Regulation (EC) No 1901/2006 of the European Parliament and of the Council of 12 December 2006 on medicinal products for paediatric use and amending Regulation (EEC) No 1768/92, Directive 2001/20/EC, Directive 2001/83/EC and Regulation (EC) No 726/2004 (Text with EEA relevance)Text with EEA relevance

• Published date: 27 December 2006
• Official Gazette Publication: Official Journal of the European Union, L 378, 27 December 2006

02006R1901 — EN — 28.01.2019 — 002.001

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►B REGULATION (EC) No 1901/2006 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 12 December 2006 on medicinal products for paediatric use and amending Regulation (EEC) No 1768/92, Directive 2001/20/EC, Directive 2001/83/EC and Regulation (EC) No 726/2004 (Text with EEA relevance) (OJ L 378 27.12.2006, p. 1)

Amended by:

		Official Journal
		No	page	date
►M1	REGULATION (EC) No 1902/2006 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 20 December 2006	L 378	20	27.12.2006
►M2	REGULATION (EU) 2019/5 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 11 December 2018	L 4	24	7.1.2019

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▼B

REGULATION (EC) No 1901/2006 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL

of 12 December 2006

on medicinal products for paediatric use and amending Regulation (EEC) No 1768/92, Directive 2001/20/EC, Directive 2001/83/EC and Regulation (EC) No 726/2004

(Text with EEA relevance)

TITLE I

INTRODUCTORY PROVISIONS

CHAPTER 1

Subject matter and definitions

Article 1

This Regulation lays down rules concerning the development of medicinal products for human use in order to meet the specific therapeutic needs of the paediatric population, without subjecting the paediatric population to unnecessary clinical or other trials and in compliance with Directive 2001/20/EC.

Article 2

In addition to the definitions laid down in Article 1 of Directive 2001/83/EC, the following definitions shall apply for the purposes of this Regulation:

1) ‘paediatric population’ means that part of the population aged between birth and 18 years;

2) ‘paediatric investigation plan’ means a research and development programme aimed at ensuring that the necessary data are generated determining the conditions in which a medicinal product may be authorised to treat the paediatric population;

3) ‘medicinal product authorised for a paediatric indication’ means a medicinal product which is authorised for use in part or all of the paediatric population and in respect of which the details of the authorised indication are specified in the summary of the product characteristics drawn up in accordance with Article 11 of Directive 2001/83/EC;

4) ‘paediatric use marketing authorisation’ means a marketing authorisation granted in respect of a medicinal product for human use which is not protected by a supplementary protection certificate under Regulation (EEC) No 1768/92 or by a patent which qualifies for the granting of the supplementary protection certificate, covering exclusively therapeutic indications which are relevant for use in the paediatric population, or subsets thereof, including the appropriate strength, pharmaceutical form or route of administration for that product.

CHAPTER 2

Paediatric committee

Article 3

1. By 26 July 2007, a Paediatric Committee shall be established within the European Medicines Agency set up under Regulation (EC) No 726/2004, hereinafter ‘the Agency’. The Paediatric Committee shall be considered as established once the members referred to in Article 4(1)(a) and (b) have been appointed.

The Agency shall fulfil the secretariat functions for the Paediatric Committee and shall provide it with technical and scientific support.

2. Save where otherwise provided for in this Regulation, Regulation (EC) No 726/2004 shall apply to the Paediatric Committee, including the provisions on the independence and impartiality of its members.

3. The Executive Director of the Agency shall ensure appropriate coordination between the Paediatric Committee and the Committee for Medicinal Products for Human Use, the Committee for Orphan Medicinal Products, their working parties and any other scientific advisory groups.

The Agency shall draw up specific procedures for possible consultations between them.

Article 4

1. The Paediatric Committee shall be composed of the following members:

(a) five members, with their alternates, of the Committee for Medicinal Products for Human Use, having been appointed to that Committee in accordance with Article 61(1) of Regulation (EC) No 726/2004. These five members with their alternates shall be appointed to the Paediatric Committee by the Committee for Medicinal Products for Human Use;

(b) one member and one alternate appointed by each Member State whose national competent authority is not represented through the members appointed by the Committee for Medicinal Products for Human Use;

(c) three members and three alternates appointed by the Commission, on the basis of a public call for expressions of interest, after consulting the European Parliament, in order to represent health professionals;

(d) three members and three alternates appointed by the Commission, on the basis of a public call for expressions of interest, after consulting the European Parliament, in order to represent patient associations.

The alternates shall represent and vote for the members in their absence.

For the purposes of points (a) and (b), Member States shall cooperate, under the coordination of the Executive Director of the Agency, in order to ensure that the final composition of the Paediatric Committee, including members and alternates, covers the scientific areas relevant to paediatric medicinal products, and including at least: pharmaceutical development, paediatric medicine, general practitioners, paediatric pharmacy, paediatric pharmacology, paediatric research, pharmacovigilance, ethics and public health.

For the purposes of points (c) and (d), the Commission shall take into account the expertise provided by the members appointed under points (a) and (b).

2. The members of the Paediatric Committee shall be appointed for a renewable period of three years. At meetings of the Paediatric Committee, they may be accompanied by experts.

3. The Paediatric Committee shall elect its Chairman from among its members for a term of three years, renewable once.

4. The names and qualifications of the members shall be made public by the Agency.

Article 5

1. When preparing its opinions, the Paediatric Committee shall use its best endeavours to reach a scientific consensus. If such a consensus cannot be reached, the Paediatric Committee shall adopt an opinion consisting of the position of the majority of the members. The opinion shall mention the divergent positions, with the grounds on which they are based. This opinion shall be made accessible to the public pursuant to Article 25(5) and (7).

2. The Paediatric Committee shall draw up its rules of procedure for the implementation of its tasks. The rules of procedure shall enter into force after receiving a favourable opinion from the Management Board of the Agency and, subsequently, from the Commission.

3. All meetings of the Paediatric Committee may be attended by representatives of the Commission, the Executive Director of the Agency or his representatives.

Article 6

1. The tasks of the Paediatric Committee shall include the following:

(a) to assess the content of any paediatric investigation plan for a medicinal product submitted to it in accordance with this Regulation and formulate an opinion thereon;

(b) to assess waivers and deferrals and formulate an opinion thereon;

(c) at the request of the Committee for Medicinal Products for Human Use, a competent authority or the applicant, to assess compliance of the application for a Marketing Authorisation with the agreed paediatric investigation plan concerned and formulate an opinion thereon;

(d) at the request of the Committee for Medicinal Products for Human Use or a competent authority, to assess any data generated in accordance with an agreed paediatric investigation plan and formulate an opinion on the quality, safety or efficacy of the medicinal product for use in the paediatric population;

(e) to advise on the content and format of data to be collected for the survey referred to in Article 42;

(f) to support and advise the Agency on establishing the European network referred to in Article 44;

(g) to assist scientifically in the elaboration of any documents related to the fulfilment of the objectives of this Regulation;

(h) to provide advice on any question related to medicinal products for use in the paediatric population, at the request of the Executive Director of the Agency or the Commission;

(i) to establish a specific inventory of paediatric medicinal product needs and update it on a regular basis, as referred to in Article 43;

(j) to advise the Agency and the Commission regarding the communication of arrangements available for conducting research into medicinal products for use in the paediatric population;

(k) to make a recommendation to the Commission on the symbol referred to in Article 32(2).

2. When carrying out its tasks, the Paediatric Committee shall consider whether or not any proposed studies can be expected to be of significant therapeutic benefit to and/or fulfil a therapeutic need of the paediatric population. The Paediatric Committee shall take into account any information available to it, including any opinions, decisions or advice given by the competent authorities of third countries.

TITLE II

MARKETING AUTHORISATION REQUIREMENTS

CHAPTER 1

General authorisation requirements

Article 7

1. An application for marketing authorisation under Article 6 of Directive 2001/83/EC in respect of a medicinal product for human use which is not...