28.4.2000 Official Journal of the European Communities L 103/5 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 as an orphan medicinal product and definitions of the concepts ‘similar medicinal product’ and ‘clinical superiority’ THE COMMISSION OF THE EUROPEAN COMMUNITIES, Having regard to the Treaty establishing the European Community, Having regard to Regulation (EC) No 141/2000 of the Euro- pean Parliament and of the Council of 16 December 1999 on orphan medicinal products (), and in particular Articles 3 and 8 thereof, Whereas: (1) Regulation (EC) No 141/2000 calls on the Commission to adopt provisions necessary for the implementation of Article 3 and to adopt definitions of ‘similar medicinal product’ and ‘clinical superiority’. (20  In order to implement Article 3 of Regulation (EC) No 141/2000, additional details on the factors that should be considered when establishing prevalence, likely return on investment and the satisfactory nature of alternative methods of diagnosis, prevention and treatment may be helpful for sponsors and the Committee for Orphan Medicinal Products. (3)  This information should be presented in accordance with the guidance drawn up by the Commission pursuant to Article 5(3) of Regulation (EC) No 141/ 2000. (4)  Given the nature of the medicinal products concerned, and the probability that the conditions to be treated are rare, it is not appropriate to lay down overly prescriptive requirements to establish that the criteria are met. (5) The assessment of the criteria referred to in Article 3 should be on the basis of information that is as objective as possible. (6)  Other Community measures in the field of rare diseases should be taken into account. (7)  In order to ensure appropriate respect of the market exclusivity provisions laid down in Article 8 of Regula- tion (EC) No 141/2000, it is necessary to lay down definitions of the concepts of ‘similar medicinal product’ and ‘clinical superiority’; these definitions should take into account the work and experience of the Committee for Proprietary Medicinal Products in evaluating existing medicinal products, and the relevant opinions of the Scientific Committee on Medicinal Products and Medical Devices. (8)  The definitions should be further supported by the guidelines foreseen by Article 8(5) of Regulation (EC) No 141/2000. (9)  These provisions should be updated regularly in the light of scientific and technical knowledge and experience () O] L 18, 22.1.2000, p. 1. with the designation and regulation of orphan medicinal products. (10)  The measures provided for in this Regulation are in conformity with the opinion of the Standing Committee on Medicinal Products for Human Use, HAS ADOPTED THIS REGULATION: Article 1 Purpose This Regulation lays down factors to be considered when implementing Article 3 of Regulation (EC) No 141/2000 on orphan medicinal products and establishes definitions of ‘similar medicinal product’ and ‘clinical superiority’ for the purposes of implementing Article 8 of the abovementioned Regulation. It is intended to assist potential sponsors, the Committee for Orphan Medicinal Products, and competent authorities in the interpretation of Regulation (EC) No 141/ 2000. Article 2 Criteria for designation 1. Prevalence of a condition in the Community For the purpose of establishing, pursuant to the first subpara- graph of Article 3(1)(a) of Regulation (EC) No 141/2000, that a medicinal product is intended for the diagnosis, prevention or treatment of a life-threatening or chronically debilitating condi- tion affecting not more than five in 10 000 persons in the Community, the following specific rules shall apply and the documentation listed below shall be provided in accordance with the guidance drawn up pursuant to Article 5(3) of Regula- tion (EC) No 141/2000: (a) the documentation shall include appended authoritative references which demonstrate that the disease or conditions for which the medicinal product would be administered, affects not more than five in 10 000 persons in the Community at the time at which the application for desig- nation is submitted, where these are available; (b) the data shall include appropriate details on the condition intended to be treated and a justification of the life-threat- ening or chronically debilitating nature of the condition supported by scientific or medical references; (c) the documentation submitted by the sponsor shall include or refer to a review of the relevant scientific literature, and shall provide information from relevant databases in the Community, where these are available. Where no database in the Community is available, reference may be made to databases available in third countries, provided the appro- priate extrapolations are made;