1. Regulation (EC) No 141/2000 of the European Parliament and of the Council of 16 December 1999; , [ http://ec.europa.eu/health/files/eudralex/vol-1/reg_2000_141/reg_2000_141_en.pdf ]
2. Guideline on the Format and Content of Applications for Designation as Orphan Medicinal Products and on the Transfer of Designations from one Sponsor to another. ENTR/6283/00 Rev 4 March 2014; , [ http://ec.europa.eu/health/files/orphanmp/2014-03_guideline_rev4_final.pdf ]
3. Recommendation on Elements Required to Support the Medical Plausibility and the Assumption of Significant Benefit for an Orphan Designation EMA/COMP/15893/2009;, [ http://www.ema.europa.eu/docs/en_GB/document_library/Regulatory_and_procedural_guideline/2010/07/WC500095341.pdf ]
4. Westermark K, Holm BB, Söderholm M, Llinares-Garcia J, Rivière F, Aarum S, Butlen-Ducuing F, Tsigkos S, Wilk-Kachlicka A, N'Diamoi C, Borvendég J, Lyons D, Sepodes B, Bloechl-Daum B, Lhoir A, Todorova M, Kkolos I, Kubáčková K, Bosch-Traberg H, Tillmann V, Saano V, Héron E, Elbers R, Siouti M, Eggenhofer J, Salmon P, Clementi M, Krieviņš D: European regulation on orphan medicinal products: 10 years of experience and future perspectives. Nat Rev Drug Discov. 2011, 10: 341-347. 10.1038/nrd3445.
5. European Medicines Agency. COMP: Agendas, minutes and meeting reports; , [ http://www.ema.europa.eu/ema/index.jsp?curl=pages/news_and_events/document_listing/document_listing_000201.jsp&mid=WC0b01ac0580028e78#section2 ]