Reports of Cases

2004 I-11583

Subject-matter

Reference for a preliminary ruling – High Court of Justice (England & Wales), Queen's Bench Division (Administrative Court) – Interpretation of Article 10(1)(a)(iii) of 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) – Marketing authorisation – Abridged procedure – Essentially similar products.

Systematic classification scheme

Citations of case-law or legislation

References in grounds of judgment

• Directive 65/65 : paragraph 17
• Directive 65/65 -A04L3PT8LA : paragraphs 22, 23
• Directive 2001/83 -A06P1 : paragraph 3
• Directive 2001/83 -A08P3 : paragraph 4
• Directive 2001/83 -A10P1LA : paragraphs 5, 22
• Directive 2001/83 -A10P1LALI : paragraph 6
• Directive 2001/83 -A10P1LALII : paragraph 6
• Directive 2001/83 -A10P1LALIII : paragraphs 6, 7, 17, 18, 30
• Court of Justice - Judgment C -368/96 : paragraph 17
• Court of Justice - Judgment C -106/01 : paragraphs 19, 23, 25, 26

Operative part

• Interprets : Directive 2001/83 -A10P1LAPT3

Opinion

• Directive 2001/83 -A01P5 : point 38
  
• Directive 2001/83 -A06 : point 6
  
• Directive 2001/83 -A06P1 : points 7, 38
  
• Directive 2001/83 -A06P1L2 : point 42
  
• Directive 2001/83 -A07 : point 6
  
• Directive 2001/83 -A08 : points 6, 8
  
• Directive 2001/83 -A08P3LI : points 8, 9
  
• Directive 2001/83 -A09 : point 6
  
• Directive 2001/83 -A10 : points 6, 8, 9, 39
  
• Directive 2001/83 -A10P1 : points 39, 42
  
• Directive 2001/83 -A10P1LA : points 10, 13, 19
  
• Directive 2001/83 -A10P1LALI : points 12, 23
  
• Directive 2001/83 -A10P1LALIII : points 11, 12, 19, 23, 27, 31, 32, 39, 55 - 57, 60, 84, 85, 87
  
• Directive 2001/83 -A10P2LB : point 40
  
• Directive 2001/83 -A10P3 : point 41
  
• Directive 2001/83 -A11 : point 6
  
• Directive 2001/83 -A12 : point 6
  
• Directive 2001/83 -N1 : point 8
  
• Directive 2004/27 : points 6, 38
  
• Directive 2004/27 -A01P8 : point 39
  
• Court of Justice - Judgment C -368/96 : points 5, 19, 20, 27 - 32, 63
  
• Court of Justice - Judgment C -106/01 : points 5, 19 - 21, 23, 56, 63 - 65, 67, 68, 76, 77, 79, 82
  

Dates

Date of the lodging of the application initiating proceedings

• 03/02/2003

Date of the Opinion

• 08/07/2004

Date of the hearing

Information not available

Date of delivery

09/12/2004

References

Publication in the Official Journal

Application: OJ C 83 from 05.04.2003, p.7

Judgment: OJ C 45 from 19.02.2005, p.5

Name of the parties

Approved Prescription Services

Notes on Academic Writings

1. Tran Thiet, Jean-Paul: Médicaments - Spécialités princepts et produits génériques: Une moindre protection des données utilisées pour la demande d'autorisation de mise sur le marché permettra de faciliter la commercialisation des produits génériques, Concurrences : revue des droits de la concurrence 2005 nº 2 p. 102-104

Procedural Analysis Information

Source of the question referred for a preliminary ruling

High Court of Justice (England & Wales), Queen's Bench Division - United Kingdom

Subject-matter

• Approximation of laws
  

Provisions of national law referred to

Information not available

Provisions of international law referred to

Information not available

Procedure and result

• Reference for a preliminary ruling
  

Formation of the Court

deuxième chambre (Cour)

Judge-Rapporteur

Gulmann

Advocate General

Jacobs

Language(s) of the Case

• English
  

Language(s) of the Opinion

• English