Open Access

Research on Approaches for Regulation of the “Off-label” use of Medicinal Products in the European Union

 and    | May 29, 2017

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1. Закон за лекарствените продукти в хуманната медицина. Available at: http://www.badibg.org/badilaws/Lawhuman/Z_lec_pr_.pdf. Last access: 2016/10/27.Search in Google Scholar

2. Ценкова, И., Я., Люцканов. Off-label: Забранените лекарства, 2014. Available at: http://www.temanews.com/index.php?p=tema&iid=836&aid=18858. Last access: 2016/10/27.Search in Google Scholar

3. Administration of pharmaceuticals for unauthorized indications (off-label use). Federal Joint Committee. Available at: http://www.english.g-ba.de/special-topics/pharmaceuticals/off-label/. Last access: 2016/10/27.Search in Google Scholar

4. Degrassat-Theas, A., F., Bocquet, M., Sinegre, et al. The „Temporary Recommendations for Use“: A dual-purpose regulatory framework for off-label drug use in France. Health Policy, 119, 2015, 1399-405.10.1016/j.healthpol.2015.09.00326455642Search in Google Scholar

5. Emmerich, J., N., Dumarcet, A., Lorence. France‘s new framework for regulating off-label drug use. N Engl J Med., 367, 2012, 1279-81.10.1056/NEJMp120834723034018Search in Google Scholar

6. Faus, J., X., Moliner. Spain – Law & Practice – Life Sciences 2017 – Chambers and Partners, 2017. Available at: http://practiceguides.chambersandpartners.com/practice-guides/life-sciences-2017/spain/37-access-to-unauthorised-products Last access: 2017/01/09.Search in Google Scholar

7. Galimberti, G., M. Mostardini, M. Turrini, E. Marchesoni. The Life Sciences Law Review. Ch.18: Italy. R. Kingham, 4. London, Law Business Research Ltd, 2016, 298p. Available at: https://www.twobirds.com/~/media/pdfs/news/articles/2016/italy.pdf?la=en Last access: 2017/01/09Search in Google Scholar

8. Gazarian, M., M., Kelly, J.R., McPhee, et al. Off-label use of medicines: consensus recommendations for evaluating appropriateness. Med J Aust., 185, 2006, 544-8.10.5694/j.1326-5377.2006.tb00689.x17115966Search in Google Scholar

9. Good practice in prescribing and managing medicines and devices (2013). Available at: http://www.gmc-uk.org/guidance/ethical_guidance/14316.asp. Last access: 2016/10/27.Search in Google Scholar

10. Guideline on good pharmacovigilance practices (GVP), Annex I – Definitions (Rev 3) Available at: http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2013/05/WC500143294.pdf. Last access: 2016/10/27.Search in Google Scholar

11. Legal mandate, procedures – Federal Joint Committee. Available at: http://www.english.g-ba.de/legalmandate/. Last access: 2016/10/27.Search in Google Scholar

12. Lenk, C., G. Duttge. Ethical and legal framework and regulation for off-label use: European perspective. Ther Clin Risk Manag., 10, 2014, 537-46.10.2147/TCRM.S40232410392825050064Search in Google Scholar

13. Liste des spécialités faisant actuellement l‘objet d‘une RTU. Available at: http://ansm.sante.fr/Activites/Recommandations-Temporaires-d-Utilisation-RTU/Liste-des-specialites-faisant-actuellement-l-objet-d-une-RTU/(offset)/1 Last access: 2017/01/09.Search in Google Scholar

14. Medicinal Products Act (The Drug Law). Available at: http://www.gesetze-im-internet.de/englisch_amg/index.html. Last access: 2016/10/27.Search in Google Scholar

15. Minfrini, F. Italian competition authority targets big pharma, triggers expansion of off-label prescription-Italy Legal Focus, 2014. Available at: http://www.legal500.com/developments/27204 Last acces: 2016/10/27Search in Google Scholar

16. Obermann, S. Off-Label Use of Medicines – General Aspects, Challenges and Strategies – Master-Thesis, 2013. Available at: http://dgra.de/deutsch/studiengang/master-thesis/2013-Sonja-Obermann-Off-Label-Use-of-Medicines-%E2%80%93-General-Aspects,-Challenges-and-S Last acces: 2016/10/27Search in Google Scholar

17. Peire, M.A. Legal responsibility prescribing off-label drugs: is spain different? Archives of Disease in Childhood, 101. e1., 2016. Available at: http://adc.bmj.com/content/101/1/e1.57. Last access: 2017/11/0110.1136/archdischild-2015-310148.60Search in Google Scholar

18. Prada, M., C., Bertozzi, B., Proietti, D., Urbinati. The Italian 648/96 List: Approvals, Rejections and Methods In Aifa’ s Evaluation Process Between January 2013 and May 2015, Value in Health, 18, 7, 2015, A680.10.1016/j.jval.2015.09.2024Search in Google Scholar

eISSN:
0324-1750
Language:
English
Publication timeframe:
4 times per year
Journal Subjects:
Medicine, Basic Medical Science, Immunology, Clinical Medicine, other