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)

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)

Article 3(2) of Directive 2001/83 must be interpreted as meaning that national legislation imposing a quantitative criterion for authorisation of pharmacy-prepared medicinal products does not fall within the scope of the directive, as the directive's exemption conditions are exhaustive and do not include quantitative limits.

Citation
[2026] EUECJ C-589/24
Parties
Applicant: Almirall BV; Applicant: Almirall SA; Respondent: Infinity BV; Respondent: Pharmaline BV
Jurisdiction
European Union
Judgment Date
19 March 2026
Procedural Posture
Preliminary Ruling / Court of Justice of the European Union Decision
Outcome
Preliminary ruling issued; Article 3(2) of Directive 2001/83 does not preclude national quantitative authorisation requirements for pharmacy-prepared medicinal products outside the directive's scope.
Legal Topics
Interpretation of Directive 2001/83/ec, Scope of Pharmaceutical Exemptions, National Authorisation Requirements, Harmonisation of EU Law
European Union Law Pharmaceutical Law Interpretation of Directive 2001/83/ec Scope of Pharmaceutical Exemptions National Authorisation Requirements Harmonisation of EU Law

Case Brief

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Parties

Almirall BV

Applicant

Almirall SA

Applicant

Infinity BV

Respondent

Pharmaline BV

Respondent

Procedural Posture

Preliminary Ruling / Court of Justice of the European Union Decision

Legal Issues

  1. 1 Whether Article 3(2) of Directive 2001/83 precludes national quantitative authorisation requirements for pharmacy-prepared medicinal products
  2. 2 Whether Member States may impose additional quantitative conditions beyond those in Article 3(2)
  3. 3 Relevance of harmonisation level in Directive 2001/83

Ratio Decidendi

Article 3(2) of Directive 2001/83 must be interpreted as meaning that national legislation imposing a quantitative criterion for authorisation of pharmacy-prepared medicinal products does not fall within the scope of the directive, as the directive's exemption conditions are exhaustive and do not include quantitative limits.

Court Disposition

Preliminary ruling issued; Article 3(2) of Directive 2001/83 does not preclude national quantitative authorisation requirements for pharmacy-prepared medicinal products outside the directive's scope.

Orders

  • Article 3(2) of Directive 2001/83 must be interpreted as meaning that legislation imposing a quantitative criterion for authorisation of pharmacy-prepared medicinal products does not fall within the scope of the directive.
  • Costs are a matter for the referring court.