Regulation (EC) No 1901/2006 of the European Parliament and of the CouncilShow full title

Article 23

1. The competent authority responsible for granting marketing authorisation shall verify whether an application for marketing authorisation or variation complies with the requirements laid down in Articles 7 and 8 and whether an application submitted pursuant to Article 30 complies with the agreed paediatric investigation plan.

Where the application is submitted in accordance with the procedure set out in Articles 27 to 39 of Directive 2001/83/EC, the verification of compliance, including, as appropriate, requesting an opinion of the Paediatric Committee in accordance with paragraph 2(b) and (c) of this Article, shall be conducted by the reference Member State.

2. The Paediatric Committee may, in the following cases, be requested to give its opinion as to whether studies conducted by the applicant are in compliance with the agreed paediatric investigation plan:

(a) by the applicant, prior to submitting an application for marketing authorisation or variation as referred to in Articles 7, 8 and 30, respectively;

(b) by the Agency, or the national competent authority, when validating an application, as referred to in point (a), which does not include an opinion concerning compliance adopted following a request under point (a);

(c) by the Committee for Medicinal Products for Human Use, or the national competent authority, when assessing an application, as referred to in point (a), where there is doubt concerning compliance and an opinion has not been already given following a request under points (a) or (b).

In the case of point (a), the applicant shall not submit its application until the Paediatric Committee has adopted its opinion, and a copy thereof shall be annexed to the application.

3. If the Paediatric Committee is requested to give an opinion under paragraph 2, it shall do so within 60 days of receiving the request.

Member States shall take account of such an opinion.