TITLE IIMARKETING AUTHORISATION REQUIREMENTS
CHAPTER 2Waivers
Article 11
1
Production of the information referred to in point (a) of Article 7(1) shall be waived for specific medicinal products or for classes of medicinal products, if there is evidence showing any of the following:
a
that the specific medicinal product or class of medicinal products is likely to be ineffective or unsafe in part or all of the paediatric population;
b
that the disease or condition for which the specific medicinal product or class is intended occurs only in adult populations;
c
that the specific medicinal product does not represent a significant therapeutic benefit over existing treatments for paediatric patients.
2
The waiver provided for in paragraph 1 may be issued with reference either to one or more specified subsets of the paediatric population, or to one or more specified therapeutic indications, or to a combination of both.
Article 12
The Paediatric Committee may of its own motion adopt an opinion, on the grounds set out in Article 11(1), to the effect that a class or a product-specific waiver, as referred to in Article 11(1), should be granted.
As soon as the Paediatric Committee adopts an opinion, the procedure laid down in Article 25 shall apply. In the case of a class waiver, only paragraphs 6 and 7 of Article 25 shall apply.
Article 13
1
The applicant may, on the grounds set out in Article 11(1), apply to the Agency for a product-specific waiver.
2
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.
3
As soon as the Paediatric Committee adopts an opinion, the procedure laid down in Article 25 shall apply.
Article 14
1
The Agency shall maintain a list of all waivers. The list shall be regularly updated (at least every year) and made available to the public.
2
The Paediatric Committee may, at any time, adopt an opinion advocating the review of a granted waiver.
In the case of a change affecting a product-specific waiver, the procedure laid down in Article 25 shall apply.
In the case of a change affecting a class waiver, paragraphs 6 and 7 of Article 25 shall apply.
3
If a particular product-specific or class waiver is revoked, the requirement set out in Articles 7 and 8 shall not apply for 36 months from the date of the removal from the list of waivers.