european Industrial Pharmacy Issue 20 (March 2014)

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DIVISION OF LIABILITY BETWEEN PHARMACEUTICAL COMPANIES AND SUPPLIERS 3

§ 94 AMG, the German Medicinal Products Act. www.gesetze-iminternet.de/englisch_amg/index.html 4 § 92 AMG, the German Medicinal Products Act. www.gesetze-iminternet.de/englisch_amg/index.html 5 Taschner HC, Frietsch E. Produkthaftungsgesetz und EGProdukthaftungsrichtlinie, 2nd Edition. München: CH Beck; § 14 sec. 10. Rolland. Produkthaftungsrecht. München: CH Beck § 14 sec. 6. 6 Kullmann HJ. In: Produzentenhaftung. Kullmann HJ, Pfister B, Stöhr K, Spindler G, Eds. Berlin: Erich Schmidt; Vol. 1, no. 3250, p 11. 7 § 93 AMG, the German Medicinal Products Act. www.gesetze-iminternet.de/englisch_amg/index.html 8 Kullmann HJ. In: Produzentenhaftung. Kullmann HJ, Pfister B, Stöhr K, Spindler G, Eds. Berlin: Erich Schmidt; Vol. 1, no. 3250, p 11. 9 § 307, Section 1 of Bürgerliches Gesetzbuch [German Civil Code]. Berlin: Federal Ministry of Justice. www.gesetzeim-internet.de/englisch_bgb/index.html 10 Schmidt, Neue Juristische Wochenschrift (NJW, http://rsw.beck.de/cms/main?site=NJW), 1991: p 150; Link, Betriebsberater (BB, www.betriebsberater.de/), 1985: p 1424 (1428); Graf von Westphalen, Der Betrieb (DB, www.derbetrieb.de/content/), 1982: p 1655.

11 Bundesgerichtshof

[BGH (Federal Court of Justice in Civil Law), www.bundesgerichtshof.de/EN/Home/home _node.html], 22 October 1974; Versicherungsrecht (VersR, www.versicherungsrecht.de), 1975: p 87 (88).

12 Kullmann

HJ. In: Produzentenhaftung. Kullmann HJ, Pfister B, Stöhr K, Spindler G, Eds. Berlin: Erich Schmidt (http://www.esv.info/978-3-503-01849-9); Vol. 1, no. 3250, p 12.

13 BGH

(Federal Court of Justice in Civil Law), www.bundesgerichtshof.de/EN/Home/home _node.html, 26 May 1954; VersR, www.versicherungsrecht.de, 1954: p 364 (365).

14 Lemppenau,

DB (www.derbetrieb.de/content/); 1980, p 1679 (1680).

15 Kullmann

HJ. In: Produzentenhaftung. Kullmann HJ, Pfister B, Stöhr K, Spindler G, Eds. Berlin: Erich Schmidt; Vol. 1, no. 3250, p 14.

16 RG

[Supreme Court of the German Reich] of 12 January 1923, JW (http://www.jura.unimuenchen.de/fakultaet/institute/leoweng/lwi_abteilung_b/bibliothek/interne_lin ks/zeitschriften/zst_12a.html), 1924, p 814; Steinmann, BB (www.betriebs-berater.de/), 1993, p 873 (874, 877); OLG [High Court] Frankfurt, NJW-RR, 1986, p 838; Graf von Westphalen, l.c. § 17 sec. 35.

continued

17 BGH

(Federal Court of Justice in Civil Law), www.bundesgerichtshof.de/EN/Home/hom e_node.html, 19 June 1991; NJW (http://rsw.beck.de/cms/main?site=NJW), 1991, p 2633 (2634).

18 BGH

(Federal Court of Justice in Civil Law), www.bundesgerichtshof.de/EN/Home/hom e_node.html, 7 June 1988; BGHZ 104, p 323 (335).

19 BGH

(Federal Court of Justice in Civil Law), www.bundesgerichtshof.de/EN/Home/hom e_node.html; VersR (www.versicherungsrecht.de), 1975, p 922 (923). Kullmann HJ. In: Produzentenhaftung. Kullmann HJ, Pfister B, Stöhr K, Spindler G, Eds. Berlin: Erich Schmidt; Vol. 1, no. 3250, p 10.

20 EU-GMP-Guidelines,

Annex 8 no. 3. http://ec.europa.eu/health/documents/eu dralex/vol-4/index_en.htm

21 European

Commission. Commission Directive 2003/94/EC of 8 October 2003. Art. 12, no. 2 and 4. Official Journal of the European Union 14 October 2003. http://ec.europa.eu/health/documents/eu dralex/vol-4/index_en.htm

22 Ensthaler,

NJW (http://rsw.beck.de/cms/main?site=NJW); 1994, p 817.

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