Reports of Cases

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

Subject-matter

Application for annulment of Commission Decision C (2012) 5894 final of 16 August 2012 granting marketing authorisation to Teva Pharma BV in respect of the medicinal product for human use ‘Zoledronic acid Teva’ in accordance with Article 3 of Regulation (EC) No 726/2004 of the European Parliament and of the Council.

Systematic classification scheme

Citations of case-law or legislation

References in grounds of judgment

• Directive 65/65 : paragraphs 1, 73, 75
• Regulation 2309/93 : paragraphs 1, 40, 48 - 50, 53 - 55, 68, 70, 71, 73, 77, 79, 80
• Regulation 2309/93 -A13P4 : paragraphs 37, 38, 43, 75, 78
• Regulation 2309/93 -C6 : paragraph 75
• Regulation 2309/93 -NPARTB : paragraphs 83, 85
• Directive 2001/83 : paragraphs 1, 54, 70, 73, 75 - 78
• Directive 2001/83 -A06P1 : paragraphs 40, 70, 71, 81, 82
• Directive 2001/83 -A06P1L2 : paragraphs 44 - 87
• Directive 2001/83 -A08P3 : paragraph 41
• Directive 2001/83 -A08P3LI : paragraphs 41, 62
• Directive 2001/83 -A10 : paragraph 65
• Directive 2001/83 -A10P1 : paragraphs 37, 42, 62, 78, 79
• Directive 2001/83 -C9 : paragraph 62
• Directive 2001/83 -C10 : paragraph 62
• Regulation 1085/2003 : paragraphs 48 - 50, 53, 54, 56
• Regulation 1085/2003 -A02 : paragraphs 50, 53
• Regulation 1085/2003 -A02P2L3 : paragraph 47
• Regulation 1085/2003 -A06 : paragraph 47
• Directive 2004/27 : paragraphs 65, 76
• Regulation 726/2004 : paragraphs 1, 40, 49, 53, 54, 68, 70, 71, 73, 76, 77, 79, 80
• Regulation 726/2004 -A01 : paragraph 74
• Regulation 726/2004 -A06 : paragraph 41
• Regulation 726/2004 -A14P11 : paragraphs 37, 38, 43, 65, 75, 78
• Regulation 726/2004 -A82P1 : paragraphs 55, 77
• Regulation 726/2004 -A89 : paragraphs 37, 38, 43
• Regulation 726/2004 -A90 : paragraph 40
• Regulation 726/2004 -C11 : paragraph 75
• Regulation 1234/2008 : paragraphs 49, 54
• Court of Justice - Judgment C -368/96 -N43 : paragraph 45
• Court of Justice - Judgment C -368/96 -N44 : paragraph 45
• Court of Justice - Judgment C -368/96 -N52 : paragraph 64
• Court of Justice - Judgment C -368/96 -N53 : paragraph 45
• Court of Justice - Judgment C -368/96 -N56 : paragraph 45
• Court of Justice - Opinion C -106/01 -N57 : paragraph 59
• Court of Justice - Judgment C -106/01 : paragraph 81
• Court of Justice - Judgment C -106/01 -N57 : paragraph 45
• Court of Justice - Judgment C -106/01 -N58 : paragraph 45
• Court of Justice - Judgment C -106/01 -N59 : paragraph 45
• Court of Justice - Judgment C -106/01 -N60 : paragraph 45
• Court of Justice - Judgment C -223/01 -N52 : paragraph 63
• Court of Justice - Judgment C -17/03 -N41 : paragraph 51
• Court of Justice - Judgment C -36/03 -N25 : paragraph 45
• Court of Justice - Judgment C -36/03 -N26 : paragraph 45
• Court of Justice - Judgment C -36/03 -N30 : paragraph 45
• Court of Justice - Judgment C -527/07 -N22 : paragraph 41
• General Court - Judgment T -236/07 -N44 : paragraph 51
• Court of Justice - Opinion C -350/08 -N90 : paragraph 73
• Court of Justice - Opinion C -350/08 -N91 : paragraph 73
• Court of Justice - Opinion C -350/08 -N92 : paragraph 73
• Court of Justice - Opinion C -535/11 -N47 : paragraph 73
• Court of Justice - Opinion C -104/13 -N39 : paragraph 67

Operative part

Information not available

Opinion

Information not available

Dates

Date of the lodging of the application initiating proceedings

• 30/10/2012

Date of the Opinion

Information not available

Date of the hearing

Information not available

Date of delivery

15/09/2015

References

Publication in the Official Journal

Judgment: OJ C 363 from 03.11.2015, p.26

Application: OJ C 389 from 15.12.2012, p.8

Name of the parties

Novartis Europharm v Commission

Notes on Academic Writings

Information not available

Procedural Analysis Information

Source of the question referred for a preliminary ruling

Information not available

Subject-matter

• Approximation of laws
  
• Public health
  

Provisions of national law referred to

Information not available

Provisions of international law referred to

Information not available

Procedure and result

• Actions for annulment : dismissal on substantive grounds
  

Formation of the Court

deuxième chambre (Tribunal)

Judge-Rapporteur

Martins Ribeiro

Advocate General

Information not available

Language(s) of the Case

• English
  

Language(s) of the Opinion

Information not available