The applicant may, on the grounds set out in Article 11(1), apply to the Agency for a product-specific waiver.

Following receipt of the application, the Paediatric Committee shall appoint a rapporteur and shall within 60 days adopt an opinion as to whether or not a product-specific waiver should be granted.

Either the applicant or the Paediatric Committee may request a meeting during that 60-day period.

Whenever appropriate, the Paediatric Committee may request the applicant to supplement the particulars and documents submitted. Where the Paediatric Committee avails itself of this option, the 60-day time-limit shall be suspended until such time as the supplementary information requested has been provided.

As soon as the Paediatric Committee adopts an opinion, the procedure laid down in Article 25 shall apply.