IP/N/1/EU/P/2  
 
15 April 2013  
(13-1969)  Page: 1/21  
Council for Trade-Related Aspects 
of Intellectual Property Rights  Original: English/anglais/inglés  
 
MAIN DEDICATED INTELLECTUAL PROPERTY LAWS AND 
REGULATIONS NOTIFIED UNDER ARTICLE 63.2 
OF THE AGREEMENT 
EUROPEAN UNION 
This document reproduces the text1 of Regulation (EC) No 1901/2006 of the European Parliament 
and of the Council of 12 December 2006 on medici nal 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, as notified by the European Union on 20 March 2013 under Article 63.2 of the 
Agreement (see document IP/N/1/EU/1).  
Conseil des aspects des droits de propriété 
intellectuelle qui touchent au commerce 
PRINCIPALES LOIS ET RÉGLEMENTATIONS CONSACRÉES À 
LA PROPRIÉTÉ INTELLECTUELLE NOTIFIÉES AU TITRE 
DE L'ARTICLE 63:2 DE L'ACCORD 
UNION EUROPÉENNE  
Le présent document contient le texte1 du Règlement (CE) n° 1901/2006 du Parlement européen 
et du Conseil du 12 décembre 2006 relatif aux médicaments à usage pédiatrique et modifiant le 
Règlement (CEE) n° 1768/92, la Directive 2001/20/CE, la Directive 2001/83/CE et le Règlement (CE) n° 726/2004, notifié par l'Union européenne le 20 mars 2013 au titre de l'article 
63:2 de l'Accord (voir le document IP/N/1/EU/1).  
Consejo de los Aspectos de los Derechos de Propiedad Intelectual relacionados con el Comercio 
PRINCIPALES LEYES Y REGLAMENTOS DEDICADOS A LA 
PROPIEDAD INTELECTUAL NOTIFICADOS EN VIRTUD 
DEL PÁRRAFO 2 DEL ARTÍCULO 63 DEL ACUERDO 
U
NIÓN EUROPEA  
En el presente documento se reproduce el texto1 del Reglamento (CE) N° 1901/2006 del 
Parlamento Europeo y del Consejo, de 12 de diciembre de 2006, sobre medicamentos para uso 
pediátrico y por el que se modifican el Reglamento (CEE) N° 1768/92, la Directiva 2001/20/CE, la 
Directiva 2001/83/CE y el Reglamento (CE) N° 726/2004, notificado por la Unión Europea el 20 de marzo de 2013 en virtud de lo dispuesto en el párrafo 2 del artículo 63 del Acuerdo (véase 
el documento IP/N/1/EU/1).  
                                               
1 In English only./En anglais seulement./En inglés solamente. IP/N/1/EU/P/2 
 
- 2 - 
 
  PP 3-21 - Offset (Pdf file attached) 
PP 3 à 21 - Offset (fichier Pdf joint) PP 3-21 - Offset (fichero Pdf adjunto) I
(Acts whose publication is obligatory)
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)
THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE EURO-
PEAN UNION,
Having regard to the Treaty establishing the European Com-
munity, and in particular Article 95 thereof,
Having regard to the proposal from the Commission,Having regard to the Opinion of the European Economic and
Social Committee (
1),
Having consulted the Committee of the Regions,
Acting in accordance with the procedure referred to in
Article 251 of the Treaty (2),
Whereas:
(1) Before a medicinal product for human use is placed on
the market in one or more Member States, it generally
has to have undergone extensive studies, including pre-clinical tests and clinical trials, to ensure that it is safe, ofhigh quality and effective for use in the target population.
(2) Such studies may not have been undertaken for use inthe paediatric population and many of the medicinalproducts currently used to treat the paediatric populationhave not been studied or authorised for such use. Market
forces alone have proven insufficient to stimulate
adequate research into, and the development and authori-sation of, medicinal products for the paediatric popula-tion.
(3) Problems resulting from the absence of suitably adaptedmedicinal products for the paediatric population includeinadequate dosage information which leads to increased
risks of adverse reactions including death, ineffective
treatment through under-dosage, non-availability to thepaediatric population of therapeutic advances, suitableformulations and routes of administration, as well as useof magistral or officinal formulations to treat the paedia-
tric population which may be of poor quality.(4) This Regulation aims to facilitate the development and
accessibility of medicinal products for use in the paedia-tric population, to ensure that medicinal products used totreat the paediatric population are subject to ethicalresearch of high quality and are appropriately authorisedfor use in the paediatric population, and to improve the
information available on the use of medicinal products in
the various paediatric populations. These objectivesshould be achieved without subjecting the paediatricpopulation to unnecessary clinical trials and withoutdelaying the authorisation of medicinal products for
other age populations.
(5) While taking into account the fact that the regulation of
medicinal products must be fundamentally aimed at safe-guarding public health, this aim must be achieved bymeans that do not impede the free movement of safemedicinal products within the Community. The differ-
ences between the national legislative, regulatory and
administrative provisions on medicinal products tend tohinder intra-Community trade and therefore directlyaffect the operation of the internal market. Any action topromote the development and authorisation of medicinalproducts for paediatric use is therefore justified with a
view to preventing or eliminating these obstacles. Article
95 of the Treaty is therefore the proper legal basis.
(6) The establishment of a system of both obligations andrewards and incentives has proved necessary to achievethese objectives. The precise nature of these obligations
and rewards and incentives should take account of the
status of the particular medicinal product concerned.This Regulation should apply to all the medicinalproducts required for paediatric use and therefore itsscope should cover products under development and yet-to-be authorised, authorised products covered by intellec-
tual property rights and authorised products no longer
covered by intellectual property rights.27.12.2006 L 378/1 Official Journal of the European Union EN
(1) OJ C 267, 27.10.2005, p. 1.
(2) Opinion of the European Parliament of 7 September 2005 (OJ C 193 E,
17.8.2006, p. 225), Council Common Position of 10 March 2006
(OJ C 132 E, 7.6.2006, p. 1) and Position of the European Parliament of
1 June 2006 (not yet published in the Official Journal). Council Deci-
sion of 23 October 2006.
IP/N/1/EU/P/2 
        - 3 -(7) Any concerns about conducting trials in the paediatric
population should be balanced by the ethical concernsabout giving medicinal products to a population inwhich they have not been appropriately tested. Publichealth threats from the use of untested medicinal
products in the paediatric population can be safely
addressed through the study of medicinal products forthe paediatric population, which should be carefullycontrolled and monitored through the specific require-ments for the protection of the paediatric population
who take part in clinical trials in the Community laid
down in Directive 2001/20/EC of the European Parlia-ment and of the Council of 4 April 2001 on the approxi-mation of the laws, regulations and administrative provi-sions of the Member States relating to the implementa-tion of good clinical practice in the conduct of clinical
trials on medicinal products for human use (
1).
(8) It is appropriate to create a scientific committee, thePaediatric Committee, within the European Medicines
Agency, hereinafter ‘the Agency’ , with expertise and
competence in the development and assessment of allaspects of medicinal products to treat paediatric popula-tions. The rules on scientific committees of the Agency,as laid down in Regulation (EC) No 726/2004 (
2), should
apply to the Paediatric Committee. Members of thePaediatric Committee should therefore not have financialor other interests in the pharmaceutical industry whichcould affect their impartiality, should undertake to act inthe public interest and in an independent manner, andshould make an annual declaration of their financial
interests. The Paediatric Committee should be primarily
responsible for the scientific assessment and agreementof paediatric investigation plans and for the system ofwaivers and deferrals thereof; it should also be central tovarious support measures contained in this Regulation. In
its work, the Paediatric Committee should consider the
potential significant therapeutic benefits for the paediatricpatients involved in the studies or the paediatric popula-tion at large including the need to avoid unnecessarystudies. The Paediatric Committee should follow existingCommunity requirements, including Directive 2001/20/
EC, as well as International Conference on Harmonisation
(ICH) guideline E11 on the development of medicinalproducts for the paediatric population, and it shouldavoid any delay in the authorisation of medicinalproducts for other populations deriving from the require-
ments for studies in the paediatric population.
(9) Procedures should be established for the Agency to agree
and modify a paediatric investigation plan, which is the
document upon which the development and authorisa-tion of medicinal products for the paediatric population
should be based. The paediatric investigation plan shouldinclude details of the timing and the measures proposedto demonstrate the quality, safety and efficacy of themedicinal product in the paediatric population. Since the
paediatric population is in fact composed of a number of
population subsets, the paediatric investigation planshould specify which population subsets need to bestudied, by what means and by when.
(10) The introduction of the paediatric investigation plan inthe legal framework concerning medicinal products forhuman use aims at ensuring that the development ofmedicinal products that are potentially to be used for thepaediatric population becomes an integral part of the
development of medicinal products, integrated into the
development programme for adults. Thus, paediatricinvestigation plans should be submitted early duringproduct development, in time for studies to be conductedin the paediatric population, where appropriate, beforemarketing authorisation applications are submitted. It is
appropriate to set a deadline for the submission of a
paediatric investigation plan in order to ensure earlydialogue between the sponsor and the PaediatricCommittee. Furthermore, early submission of a paediatricinvestigation plan, combined with the submission of a
deferral request as described below, will avoid delaying
the authorisation for other populations. As the develop-ment of medicinal products is a dynamic process depen-dent on the result of ongoing studies, provision shouldbe made for modifying an agreed plan where necessary.
(11) It is necessary to introduce a requirement for new medic-inal products and for authorised medicinal productscovered by a patent or a supplementary protection certifi-cate to present either the results of studies in the paedia-tric population in accordance with an agreed paediatric
investigation plan or proof of having obtained a waiver
or deferral, at the time of filing a marketing authorisationapplication or an application for a new indication, newpharmaceutical form or new route of administration. Thepaediatric investigation plan should be the basis upon
which compliance with that requirement is judged.
However, that requirement should not apply to genericsor similar biological medicinal products and medicinalproducts authorised through the well-established medic-inal use procedure, nor to homeopathic medicinalproducts and traditional herbal medicinal products
authorised through the simplified registration procedures
of Directive 2001/83/EC of the European Parliament andof the Council of 6 November 2001 on the Communitycode relating to medicinal products for human use (
3).27.12.2006 L 378/2 Official Journal of the European Union EN
(1) OJ L 121, 1.5.2001, p. 34.
(2) Regulation (EC) No 726/2004 of the European Parliament and of the
Council of 31 March 2004 laying down Community procedures for the
authorisation and supervision of medicinal products for human and
veterinary use and establishing a European Medicines Agency (OJ L
136, 30.4.2004, p. 1).(3) OJ L 311, 28.11.2001, p. 67. Directive as last amended by Directive
2004/27/EC (OJ L 136, 30.4.2004, p. 34).
IP/N/1/EU/P/2 
        - 4 -(12) Provision should be made for research into the paediatric
use of medicinal products which are not protected by apatent or supplementary protection certificate to befinanced under Community research programmes.
(13) In order to ensure that research in the paediatric popula-tion is only conducted to meet their therapeutic needs,there is a need to establish procedures for the Agency towaive the requirement referred to in Recital (11) for
specific products or for classes or part of classes of
medicinal products, these waivers being then made publicby the Agency. As knowledge of science and medicineevolves over time, provision should be made for the listsof waivers to be amended. However, if a waiver is
revoked, that requirement should not apply for a given
period in order to allow time for at least a paediatricinvestigation plan to be agreed and studies in the paedia-tric population to be initiated before an application formarketing authorisation is submitted.
(14) In certain cases, the Agency should defer the initiation orcompletion of some or all of the measures contained in apaediatric investigation plan, with a view to ensuring thatresearch is conducted only when safe and ethical and that
the requirement for study data in the paediatric popula-
tion does not block or delay the authorisation of medic-inal products for other populations.
(15) Free scientific advice should be provided by the Agencyas an incentive to sponsors developing medicinalproducts for the paediatric population. To ensure scien-tific consistency, the Agency should manage the interfacebetween the Paediatric Committee and the Scientific
Advice Working Group of the Committee for Medicinal
Products for Human Use, as well as the interactionbetween the Paediatric Committee and the other Com-munity committees and working groups concerningmedicinal products.
(16) The existing procedures for the marketing authorisationof medicinal products for human use should not bechanged. However, from the requirement referred to inRecital (11) it follows that competent authorities should
check compliance with the agreed paediatric investigation
plan and any waivers and deferrals at the existing valida-tion step for marketing authorisation applications. Theassessment of quality, safety and efficacy of medicinalproducts for the paediatric population and the granting
of marketing authorisations should remain the remit of
the competent authorities. Provision should be made forthe Paediatric Committee to be asked for its opinion oncompliance and on the quality, safety and efficacy of amedicinal product in the paediatric population.
(17) To provide healthcare professionals and patients withinformation on the safe and effective use of medicinalproducts in the paediatric population and as a transpar-ency measure, information on the results of studies in
the paediatric population, as well as on the status of the
paediatric investigation plans, waivers and deferrals,should be included in product information. When all themeasures in the paediatric investigation plan have beencomplied with, that fact should be recorded in themarketing authorisation, and should then be the basisupon which companies can obtain the rewards for
compliance.
(18) In order to identify medicinal products authorised for usein the paediatric population and enable their prescription,
provision should be made for the labels of medicinalproducts granted an indication for use in the paediatricpopulation to display a symbol which will be selected bythe Commission on a recommendation by the Paediatric
Committee.
(19) In order to establish incentives for authorised productsno longer covered by intellectual property rights, it is
necessary to establish a new type of marketing authorisa-tion, the Paediatric Use Marketing Authorisation. APaediatric Use Marketing Authorisation should be grantedthrough existing marketing authorisation procedures butshould apply specifically for medicinal products devel-
oped exclusively for use in the paediatric population. It
should be possible for the name of the medicinal productthat has been granted a Paediatric Use Marketing Author-isation to retain the existing brand name of the corre-sponding product authorised for adults, in order to capi-
talise on existing brand recognition, while benefiting
from the data exclusivity associated with a new marketingauthorisation.
(20) An application for a Paediatric Use Marketing Authorisa-tion should include the submission of data concerninguse of the product in the paediatric population, collectedin accordance with an agreed paediatric investigationplan. These data may be derived from the published
literature or from new studies. An application for a
Paediatric Use Marketing Authorisation should also beable to refer to data contained in the dossier of a medic-inal product which is or has been authorised in the Com-munity. This is intended to provide an additional incen-tive to encourage small and medium-sized enterprises,
including generic companies, to develop off-patent
medicinal products for the paediatric population.
(21) This Regulation should include measures to maximiseaccess by the Community population to new medicinalproducts tested and adapted for paediatric use, and tominimise the chance of Community-wide rewards andincentives being granted without sections of the Com-
munity paediatric population benefiting from the avail-
ability of a newly authorised medicine. An application fora marketing authorisation, including an application for aPaediatric Use Marketing Authorisation, which containsthe results of studies conducted in compliance with anagreed paediatric investigation plan should be eligible for
the Community centralised procedure set out in Articles 5
to 15 of Regulation (EC) No 726/2004.27.12.2006 L 378/3 Official Journal of the European Union EN
IP/N/1/EU/P/2 
        - 5 -(22) When an agreed paediatric investigation plan has led to
the authorisation of a paediatric indication for a productalready marketed for other indications, the marketingauthorisation holder should be obliged to place theproduct on the market, taking into account the paediatric
information, within two years of the date of approval of
the indication. That requirement should relate only toproducts already authorised, but not to medicinalproducts authorised via a Paediatric Use MarketingAuthorisation.
(23) An optional procedure should be established to make itpossible to obtain a single Community-wide opinion for
a nationally authorised medicinal product when data on
the paediatric population following an agreed paediatricinvestigation plan form part of the marketing authorisa-tion application. To achieve this, the procedure set out inArticles 32, 33 and 34 of Directive 2001/83/EC could be
used. This will allow the adoption of a Community
harmonised Decision on use of that medicinal product inthe paediatric population and its inclusion in all nationalproduct information.
(24) It is essential to ensure that pharmacovigilance mechan-isms are adapted to meet the specific challenges ofcollecting safety data in the paediatric population,
including data on possible long-term effects. Efficacy in
the paediatric population may also need additional studyfollowing authorisation. Therefore, an additional require-ment for applying for a marketing authorisation thatincludes the results of studies conducted in compliancewith an agreed paediatric investigation plan should be an
obligation for the applicant to indicate how he proposes
to ensure the long-term follow-up of possible adversereactions to the use of the medicinal product and efficacyin the paediatric population. Additionally, where there isa particular cause for concern, the applicant shouldsubmit and implement a risk management system and/or
perform specific post-marketing studies as a condition
for the granting of the marketing authorisation.
(25) It is necessary in the interests of public health to ensurethe continuing availability of safe and effective medicinalproducts authorised for paediatric indications developedas a result of this Regulation. If a marketing authorisationholder intends to withdraw such a medicinal product
from the market then arrangements should be in place so
that the paediatric population can continue to haveaccess to the medicinal product in question. In order tohelp achieve this, the Agency should be informed ingood time of any such intention and should make that
intention public.
(26) For products falling within the scope of the requirementto submit paediatric data, if all the measures included in
the agreed paediatric investigation plan are compliedwith, if the product is authorised in all Member Statesand if relevant information on the results of studies isincluded in product information, a reward should begranted in the form of a 6-month extension of thesupplementary protection certificate created by Council
Regulation (EEC) No 1768/92 (
1). Any decisions by
Member States' authorities as regards the setting of prices
for medicinal products or their inclusion in the scope ofnational health insurance schemes have no bearing onthe granting of this reward.
(27) An application for an extension of the duration of thecertificate pursuant to this Regulation should only beadmissible where a certificate is granted pursuant toRegulation (EEC) No 1768/92.
(28) Because the reward is for conducting studies in the
paediatric population and not for demonstrating that a
product is safe and effective in the paediatric population,the reward should be granted even when a paediatricindication is not authorised. However, to improve theinformation available on the use of medicinal products inthe paediatric population, relevant information on use in
paediatric populations should be included in authorised
product information.
(29) Under Regulation (EC) No 141/2000 of the EuropeanParliament and of the Council of 16 December 1999 onorphan medicinal products (
2), medicinal products desig-
nated as orphan medicinal products gain ten years ofmarket exclusivity on the granting of a marketing author-isation for the orphan indication. As such products arefrequently not patent-protected, the reward of supple-mentary protection certificate extension cannot beapplied; when they are patent-protected, such an exten-
sion would provide a double incentive. Therefore, for
orphan medicinal products, instead of an extension ofthe supplementary protection certificate, the ten-yearperiod of orphan market exclusivity should be extendedto twelve years if the requirement for data on use in the
paediatric population is fully met.
(30) The measures provided for in this Regulation should not
preclude the operation of other incentives or rewards. Toensure transparency on the different measures available atCommunity and Member State levels, the Commissionshould draw up a detailed list of all the incentives avail-
able, on the basis of information provided by the
Member States. The measures set out in this Regulation,including the agreement of paediatric investigation plans,should not be grounds for obtaining any other Com-munity incentives to support research, such as the
funding of research projects under the multi-annual
Community Framework Programmes for Research, Tech-nological Development and Demonstration Activities.27.12.2006 L 378/4 Official Journal of the European Union EN
(1) OJ L 182, 2.7.1992, p. 1. Regulation as last amended by the 2003 Act
of Accession.
(2) OJ L 18, 22.1.2000, p. 1.
IP/N/1/EU/P/2 
        - 6 -(31) In order to increase the availability of information on the
use of medicinal products in the paediatric population,and to avoid unnecessary repetition of studies in thepaediatric population which do not add to the collectiveknowledge, the European database provided for in Article
11 of Directive 2001/20/EC should include a European
register of clinical trials of medicinal products for paedia-tric use comprising all ongoing, prematurely terminated,and completed paediatric studies conducted both in theCommunity and in third countries. Part of the informa-
tion concerning paediatric clinical trials entered into the
database, as well as details of the results of all paediatricclinical trials submitted to the competent authorities,should be made public by the Agency.
(32) An inventory of the therapeutic needs of the paediatric
population should be established by the Paediatric
Committee after consultation with the Commission, theMember States and interested parties, and should be regu-larly updated. The inventory should identify the existingmedicinal products used by the paediatric population andhighlight the therapeutic needs of that population and
the priorities for research and development. In this way,
companies should be able easily to identify opportunitiesfor business development; the Paediatric Committeeshould be able better to judge the need for medicinalproducts and studies when assessing draft paediatric
investigation plans, waivers and deferrals; and healthcare
professionals and patients should have an informationsource available to support their decisions as to whichmedicinal products to choose.
(33) Clinical trials in the paediatric population may require
specific expertise, specific methodology and, in some
cases, specific facilities and should be carried out byappropriately trained investigators. A network, whichlinks existing national and Community initiatives andstudy centres in order to build up the necessary compe-tences at Community level, and which takes account of
Community and third country data, would help facilitate
cooperation and avoid unnecessary duplication of studies.This network should contribute to the work of strength-ening the foundations of the European Research Area inthe context of Community Framework Programmes for
Research, Technological Development and Demonstration
Activities, benefit the paediatric population and provide asource of information and expertise for industry.
(34) For certain authorised products, pharmaceutical compa-nies may already hold data on safety or efficacy in the
paediatric population. To improve the information avail-
able on the use of medicinal products in the paediatricpopulations, companies holding such data should berequired to submit them to all competent authoritieswhere the product is authorised. In this way the datacould be assessed and, if appropriate, information should
be included in the authorised product information aimed
at healthcare professionals and patients.(35) Community funding should be provided to cover allaspects of the work of the Paediatric Committee and ofthe Agency resulting from the implementation of thisRegulation, such as the assessment of paediatric investiga-tion plans, fee waivers for scientific advice, and informa-
tion and transparency measures, including the database
of paediatric studies and the network.
(36) The measures necessary for the implementation of thisRegulation should be adopted in accordance with
Council Decision 1999/468/EC of 28 June 1999 laying
down the procedures for the exercise of implementingpowers conferred on the Commission (
1).
(37) Regulation (EEC) No 1768/92, Directive 2001/20/EC,
Directive 2001/83/EC and Regulation (EC) No 726/2004
should therefore be amended accordingly.
(38) Since the objective of this Regulation, namely improvingavailability of medicinal products tested for paediatric
use, cannot be sufficiently achieved by the Member States
and can therefore be better achieved at Community level,given that this will make it possible to take advantage ofthe widest possible market and avoid the dispersion oflimited resources, the Community may adopt measures,
in accordance with the principle of subsidiarity as set out
in Article 5 of the Treaty. In accordance with the prin-ciple of proportionality, as set out in that Article, thisRegulation does not go beyond what is necessary inorder to achieve this objective,
HAVE ADOPTED THIS REGULATION:
TITLE I
INTRODUCTORY PROVISIONS
CHAPTER 1
Subject matter and definitions
Article 1
This Regulation lays down rules concerning the development ofmedicinal products for human use in order to meet the specific
therapeutic needs of the paediatric population, without
subjecting the paediatric population to unnecessary clinical orother trials and in compliance with Directive 2001/20/EC.
Article 2
In addition to the definitions laid down in Article 1 of Direc-tive 2001/83/EC, the following definitions shall apply for thepurposes of this Regulation:
1) ‘paediatric population’ means that part of the population
aged between birth and 18 years;27.12.2006 L 378/5 Official Journal of the European Union EN
(1) OJ L 184, 17.7.1999, p. 23. Decision as amended by Decision
2006/512/EC (OJ L 200, 22.7.2006, p. 11).
IP/N/1/EU/P/2 
        - 7 -2) ‘paediatric investigation plan’ means a research and develop-
ment programme aimed at ensuring that the necessary data
are generated determining the conditions in which a medic-inal product may be authorised to treat the paediatric popu-lation;
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 inthe summary of the product characteristics drawn up inaccordance with Article 11 of Directive 2001/83/EC;
4) ‘paediatric use marketing authorisation’ means a marketing
authorisation granted in respect of a medicinal product forhuman 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 supple-mentary protection certificate, covering exclusively thera-peutic indications which are relevant for use in the paediatricpopulation, or subsets thereof, including the appropriatestrength, 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 estab-
lished within the European Medicines Agency set up underRegulation (EC) No 726/2004, hereinafter ‘the Agency’ . The
Paediatric Committee shall be considered as established once themembers 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 appro-
priate coordination between the Paediatric Committee and the
Committee for Medicinal Products for Human Use, theCommittee for Orphan Medicinal Products, their workingparties 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 thefollowing members:(a) five members, with their alternates, of the Committee for
Medicinal Products for Human Use, having been appointedto that Committee in accordance with Article 61(1) of Regu-lation (EC) No 726/2004. These five members with theiralternates 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 forMedicinal Products for Human Use;
(c) three members and three alternates appointed by the
Commission, on the basis of a public call for expressions ofinterest, after consulting the European Parliament, in orderto 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 theirabsence.
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, coversthe scientific areas relevant to paediatric medicinal products,and including at least: pharmaceutical development, paediatricmedicine, general practitioners, paediatric pharmacy, paediatricpharmacology, 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 membersappointed 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 Committeeshall adopt an opinion consisting of the position of the majorityof the members. The opinion shall mention the divergent posi-tions, with the grounds on which they are based. This opinion
shall be made accessible to the public pursuant to Article 25(5)
and (7).27.12.2006 L 378/6 Official Journal of the European Union EN
IP/N/1/EU/P/2 
        - 8 -2. The Paediatric Committee shall draw up its rules of proce-
dure for the implementation of its tasks. The rules of procedureshall enter into force after receiving a favourable opinion fromthe Management Board of the Agency and, subsequently, fromthe 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 thefollowing:
(a) to assess the content of any paediatric investigation plan for
a medicinal product submitted to it in accordance with thisRegulation 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 MarketingAuthorisation with the agreed paediatric investigation planconcerned 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 datagenerated in accordance with an agreed paediatric investiga-
tion plan and formulate an opinion on the quality, safety or
efficacy of the medicinal product for use in the paediatricpopulation;
(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 Euro-
pean 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 requestof 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 referredto 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 Committeeshall consider whether or not any proposed studies can beexpected to be of significant therapeutic benefit to and/or fulfila therapeutic need of the paediatric population. The PaediatricCommittee 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 underArticle 6 of Directive 2001/83/EC in respect of a medicinalproduct for human use which is not authorised in the Com-
munity at the time of entry into force of this Regulation shall
be regarded as valid only if it includes, in addition to the parti-culars and documents referred to in Article 8(3) of Direc-tive 2001/83/EC, one of the following:
(a) the results of all studies performed and details of all infor-
mation 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.
2. 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 protectedeither by a supplementary protection certificate under Regu-lation (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 ofnew indications, including paediatric indications, new pharma-ceutical 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 administra-
tion.27.12.2006 L 378/7 Official Journal of the European Union EN
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        - 9 -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 detailedarrangements concerning the format and content which applica-
tions for agreement or modification of a paediatric investigation
plan and requests for waivers or deferrals must follow in orderto be considered valid and concerning the operation of thecompliance check referred to in Articles 23 and 28(3).
CHAPTER 2
Waivers
Article 11
1. Production of the information referred to in point (a) ofArticle 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 ofthe paediatric population;
(b) that the disease or condition for which the specific medic-
inal product or class is intended occurs only in adult popu-lations;
(c) that the specific medicinal product does not represent a
significant therapeutic benefit over existing treatments forpaediatric patients.
2. The waiver provided for in paragraph 1 may be issuedwith reference either to one or more specified subsets of thepaediatric population, or to one or more specified therapeuticindications, or to a combination of both.
Article 12
The Paediatric Committee may of its own motion adopt anopinion, on the grounds set out in Article 11(1), to the effectthat a class or a product-specific waiver, as referred to inArticle 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 aclass 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 PaediatricCommittee shall appoint a rapporteur and shall within 60 daysadopt an opinion as to whether or not a product-specific waivershould 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 documentssubmitted. Where the Paediatric Committee avails itself of thisoption, the 60-day time-limit shall be suspended until such timeas 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 avail-
able 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 ofwaivers.
CHAPTER 3
Paediatric investigation plan
Section 1
Requests for agreement
Article 15
1. Where the intention is to apply for a marketing authorisa-tion in accordance with Article 7(1)(a) or (d), Article 8 orArticle 30, a paediatric investigation plan shall be drawn up andsubmitted to the Agency with a request for agreement.
2. The paediatric investigation plan shall specify the timing
and the measures proposed to assess the quality, safety and effi-cacy of the medicinal product in all subsets of the paediatricpopulation that may be concerned. In addition, it shall describeany 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.27.12.2006 L 378/8 Official Journal of the European Union EN
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        - 10 -Article 16
1. 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 investigationplan or the application for waiver shall be submitted with arequest for agreement, except in duly justified cases, not laterthan upon completion of the human pharmaco-kinetic studies
in adults specified in Section 5.2.3 of Part I of Annex I to Direc-
tive 2001/83/EC, so as to ensure that an opinion on use in thepaediatric population of the medicinal product concerned canbe given at the time of the assessment of the marketing authori-sation or other application concerned.
2. Within 30 days following receipt of the request referred to
in paragraph 1 and in Article 15(1), the Agency shall verify thevalidity of the request and prepare a summary report for thePaediatric Committee.
3. Whenever appropriate, the Agency may ask the applicant
to submit additional particulars and documents, in which casethe time-limit of 30 days shall be suspended until such time as
the supplementary information requested has been provided.
Article 17
1. Following receipt of a proposed paediatric investigationplan which is valid in accordance with the provisions of
Article 15(2), the Paediatric Committee shall appoint a rappor-teur and shall within 60 days adopt an opinion as to whether ornot the proposed studies will ensure the generation of thenecessary data determining the conditions in which the medic-
inal product may be used to treat the paediatric population or
subsets thereof, and as to whether or not the expected thera-peutic benefits justify the studies proposed. When adopting itsopinion, the Committee shall consider whether or not themeasures proposed to adapt the formulation of the medicinalproduct 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.
2. Within the 60-day period referred to in paragraph 1, the
Paediatric Committee may request the applicant to propose
modifications to the plan, in which case the time-limit referred
to in paragraph 1 for the adoption of the final opinion shall beextended for a maximum of 60 days. In such cases, the appli-cant or the Paediatric Committee may request an additionalmeeting during this period. The time-limit shall be suspendeduntil such time as the supplementary information requested has
been provided.
Article 18
As soon as the Paediatric Committee adopts an opinion,whether positive or negative, the procedure laid down in
Article 25 shall apply.
Article 19
If, having considered a paediatric investigation plan, the Paedia-tric Committee concludes that Article 11(1)(a), (b) or (c) appliesto the medicinal product concerned, it shall adopt a negativeopinion under Article 17(1).
In such cases, the Paediatric Committee shall adopt an opinion
in favour of a waiver under Article 12, whereupon the proce-dure laid down in Article 25 shall apply.
Section 2
Deferrals
Article 20
1. At the same time as the paediatric investigation plan is
submitted under Article 16(1), a request may be made for
deferral of the initiation or completion of some or all of themeasures set out in that plan. Such deferral shall be justified onscientific and technical grounds or on grounds related to publichealth.
In any event, a deferral shall be granted when it is appropriate
to conduct studies in adults prior to initiating studies in thepaediatric population or when studies in the paediatric popula-
tion will take longer to conduct than studies in adults.
2. On the basis of the experience acquired as a result of the
operation of this Article, the Commission may adopt provisions
in accordance with the procedure referred to in Article 51(2) to
define further the grounds for granting a deferral.
Article 21
1. At the same time as the Paediatric Committee adopts apositive opinion under Article 17(1), it shall, of its own motionor following a request submitted by the applicant underArticle 20, adopt an opinion, if the conditions specified inArticle 20 are met, in favour of deferring the initiation orcompletion of some or all of the measures in the paediatric
investigation plan.
An opinion in favour of a deferral shall specify the time-limits
for initiating or completing the measures concerned.
2. As soon as the Paediatric Committee adopts an opinion in
favour of deferral, as referred to in paragraph 1, the procedurelaid down in Article 25 shall apply.
Section 3
Modification of a paediatric investigation plan
Article 22
If, following the decision agreeing the paediatric investigationplan, the applicant encounters such difficulties with its imple-mentation as to render the plan unworkable or no longer
appropriate, the applicant may propose changes or request a
deferral or a waiver, based on detailed grounds, to the PaediatricCommittee. Within 60 days, the Paediatric Committee shallreview these changes or the request for a deferral or a waiverand adopt an opinion proposing their refusal or acceptance. Assoon as the Paediatric Committee adopts an opinion, whether
positive or negative, the procedure laid down in Article 25 shall
apply.27.12.2006 L 378/9 Official Journal of the European Union EN
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        - 11 -Section 4
Compliance with the paediatric investigation
plan
Article 23
1. The competent authority responsible for granting
marketing authorisation shall verify whether an application formarketing authorisation or variation complies with the require-ments laid down in Articles 7 and 8 and whether an applicationsubmitted pursuant to Article 30 complies with the agreedpaediatric 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 accord-
ance 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 inves-
tigation plan:
(a) by the applicant, prior to submitting an application for
marketing authorisation or variation as referred to in Arti-
cles 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 complianceadopted following a request under point (a);
(c) by the Committee for Medicinal Products for Human Use,
or the national competent authority, when assessing anapplication, as referred to in point (a), where there is doubtconcerning compliance and an opinion has not been alreadygiven following a request under points (a) or (b).
In the case of point (a), the applicant shall not submit its appli-cation 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 receivingthe request.
Member States shall take account of such an opinion.
Article 24
If, when conducting the scientific assessment of a valid applica-
tion for Marketing Authorisation, the competent authorityconcludes that the studies are not in conformity with the agreedpaediatric investigation plan, the product shall not be eligible
for the rewards and incentives provided for in Articles 36, 37
and 38.CHAPTER 4
Procedure
Article 25
1. Within ten days of its receipt, the Agency shall transmitthe 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 opinionconfirming or revising its previous opinion. The rapporteurshall be able to question the applicant directly. The applicantmay 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 dulyreasoned and a statement of reasons for the conclusion reachedshall be annexed to the new opinion, which shall become defini-tive.
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 definitive opinion. This decision shall be communicated tothe applicant in writing and shall annex the definitive opinionof the Paediatric Committee.
6. In the case of a class waiver as referred to in Article 12,
the Agency shall adopt a decision within ten days followingreceipt of the opinion of the Paediatric Committee as referred toin Article 13(3). This decision shall annex the opinion of the
Paediatric Committee.
7. Decisions of the Agency shall be made public after dele-
tion of any information of a commercially confidential nature.
CHAPTER 5
Miscellaneous provisions
Article 26
Any legal or natural person developing a medicinal productintended 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 ofthe various tests and studies necessary to demonstrate thequality, safety and efficacy of the medicinal product in the
paediatric population in accordance with Article 57(1)(n) of
Regulation (EC) No 726/2004.27.12.2006 L 378/10 Official Journal of the European Union EN
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        - 12 -In addition, this legal or natural person may request advice on
the design and conduct of pharmacovigilance and risk manage-ment systems as referred to in Article 34.
The Agency shall provide advice under this Article free of
charge.
TITLE III
MARKETING AUTHORISATION PROCEDURES
Article 27
Save where otherwise provided in this Title, marketing authori-sation procedures for the marketing authorisations covered bythis Title shall be governed by the provisions laid down inRegulation (EC) No 726/2004 or in Directive 2001/83/EC.
CHAPTER 1
Marketing authorisation procedures for applications falling
within the scope of Articles 7 and 8
Article 28
1. Applications may be submitted in accordance with theprocedure laid down in Articles 5 to 15 of Regulation (EC)No 726/2004 for a marketing authorisation as referred to inArticle 7(1) of this Regulation which includes one or morepaediatric indications on the basis of studies conducted in
compliance with an agreed paediatric investigation plan.
Where authorisation is granted, the results of all those studies
shall be included in the summary of product characteristics and,
if appropriate, in the package leaflet of the medicinal product,
provided that the competent authority deems the information tobe of use to patients, whether or not all the paediatric indica-tions concerned were approved by the competent authority.
2. Where a marketing authorisation is granted or varied, any
waiver or deferral which has been granted pursuant to thisRegulation shall be recorded in the summary of product charac-teristics and, if appropriate, in the package leaflet of the medic-inal product concerned.
3. If the application complies with all the measures contained
in the agreed completed paediatric investigation plan and if thesummary of product characteristics reflects the results of studiesconducted in compliance with that agreed paediatric investiga-
tion plan, the competent authority shall include within the
marketing authorisation a statement indicating compliance ofthe application with the agreed completed paediatric investiga-tion plan. For the purpose of the application of Article 45(3),this statement shall also indicate whether significant studies
contained in the agreed Paediatric Investigation Plan have been
completed after the entry into force of this Regulation.Article 29
In the case of medicinal products authorised under Directive
2001/83/EC, an application as referred to in Article 8 of this
Regulation may be submitted, in accordance with the procedurelaid down in Articles 32, 33 and 34 of Directive 2001/83/EC,for authorisation of a new indication, including the extension ofan authorisation for use in the paediatric population, a newpharmaceutical form or a new route of administration.
That application shall comply with the requirement laid down
in point (a) of Article 7(1).
The procedure shall be limited to the assessment of the specific
sections of the summary of product characteristics to be varied.
CHAPTER 2
Paediatric use marketing authorisation
Article 30
1. Submission of an application for a paediatric usemarketing authorisation shall in no way preclude the right toapply for a marketing authorisation for other indications.
2. An application for a paediatric use marketing authorisa-
tion shall be accompanied by the particulars and documentsnecessary to establish quality, safety and efficacy in the paedia-tric population, including any specific data needed to supportan appropriate strength, pharmaceutical form or route of
administration for the product, in accordance with an agreed
paediatric investigation plan.
The application shall also include the decision of the Agency
agreeing the paediatric investigation plan concerned.
3. Where a medicinal product is or has been authorised in a
Member State or in the Community, data contained in the
dossier on that product may, where appropriate, be referred to,
in accordance with Article 14(11) of Regulation (EC) No 726/2004 or Article 10 of Directive 2001/83/EC, in an applicationfor a paediatric use marketing authorisation.
4. The medicinal product in respect of which a paediatric use
marketing authorisation is granted may retain the name of anymedicinal product which contains the same active substanceand in respect of which the same holder has been granted
authorisation for use in adults.
Article 31
Without prejudice to Article 3(2) of Regulation (EC) No 726/
2004, an application for a paediatric use marketing authorisa-
tion may be made in accordance with the procedure laid down
in Articles 5 to 15 of Regulation (EC) No 726/2004.27.12.2006 L 378/11 Official Journal of the European Union EN
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        - 13 -CHAPTER 3
Identification
Article 32
1. Where a medicinal product is granted a marketing authori-
sation for a paediatric indication, the label shall display thesymbol agreed in accordance with paragraph 2. The packageleaflet shall contain an explanation of the meaning of thesymbol.
2. By 26 January 2008, the Commission shall select a
symbol following a recommendation of the PaediatricCommittee. The Commission shall make the symbol public.
3. The provisions of this Article shall also apply to medicinal
products authorised before the entry into force of this Regu-
lation, and to medicinal products authorised after the entry into
force of this Regulation but before the symbol has been madepublic, if they are authorised for paediatric indications.
In this case, the symbol and the explanation referred to in para-
graph 1 shall be included in the labelling and package leaflet
respectively of the medicinal products concerned not later than
two years after the symbol has been made public.
TITLE IV
POST-AUTHORISATION REQUIREMENTS
Article 33
Where medicinal products are authorised for a paediatric indica-tion following completion of an agreed paediatric investigationplan and those products have already been marketed with other
indications, the marketing authorisation holder shall, within two
years of the date on which the paediatric indication isauthorised, place the product on the market taking into accountthe paediatric indication. A register, coordinated by the Agency,and made publicly available, shall mention these deadlines.
Article 34
1. In the following cases, the applicant shall detail themeasures to ensure the follow-up of efficacy and of possibleadverse reactions to the paediatric use of the medicinal product:
(a) applications for a marketing authorisation that includes a
paediatric indication;
(b) applications to include a paediatric indication in an existing
marketing authorisation;
(c) applications for a paediatric use marketing authorisation.
2. Where there is particular cause for concern, the competentauthority shall require, as a condition for granting marketing
authorisation, that a risk management system be set up or that
specific post-marketing studies be performed and submitted forreview. The risk management system shall comprise a set ofpharmacovigilance activities and interventions designed to iden-tify, characterise, prevent or minimise risks relating to medicinal
products, including the assessment of the effectiveness of those
interventions.Assessment of the effectiveness of any risk management systemand the results of any studies performed shall be included in theperiodic safety update reports referred to in Article 104(6) ofDirective 2001/83/EC and Article 24(3) of Regulation (EC)No 726/2004.
In addition, the competent authority may request submission of
additional reports assessing the effectiveness of any risk minimi-
sation system and the results of any such studies performed.
3. In addition to paragraphs 1 and 2, the provisions on phar-
macovigilance as laid down in Regulation (EC) No 726/2004
and in Directive 2001/83/EC shall apply to marketing authorisa-tions for medicinal products which include a paediatric indica-tion.
4. In the case of a deferral, the marketing authorisation
holder shall submit an annual report to the Agency providingan update on progress with paediatric studies in accordance
with the decision of the Agency agreeing the paediatric investi-
gation plan and granting a deferral.
The Agency shall inform the competent authority if it is found
that the marketing authorisation holder has failed to complywith the decision of the Agency agreeing the paediatric investi-gation plan and granting a deferral.
5. The Agency shall draw up guidelines relating to the appli-
cation of this Article.
Article 35
If a medicinal product is authorised for a paediatric indication
and the marketing authorisation holder has benefited from
rewards or incentives under Article 36, 37 or 38, and theseperiods of protection have expired, and if the marketing authori-sation holder intends to discontinue placing the medicinalproduct on the market, the marketing authorisation holder shalltransfer the marketing authorisation or allow a third party,
which has declared its intention to continue to place the medic-
inal product in question on the market, to use the pharmaceu-tical, pre-clinical and clinical documentation contained in thefile of the medicinal product on the basis of Article 10c ofDirective 2001/83/EC.
The marketing authorisation holder shall inform the Agency of
its intention to discontinue the placing on the market of the
product no less than six months before the discontinuation. The
Agency shall make this fact public.
TITLE V
REWARDS AND INCENTIVES
Article 36
1. Where an application under Article 7 or 8 includes theresults of all studies conducted in compliance with an agreedpaediatric investigation plan, the holder of the patent or supple-mentary protection certificate shall be entitled to a six-month
extension of the period referred to in Articles 13(1) and 13(2)
of Regulation (EEC) No 1768/92.27.12.2006 L 378/12 Official Journal of the European Union EN
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        - 14 -The first subparagraph shall also apply where completion of the
agreed paediatric investigation plan fails to lead to the authorisa-tion of a paediatric indication, but the results of the studiesconducted are reflected in the summary of product characteris-tics and, if appropriate, in the package leaflet of the medicinal
product concerned.
2. The inclusion in a marketing authorisation of the state-
ment referred to in Article 28(3) shall be used for the purposesof applying paragraph 1 of this Article.
3. Where the procedures laid down in Directive 2001/83/EC
have been used, the six-month extension of the period referredto in paragraph 1 shall be granted only if the product isauthorised in all Member States.
4. Paragraphs 1, 2 and 3 shall apply to products that are
protected by a supplementary protection certificate under Regu-
lation (EEC) No 1768/92, or under a patent which qualifies forthe granting of the supplementary protection certificate. Theyshall not apply to medicinal products designated as orphanmedicinal products pursuant to Regulation (EC) No 141/2000.
5. In the case of an application under Article 8 which leads
to the authorisation of a new paediatric indication, paragraphs1, 2 and 3 shall not apply if the applicant applies for, andobtains, a one-year extension of the period of marketing protec-tion for the medicinal product concerned, on the grounds thatthis new paediatric indication brings a significant clinical benefit
in comparison with existing therapies, in accordance with
Article 14(11) of Regulation (EC) No 726/2004 or the fourthsubparagraph of Article 10(1) of Directive 2001/83/EC.
Article 37
Where an application for a marketing authorisation is submittedin respect of a medicinal product designated as an orphanmedicinal product pursuant to Regulation (EC) No 141/2000and that application includes the results of all studies conductedin compliance with an agreed paediatric investigation plan, andthe statement referred to in Article 28(3) of this Regulation is
subsequently included in the marketing authorisation granted,
the ten-year period referred to in Article 8(1) of Regulation (EC)No 141/2000 shall be extended to twelve years.
The first paragraph shall also apply where completion of the
agreed paediatric investigation plan fails to lead to the authorisa-
tion of a paediatric indication, but the results of the studies
conducted are reflected in the summary of product characteris-tics and, if appropriate, in the package leaflet of the medicinalproduct concerned.
Article 38
1. Where a paediatric use marketing authorisation is grantedin accordance with Articles 5 to 15 of Regulation (EC) No 726/2004, the data and marketing protection periods referred to inArticle 14(11) of that Regulation shall apply.
2. Where a paediatric use marketing authorisation is granted
in accordance with the procedures laid down in Directive2001/83/EC, the data and marketing protection periods referredto in Article 10(1) of that Directive shall apply.
Article 39
1. In addition to the rewards and incentives provided for inArticles 36, 37 and 38, medicinal products for paediatric usemay be eligible for incentives provided by the Community or bythe Member States to support research into, and the develop-
ment and availability of, medicinal products for paediatric use.
2. By 26 January 2008, the Member States shall communi-
cate to the Commission detailed information concerning anymeasures they have enacted to support research into, and thedevelopment and availability of, medicinal products for paedia-tric use. This information shall be updated regularly at therequest of the Commission.
3. By 26 July 2008, the Commission shall make publicly
available a detailed inventory of all rewards and incentives
provided by the Community and Member States to supportresearch into, and the development and availability of, medicinalproducts for paediatric use. This inventory shall be updatedregularly and the updates shall also be made publicly available.
Article 40
1. Funds for research into medicinal products for the paedia-tric population shall be provided for in the Community budget
in order to support studies relating to medicinal products or
active substances not covered by a patent or a supplementaryprotection certificate.
2. The Community funding referred to in paragraph 1 shall
be delivered through the Community Framework Programmesfor Research, Technological Development and DemonstrationActivities or any other Community initiatives for the funding of
research.
TITLE VI
COMMUNICATION AND COORDINATION
Article 41
1. The European database created by Article 11 of Directive
2001/20/EC shall include clinical trials carried out in thirdcountries which are contained in an agreed paediatric investiga-tion plan, in addition to the clinical trials referred to in Articles
1 and 2 of that Directive. In the case of such clinical trials
carried out in third countries, the details listed in Article 11 ofthat Directive shall be entered into the database by the addresseeof the Agency's decision on a paediatric investigation plan.
By way of derogation from the provisions of Article 11 of
Directive 2001/20/EC, the Agency shall make public part of the
information on paediatric clinical trials entered in the European
database.27.12.2006 L 378/13 Official Journal of the European Union EN
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        - 15 -2. Details of the results of all the trials referred to in para-
graph 1 and of any other trials submitted to competent authori-ties in compliance with Articles 45 and 46 shall be made publicby the Agency, whether or not the trial was terminated prema-turely. These results shall be submitted without delay to the
Agency by the clinical trial sponsor, the addressee of the Agen-
cy's decision on a paediatric investigation plan, or by themarketing authorisation holder as appropriate.
3. In consultation with the Agency, Member States and inter-
ested parties, the Commission shall draw up guidance on thenature of the information referred to in paragraph 1 to beentered in the European database created by Article 11 of Direc-
tive 2001/20/EC, on which information shall be made accessible
to the public in application of paragraph 1, on how clinical trialresults shall be submitted and be made public in application ofparagraph 2, and on the Agency's responsibilities and tasks inthis regard.
Article 42
Member States shall collect available data on all existing uses ofmedicinal products in the paediatric population and shallcommunicate these data to the Agency by 26 January 2009.
The Paediatric Committee shall provide guidance on the content
and the format of the data to be collected by 26 October 2007.
Article 43
1. On the basis of the information referred to in Article 42and after consulting the Commission, the Member States andthe interested parties, the Paediatric Committee shall establishan inventory of therapeutic needs, in particular with a view toidentifying research priorities.
The Agency shall make the inventory public at the earliest by
26 January 2009 and at the latest by 26 January 2010 and shallupdate it regularly.
2. In establishing the inventory of therapeutic needs, account
shall be taken of the prevalence of the conditions in the paedia-
tric population, the seriousness of the conditions to be treated,the availability and suitability of alternative treatments for theconditions in the paediatric population, including the efficacyand the adverse reaction profile of those treatments, includingany unique paediatric safety issues, and any data resulting from
studies in third countries.
Article 44
1. The Agency shall, with the scientific support of the Paedia-
tric Committee, develop a European network of existingnational and European networks, investigators and centres with
specific expertise in the performance of studies in the paediatric
population.
2. The objectives of the European network shall be, inter alia,
to coordinate studies relating to paediatric medicinal products,to build up the necessary scientific and administrative compe-tences at European level, and to avoid unnecessary duplicationof studies and testing in the paediatric population.
3. By 26 January 2008, the Management Board of the
Agency shall, on a proposal from the Executive Director and
following consultation with the Commission, the Member Statesand interested parties, adopt an implementing strategy for thelaunching and operation of the European network. Thisnetwork must, where appropriate, be compatible with the workof strengthening the foundations of the European Research Area
in the context of the Community Framework Programmes for
Research, Technological Development and Demonstration Activ-ities.
Article 45
1. By 26 January 2008, any paediatric studies alreadycompleted, by the date of entry into force, in respect of productsauthorised in the Community shall be submitted by themarketing authorisation holder for assessment to the competentauthority.
The competent authority may update the summary of product
characteristics and package leaflet, and may vary the marketingauthorisation accordingly. Competent authorities shall exchangeinformation regarding the studies submitted and, as appropriate,their implications for any marketing authorisations concerned.
The Agency shall coordinate the exchange of information.
2. All existing paediatric studies, as referred to in paragraph
1, and all paediatric studies initiated prior to the entry intoforce of this Regulation shall be eligible to be included in a
paediatric investigation plan, and shall be taken into considera-
tion by the Paediatric Committee when assessing applicationsfor paediatric investigation plans, waivers and deferrals and bycompetent authorities when assessing applications submittedpursuant to Article 7, 8 or 30.
3. Without prejudice to the previous paragraph, the rewards
and incentives of Articles 36, 37 and 38 shall only be grantedprovided that significant studies contained in an agreed Paedia-tric Investigation Plan are completed after the entry into forceof this Regulation.
4. In consultation with the Agency, the Commission shall
draw up guidelines to establish assessment criteria for the signif-icance of studies for the purposes of applying paragraph 3.
Article 46
1. Any other marketing authorisation holder-sponsoredstudies which involve the use in the paediatric population of amedicinal product covered by a marketing authorisation,whether or not they are conducted in compliance with anagreed paediatric investigation plan, shall be submitted to the
competent authority within six months of completion of the
studies concerned.27.12.2006 L 378/14 Official Journal of the European Union EN
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        - 16 -2. Paragraph 1 shall apply independent of whether or not
the marketing authorisation holder intends to apply for amarketing authorisation of a paediatric indication.
3. The competent authority may update the summary of
product characteristics and package leaflet, and may vary themarketing authorisation accordingly.
4. Competent authorities shall exchange information
regarding the studies submitted and, as appropriate, their impli-
cations for any marketing authorisations concerned.
5. The Agency shall coordinate the exchange of information.
TITLE VII
GENERAL AND FINAL PROVISIONS
CHAPTER 1
General provisions
Section 1
Fees, community funding, penalties and reports
Article 47
1. Where an application for a paediatric use marketing
authorisation is submitted in accordance with the procedure laiddown in Regulation (EC) No 726/2004, the amount of thereduced fees for the examination of the application and themaintenance of the marketing authorisation shall be fixed in
accordance with Article 70 of Regulation (EC) No 726/2004.
2. Council Regulation (EC) No 297/95 of 10 February 1995
on fees payable to the European Medicines Agency (
1) shall
apply.
3. Assessments of the following by the Paediatric Committee
shall be free of charge:
(a) applications for waiver;
(b) applications for deferral;
(c) paediatric investigation plans;
(d) compliance with the agreed paediatric investigation plan.
Article 48
The Community contribution provided for in Article 67 of
Regulation (EC) No 726/2004 shall cover the work of the
Paediatric Committee, including scientific support provided byexperts, and of the Agency, including the assessment of paedia-tric investigation plans, scientific advice and any fee waiversprovided for in this Regulation, and shall support the Agency's
activities under Articles 41 and 44 of this Regulation.
Article 49
1. Without prejudice to the Protocol on the Privileges and
Immunities of the European Communities, each Member Stateshall determine the penalties to be applied for infringement ofthe provisions of this Regulation or the implementing measuresadopted pursuant to it in relation to medicinal productsauthorised through the procedures laid down in Directive2001/83/EC and shall take all measures necessary for their
implementation. The penalties shall be effective, proportionate
and dissuasive.
Member States shall inform the Commission of these provisions
by 26 October 2007. They shall notify any subsequent altera-tions as soon as possible.
2. Member States shall inform the Commission immediately
of any litigation instituted for infringement of this Regulation.
3. At the Agency's request, the Commission may impose
financial penalties for infringement of the provisions of thisRegulation or the implementing measures adopted pursuant toit in relation to medicinal products authorised through theprocedure laid down in Regulation (EC) No 726/2004. The
maximum amounts as well as the conditions and methods for
collection of these penalties shall be laid down in accordancewith the procedure referred to in Article 51(2) of this Regu-lation.
4. The Commission shall make public the names of anyone
infringing the provisions of this Regulation or of any imple-
menting measures adopted pursuant to it and the amounts of,
and reasons for, the financial penalties imposed.
Article 50
1. On the basis of a report from the Agency, and at least onan annual basis, the Commission shall make public a list of thecompanies and of the products that have benefited from any of
the rewards and incentives in this Regulation and the companies
that have failed to comply with any of the obligations in thisRegulation. The Member States shall provide this information tothe Agency.
2. By 26 January 2013, the Commission shall present to the
European Parliament and the Council a general report on
experience acquired as a result of the application of this Regu-
lation. This shall include in particular a detailed inventory of allmedicinal products authorised for paediatric use since its entryinto force.
3. By 26 January 2017, the Commission shall present a
report to the European Parliament and the Council on the
experience acquired as a result of the application of Articles 36,
37 and 38. The report shall include an analysis of the economicimpact of the rewards and incentives, together with an analysisof the estimated consequences for public health of this Regu-lation, with a view to proposing any necessary amendments.
4. Provided that there are sufficient data available to allow
robust analyses to be made, the provisions of paragraph 3 shall
be fulfilled at the same time as the provisions of paragraph 2.27.12.2006 L 378/15 Official Journal of the European Union EN
(1) OJ L 35, 15.2.1995, p. 1. Regulation as last amended by Regulation
(EC) No 1905/2005 (OJ L 304, 23.11.2005, p. 1).
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        - 17 -Section 2
Standing committee
Article 51
1. The Commission shall be assisted by the Standing
Committee on Medicinal Products for Human Use set up by
Article 121 of Directive 2001/83/EC, hereinafter referred to as
‘the Committee ’.
2. Where reference is made to this paragraph, Articles 5 and
7 of Decision 1999/468/EC shall apply, having regard to the
provisions of Article 8 thereof.
The period laid down in Article 5(6) of Decision 1999/468/EC
shall be set at three months.
3. The Committee shall adopt its rules of procedure.
CHAPTER 2
Amendments
Article 52
Regulation (EEC) No 1768/92 is hereby amended as follows:
1) in Article 1, the following definition shall be added:
‘(e) “Application for an extension of the duration” means
an application for an extension of the duration of the
certificate pursuant to Article 13(3) of this Regulationand of Article 36 of Regulation (EC) No 1901/2006 ofthe European Parliament and of the Council of 12
December 2006 on medicinal products for paediatric
use (*).
(*) OJ L 378, 27.12.2006, p. 1.’
2) in Article 7, the following paragraphs shall be added:
‘3. The application for an extension of the duration maybe made when lodging the application for a certificate orwhen the application for the certificate is pending and the
appropriate requirements of Articles 8(1)(d) or 8(1a),
respectively, are fulfilled.
4. The application for an extension of the duration of a
certificate already granted shall be lodged not later than
two years before the expiry of the certificate.
5. Notwithstanding paragraph 4, for five years following
the entry into force of Regulation (EC) No 1901/2006, the
application for an extension of the duration of a certificatealready granted shall be lodged not later than six monthsbefore the expiry of the certificate.’;
3) Article 8 shall be amended as follows:(a) in paragraph 1, the following point shall be added:
‘(d) where the application for a certificate includes a
request for an extension of the duration:
(i) a copy of the statement indicating compliance
with an agreed completed paediatric investiga-tion plan as referred to in Article 36(1) ofRegulation (EC) No 1901/2006;
(ii) where necessary, in addition to the copy of the
authorisations to place the product on themarket as referred to in point (b), proof that ithas authorisations to place the product on the
market of all other Member States, as referred
to in Article 36(3) of Regulation (EC)No 1901/2006.’;
(b) the following paragraphs shall be inserted:
‘1a. Where an application for a certificate is pending,
an application for an extended duration in accord-ance with Article 7(3) shall include the particularsreferred to in paragraph 1(d) and a reference to theapplication for a certificate already filed.
1b. The application for an extension of the duration of
a certificate already granted shall contain the parti-culars referred to in paragraph 1(d) and a copy of
the certificate already granted.’;
(c) paragraph 2 shall be replaced by the following:
‘2. Member States may provide that a fee is to be
payable upon application for a certificate and uponapplication for the extension of the duration of a certi-
ficate.’ ;
4) Article 9 shall be amended as follows:
(a) in paragraph 1, the following subparagraph shall be
added:
‘The application for an extension of the duration of a
certificate shall be lodged with the competent authority
of the Member State concerned.’;
(b) in paragraph 2, the following point shall be added:
‘(f) where applicable, an indication that the application
includes an application for an extension of theduration.’;
(c) the following paragraph shall be added:
‘3. Paragraph 2 shall apply to the notification of theapplication for an extension of the duration of a certifi-cate already granted or where an application for a certi-ficate is pending. The notification shall additionally
contain an indication of the application for an extended
duration of the certificate.’;27.12.2006 L 378/16 Official Journal of the European Union EN
IP/N/1/EU/P/2 
        - 18 -5) in Article 10, the following paragraph shall be added:
‘6. Paragraphs 1 to 4 shall apply mutatis mutandis to
the application for an extension of the duration.’;
6) in Article 11, the following paragraph shall be added:
‘3. Paragraphs 1 and 2 shall apply to the notification ofthe fact that an extension of the duration of a certificatehas been granted or of the fact that the application for an
extension has been rejected.’;
7) in Article 13, the following paragraph shall be added:
‘3. The periods laid down in paragraphs 1 and 2 shall beextended by six months in the case where Article 36 of
Regulation (EC) No 1901/2006 applies. In that case, theduration of the period laid down in paragraph 1 of thisArticle may be extended only once.’;
8) the following Article shall be inserted:
‘Article 15a
Revocation of an extension of the duration
1. The extension of the duration may be revoked if it
was granted contrary to the provisions of Article 36 ofRegulation (EC) No 1901/2006.
2. Any person may submit an application for revocation
of the extension of the duration to the body responsibleunder national law for the revocation of the corresponding
basic patent.’;
9) Article 16 shall be amended as follows:
(a) the text of Article 16 becomes that Article's para-
graph 1;
(b) the following paragraph shall be added:
‘2. If the extension of the duration is revoked in
accordance with Article 15a, notification thereof shallbe published by the authority referred to in Article 9
(1).’;
10) Article 17 shall be replaced by the following:
‘Article 17
Appeals
The decisions of the authority referred to in Article 9(1) or
of the bodies referred to in Articles 15(2) and 15a(2) taken
under this Regulation shall be open to the same appeals asthose provided for in national law against similar decisionstaken in respect of national patents.’.
Article 53
In Article 11 of Directive 2001/20/EC, the following paragraphshall be added:‘4. By way of derogation from paragraph 1, the Agencyshall make public part of the information on paediatric clin-ical trials entered in the European database in accordancewith the provisions of Regulation (EC) No 1901/2006 ofthe European Parliament and of the Council of 12
December 2006 on medicinal products for paediatric
use (*).
(*) OJ L 378, 27.12.2006, p. 1.’
Article 54
In Article 6 of Directive 2001/83/EC, the first subparagraph ofparagraph 1 shall be replaced by the following:
‘1. No medicinal product may be placed on the marketof a Member State unless a marketing authorisation hasbeen issued by the competent authorities of that MemberState in accordance with this Directive or unless an authori-sation has been granted in accordance with Regulation (EC)
No 726/2004, read in conjunction with Regulation (EC) No
1901/2006 of the European Parliament and of the Councilof 12 December 2006 on medicinal products for paediatricuse (*).
(*) OJ L 378, 27.12.2006, p. 1.’
Article 55
Regulation (EC) No 726/2004 is hereby amended as follows:
1) Article 56(1) shall be replaced by the following:
‘1. The Agency shall comprise:
(a) the Committee for Medicinal Products for Human Use,
which shall be responsible for preparing the opinion of
the Agency on any question relating to the evaluation of
medicinal products for human use;
(b) the Committee for Medicinal Products for Veterinary
Use, which shall be responsible for preparing theopinion of the Agency on any question relating to theevaluation of medicinal products for veterinary use;
(c) the Committee on Orphan Medicinal Products;
(d) the Committee on Herbal Medicinal Products;
(e) the Paediatric Committee;
(f) a Secretariat, which shall provide technical, scientific and
administrative support for the committees and ensureappropriate coordination between them;
(g) an Executive Director, who shall exercise the responsibil-
ities set out in Article 64;
(h) a Management Board, which shall exercise the responsi-
bilities set out in Articles 65, 66 and 67.’;27.12.2006 L 378/17 Official Journal of the European Union EN
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        - 19 -2) in Article 57(1), the following point shall be added:
‘(t) taking decisions as referred to in Article 7(1) of Regu-
lation (EC) No 1901/2006 of the European Parliament
and of the Council of 12 December 2006 on medicinalproducts for paediatric use (*).
(*) OJ L 378, 27.12.2006, p. 1.’
3) the following Article shall be inserted:
‘Article 73a
Decisions taken by the Agency under Regulation (EC) No1901/2006 may form the subject of an action before theCourt of Justice of the European Communities under the
conditions laid down in Article 230 of the Treaty.’.CHAPTER 3
Final provisions
Article 56
The requirement laid down in Article 7(1) shall not apply to
valid applications pending at the time of entry into force of thisRegulation.
Article 57
1. This Regulation shall enter into force on the thirtieth dayfollowing that of its publication in the Official Journal of the Euro-
pean Union.
2. Article 7 shall apply from 26 July 2008.Article 8 shall apply from 26 January 2009.Articles 30 and 31 shall apply from 26 July 2007.
This Regulation shall be binding in its entirety and directly applicable in all Member States.
Done at Strasbourg, 12 December 2006.
For the European Parliament
The President
J. BORRELL FONTELLESFor the Council
The President
M. PEKKARINEN27.12.2006 L 378/18 Official Journal of the European Union EN
IP/N/1/EU/P/2 
        - 20 -COMMISSION STATEMENT
In view of the risks of carcinogens, mutagens and substances toxic to reproduction, the Commission will
request the Committee for Medicinal Products for Human Use of the European Medicines Agency to drawup an opinion on the use of these categories of substances as excipients of medicinal products for humanuse, on the basis of Articles 5(3) and 57(1)(p) of Regulation (EC) No 726/2004 of 31 March 2004 laying
down Community procedures for the authorisation and supervision of medicinal products for human and
veterinary use and establishing a European Medicines Agency.
The Commission will transmit the opinion of the Committee for Medicinal Products for Human Use to the
European Parliament and the Council.
Within six months of the opinion of the Committee for Medicinal Products for Human Use, the Commis-
sion will inform the European Parliament and the Council of any necessary action it intends to take tofollow-up on this opinion.27.12.2006 L 378/19 Official Journal of the European Union EN
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        - 21 -