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You have submitted the Paediartic investigation plan to the European Medicines Agency early during product development, and the Paediatric Committee has agreed to this plan,
You have submitted the Paediartic investigation plan to the European Medicines Agency early during product development, and the Paediatric Committee has agreed to this plan, but when trying to implement, you realized aspect of it is no longer appropriate to demonstrate the quality, safety and efficacy of the medicinal product in the paediatric population, you
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