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1. Following receipt of a proposed paediatric investigation plan which is valid in accordance with the provisions of Article 15(2), the Paediatric Committee shall appoint a rapporteur and shall within 60 days adopt an opinion as to whether or not the proposed studies will ensure the generation of the necessary data determining the conditions in which the medicinal product may be used to treat the paediatric population or subsets thereof, and as to whether or not the expected therapeutic benefits justify the studies proposed. When adopting its opinion, the Committee shall consider whether or not the measures proposed to adapt the formulation of the medicinal product for use in different subsets of the paediatric population are appropriate. Within the same period, either the applicant or the Paediatric Committee may request a meeting.

2. Within the 60-day period referred to in paragraph 1, the Paediatric Committee may request the applicant to propose modifications to the plan, in which case the time-limit referred to in paragraph 1 for the adoption of the final opinion shall be extended for a maximum of 60 days. In such cases, the applicant or the Paediatric Committee may request an additional meeting during this period. The time-limit shall be suspended until such time as the supplementary information requested has been provided.