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Review, Risk, Legality and Damages

Published online by Cambridge University Press:  20 January 2017

Paul Craig*
St John's College, Oxford


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Case Notes
Copyright © Cambridge University Press 2013

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1 Judgment 19 April 2012, Third Chamber, n.y.r.

2 Second Council Directive 75/319/EEC of 20 May 1975 on the approximation of provisions laid down by law, regulation or administrative action relating to medicinal products [1975] OJ L147/13.

3 Directive 75/319/EEC, Art. 13.

4 Directive 75/319/EEC, Art. 14.

5 Council Directive 65/65/EEC of 26 January 1965 on the approximation of provisions laid down by law, regulation or administrative action relating to medicinal products [1965-66] OJ English Special Edition p. 24.

6 Joined Cases T74/00, T76/00, T83/00 to T85/00, T132/00, T137/00 and T141/00, Artegodan and Others v Commission [2002] ECR II-4945.

7 Case C-39/03 P, Commission v Artegodan and Others [2003] ECR I-7885.

8 Case T-429/05, Artegodan v Commission [2010] ECR II-491.

9 Article 11 of Directive 65/65 provides that: ‘The competent authorities of the Member States shall suspend or revoke [a marketing authorization] where that product proves to be harmful in the normal conditions of use, or where its therapeutic efficacy is lacking, or where its qualitative and quantitative composition is not as declared. Therapeutic efficacy is lacking when it is established that therapeutic results cannot be obtained with the medicinal product.’

10 Case 429/05, para. 108.

11 Case 429/05, para. 108.

12 Case 429/05, paras. 109-111.

13 Case C-221/10 P, para. 81, relying on Case C-228/90, Industrieen Handelsonderneming Vreugdenhil BV v Commission [1992] ECR I-1937, paras. 20-22.

14 Case C-221/10 P, para. 82.

15 Case C-39/03 P.

16 Case C-221/10 P, para. 86.

17 Case C-221/10 P, para. 87.

18 Case C-221/10 P, para. 92.

19 Case C-221/10 P, para. 93.

20 Case C-221/10 P, para. 104.

21 Case C-221/10 P, para. 108.

22 Case C-221/10 P, para. 109.

23 Schermers, H.G., Heukels, T., and Mead, P., (eds), The NonContractual Liability of the European Communities (Martinus Nijhoff, 1988)Google Scholar; Heukels, T. and McDonnell, A. (eds.), The Action for Damages in Community Law (The Hague: Kluwer, 1997)Google Scholar; Hilson, C., “The Role of Discretion in EC law on Non-Contractual Liability”, 42 CMLRev (2005), p. 677 et sqq Google Scholar; Oliver, P., “Enforcing Community Rights in the English Courts”, 50 MLR (1987), p. 881 et sqq Google Scholar; Tridimas, T., “Liability for Breach of Community Law: Growing Up and Mellowing Down?”, 38 CMLRev (2001), p. 301 et sqq Google Scholar.