1. European Parliament and Council, Regulation (EC) No 141/2000 of the European Parliament and of the Council of 16 December 1999, Official Journal of the European Communities, L 18, 22 January 2000, 1-5.
2. EC, Commission Regulation (EC) No 847/2000 of 27 April 2000 Laying Down the Provisions for Implementation of the Criteria for Designation of a Medicinal Product and Definitions of the Concepts ‘Similar Medicinal Product’ and ‘Clinical Superiority’, Official Journal of the European Communities, L 103, 28 April 2000, 5-8.
3. Points to Consider on the Calculation and Reporting of the Prevalence of a Condition for Orphan Designation, 26 March 2002 COMP/436/01;COMP,2002
4. 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);EC,2007
5. Relevant Sources for Orphan Disease Prevalence Data;EMA,2012