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Regulation (EC) No 1901/2006 Section 2 — Deferrals

Article 20–Article 21 · 2 articles

Compiled from an official source version. Later amendments or repeals may not be reflected; the official text prevails. · Read the official text ↗

Article 20

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1.   At the same time as the paediatric investigation plan is submitted under Article 16(1), a request may be made for deferral of the initiation or completion of some or all of the measures set out in that plan. Such deferral shall be justified on scientific and technical grounds or on grounds related to public health. In any event, a deferral shall be granted when it is appropriate to conduct studies in adults prior to initiating studies in the paediatric population or when studies in the paediatric population will take longer to conduct than studies in adults. 2.   On the basis of the experience acquired as a result of the operation of this Article, the Commission may adopt provisions in accordance with the procedure referred to in Article 51(2) to define further the grounds for granting a deferral.

Article 21

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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.

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