Reports of Cases

2004 I-03369

Subject-matter

Interpretation of Community law, particularly Article 30 EC, as regards a practice by the national authorities of refusing to grant marketing authorisation for a medicinal product that is the object of a parallel import ─ requirement for a link between products authorised for the national market and those subject to parallel import ─ link possibly taking the form of licences between authorisation holders in the respective Member States of the manufacturer (excluding a simple buyer-seller relationship)

Systematic classification scheme

Citations of case-law or legislation

References in grounds of judgment

• EC Treaty (Amsterdam), Article 28 : paragraphs 1, 12, 13, 21
• EC Treaty (Amsterdam), Article 30 : paragraphs 1, 12 - 15, 21
• Directive 2001/83 : paragraph 9
• Court of Justice - Judgment C -172/00 : paragraph 14

Operative part

• Interprets : EC Treaty (Amsterdam), Article 28
• Interprets : EC Treaty (Amsterdam), Article 30

Opinion

• EC Treaty (Amsterdam), Article 28 : points 1, 2, 70 - 73, 90
  
• EC Treaty (Amsterdam), Article 30 : points 1, 2, 70, 71
  
• Directive 65/65 : points 5, 19, 20, 39, 41
  
• Directive 65/65 -A03 : points 3, 6
  
• Directive 65/65 -A04 : points 4, 7
  
• Directive 2001/83 : points 6, 39 - 41, 64, 69, 88 - 90
  
• Directive 2001/83 -A06P1 : points 6, 46
  
• Directive 2001/83 -A08 : point 7
  
• Directive 2001/83 -A09 : point 7
  
• Directive 2001/83 -A10 : points 7, 79
  
• Directive 2001/83 -A10P1 : point 7
  
• Directive 2001/83 -A11 : point 7
  
• Directive 2001/83 -A59 : point 81
  
• Directive 2001/83 -A128 : point 40
  
• Court of Justice - Judgment C -201/94 : points 18 - 27, 47, 54 - 65, 85
  
• Court of Justice - Judgment C -94/98 : points 18, 27, 60, 61
  
• Court of Justice - Judgment C -104/75 : points 22, 23, 56, 58, 84
  
• Court of Justice - Opinion C -15/01 : point 47
  
• Court of Justice - Judgment C -368/96 : points 51, 64
  
• Court of Justice - Opinion C -368/96 : point 51
  

Dates

Date of the lodging of the application initiating proceedings

• 27/03/2002

Date of the Opinion

• 11/09/2003

Date of the hearing

Information not available

Date of delivery

01/04/2004

References

Publication in the Official Journal

Application: OJ C 156 from 29.06.2002, p.4

Judgment: OJ C 106 from 30.04.2004, p.8

Name of the parties

Kohlpharma

Notes on Academic Writings

1. Fischer, Kristian: Ursprungsidentität bei Arzneimittelzulassung, Europäische Zeitschrift für Wirtschaftsrecht 2004 p.531-533
2. Massimino, Fausto: L'orientamento della Corte di giustizia in materia di estensione delle AIC delle specialità medicinali già in commercio ai farmaci importati da uno Stato membro, Diritto pubblico comparato ed europeo 2004 p.1451-1454

Procedural Analysis Information

Source of the question referred for a preliminary ruling

Oberverwaltungsgericht für das Land Nordrhein-Westfalen - Germany

Subject-matter

• Free movement of goods
  
• - Quantitative restrictions
  
• - Measures having equivalent effect
  

Provisions of national law referred to

Arzneimittelgesetz (AMG), Paragraphen 21 ff.

Provisions of international law referred to

Information not available

Procedure and result

• Reference for a preliminary ruling
  

Formation of the Court

sixième chambre (Cour)

Judge-Rapporteur

Gulmann

Advocate General

Tizzano

Language(s) of the Case

• German
  

Language(s) of the Opinion

• Italian