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No Prohibition of Dissemination of Information on Prescription-Only Medicinal Products on a Manufacturer's Website

Published online by Cambridge University Press:  20 January 2017

Alexander M. Seitz
Alexander M. Seitz*
Affiliation:
Ludwig-Maximilians-Universität München, Germany,
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Abstract

Article 88 (1) (a) of Directive 2001/83/EC must be interpreted as meaning that it does not prohibit the dissemination on a website, by a pharmaceutical undertaking, of information relating to medicinal products available on medical prescription only, where that information is accessible on the website only to someone who seeks to obtain it and that dissemination consists solely in the faithful reproduction of the packaging of the medicinal product, in accordance with Article 62 of Directive 2001/83, and in the literal and complete reproduction of the package leaflet or the summary of the product's characteristics, which have been approved by the authorities with competence in relation to medicinal products (official headnote).

Type
Case Notes
Information
European Journal of Risk Regulation , Volume 2 , Issue 3 , September 2011 , pp. 447 - 449
Copyright
Copyright © Cambridge University Press 2010

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References

1 Judgment of 5 May 2011.

2 Especially with regard to Article 62 of Directive 2001/83/EC.

3 Opinion of AG Trstenjak in Case 316/09 in MSD Sharp & Dohme GmbH v. Merckle GmbH, 24 November 2010, para. 54.

4 Opinion of AG Trstenjak in Case 316/09, supra note 3, para. 19.

5 Case C-421/07, Damgaard, 2 April 2009; especially with regard to para. 23 and para. 28.

6 Opinion of AG Trstenjak in Case 316/09, supra note 3, para. 72.

7 Joined Cases C-171/07 and C-172/07, Apothekerkammer des Saarlandes v. Saarland (DocMorris), 19 May 2009, para. 19.

8 Jörg Fritsche in Andreas Spickhoff (ed.), Kommentar zum Medizinrecht (2011), § 1 HWG para. 11.

9 Case C-421/07, Damgaard, 2 April 2009, para. 23.

10 See also Case C-62/09, Association of British Pharmaceutical Industry, 22 April 2010, para. 40.

11 Opinion of AG Trstenjak in Case 316/09, supra note 3, para. 83.

12 Opinion of AG Trstenjak in Case 316/09, supra note 3, para. 86.