62024CJ0589_RES
Case C‑589/24
Almirall BVandAlmirall SA
v
Infinity Pharma BVandPharmaline BV
(Request for a preliminary ruling from the Hoge Raad der Nederlanden)
Judgment of the Court (Fourth Chamber) of 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)
Approximation of laws – Medicinal products for human use – Directive 2001/83 – Scope – Exceptions – Medicinal products prepared in a pharmacy in accordance with the prescriptions of a pharmacopoeia and intended to be supplied to the patients served by the pharmacy in question – National regulation subjecting those medicinal products to an authorisation requirement on the basis of a numerical criterion – Whether permissible
(European Parliament and Council Directive 2001/83, as amended by Regulation No 1394/2007, Arts 3(2) and 40(2), second subpara.)
(see paragraphs 36-41, 43, operative part)
Résumé
Ruling on a request for a preliminary ruling from the Hoge Raad der Nederlanden (Supreme Court of the Netherlands), the Court of Justice rules on the scope of Directive 2001/83 (
1
) and states that, once the conditions for excluding a medicinal product from that scope are satisfied, the legal situation concerned is governed solely by the applicable national law.
Almirall is an international pharmaceutical company which produces and distributes the medicinal product Skilarence, used for the treatment of psoriasis and for which it has a marketing authorisation and a manufacturing authorisation, issued in accordance with the Netherlands law transposing Directive 2001/83. (
2
) Infinity, a dispensing pharmacy established in the Netherlands, prepared at its premises and supplied to its customers the medicinal product Psorinovo, also intended for the treatment of psoriasis and containing the same active substance as Skilarence. Following the takeover of Infinity by Pharmaline, the latter took over the former’s business. Neither of those two dispensing pharmacies had authorisations to market and manufacture Psorinovo.
Being of the view that the volume of Psorinovo thus prepared and supplied by Infinity, and subsequently Pharmaline, did not comply with the condition regarding the quantitative limits for supplying a medicinal product without the corresponding authorisations, provided for by Netherlands legislation, Almirall brought proceedings against them before the Netherlands courts. That legislation provides, in particular, that pharmacies are exempt from the requirement to hold authorisations for the preparation and supply of medicinal products when those operations are carried out ‘on a small scale’, that is to say, when those products are dispensed in pharmacies by or on behalf of a pharmacist, where the number of different patients to whom the medicinal product in question is supplied each month does not exceed 50 in the case of long-term use. (
3
)
Against that background, the referring court asked the Court 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. In addition, it asked whether the second subparagraph of Article 40(2) of Directive 2001/83, containing the expression ‘retail supply’, which, in the Dutch-language version, can also be understood as referring to the supply of medicinal products in small quantities, is relevant to the interpretation of Article 3(2) of that directive.
Findings of the Court
The Court points out that the application of Article 3(2) of Directive 2001/83, which provides for cases in which that directive does not apply, requires only that the conditions expressly laid down in that provision, which are cumulative and exhaustive, be satisfied. According to those conditions, the medicinal products in question 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’. Thus, the Court considers that the expression ‘retail supply’ found in the second subparagraph of Article 40(2) of that directive is irrelevant for the purposes of interpreting Article 3(2) of that directive, since the former provision 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. Indeed, as 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.
The Court concludes that, where a medicinal product satisfies all the conditions laid down in Article 3(2) of Directive 2001/83, it does not come within the scope of that directive. 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 national 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.
Furthermore, the Court states 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.
In the light of those considerations, the Court concludes 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.
(
1
)	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).
(
2
)	In accordance with Articles 18 and 40 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).
(
3
)	Clarifications provided by the minister van Medische Zorg en Sport (Netherlands Minister for Medical Care and Sport) in his letter of 8 April 2019 to the Tweede Kamer der Staten-Generaal (Netherlands House of Representatives).