Judgment of the Court (First Chamber) of 26 October 2016

Hecht-Pharma GmbH v Hohenzollern Apotheke, Winfried Ertelt

Request for a preliminary ruling from the Bundesgerichtshof

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 — Point 2 of Article 3 — Officinal formula

Case C-276/15


Top of the page Documents in the Case
Document Date Name of the parties Subject-matter Curia EUR-Lex Autres Liens
Judgment (OJ)
09/12/2016 Hecht-Pharma
Judgment
ECLI:EU:C:2016:801
26/10/2016 Hecht-Pharma
Judgment (Summary)
ECLI:EU:C:2016:801
26/10/2016 Hecht-Pharma
Application (OJ)
21/08/2015 Hecht-Pharma
Opinion
ECLI:EU:C:2016:492
30/06/2016 Hecht-Pharma
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.
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
    4.11.14 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
    4.11.14 Pharmaceutical and cosmetic products
      4.11.14.01 Medicinal products for human use
        4.11.14.01.01 Scope of the legislation


Citations of case-law or legislation

References in grounds of judgment

Operative part

Opinion


Dates

Date of the lodging of the application initiating proceedings

  • 09/06/2015

Date of the Opinion

  • 30/06/2016

Date of the hearing

Information not available

Date of delivery

26/10/2016


References

Publication in the Official Journal

Judgment: OJ C 6 from 09.01.2017, p.18

Application: OJ C 294 from 07.09.2015, p.27

Name of the parties

Hecht-Pharma

Notes on Academic Writings

  1. Douglas, Morton: EuGH: Regelungen über Defekturarzneimittel europarechtskonform, Gewerblicher Rechtsschutz und Urheberrecht PRAX 2016 p.571 (DE)
  2. Daniel, Élise: Un médicament humain n'est pas soumis à une autorisation de mise sur le marché du fait qu'il est fabriqué en pharmacie pour les étapes essentielles de sa fabrication dans une quantité allant jusqu'à 100 boîtes par jour. Il ne saurait être considéré comme ayant été préparé industriellement, Europe 2016 Décembre Comm. nº 12 p.39 (FR)
  3. Daniel, Élise: Autorisation de mise sur le marché, Europe 2016 Décembre nº 12 p.39 (FR)
  4. Forni, Federico: Medicinale galenico e pubblicità : questo matrimonio non s'ha da fare ?, Diritto comunitario e degli scambi internazionali 2017 p.83-113 (IT)



Procedural Analysis Information

Source of the question referred for a preliminary ruling

Bundesgerichtshof - Germany

Subject-matter

  • Approximation of laws

Provisions of national law referred to

Arzneimittelgesetz (AMG), Paragraph 21 Abs. 2 Nr. 1 Apothekenbetriebsordnung (ApBetrO), Paragraph 6 Abs. 1 Heilmittelwerbegesetz (HWG), Paragraph 3a

Provisions of international law referred to

Information not available

Procedure and result

  • Reference for a preliminary ruling

Formation of the Court

Information not available

Judge-Rapporteur

Fernlund

Advocate General

Information not available

Language(s) of the Case

  • German

Language(s) of the Opinion

    Information not available