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Regulation (EC) No 1901/2006 of the European Parliament and of the Council of 12 December 2006 on medicinal products for paediatric use and amending Regulation (EEC) No 1768/92, Directive 2001/20/EC, Directive 2001/83/EC and Regulation (EC) No 726/2004 (Text with EEA relevance) article 21 CELEX: 02006R1901-20190128 1. At the same time as the Paediatric Committee adopts a positive opinion under Article 17(1), it shall, of its own motion or following a request submitted by the applicant under Article 20, adopt an opinion, if the conditions specified in Article 20 are met, in favour of deferring the initiation or completion of some or all of the measures in the paediatric investigation plan.
An opinion in favour of a deferral shall specify the time-limits for initiating or completing the measures concerned. 2. As soon as the Paediatric Committee adopts an opinion in favour of deferral, as referred to in paragraph 1, the procedure laid down in Article 25 shall apply. |