Judgment of the Court (Third Chamber) of 16 July 2015

Abcur AB v Apoteket Farmaci AB and Apoteket AB

Requests for a preliminary ruling from the Stockholms tingsrätt

Reference for a preliminary ruling — Medicinal products for human use — Directive 2001/83/EC — Scope — Articles 2(1) and 3, points 1 and 2 — Medicinal products prepared industrially or manufactured by a method involving an industrial process — Exceptions — Medicinal products prepared in a pharmacy in accordance with a medical prescription for an individual patient — 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 — Directive 2005/29/EC

Joined Cases C-544/13 and C-545/13


For joined cases, a document which relates to a single case is, as a general rule, posted only under that case, whereas a document which relates to several cases is posted only under the first case concerned.
Top of the page Documents in the Case
Document Date Name of the parties Subject-matter Curia EUR-Lex Autres Liens
Judgment (OJ)
28/08/2015 Abcur
Judgment
ECLI:EU:C:2015:481
16/07/2015 Abcur
Judgment (Summary)
ECLI:EU:C:2015:481
16/07/2015 Abcur
Application (OJ)
20/12/2013 Abcur
Opinion
ECLI:EU:C:2015:136
03/03/2015 Abcur
Top of the page Legal analysis of the decision or of the case

Reports of Cases

published in the electronic Reports of Cases (Court Reports - general)

Subject-matter

Information not available

Systematic classification scheme

1.
3 Legal proceedings
  3.04 Reference for a preliminary ruling
    3.04.02 Jurisdiction of the Court of Justice
1 The legal order of the European Union
  1.07 Interpretation of EU law
4 Internal policy of the European Union
  4.11 Approximation of laws
    4.11.02 Public procurement
      4.11.02.02 General rules applicable to public contracts
4 Internal policy of the European Union
  4.11 Approximation of laws
    4.11.14 Pharmaceutical and cosmetic products
      4.11.14.01 Medicinal products for human use
        4.11.14.01.01 Scope of the legislation
4 Internal policy of the European Union
  4.11 Approximation of laws
    4.11.02 Public procurement
      4.11.02.02 General rules applicable to public contracts
4 Internal policy of the European Union
  4.11 Approximation of laws
    4.11.14 Pharmaceutical and cosmetic products
      4.11.14.01 Medicinal products for human use
        4.11.14.01.01 Scope of the legislation
4 Internal policy of the European Union
  4.11 Approximation of laws
    4.11.02 Public procurement
      4.11.02.02 General rules applicable to public contracts
4 Internal policy of the European Union
  4.11 Approximation of laws
    4.11.14 Pharmaceutical and cosmetic products
      4.11.14.01 Medicinal products for human use
        4.11.14.01.01 Scope of the legislation
4 Internal policy of the European Union
  4.11 Approximation of laws
    4.11.02 Public procurement
      4.11.02.02 General rules applicable to public contracts
4 Internal policy of the European Union
  4.11 Approximation of laws
    4.11.14 Pharmaceutical and cosmetic products
      4.11.14.01 Medicinal products for human use
        4.11.14.01.01 Scope of the legislation
4 Internal policy of the European Union
  4.11 Approximation of laws
    4.11.02 Public procurement
      4.11.02.02 General rules applicable to public contracts
4 Internal policy of the European Union
  4.18 Consumer protection
    4.18.05 Unfair commercial practices
      4.18.05.01 Scope of the legislation
4 Internal policy of the European Union
  4.11 Approximation of laws
    4.11.14 Pharmaceutical and cosmetic products
      4.11.14.01 Medicinal products for human use
        4.11.14.01.05 Terms of sale


Citations of case-law or legislation

References in grounds of judgment

Operative part

Opinion


Dates

Date of the lodging of the application initiating proceedings

  • 21/10/2013

Date of the Opinion

  • 03/03/2015

Date of the hearing

Information not available

Date of delivery

16/07/2015


References

Publication in the Official Journal

Judgment: OJ C 302 from 14.09.2015, p.3

Application: OJ C 15 from 18.01.2014, p.6

Name of the parties

Abcur

Notes on Academic Writings

  1. Schmidt, Florian: Arzneimittelrecht: Rezepturarzneimittel, Europäische Zeitschrift für Wirtschaftsrecht 2015 Heft18 p.711-712 (DE)
  2. Pouppez, Céline ; Slegers, Pierre: Arrêt "Abcur AB" : clarification des exceptions magistrales et officinales dans le secteur pharmaceutique, Journal de droit européen 2015 nº 223 p.361-362 (FR)
  3. Tillmanns, Christian: Voraussetzungen der Zulassungsfreiheit von Rezepturarzneimitteln, Arzneimittel & Recht : Zeitschrift für Arzneimittelrecht und Arzneimittelpolitik 2015 p.229-231 (DE)
  4. Roset, Sébastien: Médicaments, Europe 2015 Octobre Comm. nº 10 p.23 (FR)
  5. Roset, Sébastien: Médicaments, Europe 2015 Octobre Comm. nº 10 p.23 (FR)
  6. Schmidt, Florian: Arzneimittelrecht: Rezepturarzneimittel, Europäische Zeitschrift für Wirtschaftsrecht 2015 Heft 18 p.711-712 (DE)
  7. Syx, Eugenie: Droit de la consommation 2016 p.84-93 (NL)



Procedural Analysis Information

Source of the question referred for a preliminary ruling

Stockholms tingsrätt - Sweden

Subject-matter

  • Approximation of laws

Provisions of national law referred to

Läkemedelslag (1992:859), 5 §, 16 §, 21a § et 21b § Lag (2010:268) om ändring i läkemedelslagen Lag (2011:234) om ändring i läkemedelslagen Lag (1996:1152) om handel med läkemedel Läkemedelsverkets förskrifter om förordnande och utlämnande av läkemedel m.m. (receptföreskrifter) (LVFS 1997:10) Läkemedelsverkets föreskrifter om tillstånd till försäljning av icke godkänt läkemedel (LVFS 2008:1), 3 kap. 1-4 §§ et 1 kap. 2 § Läkemedelsverkets förskrifter om förordnande och utlämnande av läkemedel och teknisk sprit (LVFS 2009:13) Läkemedelsverkets föreskrifter om tillverkning av extemporeläkemedel (LVFS 2010:4), 1 § Marknadsföringslag (2008:486), 3 §, 5 §, 6 §, 8 §, 1er paragraphe, et 10 §

Provisions of international law referred to

Information not available

Procedure and result

  • Reference for a preliminary ruling

Formation of the Court

Troisième chambre (Cour)

Judge-Rapporteur

Ilešič

Advocate General

Szpunar

Language(s) of the Case

  • Swedish

Language(s) of the Opinion

  • English