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Judgment of the Court (First Chamber) of 21 November 2018

Novartis Farma SpA v Agenzia Italiana del Farmaco (AIFA) and Others

Request for a preliminary ruling from the Consiglio di Stato

Reference for a preliminary ruling — Medicinal products for human use — Directive 2001/83/EC — Article 3(1) — Article 6 — Directive 89/105/EEC — Regulation (EC) No 726/2004 — Articles 3, 25 and 26 — Repackaging of a medicinal product for use as a treatment not covered by its marketing authorisation (off-label use) — Reimbursement by the national healthcare insurance system

Case C-29/17

Documents in the Case

Document

Date

Name of the parties

Subject-matter

Curia

EUR-Lex

Autres Liens

Judgment (OJ)

04/01/2019

Novartis Farma

Approximation of laws

Judgment
ECLI:EU:C:2018:931

21/11/2018

Novartis Farma

Approximation of laws

Judgment (Summary)
ECLI:EU:C:2018:931

21/11/2018

Novartis Farma

Approximation of laws

Application (OJ)

02/06/2017

Novartis Farma

Approximation of laws

Opinion
ECLI:EU:C:2018:619

25/07/2018

Novartis Farma

Approximation of laws

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 The legal order of the European Union
1.03 Respective powers and obligations of the European Union and of the Member States
1.03.01 Conferring of powers

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
        4.11.14.01.04 Marketing authorisation
          4.11.14.01.04.01 Obligation to obtain

2 Institutional framework of the European Union
2.02 Other EU bodies and agencies
2.02.07 Agencies, offices and foundations

Citations of case-law or legislation

References in grounds of judgment

TFEU, Article 168 -P7 : paragraph 48
TFEU, Article 267 : paragraph 43
Directive 89/105 : paragraph 47
Directive 89/105 -A01P3 : paragraphs 1, 12, 39, 80
Directive 2001/83 : paragraphs 45, 47, 52
Directive 2001/83 -A02P1 : paragraphs 4, 36, 55
Directive 2001/83 -A03 : paragraphs 39, 56 - 59, 61, 63, 64
Directive 2001/83 -A03PT1 : paragraphs 1, 5, 34, 36, 38, 39, 53 - 55, 65
Directive 2001/83 -A03PT2 : paragraphs 5, 55
Directive 2001/83 -A04P3 : paragraphs 6, 49
Directive 2001/83 -A05 : paragraphs 1, 35, 39, 66, 78
Directive 2001/83 -A05P1 : paragraph 7
Directive 2001/83 -A06 : paragraphs 1, 66, 68, 78 - 80
Directive 2001/83 -A06P1 : paragraphs 8, 32
Directive 2001/83 -A06P1L1 : paragraphs 69, 70
Directive 2001/83 -A06P1L2 : paragraphs 61, 70
Directive 2001/83 -A23P2 : paragraphs 9, 84
Directive 2001/83 -A40 : paragraphs 68, 78
Directive 2001/83 -A40P1 : paragraphs 10, 76, 77
Directive 2001/83 -A40P2 : paragraphs 10, 36
Directive 2001/83 -A40P2L2 : paragraphs 62, 63, 76, 77
Directive 2001/83 -A101P1 : paragraphs 11, 84
Directive 2001/83 -A101P1L2 : paragraph 64
Directive 2001/83 -C2 : paragraphs 3, 39
Directive 2001/83 -C35 : paragraphs 3, 60
Regulation 726/2004 : paragraphs 18, 33, 37, 45, 47, 85
Regulation 726/2004 -A01L2 : paragraphs 13, 49
Regulation 726/2004 -A03 : paragraphs 1, 39, 82, 86
Regulation 726/2004 -A03P1 : paragraph 14
Regulation 726/2004 -A04 : paragraph 15
Regulation 726/2004 -A05 : paragraphs 15, 83
Regulation 726/2004 -A06 : paragraphs 15, 83
Regulation 726/2004 -A07 : paragraphs 15, 83
Regulation 726/2004 -A08 : paragraphs 15, 83
Regulation 726/2004 -A09 : paragraphs 15, 83
Regulation 726/2004 -A10 : paragraph 15
Regulation 726/2004 -A11 : paragraph 15
Regulation 726/2004 -A12 : paragraph 15
Regulation 726/2004 -A13 : paragraph 15
Regulation 726/2004 -A14 : paragraph 15
Regulation 726/2004 -A15 : paragraph 15
Regulation 726/2004 -A22 : paragraph 16
Regulation 726/2004 -A25 : paragraphs 1, 39, 82, 84, 86
Regulation 726/2004 -A25BIS : paragraph 16
Regulation 726/2004 -A26 : paragraphs 1, 16, 39, 82, 84, 86
Regulation 726/2004 -N : paragraphs 1, 69
Court of Justice - Judgment C -433/00 : paragraph 73
Court of Justice - Judgment C -433/00 -N25 : paragraph 71
Court of Justice - Judgment C -352/07 -N19 : paragraph 50
Court of Justice - Judgment C -352/07 -N20 : paragraph 50
Court of Justice - Judgment C -62/09 -N36 : paragraph 48
Court of Justice - Judgment C -185/10 -N26 : paragraph 69
Court of Justice - Judgment C -7/11 -N35 : paragraph 76
Court of Justice - Judgment C -535/11 : paragraph 36
Court of Justice - Judgment C -535/11 -N42 : paragraphs 72, 74
Court of Justice - Judgment C -535/11 -N43 : paragraph 74
Court of Justice - Judgment C -535/11 -N51 : paragraph 76
Court of Justice - Judgment C -535/11 -N52 : paragraph 76
Court of Justice - Judgment C -636/11 -N31 : paragraph 68
Court of Justice - Judgment C -544/13 : paragraph 38
Court of Justice - Judgment C -544/13 -N38 : paragraph 55
Court of Justice - Judgment C -544/13 -N39 : paragraph 55
Court of Justice - Judgment C -182/15 -N19 : paragraph 43
Court of Justice - Judgment C -112/16 -N24 : paragraph 44
Court of Justice - Judgment C -179/16 : paragraph 23
Court of Justice - Judgment C -179/16 -N53 : paragraph 69
Court of Justice - Judgment C -179/16 -N59 : paragraph 51
Court of Justice - Opinion C -29/17 : paragraphs 60, 77

Operative part

Interprets : Directive 2001/83
Interprets : Directive 2001/83 -A03PT1
Interprets : Directive 2001/83 -A06
Interprets : Regulation 726/2004 -A03
Interprets : Regulation 726/2004 -A25
Interprets : Regulation 726/2004 -A26

Opinion

TFEU, Article 168 -P7 : point 45
TFEU, Article 267 : point 49
Directive 89/105 -A01P3 : points 1, 11, 35, 38, 106, 108
Directive 2001/83 : points 44, 58, 61, 67
Directive 2001/83 -A01PT17 : point 82
Directive 2001/83 -A02 : points 55, 62
Directive 2001/83 -A02P1 : points 5, 54
Directive 2001/83 -A03 : points 6, 38, 55, 56, 62
Directive 2001/83 -A03PT1 : points 1, 35, 37, 38, 51, 52, 54, 67, 69, 109
Directive 2001/83 -A03PT2 : point 83
Directive 2001/83 -A04P3 : point 45
Directive 2001/83 -A05 : point 38
Directive 2001/83 -A05P1 : points 7, 35, 37, 43, 46, 50, 88, 90, 92, 93, 95, 96, 98 - 100, 109
Directive 2001/83 -A05PT1 : point 1
Directive 2001/83 -A06 : points 14, 38
Directive 2001/83 -A06P1 : points 1, 8, 35, 42, 43, 65, 87, 92, 106, 109
Directive 2001/83 -A08P3 : points 9, 15
Directive 2001/83 -A11 : point 9
Directive 2001/83 -A23P2L2 : point 61
Directive 2001/83 -A40 : point 10
Directive 2001/83 -A40P1 : points 65, 75, 76, 78, 87, 96, 109
Directive 2001/83 -A40P2L2 : points 37, 66, 76, 79, 83, 109
Directive 2001/83 -A41 : point 77
Directive 2001/83 -A41L2 : point 77
Directive 2001/83 -A42 : point 77
Directive 2001/83 -A42P1 : point 77
Directive 2001/83 -A43 : point 77
Directive 2001/83 -A44 : point 77
Directive 2001/83 -A45 : point 77
Directive 2001/83 -A46 : point 77
Directive 2001/83 -A47 : point 77
Directive 2001/83 -A48 : point 77
Directive 2001/83 -A49 : point 77
Directive 2001/83 -A50 : point 77
Directive 2001/83 -A51 : point 77
Directive 2001/83 -A52 : point 77
Directive 2001/83 -A53 : point 77
Directive 2001/83 -A101P1 : point 61
Directive 2001/83 -C35 : point 63
Regulation 726/2004 : points 4, 12, 22, 36, 109
Regulation 726/2004 -A01L2 : point 45
Regulation 726/2004 -A03 : points 1, 38, 102
Regulation 726/2004 -A03P1 : points 13, 56, 87
Regulation 726/2004 -A05 : point 104
Regulation 726/2004 -A06 : point 104
Regulation 726/2004 -A07 : point 104
Regulation 726/2004 -A08 : point 104
Regulation 726/2004 -A09 : point 104
Regulation 726/2004 -A13P1 : point 14
Regulation 726/2004 -A16P2 : points 15, 61
Regulation 726/2004 -A21 : point 16
Regulation 726/2004 -A22 : point 16
Regulation 726/2004 -A23 : point 16
Regulation 726/2004 -A24 : point 16
Regulation 726/2004 -A24P1 : points 17, 61
Regulation 726/2004 -A25 : points 1, 16, 18, 38, 102, 105
Regulation 726/2004 -A26 : points 1, 16, 19, 38, 102, 105
Regulation 726/2004 -A27 : point 16
Regulation 726/2004 -A28 : point 16
Regulation 726/2004 -A29 : point 16
Regulation 726/2004 -N : points 1, 38
Regulation 726/2004 -NPT1 : points 13, 56, 59
Regulation 724/2006 -A03P1 : point 109
Regulation 1234/2008 -N2PT2LA : point 42
Directive 2012/26 : point 1
Court of Justice - Judgment C -352/07 -N19 : point 46
Court of Justice - Judgment C -352/07 -N20 : point 47
Court of Justice - Judgment C -62/09 -N32 : point 48
Court of Justice - Judgment C -62/09 -N33 : point 48
Court of Justice - Judgment C -62/09 -N34 : point 48
Court of Justice - Judgment C -62/09 -N35 : point 48
Court of Justice - Judgment C -62/09 -N36 : points 46, 48
Court of Justice - Judgment C -62/09 -N37 : point 48
Court of Justice - Opinion C -185/10 -N27 : point 90
Court of Justice - Judgment C -185/10 : point 92
Court of Justice - Judgment C -185/10 -N31 : point 93
Court of Justice - Judgment C -185/10 -N36 : point 94
Court of Justice - Judgment C -185/10 -N37 : point 94
Court of Justice - Judgment C -185/10 -N38 : point 95
Court of Justice - Judgment C -185/10 -N39 : point 95
Court of Justice - Judgment C -185/10 -N40 : point 95
Court of Justice - Judgment C -185/10 -N41 : point 95
Court of Justice - Judgment C -185/10 -N42 : point 95
Court of Justice - Judgment C -185/10 -N43 : point 95
Court of Justice - Judgment C -185/10 -N44 : point 95
Court of Justice - Judgment C -185/10 -N45 : point 95
Court of Justice - Judgment C -185/10 -N46 : point 95
Court of Justice - Judgment C -185/10 -N47 : points 46, 47
Court of Justice - Judgment C -7/11 -N35 : point 82
Court of Justice - Judgment C -7/11 -N36 : point 82
Court of Justice - Judgment C -535/11 : points 4, 51
Court of Justice - Judgment C -535/11 -N28 : point 59
Court of Justice - Judgment C -535/11 -N40 : points 58, 59
Court of Justice - Judgment C -535/11 -N41 : points 58, 59, 71
Court of Justice - Judgment C -535/11 -N42 : points 58, 59, 71
Court of Justice - Judgment C -535/11 -N43 : points 71, 73
Court of Justice - Judgment C -535/11 -N44 : point 75
Court of Justice - Judgment C -535/11 -N46 : point 96
Court of Justice - Judgment C -535/11 -N48 : point 97
Court of Justice - Judgment C -535/11 -N52 : point 79
Court of Justice - Judgment C -535/11 -N53 : point 83
Court of Justice - Judgment C -544/13 : point 69
Court of Justice - Judgment C -544/13 -N39 : point 54
Court of Justice - Judgment C -544/13 -N55 : point 68
Court of Justice - Judgment C -544/13 -N56 : point 94
Court of Justice - Judgment C -544/13 -N57 : point 94
Court of Justice - Judgment C -544/13 -N69 : point 83
Court of Justice - Judgment C -544/13 -N70 : point 83
Court of Justice - Judgment C -544/13 -N71 : point 68
General Court - Judgment T -452/14 -N79 : point 46
Court of Justice - Judgment C -276/15 -N29 : point 54
Court of Justice - Judgment C -179/16 : points 4, 46
Court of Justice - Judgment C -179/16 -N27 : point 25
Court of Justice - Judgment C -179/16 -N28 : point 25
Court of Justice - Judgment C -179/16 -N29 : point 25
Court of Justice - Judgment C -179/16 -N55 : point 60
Court of Justice - Judgment C -179/16 -N57 : point 94
Court of Justice - Judgment C -179/16 -N58 : points 60, 79
Court of Justice - Judgment C -179/16 -N59 : point 46
Court of Justice - Judgment C -185/17 -N28 : point 49

Dates

Date of the lodging of the application initiating proceedings

19/01/2017

Date of the Opinion

25/07/2018

Date of the hearing

Information not available

Date of delivery

21/11/2018

References

Publication in the Official Journal

Judgment: OJ C 25 from 21.01.2019, p.4

Application: OJ C 195 from 19.06.2017, p.9

Name of the parties

Novartis Farma

Notes on Academic Writings

Simon, Denys: Médicaments, Europe 2019 Janvier Comm. nº 1 p.45 (FR)
Mignolet, Olivier ; Murovec, Vladimir: Arrêt "Novartis Farma" : la Cour précise les règles de commercialisation des médicaments prescrits hors indication (off-label), Journal de droit européen 2019 nº 259 p.202-203 (FR)
Parziale, Andrea: Rimborsabilità degli usi off-label di medicinali: via libera della Corte di giustizia, Il Foro italiano 2019 N°2 Parte IV Col.115-120 (IT)
Raposo, Vera Lúcia: The CJEU’s ruling in the Novartis Farma case: money, health and medicines, Maastricht Journal of European and Comparative Law 2020 p. 178-198 (EN)