apply if one of them is not satisfied (see, to that effect, judgment of 26 October 2016, Hecht-Pharma, C‑276/15, EU:C:2016:801, paragraph 37 and the case-law cited).

37 The application of Article 3(2) of Directive 2001/83 requires only that the conditions expressly laid down in that provision be satisfied (see, to that effect, judgment of 16 July 2015, Abcur, C‑544/13 and C‑545/13, EU:C:2015:481, paragraph 55).

38 It follows that, first, Article 3(2) of Directive 2001/83 lists those conditions exhaustively. Second, the fact mentioned by the referring court that the second subparagraph of Article 40(2) of that directive contains the expression 'retail supply', which could also be understood, in the Dutch-language version, as referring to the supply of medicinal products in small quantities, is irrelevant for the purposes of interpreting Article 3(2) of that directive. Indeed, the second subparagraph of Article 40(2) lays down the conditions under which certain processes concerning medicinal products coming within the scope of that directive are exempt from the requirement to hold a manufacturing authorisation, within the meaning of paragraph 1 of that article. Since the respective objectives and fields of application of Article 3(2) and the second subparagraph of Article 40(2) of Directive 2001/83 are different, the latter article is in no way intended to supplement the conditions laid down in the former article.

39 Accordingly, where a medicinal product satisfies all the conditions laid down in Article 3(2) of Directive 2001/83, set out in paragraph 36 of the present judgment, the medicinal product in question does not come within the scope of that directive.

40 As a result, where the Member States lay down, in their national law, an authorisation requirement for the manufacture or placing on the market of such a medicinal product, such a requirement, and the conditions for the grant of such authorisations, come within the competencies retained by the Member States, without being governed by Directive 2001/83, and therefore do not have to be assessed in the light of that directive. Indeed, such legislation is in a situation that is different from that in which an act of the European Union gives the Member States the freedom to choose between various methods of implementation or grants them a margin of discretion which is an integral part of the regime established by that act, and is also different from the situation in which such an act authorises the adoption, by the Member States, of specific measures intended to contribute to the achievement of the objective of that act or derogatory measures, such as those referred to in Article 5 of that directive (see, to that effect, judgments of 19 November 2019, TSN and AKT, C‑609/17 and C‑610/17, EU:C:2019:981, paragraphs 50 and 52, and of 10 June 2021, Land Oberösterreich (Housing assistance), C‑94/20, EU:C:2021:477, paragraphs 46 to 48 and the case-law cited).

41 Furthermore, in the light of the foregoing, it must be stated that the level of harmonisation effected by Directive 2001/83 has no effect on the margin of discretion which the Member States have when adopting legislation concerning medicinal products that come within the scope of Article 3(2) of that directive, or on the interpretation thereof.

42 In the present case, it is apparent from the order for reference that the medicinal product Psorinovo is prepared in accordance with the prescriptions of a pharmacopoeia by two dispensing pharmacies, Infinity and Pharmaline, which supply that medicinal product to the patients they serve. Thus, subject to the verifications which it is for the referring court to carry out, all the conditions for the application of Article 3(2) of Directive 2001/83 referred to in paragraph 36 of the present judgment appear to be satisfied, with the result that that provision applies to a medicinal product such as that in question in the main proceedings and that that medicinal product does not come within the scope of that directive.

43 In the light of the foregoing considerations, the answer to the questions referred is that Article 3(2) of Directive 2001/83 must be interpreted as meaning that legislation which provides that the preparation of medicinal products in a pharmacy in accordance with the prescriptions of a pharmacopoeia and intended to be supplied directly to the patients served by the pharmacy in question is subject to a national authorisation requirement in cases where that preparation does not satisfy the condition that the medicinal products concerned must be intended for retail supply or supply in small quantities, that condition being expressed, in practice, in the form of a specific numerical criterion, does not come within the scope of that directive.

Costs

44 Since these proceedings are, for the parties to the main proceedings, a step in the action pending before the referring court, the decision on costs is a matter for that court. Costs incurred in submitting observations to the Court, other than the costs of those parties, are not recoverable.

On those grounds, the Court (Fourth Chamber) hereby rules:

Article 3(2) 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 Regulation (EC) No 1394/2007 of the European Parliament and of the Council of 13 November 2007,

must be interpreted as meaning that legislation which provides that the preparation of medicinal products in a pharmacy in accordance with the prescriptions of a pharmacopoeia and intended to be supplied directly to the patients served by the pharmacy in question is subject to a national authorisation requirement in cases where that preparation does not satisfy the condition that the medicinal products concerned must be intended for retail supply or supply in small quantities, that condition being expressed, in practice, in the form of a specific numerical criterion, does not come within the scope of that directive.

[Signatures]

* Language of the case: Dutch.

© European Union
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