7696081996

L 378/10 Official Journal of the European Union 27.12.2006

L 378/10 Official Journal of the European Union 27.12.2006

CHARTER 4 Procedurę

Section 4

Compliance with the paediatric investigation plan

Artide 23

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

Where the application is submitted in accordance with the procedurę 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 Artide, 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 inves-tigation 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 Humań 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.

Artide 24

If, when conducting the scientific assessment of a valid application for Marketing Authorisation, the competent authority concludes that the studies are not in conformity with the agreed paediatric investigation plan, the product shall not be eligible for the rewards and incentives provided for in Articles 36, 37 and 38.

Artide 25

1.    Within ten days of its receipt, the Agency shall transmit the opinion of the Paediatric Committee to the applicant.

2.    Within 30 days following receipt of the opinion of the Paediatric Committee, the applicant may submit to the Agency a written request, citing detailed grounds, for a re-examination of the opinion.

3.    Within 30 days following receipt of a request for re-exami-nation pursuant to paragraph 2, the Paediatric Committee, having appointed a new rapporteur, shall issue a new opinion confirming or revising its previous opinion. The rapporteur shall be able to question the applicant directly. The applicant may also offer to be questioned. The rapporteur shall inform the Paediatric Committee without delay in writing about details of contacts with the applicant. The opinion shall be duły reasoned and a statement of reasons for the conclusion reached shall be annexed to the new opinion, which shall become defini-

4.    If, within the 30-day period referred to in paragraph 2, the applicant does not request re-examination, the opinion of the Paediatric Committee shall become definitive.

5.    The Agency shall adopt a decision within a period not exceeding 10 days following receipt of the Paediatric Commit-tee's delinitive opinion. This decision shall be communicated to the applicant in writing and shall annex the defmitive opinion of the Paediatric Committee.

6.    In the case of a class waiver as referred to in Artide 12, the Agency shall adopt a decision within ten days following receipt of the opinion of the Paediatric Committee as referred to in Artide 13(3). This decision shall annex the opinion of the Paediatric Committee.

7.    Decisions of the Agency shall be madę public after dele-tion of any information of a commercially confidential naturę.

CHARTER 5 Miscellatteous proi

Artide 26

Any legał or natura] person developing a medicinal product intended for paediatric use may, prior to the submission of a paediatric investigation plan and during its implementation, request advice from the Agency on the design and conduct of the various tests and studies necessary to demonstrate the quality, safety and efficacy of the medicinal product in the paediatric population in accordance with Artide 57(l)(n) of Regułation (EQ No 726/2004.