74Regarding the first argument, the Commission contends that, under Article 7(1) of Regulation No 1901/2006, applications for an MA for a medicinal product which is not yet authorised must include, in addition to the particulars and documents referred to in Article 8(3) of Directive 2001/83, the results of all studies performed and details of all information collected in compliance with an agreed paediatric investigation plan. Regarding the second argument, recital 4 in the preamble to Commission Directive 1999/83/EC of 8 September 1999 amending the Annex to Council Directive 75/318/EEC on the approximation of the laws of the Member States relating to analytical, pharmacotoxicological and clinical standards and protocols in respect of the testing of medicinal products (OJ 1999 L 243, p. 9) expresses the legislature’s opinion that the possibility of submitting a bibliographical application ought not to undermine research and the publication of the results of clinical trials. The Commission argues that, if the requirements for proving well-established medicinal use over a 10-year period were to be relaxed by accepting that the use of active substances without an MA was sufficient to show such use, the reward system established by the legislation to encourage innovation would be seriously undermined.
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