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PATIENTS RIGHT TO HIGH QUALITY MEDICINAL PRODUCTS BY INTEGRATING THE CONCEPT OF SUSTAINABLE DEVELOPMENT IN A RESPONSIBLE EUROPEAN MARKET

Erimia, Cristina-Luiza, Sоrbu, Rodica, Paris, Stelian

First published: 2015https://doi.org/10.5593/sgem2015/b52/s23.100View metrics

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Title
PATIENTS RIGHT TO HIGH QUALITY MEDICINAL PRODUCTS BY INTEGRATING THE CONCEPT OF SUSTAINABLE DEVELOPMENT IN A RESPONSIBLE EUROPEAN MARKET
Authors
Erimia, Cristina-Luiza, Sоrbu, Rodica, Paris, Stelian
Proceedings
SGEM International Multidisciplinary Scientific GeoConference EXPO Proceedings; 15th International Multidisciplinary Scientific GeoConference SGEM2015, ECOLOGY, ECONOMICS, EDUCATION AND LEGISLATION
Publisher
Stef92 Technology
Year
2015
Pages
755-760
ISSN
1314-2704
ISBN
978-619-7105-40-7
Language
en
Publication type
Conference Paper
References24

  1. Directive 2001/83/EC, of the European Parliament and of the Council of 6 November 2001 on the Community code relating to medicinal products for human use, published in the Official Journal of the European Union L 311 of 28.1.2001 . The consolidated version was published in the Official Journal of the European Union L 87 of 31.3.2009.

  2. See, for example, Directive 2004/27/EC of the European Parliament and of the Council of 31 March 2004 amending Directive 2001/83/EC on the Community code relating to medicinal products for human use , published in the Official Journal of the European Union L 136 of 30.4.2004.

  3. For an analysis of the implementation of Directive 2004/27/EC and of the operation of the Bolar provision in the EU Member States, see: CMS, Bolar Provision and Regulatory Data Exclusivity in Europe , available at : http://www.cms-cmck.com/Hubbard.FileSystem/files/Publication/3ed51f5e- 7615-44dc-a399-076a7ccc3745/Presentation/PublicationAttachment/2a4563f5- b970-4fa2-9d61-0bac21c0b232/BolarProvisioninEU.pdf (accessed on 23.07.2014).

  4. Treaty on the Functioning of the European Union (consolidated version), published in the Official Journal of the European Union (OJEU) C 326 of 26 December 2012.

  5. Cristina-Luiza Erimia, Protecting European Pacients Againsta the Entry Falsified Medicinal Products into the Legal Supply Chain, Journal of Law and Administrative Sciences, No. 2/2014, p. 127.

  6. Case C-322/01 Deutscher Apothekerverband eV, Rec. 2003 I-14887.

  7. See, for example, Ca se C-350/92 Spain/The Council, Rec. 1995, p. I-1985, and Case C-300/89 Commission/the Council (titanium dioxide ), Rec. 1991, p. I- 2867.

  8. Case C-376/98 Germany/The Parliament and the Council (tobacco advertisement), Rec. 2000, p. I-8419. This case refers to the validity of Directive 98/43 on the approximation of the laws, regulations and administrative provisions of the Member States relating to the advertising and sponsorship of tobacco products.

  9. Case C-376/98 Germany/The Parliament and the Council , Rec. 2000, p. I-8419, paragraph 88. International Multidisciplinary Scientific GeoConfenferences SGEM 2015 www.sgem.org 15th International Multidisciplinary Scientific GeoConferences SGEM2015

  10. Pursuant to article 114 paragraphs (4)-(9) of the Treaty for the Functioning of the European Union (consolidated version), published in the Official Journal of the European Union C 326 of 26 December 2012.

  11. See, for example, Commission Decision of 18 July 2001 on the national provisions notified by Germany in the field of pharmacovigilance, OJ L 202, 27.7.2001, p. 46; Commission Decision of 14 September 1994, OJ L 316, 9.12.1994, p. 43; Commission Decision of 26 February 1996, OJ L 69, 19.3.1996, p 32; Commission Decision of 21 December 1998, OJ L 3, 7.1.1999, p. 13, sand seven Commission decisions of 26 October 1999, OJ L 329, 22.12.1999.

  12. See case C-41/93 France/Commission, Rec. 1994, p. I-1829, and Case C-319/97 Kortas, Rec. 1999, p. I-3143. In this respect, also see Case C-3/00 Denmark/ Commission, Rec. 2003, p. I-2643, in which the Court annuls the Commission Decision. International Multidisciplinary Scientific GeoConfenferences SGEM 2015 www.sgem.org

  13. Directive 2001/83/EC, of the European Parliament and of the Council of 6 November 2001 on the Community code relating to medicinal products for human use, published in the Official Journal of the European Union L 311 of 28.1.2001 . The consolidated version was published in the Official Journal of the European Union L 87 of 31.3.2009.

  14. See, for example, Directive 2004/27/EC of the European Parliament and of the Council of 31 March 2004 amending Directive 2001/83/EC on the Community code relating to medicinal products for human use , published in the Official Journal of the European Union L 136 of 30.4.2004.

  15. For an analysis of the implementation of Directive 2004/27/EC and of the operation of the Bolar provision in the EU Member States, see: CMS, Bolar Provision and Regulatory Data Exclusivity in Europe , available at : http://www.cms-cmck.com/Hubbard.FileSystem/files/Publication/3ed51f5e- 7615-44dc-a399-076a7ccc3745/Presentation/PublicationAttachment/2a4563f5- b970-4fa2-9d61-0bac21c0b232/BolarProvisioninEU.pdf (accessed on 23.07.2014).

  16. Treaty on the Functioning of the European Union (consolidated version), published in the Official Journal of the European Union (OJEU) C 326 of 26 December 2012.

  17. Cristina-Luiza Erimia, Protecting European Pacients Againsta the Entry Falsified Medicinal Products into the Legal Supply Chain, Journal of Law and Administrative Sciences, No. 2/2014, p. 127.

  18. Case C-322/01 Deutscher Apothekerverband eV, Rec. 2003 I-14887.

  19. See, for example, Ca se C-350/92 Spain/The Council, Rec. 1995, p. I-1985, and Case C-300/89 Commission/the Council (titanium dioxide ), Rec. 1991, p. I- 2867.

  20. Case C-376/98 Germany/The Parliament and the Council (tobacco advertisement), Rec. 2000, p. I-8419. This case refers to the validity of Directive 98/43 on the approximation of the laws, regulations and administrative provisions of the Member States relating to the advertising and sponsorship of tobacco products.

  21. Case C-376/98 Germany/The Parliament and the Council , Rec. 2000, p. I-8419, paragraph 88. International Multidisciplinary Scientific GeoConfenferences SGEM 2015 www.sgem.org 15th International Multidisciplinary Scientific GeoConferences SGEM2015

  22. Pursuant to article 114 paragraphs (4)-(9) of the Treaty for the Functioning of the European Union (consolidated version), published in the Official Journal of the European Union C 326 of 26 December 2012.

  23. See, for example, Commission Decision of 18 July 2001 on the national provisions notified by Germany in the field of pharmacovigilance, OJ L 202, 27.7.2001, p. 46; Commission Decision of 14 September 1994, OJ L 316, 9.12.1994, p. 43; Commission Decision of 26 February 1996, OJ L 69, 19.3.1996, p 32; Commission Decision of 21 December 1998, OJ L 3, 7.1.1999, p. 13, sand seven Commission decisions of 26 October 1999, OJ L 329, 22.12.1999.

  24. See case C-41/93 France/Commission, Rec. 1994, p. I-1829, and Case C-319/97 Kortas, Rec. 1999, p. I-3143. In this respect, also see Case C-3/00 Denmark/ Commission, Rec. 2003, p. I-2643, in which the Court annuls the Commission Decision. International Multidisciplinary Scientific GeoConfenferences SGEM 2015 www.sgem.org

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