LegalizeRegulation (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)
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
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.
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.
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
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).
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.
The Paediatric Committee shall elect its Chairman from among its members for a term of three years, renewable once.
The names and qualifications of the members shall be made public by the Agency.
Article 5
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).
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.
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
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).
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
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 authorised in the Community at the time of entry into force of this Regulation shall be regarded as valid only if it includes, in addition to the particulars and documents referred to in Article 8(3) of Directive 2001/83/EC, one of the following:
(a)the results of all studies performed and details of all information collected in compliance with an agreed paediatric investigation plan;
(b)a decision of the Agency granting a product-specific waiver;
(c)a decision of the Agency granting a class waiver pursuant to Article 11;
(d)a decision of the Agency granting a deferral.
For the purposes of point (a), the decision of the Agency agreeing the paediatric investigation plan concerned shall also be included in the application.
The documents submitted pursuant to paragraph 1 shall, cumulatively, cover all subsets of the paediatric population.
Article 8
In the case of authorised medicinal products which are protected either 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, Article 7 of this Regulation shall apply to applications for authorisation of new indications, including paediatric indications, new pharmaceutical forms and new routes of administration.
For the purposes of the first subparagraph, the documents referred to in Article 7(1) shall cover both the existing and the new indications, pharmaceutical forms and routes of administration.
Article 9
Articles 7 and 8 shall not apply to products authorised under Articles 10, 10a, 13 to 16 or 16a to 16i of Directive 2001/83/EC.
Article 10
In consultation with the Member States, the Agency and other interested parties, the Commission shall draw up the detailed arrangements concerning the format and content which applications for agreement or modification of a paediatric investigation plan and requests for waivers or deferrals must follow in order to be considered valid and concerning the operation of the compliance check referred to in Articles 23 and 28(3).
CHAPTER 2
Waivers
Article 11
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.
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
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.
Article 14
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.
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.
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.
CHAPTER 3
Paediatric investigation plan
Section 1
Requests for agreement
Article 15
Where the intention is to apply for a marketing authorisation in accordance with Article 7(1)(a) or (d), Article 8 or Article 30, a paediatric investigation plan shall be drawn up and submitted to the Agency with a request for agreement.
The paediatric investigation plan shall specify the timing and the measures proposed to assess the quality, safety and efficacy of the medicinal product in all subsets of the paediatric population that may be concerned. In addition, it shall describe any measures to adapt the formulation of the medicinal product so as to make its use more acceptable, easier, safer or more effective for different subsets of the paediatric population.
Article 16
In the case of the applications for marketing authorisation referred to in Articles 7 and 8 or the applications for waiver referred to in Articles 11 and 12, the paediatric investigation plan or the application for waiver shall be submitted with a request for agreement, except in duly justified cases, not later than upon completion of the human pharmaco-kinetic studies in adults specified in Section 5.2.3 of Part I of Annex I to Directive 2001/83/EC, so as to ensure that an opinion on use in the paediatric population of the medicinal product concerned can be given at the time of the assessment of the marketing authorisation or other application concerned.
Within 30 days following receipt of the request referred to in paragraph 1 and in Article 15(1), the Agency shall verify the validity of the request and prepare a summary report for the Paediatric Committee.
Whenever appropriate, the Agency may ask the applicant to submit additional particulars and documents, in which case the time-limit of 30 days shall be suspended until such time as the supplementary information requested has been provided.
Article 17
Following receipt of a proposed paediatric investigation plan which is valid in accordance with the provisions of Article 15(2), the Paediatric Committee shall appoint a rapporteur and shall within 60 days adopt an opinion as to whether or not the proposed studies will ensure the generation of the necessary data determining the conditions in which the medicinal product may be used to treat the paediatric population or subsets thereof, and as to whether or not the expected therapeutic benefits justify the studies proposed. When adopting its opinion, the Committee shall consider whether or not the measures proposed to adapt the formulation of the medicinal product for use in different subsets of the paediatric population are appropriate.
Within the same period, either the applicant or the Paediatric Committee may request a meeting.
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