Provisional text

OPINION OF ADVOCATE GENERAL

SZPUNAR

delivered on 9 October 2025 (1)

Case C‑589/24

Almirall BV,

Almirall SA

v

Infinity Pharma BV,

Pharmaline BV

(Request for a preliminary ruling from the Hoge Raad der Nederlanden (Supreme Court of the Netherlands))

( Reference for a preliminary ruling – Approximation of laws – Medicinal products for human use – Directive 2001/83/EC – Scope – 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 – National legislation limiting the scope of the derogation from the requirement to obtain an authorisation laid down for such medicinal products using a criterion relating to the quantity supplied per month )

I.      Introduction

1.        In accordance with Article 3(2) of Directive 2001/83/EC, (2) the Community code relating to medicinal products for human use, established by that directive, excludes from its scope, inter alia, 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 (‘the officinal formula’). The preparation and supply of the officinal formula are therefore not subject to the conditions laid down by that directive, namely, inter alia, the requirement to obtain a marketing authorisation and a manufacturing authorisation, the scale of a pharmacy’s activity in that area being irrelevant in that regard.

2.        As regards that exemption, Netherlands law contains a condition for its application in addition to those deriving from Directive 2001/83, namely that the preparation and supply of the officinal formula must be carried out ‘on a small scale’ (‘the quantitative condition’). That condition is considered to be satisfied where the monthly number of different patients to whom the officinal formula is supplied does not exceed a cap set at around 50 in the case of long-term use of the medicinal product (‘the numerical criterion’).

3.        In the light of that quantitative condition and the numerical criterion, Almirall BV and Almirall SA, two undertakings belonging to an international pharmaceutical group (together, ‘Almirall’), brought various actions against Infinity Pharma BV and Pharmaline BV, two undertakings established in the Netherlands (‘the defendants in the main proceedings’), seeking, in essence, to prohibit the defendants from supplying the officinal formula if the limit set by the numerical criterion is exceeded. The referring court, the Hoge Raad der Nederlanden (Supreme Court of the Netherlands), hearing an appeal on a point of law brought by Almirall, asks, in essence, whether, as regards the derogation from the requirement to obtain a marketing authorisation and a manufacturing authorisation, laid down for the officinal formula, Directive 2001/83 precludes the limitation of its scope as a result of the application of a quantitative condition and a numerical criterion.

II.    Legal framework

A.      European Union law

4.        Recitals 2, 4 and 5 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 Community 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.’

5.        Article 1(2) of that directive provides:

‘For the purposes of this Directive, the following terms shall bear the following meanings:

…

(2)      Medicinal product:

(a)      Any substance or combination of substances presented as having properties for treating or preventing disease in human beings; or

(b)      Any substance or combination of substances which may be used in or administered to human beings either with a view to restoring, correcting or modifying physiological functions by exerting a pharmacological, immunological or metabolic action, or to making a medical diagnosis.’

6.        Article 2(1) of that directive provides that it ‘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’.

7.        Article 3(2) of that directive provides that it is not to apply, inter alia, 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)’.

8.        The first subparagraph of Article 6(1) of Directive 2001/83 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, ^[(3)^] read in conjunction with Regulation (EC) No 1901/2006 … ^[(4)^] and Regulation (EC) No 1394/2007. ^[(5)^]’

9.        Article 40(1) and (2) of that directive 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 notwithstanding 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.’

B.      Netherlands law

10.      Article 18(1) and (5) of the Geneesmiddelenwet (Law on Medicinal Products) of 8 February 2007, (6) as amended by the Law of 7 November 2011 (7) (‘the Law of 8 February 2007’), provides:

‘1.      It is prohibited to prepare or import investigational medicinal products without authorisation [from the] Minister. It is also prohibited, without authorisation [from the] Minister, to prepare, import, stock, offer for sale, supply or export or otherwise bring into or take out of Netherlands territory medicinal products other than those referred to in the first sentence, or to distribute them wholesale …

…

5.      The second sentence of paragraph 1 does not apply to the small-scale preparation of medicinal products for the purpose of being dispensed in a pharmacy by or on the instructions of a pharmacist, or of a general practitioner [authorised to prepare medicinal products], and to the stocking or offering for 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 an EU marketing authorisation granted in accordance with [Regulation No 726/2004] or in accordance with that regulation read in conjunction with Regulation No 1394/2007, or an authorisation from the Agency for the Evaluation of Medicinal Products, granted in accordance with this Chapter.

2.      It is prohibited to stock, offer for sale, sell, supply, make available, import, export or otherwise bring into or take out of Netherlands territory a medicinal product without a marketing authorisation.

3.      The prohibition referred to in paragraph 1 or 2 shall not apply to:

(a)      medicinal products which are prepared and supplied on a small scale by or on the instructions of a pharmacist, or of a general practitioner [authorised to prepare medicinal products], in his or her pharmacy;

…’

III. The dispute in the main proceedings, the questions referred for a preliminary ruling and the proceedings before the Court

12.      Almirall produces and distributes the medicinal product Skilarence, which is used for the treatment of psoriasis. That medicinal product contains the active ingredient dimethyl fumarate and has been available on the Netherlands market since 1 July 2008.

13.      Until December 2021, Infinity Pharma, established in the Netherlands, prepared in its pharmacy the medicinal product Psorinovo, which is also intended for the treatment of psoriasis and contains the same active ingredient as Skilarence. Pharmaline, a sister company of Infinity Pharma, has been preparing Psorinovo in its pharmacy since 1 January 2021.

14.      Almirall holds a marketing authorisation and a manufacturing authorisation for Skilarence in accordance with Articles 18 and 40 of the Law of 8 February 2007. The defendants in the main proceedings, do not hold those authorisations for Psorinovo.

15.      On 8 April 2019, the Netherlands Minister for Medical Care and Sport (‘the Minister’) sent a letter to the Tweede Kamer (House of Representatives of the Netherlands Parliament) stating that compliance with the quantitative condition is subject to the application of the numerical criterion. (8)

16.      Almirall then brought, inter alia, civil proceedings against Infinity Pharma in which the Rechtbank Oost-Brabant (East Brabant District Court, Netherlands) ordered Infinity Pharma, by a provisionally enforceable judgment of 8 September 2021, to cease preparing medicinal products intended to be supplied on an individual basis as a magistral formula once the number of different patients to whom those medicinal products had been supplied or dispensed reached the limit of 50 per month for long-term use of the medicinal product (‘the judgment of 8 September 2021’).

17.      In addition, Almirall also brought an application for interim measures seeking to impose on the defendants in the main proceedings, in essence, a prohibition corresponding to that laid down in the judgment of 8 September 2021 and concerning Psorinovo. By judgment of 15 December 2021, the Rechtbank Overijssel (District Court, Overijssel, Netherlands) prohibited the defendants in the main proceedings from preparing or supplying, after 1 January 2022, Psorinovo or any pharmaceutical preparation containing the active ingredient dimethyl fumarate, intended to be supplied on an individual basis as a magistral formula, once the limit set by the numerical criterion has been reached (‘the judgment of 15 December 2021’).

18.      The defendants in the main proceedings brought an appeal against that judgment before the Gerechtshof Arnhem-Leeuwarden (Court of Appeal, Arnhem-Leeuwarden, Netherlands). By judgment of 15 November 2022, on the ground that its decision had to based on the judgment of 8 September 2021, that court imposed a prohibition on Infinity Pharma that was, in essence, the same as that imposed by the judgment of 15 December 2021, but concerning Psorinovo or any pharmaceutical preparation containing the active ingredient dimethyl fumarate, intended to be supplied on an individual basis as an officinal formula. (9) As regards Pharmaline, on the other hand, taking into account the fact that that undertaking was not a party to the procedure concluded by that decision, that court imposed a less far-reaching prohibition that was limited, in essence, to situations in which the conditions laid down in Article 3(2) of Directive 2001/83 were not fulfilled. Specifically, Pharmaline was prohibited from preparing or supplying Psorinovo or a pharmaceutical preparation containing dimethyl fumarate as the active ingredient, intended to be supplied on an individual basis as an officinal formula, once the limit set by the numerical criterion has been reached, if the officinal formula does not comply with the pharmacopoeia or if the medicinal product is not supplied directly to the customers of its pharmacy.

19.      It is apparent from the judgment of 15 November 2022 that, according to the Gerechtshof Arnhem-Leeuwarden (Court of Appeal, Arnhem Leeuwarden), Pharmaline satisfies the conditions laid down in Article 3(2) of Directive 2001/83 as regards the preparation and supply of Psorinovo. Given that that provision does not impose a quantitative condition and in view of the directive-compliant interpretation of the Law of 8 February 2007 and the rules laid down as a result thereof – in so far as the Minister’s letter can be regarded as such – that court held that the quantitative condition and the numerical criterion could not be taken into consideration.

20.      Almirall brought an appeal on a point of law against that judgment before the referring court, claiming, inter alia, that Article 3(2) of Directive 2001/83 is limited to defining the scope of that directive. According to Almirall, that directive does not apply if the conditions laid down by that provision are satisfied and, consequently, the sovereignty of the Member States is not limited and a directive-compliant interpretation of the national provisions concerned is not required.

21.      In that context, the referring court asks whether Article 3(2) of Directive 2001/83 must be interpreted as meaning that that directive does not apply where a medicinal product satisfies the conditions laid down therein. If so, that directive would not limit the sovereignty of the Member States and national legislation would not need to be interpreted in conformity with that directive, with the result that the Member States would be free to subject such a medicinal product to the authorisation requirement. However, according to that court, if a medicinal product both meets the definition in Article 2 of Directive 2001/83 and satisfies the conditions laid down in Article 3(2) thereof, it could be considered that it does not fall outside the scope of that directive. Consequently, the sovereignty of the Member States as regards that medicinal product would be limited and a directive-compliant interpretation of the national provisions concerned would be required.

22.      In that regard, the referring court submits that, in order to answer that question, it is necessary to examine, first, whether Directive 2001/83 or, at least, Article 3(2) thereof, provides for full harmonisation and, second, whether the quantitative condition expressed by the numerical criterion is compatible with the qualitative conditions laid down in Article 3(2) of that directive. According to that court, it is possible to infer from the English, French and Italian language versions of the second subparagraph of Article 40(2) of that directive that that provision is intended to exempt from the authorisation requirement a number of operations carried out by pharmacists in the course of their activities as retailers and therefore requires 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 Geneesmiddelenwet (Law on medicinal products), in the light of the provisions of Article 3(2) of the Medicinal Products Directive, 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 the Medicinal Products Directive, 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 the Medicinal Products Directive 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 the Medicinal Products Directive applies ‘voor verstrekking in het klein’ (‘for supply at retail’) 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?’

24.      Written observations were submitted by the parties to the main proceedings, by the Netherlands, Estonian, Greek, and Polish Governments and Ireland and by the European Commission. No hearing was held.

IV.    Analysis

A.      Preliminary observations

25.      As a preliminary point, I note that, in its written observations, Almirall disputes the factual background presented by the referring court and the legal classification of the activity carried out by the defendants in the main proceedings in the light of Article 3(2) of Directive 2001/83. Almirall also proposes to ‘reformulate’ the questions referred for a preliminary ruling.

26.      In that regard, the referring court states that the dispute in the main proceedings concerns the officinal formula referred to in Article 3(2) of Directive 2001/83. In the light of that observation, and of the wording of and grounds for the questions referred for a preliminary ruling, it must be observed that that court starts from the premiss that the activity of the defendants in the main proceedings, consisting of preparing and supplying Psorinovo to their customers, satisfies all the conditions laid down in that provision and it therefore considers, inter alia, that the defendants in the main proceedings are pharmacies, within the meaning of that provision, and that Psorinovo is prepared in accordance with the prescriptions of a pharmacopoeia. (10)

27.      By contrast, Almirall submits, in essence, that those two conditions are not satisfied. In that regard, it claims, in the first place, that the defendants in the main proceedings are wholly owned by Fagron N.V., one of the largest manufacturers of pharmaceutical preparations in the European Union, one of whose main activities is the production of medicinal products without a marketing authorisation. However, none of Fagron’s establishments or subsidiaries established in Europe is described, in Fagron’s annual report, as a pharmacy, let alone as a dispensing pharmacy. In the second place, Psorinovo is manufactured not in a pharmacy in the traditional sense of the term, but in what Fagron describes as one of its ‘preparation facilities’, namely an industrial building located in an industrial zone of the municipality of Oldenzaal (Netherlands), and that facility is not known as a pharmacy providing ordinary pharmaceutical services to patients. In the third place, Psorinovo is not prepared in accordance with the ‘prescriptions’ of a pharmacopoeia which describes the preparation or composition of dimethyl fumarate. In the fourth place, that medicinal product is manufactured on a large scale.

28.      For all those reasons, Almirall asks the Court to ‘reformulate’ the questions referred for a preliminary ruling and to interpret two of the conditions laid down in Article 3(2) of Directive 2001/83, namely the conditions that medicinal products must be prepared in accordance with the prescriptions of a pharmacopoeia and be supplied directly to the patients served by the pharmacy in question.

29.      In that context, I would point out, in the first place, that it is settled case-law that, under the division of jurisdiction between the Courts of the European Union and the national courts, the Court must take into account the factual and legal context, as set out in the order for reference, of the questions referred for a preliminary ruling. 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. (11)

30.      In the second place, although Almirall formally proposes to ‘reformulate’ the questions, it is in fact asking the Court to answer questions other than those asked by the referring court. In that regard, I would point out that, according to settled case-law, 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, both the need for a preliminary ruling in order to enable it to deliver judgment and the relevance of the questions which it submits 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. (12) That is the case a fortiori where a party proposes that the Court answer questions other than those put by the referring court.

31.      In the light of that case-law, I shall consider that the case in the main proceedings concerns an action brought by Almirall against two pharmacies in respect of their activity of preparing and supplying the officinal formula, within the meaning of Article 3(2) of Directive 2001/83. It is on the basis of that premiss that I shall analyse the present questions referred for a preliminary ruling.

32.      That being said, I would point out that the Court has already observed, in the judgment in Abcur, (13) that the implementation of the derogation provided for in Article 3(2) of Directive 2001/83 is subject to the fulfilment of a set of conditions concerning the medicinal products in question. They must be 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’. Those conditions are also cumulative, so that the derogation provided for in that provision cannot be applied if one of them is not satisfied. (14) In the light of the information in the order for reference, it is appropriate, in this case, to proceed on the assumption that all the conditions for the exclusion of medicinal products from the scope of that directive, laid down in Article 3(2) thereof, are satisfied.

B.      The questions referred for a preliminary ruling

33.      In so far as the officinal formula referred to in Article 3(2) of Directive 2001/83 is excluded from the scope of that directive, the referring court is uncertain as to the competence of the Member States to adopt legislation concerning it and, in particular, to impose quantitative limitations on the activity relating thereto, namely, in the present case, those laid down in Article 18(5) and Article 40(3)(a) of the Law of 8 February 2007 (‘the national provisions concerned’). Those limitations derive from the introduction of the quantitative condition, interpreted in practice using the numerical criterion set out in the Minister’s letter.

34.      The referring court has referred four questions to the Court for a preliminary ruling. The first and second questions each have a distinct character and concern, respectively, the interpretation of the national provisions concerned in conformity with Article 3(2) of Directive 2001/83 and the possibility for Member States to subject the officinal formula to a national authorisation requirement. However, the third and fourth questions merely supplement the first two questions with premisses which may have an impact on the answers to be given to the first and second questions relating, first, to the nature of the harmonisation brought about by Directive 2001/83 and, second, the differences between certain language versions of the second subparagraph of Article 40(2) thereof.

35.      In view of their supplementary nature, I shall include the examination of the third and fourth questions referred for a preliminary ruling in the examination of the first two questions.

1.      The first question referred for a preliminary ruling

36.      Although the first question referred for a preliminary ruling expressly concerns the interpretation of the national provisions concerned in conformity with Article 3(2) of Directive 2001/83, it should nevertheless be noted, in the light of the grounds for the questions referred for a preliminary ruling, that the referring court is in fact uncertain whether that directive precludes those provisions.

37.      In those circumstances, in my view, it should be considered that, by its first question, the referring court is in fact seeking to ascertain, in essence, whether Directive 2001/83, and in particular Article 3(2) thereof, precludes national legislation which exempts the officinal formula from the requirement to obtain a marketing authorisation and a manufacturing authorisation provided that the monthly number of patients served by a pharmacy does not exceed the limit determined using a numerical criterion.

38.      In order to answer that question, I shall set out, in the first place, the rules relating to the officinal formula established by Directive 2001/83 and, in the second place, the content of the national provisions concerned; I shall examine, in the third place, whether that directive precludes those provisions; in the fourth place, I shall explain why, in the present case, it is not possible to examine whether primary law precludes those provisions and, in the fifth place, I shall propose an answer to the present question.

(a)    The rules relating to the officinal formula in Directive 2001/83

39.      Adopted on the basis of Article 95 EC, now Article 114 TFEU, Directive 2001/83 constitutes a measure for the approximation of the provisions laid down by law, regulation or administrative action in Member States which have as their object the establishment and functioning of the internal market. According to recitals 2, 4 and 5 of that directive, it aims to ‘safeguard public health’ and remove barriers to ‘trade in medicinal products within the [European Union]’.

40.      Directive 2001/83 is intended to apply to industrially produced medicinal products for human use. In that regard, Article 2(1) of thereof positively defines 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. Article 3 thereof provides for certain exceptions to the scope of the directive. It follows that, in order to fall within the scope of that directive, the product in question must, first, satisfy the conditions laid down in Article 2(1) thereof and, second, must not fall within one of the exceptions expressly provided for in Article 3 (15) thereof, including the exception provided for in paragraph 1 of that article for the magistral formula and that provided for in paragraph 2 thereof for the officinal formula.

41.      I note that the exceptions provided for in Article 3(1) and (2) of Directive 2001/83 were introduced into Directive 65/65/EEC (16) by Directive 89/341/EEC, (17) which extended the scope of Directive 65/65 to cover industrially produced medicinal products which had previously been excluded. (18) Those exceptions were not provided for in the original Commission proposal for a directive, (19) but were added by the European Parliament following consultation with the European Economic and Social Committee which had stated, in its opinion, regarding the proposed provision extending the scope of the directive, that ‘a justifiable limit should be placed on the preparation of medicines in pharmacies’. (20)

42.      It is apparent from the context in which the rule currently laid down in Article 3(2) of Directive 2001/83 was adopted that the clear intention of the EU legislature was to exempt the officinal formula from the requirements laid down by Directive 65/65, since that directive is intended to apply to industrially manufactured medicinal products and not to those prepared by artisanal methods, which is, as a rule, how medicinal products are prepared in a pharmacy. In order to attain that objective, it nevertheless decided not to legislate positively on the requirements concerning the latter medicinal products, but to exclude them from the scope of Directive 2001/83. It follows, in my view, that that directive does not contain provisions harmonising the preparation and supply of the officinal formula.

(b)    The legislation relating to the officinal formula in the national provisions concerned

43.      The national provisions concerned apply to medicinal products prepared and supplied by or on behalf of a pharmacist at his or her pharmacy. Those provisions thus contain rules relating to the officinal formula, within the meaning of Article 3(2) of Directive 2001/83. It is true that those provisions do not include all the characteristics of the officinal formula and, in particular, do not state that medicinal products must be prepared in accordance with the prescriptions of a pharmacopoeia. However, as the Netherlands Government stated in its written observations, that condition appears in another provision of Netherlands law. (21)

44.      There are two differences as regards the wording of the national legislation contained in the Law of 8 February 2007 and that of Directive 2001/83.

45.      The first difference lies in the application of a different legislative technique in each of the two legislative acts: in the Law of 8 February 2007, the rules relating to the officinal formula are set out in two chapters relating, respectively, to marketing authorisations and to manufacturing authorisations for medicinal products, whereas, in Directive 2001/83, they appear in the rules determining the scope of that directive. That difference does not, in my view, lead to results which contradict those laid down in that directive. The national provisions concerned provide for derogations, as regards the officinal formula, from the prohibition on the placing on the market and manufacture of medicinal products without authorisation. As for the exclusion of the officinal formula from the scope of Directive 2001/83, that has the effect that the officinal formula is not subject to the requirement to obtain a marketing authorisation and a manufacturing authorisation and, consequently, its preparation and supply without authorisation cannot be prohibited.

46.      The second difference lies in the fact that the national provisions concerned lay down, as regards the officinal formula, a condition that does not appear in Directive 2001/83. The Law of 8 February 2007 lays down the quantitative condition, which limits the scope of the derogations concerning the officinal formula. Thus, the derogations from the prohibitions provided for in that law apply only if the medicinal products in question are prepared and supplied ‘on a small scale’, compliance with that condition being assessed using the numerical criterion.

47.      Unlike the first difference, the second has the effect that the scope of the derogation, applicable to the officinal formula, from the requirement to obtain a marketing authorisation and a manufacturing authorisation is considerably reduced by comparison to the scope of the derogation laid down in Directive 2001/83.

(c)    The interpretation of Directive 2001/83 as regards the officinal formula

48.      Although the referring court considers that the officinal formula is excluded from the scope of Directive 2001/83, it nevertheless envisages the possibility that a medicinal product could satisfy, first, the definition in Article 2 of Directive 2001/83 and, second, the conditions laid down in Article 3(2) thereof and, accordingly, may not fall outside the scope of that directive. In its third and fourth questions, the referring court mentions two factors, asking whether they are capable of affecting the interpretation of Directive 2001/83 in the present case.

49.      Thus, in the first place, by its third question, the referring court seeks to ascertain whether the nature of the harmonisation brought about by Directive 2001/83 may have an impact on the assessment of the Member States’ discretion in adopting legislation relating to the officinal formula.

50.      In that regard, the Commission considers that Directive 2001/83 established a harmonised regulatory framework for medicinal products for human use and also achieved exhaustive harmonisation as regards the meaning and scope of the exceptions to the application of that directive provided for in Article 3 thereof. The defendants in the main proceedings express the same view in their written observations. The Estonian Government, for its part, considers that Directive 2001/83 introduces the principle that medicinal products prepared in a pharmacy are exempt from obtaining marketing or manufacturing authorisations. On the other hand, the Greek and Netherlands Governments and Ireland are of the opinion that an area which is excluded from the scope of that directive, in accordance with Article 3(2) thereof, cannot be considered to have been harmonised.

51.      I share that view.

52.      It is true that, in the event of ‘complete’ or ‘full’ harmonisation of an area, the discretion of the Member States to adopt legislation implementing a directive is limited. (22)

53.      As regards Directive 2001/83, the Court has already held, inter alia, that it lays down a complete system of authorisation procedures for medicinal products (23) and, so far as concerns the registration and marketing authorisation of medicinal products for human use, has established a comprehensive regulatory framework. (24) It follows, in particular, that if a product is correctly classified as a ‘medicinal product’ for the purposes of Directive 2001/83, its marketing is subject to the issue of marketing authorisation pursuant to Article 6(1) thereof. The procedure governing the issue and the effects of such authorisation are set out in detail in Articles 7 to 39 of that directive. (25) However, the Court has also held that national legislation relating to certain conditions for the supply of medicinal products does not fall within a harmonised area of EU law. (26)

54.      As Advocate General Bot has observed, providing an answer to the question whether Directive 2001/83 carried out a complete harmonisation in each of the areas it governs requires consideration of the relationship between the provisions in each title of the directive. Determining whether that directive was intended to carry out a complete harmonisation cannot be done in a general manner, but only area by area. (27)

55.      It must nevertheless be stated that the question of the nature of the harmonisation brought about by Directive 2001/83 and the implications thereof is relevant only as regards the area harmonised by that directive, the extent of which is determined, first of all, by the scope of that directive.

56.      In that regard, as is apparent from my analysis of the relevant rules contained in Directive 2001/83, (28) the officinal formula is expressly excluded from the scope of that directive by virtue of Article 3(2) thereof. In my view, where a product satisfies all the cumulative conditions of the exception provided for in that provision and consequently does not fall within the scope of that directive, the nature of the harmonisation brought about by that directive does not affect the discretion enjoyed by the Member States in adopting national legislation concerning that product. The premiss set out in the referring court’s third question therefore has no bearing on the answer to be given to the first question.

57.      In the second place, in its fourth question, it appears that the referring court envisages the possibility that the officinal formula, within the meaning of Article 3(2) of Directive 2001/83, may be governed in part by the second subparagraph of Article 40(2) of that directive, some of the language versions of which suggest that the quantitative condition laid down by the national provisions concerned is consistent with that directive.

58.      However, where a medicinal product is excluded from the scope of Directive 2001/83, in so far as the conditions for classifying it as an officinal formula are satisfied, the provisions of that directive do not apply. In those circumstances, I am of the view that the existence of any differences between the language versions of the second subparagraph of Article 40(2) of Directive 2001/83 has no bearing on requirements concerning the officinal formula that may exist in the Member States. Consequently, the premiss set out in the referring court’s fourth question also has no bearing on the answer to be given to the first question referred for a preliminary ruling.

59.      In the light of the foregoing, I take the view that, in so far as the preparation and supply of the officinal formula is excluded from the scope of Directive 2001/83, (29) that directive does not, in principle, preclude Member States from adopting national legislation in respect of that activity.

60.      That said, national legislation relating to an area excluded from the scope of Directive 2001/83 must comply with the requirements imposed on Member States by EU law. In particular, first, the application of such rules must not jeopardise the achievement of the objectives pursued by that directive. (30) Second, it must comply with the Treaties and, in particular, the free movement of goods.

61.      Consequently, in so far as the referring court considers that the preparation and supply of Psorinovo satisfy the conditions for the exception provided for in Article 3(2) of Directive 2001/83, the answer to be given to the first question referred for a preliminary ruling depends on whether the application of the national provisions concerned undermines the objectives pursued by that directive, namely the safeguarding of public health and the removal of barriers to trade in medicinal products within the European Union.

62.      As regards the objective of safeguarding public health, as the Estonian Government pointed out in its written observations, the preparation of medicinal products in pharmacies as part of the pharmaceutical service is not a substitute for the manufacture of medicinal products, but is based primarily on need and on medical grounds.

63.      In that context, it seems to me that the exclusion of the officinal formula from the scope of Directive 2001/83 does indeed demonstrate the intention of the EU legislature not to introduce rules that may jeopardise patients’ interest in having access to certain medicinal products that can be prepared in a pharmacy.

64.      The national provisions concerned take that interest into account in so far as they do not prohibit pharmacies from supplying the officinal formula but impose certain restrictions on the scale of their activity. Indeed, the quantitative condition applies not to patients but to pharmacies. Moreover, the numerical criterion which defines that condition takes into account not a pharmacy’s total number of patients, but only the number of its patients using a medicinal product in the long term.

65.      In the light of the foregoing, I take the view that the attainment of the objective of safeguarding public health is not jeopardised by the national provisions concerned or by the application of the numerical criterion.

66.      As regards the objective of removing barriers to trade in medicinal products within the European Union with a view to establishing the internal market, I would point out that the officinal formula is, according to its definition, a medicinal product supplied by the pharmacy that prepared it directly to the patient served by that pharmacy. It follows from that definition that movement of the officinal formula is unlikely.

67.      In that context, the achievement of the objective of removing barriers to trade in medicinal products within the European Union also does not seem to me to be jeopardised by the national provisions concerned or by the application of the numerical criterion.

(d)    The impossibility of examining whether primary law precludes the national provisions concerned

68.      In its written observations, the Netherlands Government analysed the national provisions concerned in the light of the rules of primary law on the free movement of goods and services and the freedom of establishment.

69.      In that regard, it is true that, in so far as the supply of the officinal formula is excluded from the scope of Directive 2001/83, the question could arise as to whether primary law precludes the national provisions concerned. However, the content of the request for a preliminary ruling does not enable an answer to that question to be given.

70.      The provisions of the FEU Treaty relating to, inter alia, the free movement of goods, the freedom of establishment and the freedom to provide services do not apply, in principle, to a situation which is confined in all respects within a single Member State. (31) In the light of the information in the order for reference, that is the case with regard to the dispute in the main proceedings. Thus, the Court, on a question being referred to it by a national court in connection with a situation which is confined in all respects within a single Member State, cannot, where the referring court gives no indication to that effect, consider that a request for a preliminary ruling concerning the interpretation of the provisions of the FEU Treaty relating to the fundamental freedoms is necessary for the purpose of resolving the dispute pending before that court. (32) The specific factors that allow a link to be established between the subject or circumstances of a dispute, confined in all respects within a single Member State, and Articles 49, 56 or 63 TFEU must be apparent from the order for reference. (33)

(e)    Proposed answer to the first question referred for a preliminary ruling

71.      In those circumstances, I propose that the Court’s answer to the first question referred for a preliminary ruling should be that Article 3(2) of Directive 2001/83 must be interpreted as not precluding national legislation which exempts the officinal formula from the requirement to obtain a marketing authorisation and a manufacturing authorisation, provided that the monthly number of patients served by the pharmacy in question does not exceed the limit determined using a numerical criterion.

2.      The second question referred for a preliminary ruling

72.      By its second question, the referring court seeks to ascertain, in essence, whether Directive 2001/83, and in particular Article 3(2) of that directive, must be interpreted as precluding the officinal formula from being subject to a national authorisation requirement in a situation where the monthly number of patients served by a pharmacy exceeds a limit determined using a numerical criterion.

73.      That question is based on the premiss, put forward by the referring court, that national legislation provides that a pharmacy may obtain an authorisation to prepare and supply the officinal formula if the limit determined by the quantitative condition and the numerical criterion is exceeded. However, the order for reference does not contain any information on the national procedures laid down for obtaining such authorisation. The referring court seems to infer, solely from the national provisions concerned, that is possible to initiate such procedures. However, I would point out that those provisions merely provide for a derogation from the prohibition on, inter alia, the preparation and supply of medicinal products without authorisation.

74.      I am of the view that it is impossible to give a useful answer to the second question referred without knowledge of the national legal framework relating to the national authorisation procedures applicable to obtaining an authorisation to prepare and supply the officinal formula.

75.      I would point out that, in so far as Directive 2001/83 does not lay down any requirement to obtain an authorisation for the officinal formula, it cannot be considered that, in order to obtain an authorisation provided for by national law, only the procedures implementing that directive may be applied. That seems to me to be a hypothetical situation. The procedure for obtaining a marketing authorisation provided for in that directive is not appropriate for the officinal formula, since it was established not for medicinal products prepared by pharmacies but for medicinal products produced on a large scale. If that procedure were applicable, I doubt, in view of its cost and complexity, that it would be of interest to pharmacies in the common sense of that term, that is to say, dispensing pharmacies. It is highly probable, as the Estonian Government has observed, that the application of that procedure to the officinal formula would in reality have the sole effect of prohibiting the supply of the officinal formula if the limit determined by the numerical criterion were exceeded. On the other hand, it cannot be ruled out that, in Netherlands law, there are other procedures for obtaining an authorisation to supply an officinal formula.

76.      In any event, I am of the view that, in the absence of information on the national procedures for obtaining, in the Netherlands, authorisations for the preparation and supply of the officinal formula, it is not possible to assess whether the application of such procedures could jeopardise the attainment of the objectives pursued by Directive 2001/83.

77.      Article 94(b) of the Rules of Procedure of the Court of Justice provides that the request for a preliminary ruling is to contain the tenor of any national provisions applicable in the case and, where appropriate, the relevant national case-law. In the present case, in so far as the order for reference does not contain those elements, the second question is, in my view, inadmissible.

V.      Conclusion

78.      In the light of all the foregoing considerations, I propose that the Court should answer the questions referred for a preliminary ruling by the Hoge Raad der Nederlanden (Supreme Court of the Netherlands) as follows:

(1)      Article 3(2) of Directive 2001/83/EC 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,

must be interpreted as not precluding national legislation which exempts the officinal formula, that is to say, 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, from the requirement to obtain a marketing authorisation and a manufacturing authorisation, provided that the monthly number of patients served by that pharmacy does not exceed the limit determined using a numerical criterion.

(2)      The second question referred for a preliminary ruling is inadmissible.

1      Original language: French.

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), 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’).

3      Regulation 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).

4      Regulation of the European Parliament and of the Council of 12 December 2006 on medicinal products for paediatric use  and amending Regulation (EEC) No 1768/92, Directive 2001/20/EC, Directive 2001/83/EC and Regulation (EC) No 726/2004 (OJ 2006 L 378, p. 1).

5      Regulation of the European Parliament and of the Council of 13 November 2007 on advanced therapy medicinal products and amending Directive 2001/83/EC and Regulation (EC) No 726/2004 (OJ 2007 L 324, p. 121).

6      Stb. 2007, No 93.

7      Stb. 2011, No 572.

8      See point 2 of this Opinion.

9      And not as a magistral formula according to the classification in the judgment of 15 December 2021.

10      I do not rule out the possibility that, in the light of the applicable national rules of procedure, the referring court, hearing an appeal on a point of law, may be bound as regards those facts by the findings of fact made by the judges at first and second instance.

11      See 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).

12      Judgment of 7 June 2018, Scotch Whisky Association (C‑44/17, EU:C:2018:415, paragraph 22 and the case-law cited).

13      Judgment of 16 July 2015 (C‑544/13 and C‑545/13, EU:C:2015:481).

14      Judgment of 16 July 2015, Abcur (C‑544/13 and C‑545/13, EU:C:2015:481, paragraph 66).

15      Judgments of 26 October 2016, Hecht-Pharma  (C‑276/15, EU:C:2016:801, paragraph 29 and the case-law cited), and of 21 November 2018, Novartis Farma (C‑29/17, EU:C:2018:931, paragraph 55 and the case-law cited).

16      Council Directive of 26 January 1965 on the approximation of provisions laid down by Law, Regulation or Administrative Action relating to proprietary medicinal products (English special edition: Series I Volume 1965-1966 pp. 20-24).

17      Council Directive of 3 May 1989 amending Directives 65/65/EEC, 75/318/EEC and 75/319/EEC on the approximation of provisions laid down by law, regulation or administrative action relating to proprietary medicinal products (OJ 1989 L 142, p. 11).

18      See seventh recital of Directive 89/341.

19      Proposal for a Council Directive amending Directives 65/65/EEC, 75/318/EEC and 75/319/EEC on the approximation of provisions laid down by law, regulation or administrative action relating to proprietary medicinal products (COM(87) 697 final).

20      Paragraph 3.2 of Opinion 88/C 208/18, OJ 1988 C 208, p. 64.

21      Namely, Article 2 of the Besluit Geneesmiddelenwet (Regulation implementing the Law of 8 February 2007).

22      See, as regards the meaning of those two concepts, my Opinion in Kamenova (C‑105/17, EU:C:2018:378, footnote 15).

23      Judgment of 20 September 2007, Antroposana and Others (C‑84/06, EU:C:2007:535, paragraph 41).

24      Judgment of 8 July 2021, Pharma Expressz (C‑178/20, EU:C:2021:551, paragraph 58).

25      Judgment of 9 June 2005, HLH Warenvertrieb and Orthica (C‑211/03, C‑299/03 and C‑316/03 to C‑318/03, EU:C:2005:370, paragraph 57).

26      Judgments of 18 September 2019, VIPA (C‑222/18, EU:C:2019:751, paragraph 56), and of 8 July 2021, Pharma Expressz (C‑178/20, EU:C:2021:551, paragraph 56).

27      Opinion of Advocate General Bot in Antroposana and Others (C‑84/06, EU:C:2007:301, point 48 and footnote 25).

28      See points 40 to 42 of this Opinion.

29      See point 42 of this Opinion.

30      See, to that effect, judgments of 4 June 2015, P and S (C‑579/13, EU:C:2015:369, paragraph 45 and the case-law cited); of 1 October 2015, Celaj (C‑290/14, EU:C:2015:640, paragraph 21 and the case-law cited); and of 7 June 2016, Affum (C‑47/15, EU:C:2016:408, paragraph 63 and the case-law cited).

31      Judgment of 15 November 2016, Ullens de Schooten (C‑268/15, EU:C:2016:874, paragraph 47 and the case-law cited).

32      Judgment of 18 January 2022, Thelen Technopark Berlin (C‑261/20, EU:C:2022:33, paragraph 52).

33      See, to that effect, judgment of 15 November 2016, Ullens de Schooten (C‑268/15, EU:C:2016:874, paragraph 54).