71The applicant submits that a procedure for mutual recognition was instituted by Article 7(2) of Council Directive 65/65/EEC of 26 January 1965 on the approximation of provisions laid down by law, regulation or administrative action relating to proprietary medicinal products (OJ, English Special Edition 1965-1966, p. 24), as amended by Council Directive 93/39/EEC of 14 June 1993 (OJ 1993 L 214, p. 22), as a variation on the decentralised authorisation procedure. It conferred on producers of earlier orphan medicinal products the right to opt for reciprocal recognition by all the Member States of an authorisation granted by one of them, as an ‘individual public economic right’. Article 5(1) of Regulation No 141/2000 deprives, in a legally binding manner, the producers of earlier orphan medicinal products of their right to opt for reciprocal recognition of their medicinal product, since it precludes the continuation of designation procedures in respect of medicinal products to treat rare conditions authorised before 22 January 2000. If market exclusivity were granted to another producer for an equivalent product, the producer of the orphan medicinal product could no longer obtain fresh authorisations for its medicinal product. The applicant states that by ‘equivalent product’ it means a similar competing medicinal product with the same rare therapeutic indication for which an earlier orphan medicinal product is indicated and which EMA has accepted as offering a significant benefit.
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