Common Position (EC) No 7/2006 of  10 March 2006  adopted by the Council, acting in accordance with the procedure referred to in Article 251 of the Treaty establishing the European Community, with a view to adopting a Regulation of the European Parliament and of the Council on medical 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
Date: 2006-03-10
Institutions: Council of the European Union
Subjects: European Medicines Agency, child, child protection, drug surveillance, market approval, medical research, medicinal product, paediatrics, pharmaceutical legislation

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I

(Information)

COUNCIL

COMMON POSITION (EC) No 7/2006

adopted by the Council on 10 May 2006

with a view to adopting Regulation (EC) No …/2006 of the European Parliament and of the
Council of … 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

(2006/C 132 E/01)

(Text with EEA relevance)

THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE EURO-
PEAN UNION,

(3)

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),

(4)

Whereas:

(1)

(2)

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, of
high quality and effective for use in the target popula-
tion.

Such studies may not have been undertaken for use in
the paediatric population and many of the medicinal
products currently used to treat the paediatric popula-
tion have not been studied or authorised for such use.
Market forces alone have proven insufficient to stimulate
adequate research into, and the development and author-
isation of, medicinal products for the paediatric popula-
tion.

(1) Opinion delivered on 11 May 2005 (OJ C 267, 27.10.2005, p. 1).
(2) European Parliament Opinion of 7 September 2005 (not yet
published in the Official Journal), Council Common Position of 10
March 2006 and European Parliament Position (not yet published in
the Official Journal).

Problems resulting from the absence of suitably adapted
medicinal products for the paediatric population include
inadequate dosage information which leads to increased
ineffective
risks of adverse reactions including death,
treatment through under-dosage, non-availability to the
paediatric population of therapeutic advances, suitable
formulations and routes of administration, as well as use
of magistral or officinal formulations to treat the paedia-
tric population which may be of poor quality.

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
to treat the paediatric population are subject to ethical
research of high quality and are appropriately authorised
for use in the paediatric population, and to improve the
information available on the use of medicinal products
in the various paediatric populations. These objectives
should be achieved without subjecting the paediatric
population to unnecessary clinical
trials and without
delaying 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 by
means that do not impede the free movement of safe
medicinal products within the Community. The differ-
legislative, regulatory and
ences between the national
administrative provisions on medicinal products tend to
hinder
intra-Community trade and therefore directly
affect the operation of the internal market.

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(9)

(10)

(11)

(6)

(7)

(8)

The establishment of a system of both obligations and
rewards and incentives has proved necessary to achieve
these 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 medicinal
products required for paediatric use and therefore its
scope should cover products under development and
yet-to-be authorised, authorised products covered by
intellectual property rights and authorised products no
longer covered by intellectual property rights.

Any concerns about conducting trials in the paediatric
population should be balanced by the ethical concerns
about giving medicinal products to a population in
which they have not been appropriately tested. Public
from the use of untested medicinal
health threats
products in the paediatric population can be safely
addressed through the study of medicinal products for
the paediatric population, which should be carefully
controlled 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 approx-
regulations and administrative
imation of
provisions of the Member States relating to the imple-
mentation of good clinical practice in the conduct of
clinical trials on medicinal products for human use. (1)

the laws,

It is appropriate to create a scientific committee, the
Paediatric Committee, within the European Medicines
Agency, hereinafter 'the Agency', with expertise and
competence in the development and assessment of all
aspects of medicinal products to treat paediatric popula-
tions. To this end, the Paediatric Committee should be
independent
industry. The
from the pharmaceutical
Paediatric Committee should be primarily responsible for
the scientific assessment and agreement of paediatric
investigation plans and for the system of waivers and
it should also be central to various
deferrals thereof;
support measures contained in this Regulation.
In its
work,
the Paediatric Committee should consider the
potential significant therapeutic benefits for the paedia-
tric patients involved in the studies or the paediatric
population at large including the need to avoid unneces-
sary studies. The Paediatric Committee should follow
existing Community requirements,
including Direc-
tive 2001/20/EC, as well as International Conference on
Harmonisation (ICH) guideline E11 on the development
of medicinal products for the paediatric population, and
it should avoid any delay in the authorisation of medic-
inal products for other populations deriving from the
requirements for studies in the paediatric population.

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
should include details of the timing and the measures
proposed to demonstrate the quality, safety and efficacy
of the medicinal product in the paediatric population.
Since the paediatric population is in fact composed of a
number of population subsets, the paediatric investiga-
tion plan should specify which population subsets need
to be studied, by what means and by when.

The introduction of the paediatric investigation plan in
the legal framework concerning medicinal products for
human use aims at ensuring that the development of
medicinal products that are potentially to be used for
the paediatric population becomes an integral part of
the development of medicinal products, integrated into
the development programme for adults. Thus, paediatric
investigation plans should be submitted early during
product development,
to be
conducted in the paediatric population before marketing
authorisation applications are submitted.
is appro-
priate to set a deadline for the submission of a paediatric
investigation plan in order to ensure early dialogue
between the sponsor and the Paediatric Committee. As
the development of medicinal products is a dynamic
process dependent on the result of ongoing studies,
provision should be made for modifying an agreed plan
where necessary.

in time

studies

for

It

is necessary to introduce a requirement

for new
It
authorised medicinal
and for
medicinal products
products covered by a patent or a supplementary protec-
tion certificate to present either the results of studies in
the paediatric 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
authorisation application or an application for a new
indication, new pharmaceutical form or new route of
administration. The paediatric investigation plan should
be the basis upon which compliance with that require-
ment is judged. However, that requirement should not
apply to generics or
similar biological medicinal
products and medicinal products authorised through the
well-established medicinal use procedure, nor to homeo-
pathic medicinal products and traditional herbal medic-
inal products authorised through the simplified registra-
tion procedures of Directive 2001/83/EC of the Euro-
pean Parliament and of the Council of 6 November 2001
on the Community code relating to medicinal products
for human use (2).

(1) OJ L 121, 1.5.2001, p. 34.

(2) 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).

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(12)

Provision should be made for research into the paedia-
tric use of medicinal products which are not protected
by a patent or supplementary protection certificate to be
financed under Community research programmes.

(17)

(13)

(14)

(15)

(16)

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 to
waive 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
public by the Agency. As knowledge of science and
medicine evolves over time, provision should be made
for the lists of 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
paediatric investigation plan to be agreed and studies in
the paediatric population to be initiated before an appli-
cation for marketing authorisation is submitted.

In certain cases, the Agency should defer the initiation
or completion of some or all of the measures contained
in a paediatric investigation plan, with a view to
ensuring that research is conducted only when safe and
ethical and that the requirement for study data in the
paediatric population does not block or delay the
authorisation of medicinal products for other popula-
tions.

Free scientific advice should be provided by the Agency
as an incentive
to sponsors developing medicinal
products for the paediatric population. To ensure scien-
tific consistency, the Agency should manage the inter-
face between the Paediatric Committee and the Scientific
Advice Working Group of the Committee for Medicinal
Products for Human Use, as well as the interaction
between the Paediatric Committee and the other Com-
munity committees and working groups concerning
medicinal products.

The existing procedures for the marketing authorisation
of medicinal products for human use should not be
changed. However, from the requirement referred to in
recital 11 it follows that competent authorities should
check compliance with the agreed paediatric investiga-
tion plan and any waivers and deferrals at the existing
validation step for marketing authorisation applications.
The assessment of quality, safety and efficacy of medic-
inal products for the paediatric population and the
granting of marketing authorisations should remain the
remit of the competent authorities. Provision should be
made for the Paediatric Committee to be asked for its
opinion on compliance and on the quality, safety and
efficacy of a medicinal product in the paediatric popula-
tion.

To provide healthcare professionals and patients with
information on the safe and effective use of medicinal
products 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 the
measures in the paediatric investigation plan have been
fact should be recorded in the
complied with,
marketing authorisation, and should then be the basis
upon which companies can obtain the rewards for
compliance.

that

In order to identify medicinal products authorised for
use in the paediatric population and enable their
prescription, provision should be made for the labels of
medicinal products granted an indication for use in the
paediatric population to display a symbol which will be
selected by the Commission on a recommendation by
the Paediatric Committee.

In order to establish incentives for authorised products
no longer covered by intellectual property rights,
it is
necessary to establish a new type of marketing authorisa-
tion,
the Paediatric Use Marketing Authorisation. A
Paediatric Use Marketing Authorisation should be
granted through existing marketing authorisation proce-
dures but
should apply specifically for medicinal
products developed exclusively for use in the paediatric
population. It should be possible for the name of the
medicinal product that has been granted a Paediatric Use
Marketing Authorisation to retain the existing brand
name of
the corresponding product authorised for
adults, in order to capitalise on existing brand recogni-
tion, while benefiting from the data exclusivity asso-
ciated with a new marketing authorisation.

(18)

(19)

(20) An application for a Paediatric Use Marketing Authorisa-
tion should include the submission of data concerning
use of the product in the paediatric population, collected
in accordance with an agreed paediatric investigation
plan. These data may be derived from the published
literature or from new studies. An application for a
Paediatric Use Marketing Authorisation should also be
able to refer to data contained in the dossier of a medic-
inal product which is or has been authorised in the
Community. This is intended to provide an additional
incentive to encourage small and medium-sized enter-
prises,
to develop off-
patent medicinal products for the paediatric population.

including generic companies,

(21)

This Regulation should include measures to maximise
access by the Community population to new medicinal
products tested and adapted for paediatric use, and to
minimise the chance of Community-wide rewards and

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incentives being granted without sections of the Com-
munity paediatric population benefiting from the avail-
ability of a newly authorised medicine. An application
for a marketing authorisation, including an application
for a Paediatric Use Marketing Authorisation, which
contains the results of studies conducted in compliance
with an agreed paediatric investigation plan should be
eligible for the Community centralised procedure set out
in Articles 5 to 15 of Regulation (EC) No 726/2004 of
the European Parliament
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 Euro-
pean Medicines Agency (1).

and of

(22) When an agreed paediatric investigation plan has led to
the authorisation of a paediatric indication for a product
already marketed for other indications, the marketing
authorisation holder should be obliged to place the
product on the market, taking into account the paedia-
tric information, within two years of
the date of
approval of
the indication. That requirement should
relate only to products already authorised, but not to
medicinal products authorised via a Paediatric Use
Marketing Authorisation.

(25)

(26)

should be made for the possibility of requiring the appli-
cant
to submit and implement a risk management
system and/or perform specific post-marketing studies as
a condition for the granting of the marketing authorisa-
tion.

intends

It is necessary in the interests of public health to ensure
the continuing availability of safe and effective medicinal
products authorised for paediatric indications developed
as a result of this Regulation. If a marketing authorisa-
to withdraw such a medicinal
tion holder
product from the market then arrangements should be
in place so that the paediatric population can continue
to have access to the medicinal product in question. In
the Agency should be
order
informed in good time of any such intention and should
make that intention public.

to help achieve this,

For products falling within the scope of the requirement
to submit paediatric data, if all the measures included in
the agreed paediatric investigation plan are complied
with, if the product is authorised in all Member States
and if relevant information on the results of studies is
included in product information, a reward should be
granted in the form of a 6-month extension of the
supplementary protection certificate created by Council
Regulation (EEC) No 1768/92 (2).

(23) An optional procedure should be established to make it
possible to obtain a single Community-wide opinion for
a nationally authorised medicinal product when data on
the paediatric population following an agreed paediatric
investigation plan form part of the marketing authorisa-
tion application. To achieve this, the procedure set out
in Articles 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
in the paediatric population and its inclusion in all
national product information.

(24)

It is essential to ensure that pharmacovigilance mechan-
isms are adapted to meet
the specific challenges of
collecting safety data in the paediatric population,
including data on possible long-term effects. Efficacy in
the paediatric population may also need additional study
following authorisation. Therefore, an additional require-
ment for applying for a marketing authorisation that
includes the results of studies conducted in compliance
with 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
adverse reactions to the use of the medicinal product
and efficacy in the paediatric population. Additionally,
where there is a particular cause for concern, provision

(27) An application for an extension of the duration of the
certificate pursuant to this Regulation should only be
admissible where a certificate is granted pursuant
to
Regulation (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 paediatric
indication is not authorised. However, to improve the
information available on the use of medicinal products
in the paediatric population, relevant information on use
in paediatric populations
included in
authorised product information.

should be

(29) Under Regulation (EC) No 141/2000 of the European
Parliament and of the Council of 16 December 1999 on
orphan medicinal products (3), medicinal products desig-
nated as orphan medicinal products gain 10 years of
market exclusivity on the granting of a marketing
authorisation for
such
products are frequently not patent-protected, the reward
of supplementary protection certificate extension cannot

the orphan indication. As

(2) OJ L 182, 2.7.1992, p. 1. Regulation as last amended by the 2003

Act of Accession.

(1) OJ L 136, 30.4.2004, p. 1.

(3) OJ L 18, 22.1.2000, p. 1.

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(30)

(31)

be applied; when they are patent-protected, such an
extension would provide a double incentive. Therefore,
for orphan medicinal products, instead of an extension
of the supplementary protection certificate, the 10-year
period of orphan market exclusivity should be extended
to twelve years if the requirement for data on use in the
paediatric population is fully met.

The measures provided for in this Regulation should not
preclude the operation of other incentives or rewards.
To ensure transparency on the different measures avail-
able at Community and Member State levels,
the
Commission should draw up a detailed list of all the
incentives available, on the basis of information provided
by the Member States. The measures set out in this
Regulation, including the agreement of paediatric investi-
gation plans, should not be grounds for obtaining any
other Community incentives to support research, such
as the funding of research projects under the multi-
for
annual
Research, Technological Development and Demonstra-
tion Activities.

Programmes

Community

Framework

In order to increase the availability of information on
the use of medicinal products in the paediatric popula-
tion, and to avoid unnecessary repetition of studies in
the paediatric population which do not add to the
collective knowledge, 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 paediatric use comprising all ongoing,
completed paediatric
prematurely
studies conducted both in the Community and in third
countries. Part of the information concerning paediatric
clinical trials entered into the database, as well as details
of the results of all paediatric clinical trials submitted to
the competent authorities, should be made public by the
Agency.

terminated,

and

(32) An inventory of the therapeutic needs of the paediatric
population should be established by the Paediatric
Committee after consultation with the Commission, the
Member States and interested parties, and should be
regularly updated. The inventory should identify the
existing medicinal products used by the paediatric popu-
lation and highlight the therapeutic needs of that popu-
lation and the priorities for research and development.
In this way, companies should be able easily to identify
opportunities for business development; the Paediatric
Committee should be able better to judge the need for
medicinal products and studies when assessing draft
paediatric investigation plans, waivers and deferrals; and
healthcare professionals and patients should have an
information source available to support their decisions
as to which medicinal products to choose.

cases, specific facilities and should be carried out by
appropriately trained investigators. A network, which
links existing national and Community initiatives and
study 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
strengthening the foundations of the European Research
Area
Framework
Programmes for Research, Technological Development
and Demonstration Activities, benefit
the paediatric
population and provide a source of information and
expertise for industry.

context of Community

in the

(34)

(35)

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 paediatric
populations, companies holding such data should be
required to submit them to all competent authorities
where the product is authorised. In this way the data
could be assessed and, if appropriate, information should
be included in the authorised product information aimed
at healthcare professionals and patients.

Community funding should be provided to cover all
aspects of the work of the Paediatric Committee and of
the Agency resulting from the implementation of this
Regulation, such as the assessment of paediatric investi-
gation plans, fee waivers for scientific advice, and infor-
mation and transparency measures, including the data-
base of paediatric studies and the network.

(36)

The measures necessary for the implementation of this
Regulation should be adopted in accordance with
Council Decision 1999/468/EC of 28 June 1999 laying
down the procedures for the exercise of implementing
powers 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 improving
availability of medicinal products tested for paediatric
use, cannot be sufficiently achieved by the Member
States and can therefore be better achieved at Com-
munity level, given that this will make it possible to take
advantage of the widest possible market and avoid the
the Community may
dispersion of
in accordance with the principle of
adopt measures,
subsidiarity as set out in Article 5 of the Treaty.
In
accordance with the principle of proportionality, as set
out in that Article, this Regulation does not go beyond
what is necessary in order to achieve this objective,

limited resources,

(33)

Clinical trials in the paediatric population may require
in some
specific expertise, specific methodology and,

(1) OJ L 184, 17.7.1999, p. 23.

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HAVE ADOPTED THIS REGULATION:

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 Direc-
tive 2001/83/EC, the following definitions shall apply for the
purposes of this Regulation:

1.

2.

3.

4.

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

‘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;

‘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;

‘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 supple-
mentary protection certificate, covering exclusively thera-
peutic indications which are relevant for use in the paedia-
tric population, or subsets thereof, including the appropriate
strength, pharmaceutical form or route of administration for
that product.

CHAPTER 2

Paediatric Committee

Article 3

By … (*), a Paediatric Committee shall be established
1.
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.

(*) Six months from the entry into force of this Regulation.

The Agency shall fulfil the secretariat functions for the Paedia-
tric 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.

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

for Human Use,

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

Article 4

The Paediatric Committee shall be composed of

1.
following members:

the

(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 repre-
sented 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
including members and alternates,
the Paediatric Committee,
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, pharmacovigi-
lance, 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
2.
appointed for a renewable period of three years. At meetings of
the Paediatric Committee,
they may be accompanied by
experts.

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The Paediatric Committee shall elect its Chairman from

3.
among its members for a term of three years, renewable once.

The names and qualifications of the members shall be

4.
made public by the Agency.

Article 5

1. When preparing its opinions, the Paediatric Committee
shall use its best endeavours to reach a scientific consensus. If
such a consensus cannot be reached, the Paediatric Committee
the
shall adopt an opinion consisting of
majority of the members. The opinion shall mention the diver-
gent positions, with the grounds on which they are based.

the position of

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

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

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

(k) to make a recommendation to the Commission on the

symbol referred to in Article 32(2).

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

TITLE II

MARKETING AUTHORISATION REQUIREMENTS

CHAPTER 1

General authorisation requirements

Article 6

Article 7

The tasks of the Paediatric Committee shall include the

1.
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 concerned agreed paediatric investi-
gation plan 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 investi-
gation plan and formulate an opinion on the quality, safety
or efficacy of the medicinal product for use in the paedia-
tric 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 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 request
of the Executive Director of the Agency or the Commis-
sion;

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

An application for marketing

1.
authorisation under
Article 6 of Directive 2001/83/EC in respect of a medicinal
product 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.

The documents submitted pursuant to paragraph 1 shall,

2.
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 certi-
ficate, Article 7 of this Regulation shall apply to applications
for authorisation of new indications, including paediatric indi-
cations, new pharmaceutical forms and new routes of adminis-
tration.

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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 adminis-
tration.

Following receipt of

2.
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.

the application,

Article 9

Either the applicant or the Paediatric Committee may request a
meeting during that 60-day period.

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 appli-
cations for agreement or modification of a paediatric investiga-
tion 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

1.
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 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 for
paediatric patients.

The waiver provided for in paragraph 1 may be issued
2.
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

1.
in
Article 11(1), apply to the Agency for a product-specific
waiver.

set out

grounds

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,

3.
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.

The Paediatric Committee may, at any time, adopt an

2.
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,
3.
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

S e c t i o n 1

R e q u e s t s f o r a g r e e m e n t

Article 15

1. Where the intention is to apply for a marketing authori-
sation 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.

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 paediatric
population that may be concerned. In addition, it shall describe
any measures to adapt
the medicinal
product so as to make its use more acceptable, easier, safer or
more effective for different subsets of the paediatric population.

the formulation of

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Article 16

1.
In the case of the applications referred to in Articles 7
and 8, the paediatric investigation plan shall be submitted with
a request for agreement, unless otherwise justified, 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.

2. 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.

3. 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
1.
plan 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
or not the proposed studies will ensure the generation of the
necessary 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 its
opinion,
the
measures proposed to adapt the formulation of the medicinal
product for use in different subsets of the paediatric population
are appropriate.

the Committee shall consider whether or not

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 be
extended for a maximum of 60 days. In such cases, the appli-
cant or the Paediatric Committee may request an additional
meeting during this period. The time-limit shall be suspended
until such time as the supplementary information requested has
been provided.

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.

S e c t i o n 2

D e f e r r a l s

Article 20

At the same time as the paediatric investigation plan is
1.
submitted under Article 16(1), a request may be made for
deferral of the initiation or completion of some or all of the
measures set out in that plan. Such deferral shall be justified on
scientific and technical grounds or on grounds related to public
health.

In any event, a deferral shall be granted when it is appropriate
to conduct studies in adults prior to initiating studies in the
paediatric 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 a
positive opinion under Article 17(1), it shall, of its own motion
following a request submitted by the applicant under
or
if the conditions specified in
Article 20, adopt an opinion,
Article 20 are met,
in favour of deferring the initiation or
completion 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 proce-
dure laid down in Article 25 shall apply.

S e c t i o n 3

M o d i f i c a t i o n o f a p a e d i a t r i c i n v e s t i g a t i o n p l a n

Article 18

Article 22

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) applies
to the medicinal product concerned, it shall adopt a negative
opinion under Article 17(1).

If, following the decision agreeing the paediatric investigation
plan, 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 Paedia-
tric Committee. Within 60 days, the Paediatric Committee shall
review these changes or the request for a deferral or a waiver
and adopt an opinion proposing their refusal or acceptance. As
soon as the Paediatric Committee adopts an opinion, whether
positive or negative, the procedure laid down in Article 25
shall apply.

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S e c t i o n 4

C o m p l i a n c e w i t h t h e p a e d i a t r i c i n v e s t i g a t i o n
p l a n

CHAPTER 4

Procedure

Article 25

Article 23

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

The

authority

competent

responsible

1.
granting
marketing authorisation shall verify whether an application for
marketing authorisation or variation complies with the require-
ments laid down in Articles 7 and 8 and whether an applica-
tion submitted pursuant to Article 30 complies with the agreed
paediatric investigation plan.

for

set out

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

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

(a) by the applicant, prior to submitting an application for
marketing authorisation or variation as referred to in 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 compliance
adopted following a request under point (a);

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

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

If

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

Member States shall take account of such an opinion.

Article 24

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.

to

pursuant

paragraph

3. Within 30 days following receipt of a request for re-
Paediatric
examination
Committee, having appointed a new rapporteur, shall issue a
new opinion confirming or revising its previous opinion. The
opinion shall be duly reasoned and a statement of reasons for
the conclusion reached shall be annexed to the new opinion,
which shall become definitive.

the

2,

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 to
the applicant in writing and shall annex the definitive opinion
of the Paediatric Committee.

6.
In the case of a class waiver as referred to in Article 12,
the Agency shall adopt a decision within 10 days following
receipt of the opinion of the Paediatric Committee as referred
to in Article 13(3). This decision shall annex the opinion of the
Paediatric Committee.

Decisions of the Agency shall be made public after dele-

7.
tion of any information of a commercially confidential nature.

CHAPTER 5

Miscellaneous provisions

Article 26

Any legal or natural person developing a medicinal product
intended for paediatric use may, prior to the submission of a
paediatric investigation plan and during its implementation,
request advice from the Agency on the design and conduct of
the various tests and studies necessary to demonstrate the
quality, safety and efficacy of the medicinal product in the
paediatric population in accordance with Article 57(1)(n) of
Regulation (EC) No 726/2004.

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

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.

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TITLE III

MARKETING AUTHORISATION PROCEDURES

Article 27

Save where otherwise provided in this Title, marketing authori-
sation procedures for the marketing authorisations covered by
this Title shall be governed by the provisions laid down in
Regulation (EC) No 726/2004 or in Directive 2001/83/EC.

Regulation may be submitted, in accordance with the proce-
dure laid down in Articles 32, 33 and 34 of Directive
2001/83/EC, for authorisation of a new indication, including
the extension of an authorisation for use in the paediatric
population, a new pharmaceutical
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 1

Marketing authorisation procedures for applications falling
within the scope of Articles 7 and 8

CHAPTER 2

Paediatric use marketing authorisation

Article 28

Article 30

Applications may be submitted in accordance with the
1.
procedure laid down in Articles 5 to 15 of Regulation (EC)
No 726/2004 for a marketing authorisation as referred to in
Article 7(1) of this Regulation which includes one or more
paediatric 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
in the package leaflet of the medicinal
if appropriate,
and,
product, provided that
the competent authority deems the
information to be of use to patients, whether or not all the
paediatric indications concerned were approved by the compe-
tent authority.

2. Where a marketing authorisation is granted or varied, any
waiver or deferral which has been granted pursuant to this
Regulation shall be recorded in the summary of product char-
in the package leaflet of the
acteristics and,
medicinal product concerned.

if appropriate,

If

the application complies with all

3.
the measures
contained in the agreed completed paediatric investigation plan
and if
the summary of product characteristics reflects the
results of studies conducted in compliance with that agreed
paediatric investigation plan,
the competent authority shall
include within the marketing authorisation a statement indi-
cating compliance of the application with the agreed completed
paediatric investigation plan. For the purpose of the application
of Article 45(3),
this statement shall also indicate whether
significant studies contained in the agreed Paediatric Investiga-
tion Plan have been completed after the entry into force of this
Regulation.

1.
Submission of an application for a paediatric use
marketing authorisation shall in no way preclude the right to
apply for a marketing authorisation for other indications.

2.
An application for a paediatric use marketing authorisa-
tion shall be accompanied by the particulars and documents
necessary to establish quality, safety and efficacy in the paedia-
tric population, including any specific data needed to support
form or route of
an appropriate strength, pharmaceutical
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 application
for 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
same active
any medicinal product which contains
substance and in respect of which the same holder has been
granted authorisation for use in adults.

the

Article 31

Article 29

In the case of medicinal products authorised under Directive
2001/83/EC, an application as referred to in Article 8 of this

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.

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CHAPTER 3

Identification

Article 32

1. Where a medicinal product
is granted a marketing
authorisation for a paediatric indication, the label shall display
the symbol agreed in accordance with paragraph 2. The
package leaflet shall contain an explanation of the meaning of
the symbol.

2.
By … (*), the Commission shall select a symbol following
a recommendation of the Paediatric Committee. The Commis-
sion 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
made public, 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 indi-
cation following completion of an agreed paediatric investiga-
tion plan and those products have already been marketed with
the marketing authorisation holder shall,
other indications,
within two years of the date on which the paediatric indication
is authorised, place the product on the market taking into
account the paediatric indication. A register, coordinated by the
Agency, and made publicly available, shall mention these dead-
lines.

Article 34

1.
In the following cases, the applicant shall detail, in addi-
tion to the normal requirements for post-marketing moni-
toring, the measures to ensure the follow-up of efficacy and of
possible adverse reactions to the paediatric use of the medicinal
product:

(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 compe-
tent authority may 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 for
system shall
review. A risk management
comprise a set of pharmacovigilance activities and interventions
designed to identify, 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 system
and the results of any studies performed shall be included in
the periodic safety update reports referred to in Article 104(6)
of Directive 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
minimisation system and the results of any such studies
performed.

In the case of a deferral,

3.
the marketing authorisation
holder shall submit an annual report to the Agency providing
an 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 comply
with the decision of the Agency agreeing the paediatric investi-
gation plan and granting a deferral.

The Agency shall draw up guidelines relating to the appli-

4.
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 these
periods of protection have expired, and if
the marketing
authorisation holder intends to discontinue placing the medic-
inal product on the market, the marketing authorisation holder
shall
transfer the marketing authorisation or allow a third
party, which has declared its intention to continue to place the
medicinal product in question on the market, to use the phar-
maceutical, pre-clinical and clinical documentation contained in
the file of the medicinal product on the basis of Article 10c of
Directive 2001/83/EC.

(a) applications for a marketing authorisation that includes a

paediatric indication;

(*) One year from the entry into force of this Regulation.

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.

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TITLE V

REWARDS AND INCENTIVES

Article 36

1. Where an application under Article 7 or 8 includes the
results of all studies conducted in compliance with an agreed
the patent or
paediatric investigation plan,
supplementary 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.

the holder of

The first subparagraph shall also apply where completion of
the agreed paediatric investigation plan fails to lead to the
authorisation of a paediatric indication, but the results of the
studies conducted are reflected in the summary of product
characteristics and, if appropriate, in the package leaflet of the
medicinal product concerned.

tion granted, the 10-year period referred to in Article 8(1) of
Regulation (EC) No 141/2000 shall be extended to 12 years.

The first paragraph shall also apply where completion of the
agreed paediatric investigation plan fails to lead to the authori-
sation 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 medicinal
product concerned.

Article 38

1. Where a paediatric use marketing authorisation is granted
in accordance with Articles 5 to 15 of Regulation (EC) No 726/
2004, the data and marketing protection periods referred to in
Article 14(11) of that Regulation shall apply.

2. Where a paediatric use marketing authorisation is granted
in accordance with the procedures laid down in Directive
the data and marketing protection periods
2001/83/EC,
referred to in Article 10(1) of that Directive shall apply.

2.
The inclusion in a marketing authorisation of the state-
ment referred to in Article 28(3) shall be used for the purposes
of applying paragraph 1 of this Article.

Article 39

3. Where the procedures laid down in Directive 2001/83/EC
have been used, the six-month extension of the period referred
to in paragraph 1 shall be granted only if the product is
authorised in all Member States.

Paragraphs 1, 2 and 3 shall apply to products that are
4.
protected by a supplementary protection certificate under
Regulation (EEC) No 1768/92, or under a patent which quali-
fies for the granting of the supplementary protection certificate.
They shall not apply to medicinal products designated as
to Regulation (EC)
orphan medicinal products pursuant
No 141/2000.

5.
In the case of an application under Article 8 which leads
to the authorisation of a new paediatric indication, paragraphs
1, 2 and 3 shall not apply if the applicant applies for, and
obtains, a one-year extension of
the period of marketing
protection for
the medicinal product concerned, on the
grounds that this new paediatric indication brings a significant
clinical benefit
in
accordance with Article 14(11) of Regulation (EC) No 726/
2004 or the fourth subparagraph of Article 10(1) of Direc-
tive 2001/83/EC.

in comparison with existing therapies,

Article 37

an application for

Where
a marketing authorisation is
submitted in respect of a medicinal product designated as an
orphan medicinal product pursuant to Regulation (EC) No 141/
2000 and that application includes the results of all studies
conducted in compliance with an agreed paediatric investiga-
tion plan, and the statement referred to in Article 28(3) of this
Regulation is subsequently included in the marketing authorisa-

1.
In addition to the rewards and incentives provided for in
Articles 36, 37 and 38, medicinal products for paediatric use
may be eligible for incentives provided by the Community or
by the Member States to support research into, and the devel-
opment and availability of, medicinal products for paediatric
use.

By … (*), the Member States shall communicate to the
2.
Commission detailed information concerning any measures
they have enacted to support research into, and the develop-
ment and availability of, medicinal products for paediatric use.
This information shall be updated regularly at the request of
the Commission.

3.
By … (**), the Commission shall make publicly available a
detailed inventory of all rewards and incentives provided by the
Community and Member States to support research into, and
the development and availability of, medicinal products for
paediatric use. This inventory shall be updated regularly and
the updates shall also be made publicly available.

Article 40

Funds for research into medicinal products for the paedia-
1.
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 supplementary
protection certificate.

2.
This Community funding shall be delivered through the
Community Framework Programmes for Research, Technolo-
gical Development and Demonstration Activities or any other
Community initiatives for the funding of research.

(*) One year from the entry into force of this Regulation.
(**) 18 months from the entry into force of this Regulation.

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TITLE VI

COMMUNICATION AND COORDINATION

the interested parties, the Paediatric Committee shall establish
an inventory of therapeutic needs, in particular with a view to
identifying research priorities.

By … (***), the Agency shall make the inventory public and
shall update it regularly.

Article 41

The European database created by Article 11 of Directive
1.
2001/20/EC shall
include clinical trials carried out in third
countries 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 of
that Directive shall be entered into the database by the
addressee of 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 Euro-
pean database.

2.
Details of the results of all the trials referred to in para-
graph 1 and of any other trials submitted to competent autho-
rities in compliance with Articles 45 and 46 shall be made
public by the Agency, whether or not the trial was terminated
prematurely. These results shall be submitted without delay to
the Agency by the clinical trial sponsor, the addressee of the
Agency's decision on a paediatric investigation plan, or by the
marketing authorisation holder as appropriate.

In consultation with the Agency, Member States and
3.
interested parties, the Commission shall draw up guidance on
the nature of the information referred to in paragraph 1 to be
entered in the European database created by Article 11 of
Directive 2001/20/EC, on which information shall be made
accessible to the public in application of paragraph 1, on how
clinical trial results shall be submitted and be made public in
application of paragraph 2, and on the Agency's responsibilities
and tasks in this regard.

inventory of

In establishing the

2.
therapeutic needs,
account shall be taken of the prevalence of the conditions in
the paediatric population, the seriousness of the conditions to
be treated, the availability and suitability of alternative treat-
ments for the conditions in the paediatric population, including
the efficacy and the adverse reaction profile of those treat-
ments, including any unique paediatric safety issues, and any
data resulting from studies in third countries.

Article 44

the
The Agency shall, with the scientific support of
1.
Paediatric Committee, develop a European network of existing
national and European networks, investigators and centres with
specific expertise in the performance of studies in the paediatric
population.

The objectives of the European network shall be,
2.
inter
alia,
to coordinate studies relating to paediatric medicinal
products, to build up the necessary scientific and administrative
competences at European level, and to avoid unnecessary dupli-
cation of studies and testing in the paediatric population.

3.
By … (****), the Management Board of the Agency shall,
from the Executive Director and following
on a proposal
consultation with the Commission, the Member States and
interested parties, adopt an implementing strategy for the
launching and operation of
the European network. This
network must, where appropriate, be compatible with the work
of strengthening the foundations of the European Research
Area in the context of the Community Framework Programmes
for Research, Technological Development and Demonstration
Activities.

Article 42

Article 45

Member States shall collect available data on all existing uses of
medicinal products in the paediatric population and shall
communicate these data to the Agency by … (*).

The Paediatric Committee shall provide guidance on the
content and the format of the data to be collected by … (**).

Article 43

1.
By … (****), any paediatric studies already completed, by
the date of entry into force, in respect of products authorised
in the Community shall be submitted by the marketing authori-
sation holder for assessment to the competent authority.

The competent authority may update the summary of product
characteristics and package leaflet, and may vary the marketing
authorisation
shall
exchange information regarding the studies submitted and, as
appropriate, their implications for any marketing authorisations
concerned.

accordingly.

Competent

authorities

1.
On the basis of the information referred to in Article 42
and after consulting the Commission, the Member States and

The Agency shall coordinate the exchange of information.

(*) Two years from the entry into force of this Regulation.
(**) Nine months from the entry into force of this Regulation.

(***) Three years from the entry into force of this Regulation.
(****) One year from the date of entry into force of this Regulation.

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2.
All existing paediatric studies, as referred to in paragraph
1, and all paediatric studies initiated prior to the entry into
force 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 applications
for paediatric investigation plans, waivers and deferrals and by
competent authorities when assessing applications submitted
pursuant 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 granted
provided that significant studies contained in an agreed Paedia-
tric Investigation Plan are completed after the entry into force
of this Regulation.

laid down in Regulation (EC) No 726/2004, the amount of the
reduced fees for the examination of the application and the
maintenance 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 Agency for the Evaluation of
Medicinal Products (1) shall apply.

Assessments of the following by the Paediatric Committee

3.
shall be free of charge:

(a) applications for waiver;

(b) applications for deferral;

Article 46

(c) paediatric investigation plans;

1.
Any other marketing authorisation holder-sponsored
studies which involve the use in the paediatric population of a
medicinal product covered by a marketing authorisation,
whether or not they are conducted in compliance with an
agreed paediatric investigation plan, shall be submitted to the
competent authority within six months of completion of the
studies concerned.

2.
Paragraph 1 shall apply independent of whether or not
the marketing authorisation holder intends to apply for a
marketing authorisation of a paediatric indication.

3.
The competent authority may update the summary of
product characteristics and package leaflet, and may vary the
marketing authorisation accordingly.

Competent

4.
information
regarding the studies submitted and, as appropriate, their impli-
cations for any marketing authorisations concerned.

authorities

exchange

shall

5.

The Agency shall coordinate the exchange of information.

TITLE VII

GENERAL AND FINAL PROVISIONS

CHAPTER 1

General provisions

S e c t i o n 1

F e e s , C o m m u n i t y f u n d i n g , p e n a l t i e s a n d r e p o r t s

Article 47

(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 by
experts, and of the Agency, including the assessment of paedia-
tric investigation plans, scientific advice and any fee waivers
provided 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 State
shall determine the penalties to be applied for infringement of
the provisions of this Regulation or the implementing measures
in relation to medicinal products
adopted pursuant
authorised through the procedures laid down in Directive
2001/83/EC and shall take all measures necessary for their
implementation. The penalties shall be effective, proportionate
and dissuasive.

to it

Member States shall inform the Commission of these provisions
by … (*). They shall notify any subsequent alterations as soon
as possible.

2. Member States shall inform the Commission immediately
of any litigation instituted for infringement of this Regulation.

At the Agency's request, the Commission may impose
3.
financial penalties for infringement of the provisions of this
Regulation or the implementing measures adopted pursuant to
it in relation to medicinal products authorised through the
procedure 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 accordance
with the procedure referred to in Article 51(2) of this Regu-
lation.

1. Where an application for a paediatric use marketing
authorisation is submitted in accordance with the procedure

(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).

(*) Nine months from the date of entry into force of this Regulation.

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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 on
an annual basis, the Commission shall make public a list of the
companies and of the products that have benefited from any of
the rewards and incentives in this Regulation and the compa-
nies that have failed to comply with any of the obligations in
this Regulation. The Member States shall provide this informa-
tion to the Agency.

2.
By … (*), 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 Regulation. This
shall include in particular a detailed inventory of all medicinal
products authorised for paediatric use since its entry into force.

By… (**), the Commission shall present a report to the
3.
European Parliament and the Council on the experience
acquired as a result of the application of Articles 36, 37 and
38. The report shall
the economic
impact of the rewards and incentives, together with an analysis
of the estimated consequences for public health of this Regu-
lation, with a view to proposing any necessary amendments.

include an analysis of

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.

S e c t i o n 2

S t a n d i n g C o m m i t t e e

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.

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 Regulation
and of Article 36 of Regulation (EC) No …/2006 of
the European Parliament and of the Council, of …, on
medicinal products for paediatric use (*);

(*) OJ L …, …, p. …’;

2.

in Article 7, the following paragraphs shall be added:

The application for an extension of the duration
‘3.
may be made when lodging the application for a certificate
or when 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.’;

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) of
Regulation (EC) No …/2006;

(ii) where necessary, in addition to the copy of the
authorisations to place the product on the
market as referred to in point (b), proof that it
has authorisations to place the product on the
market of all other Member States, as referred
to in Article 36(3) of Regulation (EC) No …/
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 particulars
referred to in paragraph 1(d) and a reference to
the application for a certificate already filed.

1b. The application for an extension of the duration
of a certificate already granted shall contain the
particulars referred to in paragraph 1(d) and a
copy of the certificate already granted.’;

3.

The Committee shall adopt its rules of procedure.

(c) paragraph 2 shall be replaced by the following:

CHAPTER 2

Amendments

Article 52

Regulation (EEC) No 1768/92 is hereby amended as follows:

(*) Six years from the date of entry into force of this Regulation.
(**) Ten years from the date of entry into force of this Regulation.

‘2. Member States may provide that a fee is to be
payable upon application for a certificate and upon
application 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.’;

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(b) in paragraph 2, the following point shall be added:

Article 53

‘(f) where applicable, an indication that the application
includes an application for an extension of the
duration.’;

(c) the following paragraph shall be added:

Paragraph 2 shall apply to the notification of the
‘3.
application for an extension of the duration of a certifi-
cate already granted or where an application for a
certificate is pending. The notification shall additionally
contain an indication of
the application for an
extended duration of the certificate.’;

5.

in Article 10, the following paragraph shall be added:

Paragraphs 1 to 4 shall apply, mutatis mutandis, to

‘6.
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 of
the fact that an extension of the duration of a certificate
has 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
be extended by six months in the case where Article 36 of
Regulation (EC) No …/2006 applies. In that case, the dura-
tion of
this
Article may be extended only once.’;

the period laid down in paragraph 1 of

8. the following Article shall be inserted:

‘Article 15a

In Article 11 of Directive 2001/20/EC, the following paragraph
shall be added:

‘4.
By way of derogation from paragraph 1, the Agency
shall make public part of the information on paediatric
clinical trials entered in the European database in accord-
ance with the provisions of Regulation (EC) No …/2006 of
the European Parliament and of the Council, of … on
medicinal products for paediatric use (*).

(*) OJ L …, …, p. …’;

Article 54

In Article 6 of Directive 2001/83/EC, the first subparagraph of
paragraph 1 shall be replaced by the following:

‘1.
No medicinal product may be placed on the market
of a Member State unless a marketing authorisation has
been issued by the competent authorities of that Member
State 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 …/2006 (*).

(*) OJ L …, …, p. …’;

Article 55

Revocation of an extension of the duration

Regulation (EC) No 726/2004 is hereby amended as follows:

1.
The extension of the duration may be revoked if it
was granted contrary to the provisions of Article 36 of
Regulation (EC) No …/….

2.
Any person may submit an application for revoca-
tion of the extension of the duration to the body respon-
sible under national law for the revocation of the corre-
sponding basic patent.’;

9. Article 16 shall be amended as follows:

(a) the text of Article 16 becomes paragraph 1;

(b) the following paragraph shall be added:

‘2.
If the extension of the duration is revoked in
accordance with Article 15a, notification thereof shall
to in
be published by
Article 9(1).’;

authority

referred

the

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 the
opinion of the Agency on any question relating to the
evaluation of medicinal products for veterinary use;

(c) the Committee on Orphan Medicinal Products;

(d) the Committee on Herbal Medicinal Products;

10. Article 17 shall be replaced by the following:

(e) the Paediatric Committee;

‘Article 17

Appeals

(f) a Secretariat, which shall provide technical, scientific
the committees and

and administrative support
ensure appropriate coordination between them;

for

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 as
those provided for in national law against similar decisions
taken in respect of national patents.’

(g) an Executive Director, who shall exercise the responsi-

bilities set out in Article 64;

(h) a Management Board, which shall exercise the responsi-

bilities set out in Articles 65, 66 and 67.’;

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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 …/2006 of the European Parliament and
of the Council, of …, on medicinal products for paedia-
tric use (*).

(*) OJ L …, …, p. …’;

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
this Regulation.

3. the following Article shall be inserted:

Article 57

‘Article 73a

1.
This Regulation shall enter into force on the 30th day
following its publication in the Official Journal of the European
Union.

Decisions taken by the Agency under Regulation (EC) No
…/2006 may form the subject of an action before the Court
of Justice of the European Communities under the condi-
tions laid down in Article 230 of the Treaty.’.

2.

Article 7 shall apply from … (*).

Article 8 shall apply from … (**).

Articles 30 and 31 shall apply from … (***).

This Regulation shall be binding in its entirety and directly applicable in all Member States.

Done at Brussels, …

For the European Parliament

The President

…

For the Council

The President

…

(*) 18 months following the date of entry into force of this Regulation.
(**) 24 months following the date of entry into force of this Regu-

lation.

(***) Six months following the date of entry into force of this Regu-

lation.

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STATEMENT OF THE COUNCIL'S REASONS

I.

INTRODUCTION

1. On 29 September 2004 the Commission adopted a proposal for a Regulation of the European
Parliament and of the Council on Medicinal Products for Paediatric Use and amending Regulation
(EEC) No 1768/92, Directive 2001/83/EC and Regulation (EC) No 726/2004 (1).

2. The Economic and Social Committee adopted its opinion at its 417th plenary session on 11 and

12 May 2005 (2).

3. The European Parliament adopted its first-reading opinion on 7 September 2005 (3).

4. The Commission adopted an amended proposal on 10 November 2005 (4).

5. On 9 December 2005, the Council reached a political agreement with a view to adopting a

common position in accordance with Article 251 of the Treaty.

6. On 10 March 2006, the Council adopted its common position on the proposal as set out in doc.

15763/05.

II. OBJECTIVES

7. The general objectives of the Commission proposal are to:

— increase the development of medicines for use in children,

— ensure that medicines used to treat children are subject to high quality research,

— ensure that medicines used to treat children are appropriately authorised for use in children,

— improve the information available on the use of medicines in children,

— achieve these objectives without subjecting children to unnecessary clinical trials and in full

compliance with Directive 2001/20/EC (the Clinical Trials Directive) (5).

III. COMMON POSITION

General

8. The Council, which agrees with the objectives of the proposal, has nevertheless endeavoured to
improve some of the provisions and to add further features, notably as regards research into
paediatric use of off-patent medicines (Article 40), safeguarding measures aiming at keeping
paediatric products on the market (Article 35) and as concerns transparency (Articles 25 and 41).
During the detailed reading of the proposal (November 2004 to November 2005) a number of
drafting changes have been introduced to clarify the text, address legal/linguistic issues and to
ensure the overall coherence of the Regulation. Amendments that are of a pure legal/linguistic
nature are normally not mentioned below.

9.

In its Plenary vote on 7 September 2005, the European Parliament adopted 69 amendments to
the proposal.

(a) 42 of these have been incorporated, either in full, in part or in principle into the Council's

common position corresponding to around two thirds of the proposed amendments,

(b) 27 amendments have not been accepted.

(1) OJ C 321, 28.12.2004, p. 12, text in doc. 13880/04 ECO 168 SAN 157 CODEC 1166.
(2) OJ C 267, 27.10.2005, p. 1.
(3) 11956/05 CODEC 705 ECO 94 SAN 134.
(4) 14487/05 ECO 138 SAN 175 CODEC 1019.
(5) OJ L 121, 01.05.2001, p. 34.

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10. When preparing its common position, the Council examined closely the Commission's amended
proposal. With the exception of redrafts (notably to Articles 32 and 49) the common position
incorporates most of the amendments proposed by the European Parliament accepted or accepted
in principle by the Commission in its amended proposal.

11. In the legal-linguistic finalisation of the text of the common position certain recitals and articles
have been renumbered. This document follows the numbering used in the common position and
therefore the numbering sometimes differs from that of the texts of the Parliament's Opinion and
the amended proposal.

Recitals

12. In recital 3, the European Parliament proposed additional wording on types of formulation and
the route of administration (Amendment 1), which has been accepted with minor redrafting to
improve clarity.

13. The European Parliament also proposed some clarifications to recital 4 (Amendment 2), Recital
(5) (Amendment 4) and Recital (7) (Amendment 5), which were all included in the Common Posi-
tion, although the words ‘where indicated’ in recital 4 were considered to be redundant and were
not included.

14. The European Parliament proposed to insert a new recital 4a concerning an inventory of paedia-
tric medicinal products (Amendment 3), which the Council decided not to include, since it prefers
the structure of the Commission proposal. The provision regarding the inventory should remain
in Article 42 in Title VI (communication and coordination).

15. As concerns recital 8 on the Paediatric Committee, the first and third parts of Amendment 6 were
accepted with minor redrafting, although the Council did not consider the Paediatric Committee
to be primarily responsible for the ethical assessment of the Paediatric Investigation Plan. Ethical
assessment of proposals for clinical trials is the primary responsibility of the Ethics Committees.
The Council does not support the second part of the amendment as it does not consider that
members of the Paediatric Committee must have international-level experience and knowledge of
the pharmaceutical industry.

16. In recital 10 the Council agrees with part of Amendment 7. As for the second part of this Amend-
ment, the Council has deemed it more appropriate to clarify that the reason for the legal provi-
sions in Article 16(1) is to ensure an early dialogue between the physical or legal person devel-
oping a new medicinal product and the Paediatric Committee.

17. In recital 11 the Council agreed in principle to Amendment 8, but made a minor redrafting,
pointing to the use of waivers and deferrals, in order to maintain coherence within the Regu-
lation.

18. The Council shares the view of the European Parliament that research into the paediatric use of
medicinal products, which are not protected by a patent or supplementary protection certificate,
is important and to this aim proposes a new Article 40 as well as a new recital 12 that contains
the ideas behind Amendment 9, but with minor redrafting to maintain coherence with the new
article to which it refers.

19. Amendment 10 to recital 16 has been included in the common position.

20. The Council has amended recital 18 to correspond to the amendments of Article 32.

21. The European Parliament in Amendment 11 proposed to amend recital 22. The Council, for

reasons set out in relation to Article 33, cannot support this amendment.

22. Amendment 12 proposes to introduce in recital 23 reference to ‘a European paediatric form’
aimed at facilitating Community wide marketing of paediatric medicines placed on the market
only at national level. The Council cannot support this amendment since it does not correspond
to any existing provisions in the Proposal or any proposed amendments to the existing provi-
sions.

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23. The Council is also unable to support Amendment 13 to recital 24 since the competent authori-
ties that grant the marketing authorisations monitor the fulfilment of the terms and conditions of
the marketing authorisation and the post-authorisation obligations; this is not the responsibility of
the Paediatric Committee.

24. The common position also contains a new recital 25, which refers to the new Article 35.

25. The Council does not support Amendment 14 to recital 26, for reasons that are outlined in the

text regarding Article 36 below.

26. In order to give an explanation for certain provisions in Article 52 (amendments to the SPC Regu-
lation), relating to the reward mechanisms foreseen under Title V, the Council inserted a new
recital 27.

27. As regards recital 31, the Council has decided to stress that unnecessary repetition of studies
should be avoided and to include the first part of Amendment 15 proposed by the Parliament
concerning a European register of paediatric clinical trials. The second and third parts of this
amendment have not been accepted as the former repeats text already in place and the latter does
not correspond to any existing provisions or proposed amendments of existing provisions. An
additional sentence was added at the end of the paragraph to echo the amendment to Article 41
which provides that parts of the paediatric clinical trials database shall be publicly accessible.

28. The Council supports the structure of the Commission proposal, and, consequently, holds that the
provisions on the inventory of therapeutic needs should be maintained in Title VI (communication
and coordination). It can therefore not support Amendment 16, which proposes that recital 32
should be deleted.

29. The Council supports the proposal in Amendment 17 to stress the importance of using also data
from third countries, but made some minor redrafting of this amendment to recital 33 to
improve clarity.

30. The Council has included a new recital 38 that explains why the proposed Regulation is in
accordance with the principles of subsidiarity and proportionality required in Article 5 of the
Treaty.

Title I — Introductory provisions

31. Like the European Parliament, the Council considers it necessary to clarify that the paediatric
population should not be subject to any kind of unnecessary trials and has therefore included the
first part of amendment 18 into Article 1. However, the Council cannot support the second part
of the Amendment as the Regulation applies to the entire paediatric population without excep-
tion.

32. The Council considers it appropriate to move the definition of paediatric use marketing authorisation

to Article 2, which contains other definitions.

33. The Council shares the position of the European Parliament that it is important that the Paediatric
Committee be established within six months after the entry into force of the Regulation and has
therefore included Amendment 20 in the first subparagraph of Article 3(1), together with a
redrafting to ensure that the other deadlines of the Regulation can still be met. For legal/linguistic
reasons, a minor redrafting was also made in the second subparagraph of this paragraph.

34. Article 4 of the Proposal deals with the composition of the Paediatric Committee. Here, the
Council, in analogy to what is the case for the Committee for Human Medicinal Products, has
decided to introduce alternates for the members and to specify the procedure for their appoint-
ment.

The Council has also accepted in principle in subparagraphs (c) and (d) of Article 4(1) Amend-
ment 21 proposed by the European Parliament but with redrafting. The Council accepted the part
of the amendment that concerns consultation of the European Parliament. In view of the introduc-
tion of alternates, the Council considers that six members are sufficient to represent the interests
of healthcare professionals and patient associations. However, the Council considers that it should
be made clear that three members should represent healthcare professionals and three members
should represent patient associations. The list of disciplines represented on the Committee applies
to the Committee as a whole and should be incorporated in the list of disciplines set out at the
end of the paragraph.

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35. Article 5(1) sets out the procedure for agreeing an opinion in the Paediatric Committee. Here, the
Council has integrated in principle Amendment 22. The first part has been accepted with minor
redrafting to improve clarity. The Council supports the transparency intended in the second part,
but considers that the provision should be included in Article 25, which deals with procedural
issues, including transparency.

As for Amendment 23 to Article 5(3), the Council considers it unnecessary to define the respec-
tive numbers of representatives of the Commission or Executive Director of the Agency that
could attend the meetings of the Paediatric Committee.

36. The Council has decided to delete Article 6 of the Proposal on independence and impartiality of
the members of the Paediatric Committee, since detailed provisions on such requirements are
already set out in Regulation (EC) No 726/2004, to which explicit reference is made in Article
3(2). For this reason, the Council cannot support Amendment 24.

37. Article 6 of the common position sets out the tasks of the Paediatric Committee. Here, the
Council supports the objective of Amendment 25 to paragraph (1)(g), but notes that the Regu-
lation already provides for free scientific advice in Article 27. Also, Article 47(3) provides that
assessments by the Committee will be free of charge. If this amendment were to be included it
would, for reasons of consistency, be necessary to specify ‘free of charge’ for all other tasks listed
in Article 6(1), and therefore the Council cannot support it.

The Council agrees in principle to Amendments 26 and 29 by the European Parliament to form a
new subparagraph (i) of Article 6(1) on establishment of an inventory of paediatric medicinal
products needs. But the Council noted that this requires amendment of subparagraph (e) of
Article 6(1) in order to avoid unnecessary repetition.

The Council supports the principle that the Committee should advise on communication about
the conduct of clinical trials in children (Amendment 27) and therefore agrees to introduce a new
subparagraph (j) of Article 6(1), but does not consider it appropriate for the Paediatric Committee
to have a self-promoting function.

Further, the Council has added a new subparagraph (k) of Article 6(1) concerning the selection of
the symbol for paediatric medicines (see Article 32).

Finally, the Council has included Amendment 28 on advice available from third countries in
Article 6(2) with minor redrafting to improve clarity.

Title II — Marketing authorisation requirements

38. Article 7 deals with General authorisation requirements. The Council considers that Amendment
30, which opens a possibility to provide information on ongoing paediatric studies, is not neces-
sary. The Commission Proposal does not require the completion of all paediatric studies at the
time of application for marketing authorisation. The ‘deferral’ provision allows for delay in the
initiation of paediatric clinical studies so as to ensure that the studies are only done when it is
safe and ethical to do so. The Commission Proposal also provides for the deferral decision to
contain a timetable to complete the studies. The Council agrees with the Commission proposal in
these respects.

39. Article 8 also deals with General authorisation requirements. This Article has been slightly

redrafted to clarify the scope.

The Council agrees in principle with the ideas behind Amendment 31 to Article 8, but considers
this amendment to be redundant. Article 27 already refers to the application of Regulation (EC)
No 726/2004 and Directive 2001/83/EC, which by association includes their implementing
measures such as the variation regulations,
in particular Commission Regulation (EC) No
1085/2003, to which the amendment introduces a reference.

The Council also considers that Amendment 32 is not necessary, since Article 28(1) of the
proposed Regulation already opens the centralised procedure to marketing authorisation applica-
tions which include one or more paediatric indications selected on the basis of studies conducted
in compliance with an agreed paediatric investigation plan. In addition, Article 29 provides that

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applications referred to in Article 8 relating to products authorised through the mutual recogni-
tion procedure may obtain an opinion from the Committee on Human Medicinal Products of the
European Medicines Agency. This in turn will
lead to a Commission Decision which will be
binding on Member States.

40. The provisions in Article 10 on compliance checks of paediatric investigation plans have been

adjusted to clarify the responsibilities of various actors.

41. The Council agrees to Amendment 33, which states that the Paediatric Committee should appoint
a rapporteur as part of the preparation of decisions on product specific waivers (first sub-
paragraph of Article 13(2)).

The Council also agrees in principle to Amendment 34 in Article 13(3). But the reference to
informing the applicant has been moved to Article 25 to improve coherence in the text. The
deadline has been changed to ‘10 days’ as it is not the practice to use the term ‘working days’ in
the Community legislation relating to medicinal products.

42. In Article 14(1), the Council agrees to Amendment 35 on updating and public availability of the

list of waivers.

43. Article 16 sets out provisions for the timing of the submission of the Paediatric Investigation Plan.
The European Parliament had proposed three amendments (36, 37 and 38) to this Article. The
Council cannot support these for the following reasons:

The Council agrees with the Commission proposal that provides for the summary report to be
prepared by the Agency. This is consistent with the operating methods of the Committee on
Orphan Medicinal Products. Ten days are inadequate for the preparation of the summary report
by the Agency.

The introduction of the paediatric investigation plan into the legal framework concerning medic-
inal products for human use aims at ensuring that the development of medicines for children
becomes integrated into the overall development programme for medicinal products. The Council
agrees that it is appropriate, therefore, to set a deadline for the submission of a paediatric investi-
gation plan in order to ensure early dialogue between the sponsor and the Paediatric Committee
on whether studies are required and, if so, the type of studies and their timing compared to
studies in adults.

The deadline provided for in Article 16(1) of the proposed Regulation is a dead-line to submit a
draft plan and not a dead-line for the initiation of studies. In addition, the plan may contain a
request for a deferral of the initiation or completion of studies.

The Commission proposal provides a mechanism for the modification of the paediatric investiga-
tion plan. This will ensures continuing dialogue between the applicant and the Paediatric
Committee during the product development.

The Council considers that the proposed amendment would result in little, if any, investigation of
the use of a product in children early in the product's development. This would impede innova-
tion in paediatric therapeutics and have negative consequences for public health.

44. In Article 17(1) on handling of a proposal for a paediatric investigation plan, the Council has
included Amendment 39 with a minor addition to improve clarity, and also clarified the scope.

45. Article 22 deals with the modification of a paediatric investigation plan. Here, the Council agrees
to the first two parts of Amendment 40. The last part has not been accepted since the Proposal
provides that the applicant has to request modifications to an agreed plan. As this request is the
modified plan, it is unnecessary for the opinion on the modified plan to contain a dead-line for
the submission of the modified plan.

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46. The provisions in Article 23 on compliance checks of paediatric investigation plans have been

adjusted to clarify the responsibilities of various actors.

47. The Council has inserted a number of amendments to Article 25 in order to clarify the procedure
and support transparency. The second part of Amendment 22 from the European Parliament
(compare Article 5) has been included, as has Amendment 42 to Article 25(5), with minor
redrafting. The Council considers that ten days should be sufficient time for the Agency to adopt
a decision. The Council is however not able to support Amendment 41, since details on the inter-
action between the rapporteurs and the applicants should be set out in the rules of procedure of
the Paediatric Committee.

Title III — Marketing authorisation procedures

48. Article 28 deals with marketing authorisation procedures for applications falling within the scope
of Articles 7 and 8. Parts one and two of Amendment 43 are adopted in principle in the second
subparagraph of Article 28(1), but the Council suggests some minor redrafting. The third part has
not been accepted as there are detailed scientific Community guidelines on the presentation of
information on indications that have been approved, not approved and contra-indicated. The aims
of this amendment are achieved through the application of these guidelines, which are amended
regularly to take account of technical progress. The Council has also introduced changes to para-
graph 3 in order to meet concerns on double rewards similar to those raised by the European
Parliament in Amendment 52 (see Article 36 below).

49. The definition of a paediatric use marketing authorisation was moved from Article 30 to Article 2 for

reasons of clarity.

50. Article 32 deals with the identification of medicinal products for paediatric use. Here, the Council
introduced a number of changes, notably to clarify that all medicinal product granted a marketing
authorisation for a paediatric indication should display a specific symbol on their labels, and to
clarify the procedure for selecting this symbol.

The European Parliament had proposed two amendments to this Article. The Council agrees in
principle to the first part of Amendment 44, but with a suggested redraft. The second part cannot
be accepted as the Council considers that it is preferable to make use of available expertise and
adopt the symbol with the minimum delay. The Council agrees, therefore, that the Commission
should adopt the symbol based on a recommendation from the Paediatric Committee.

The Council accepts in principle Amendment 45 and has therefore introduced a new sub-
paragraph in Article 32. The Council, however considers that it would be confusing for the
patient and carer if some, but not all, products authorised for paediatric use were identified by a
Community symbol on the label. The symbol, therefore, should apply to all medicinal products
with a paediatric indication. In addition, the meaning of the symbol should be explained in the
patient information leaflet and a deadline should be introduced for the application of the symbol.

Title IV — Post-authorisation requirements

51. Article 33 deals with the deadline for placing products authorised for a paediatric indication on
the market. The second part of Amendment 46 has been included in Article 33, with a slight
redrafting. The Council considers that the register should be coordinated by the European Medi-
cines Agency. In order to maintain flexibility, no reference to the competent authorities is made,
since it may be possible to use existing databases for the register. The Council does not accept the
first part; since it considers it inappropriate to include a provision that does not create any legal
obligation. The Council supports the text of the Commission Proposal which makes it clear that
the legal obligation is to market within two years. In addition, the Council does not agree to the
third part of the amendment (which corresponds to Amendment 11). Existing EC pharmaceutical
legislation sets out clear dead-lines both for the granting of a marketing authorisation and for
national decisions concerning the pricing and reimbursement for medicinal products. The Council
considers that it is inappropriate, therefore, to provide for derogations in the application of this
provision in cases where competent authorities are unable to meet such deadlines.

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52. Article 34(2) deals with risk management systems when the Competent Authority has cause for
concern. The European Parliament, in Amendment 47, proposed to make such a system compul-
sory. The Council recalls that the EC pharmaceutical legislation has recently been amended and
including risk management
now contains strengthened and new pharmacovigilance measures,
systems. The proposed Regulation contains a provision for the competent authority, whenever it
has cause for concern, to require a risk management system to be put in place. The Council does
not find it appropriate to make this provision compulsory, as there may be occasions when such
a requirement would add an unnecessary burden and may present a barrier to access to appro-
priate medicines.

Although the Council supports the objective of Amendments 48, 49 and 83 that introduce new
they are not considered to be necessary; since provisions
provisions on pharmacovigilance,
relating to the communication of information on pharmacovigilance matters already exist in EC
pharmaceutical
legislation and apply to all medicinal products authorised in the Community
(Article 24(5) of Regulation (EC) No 726/2004 and Article 104(9) of Directive 2001/83/EC).

53. The Council has decided to insert a new Article 35 to ensure that products with a paediatric indi-
cation for which the market authorisation holder has benefited from the rewards in this Regu-
lation stay on the market. This new article is very similar to Amendment 50 of the European
Parliament, with some redrafting. The Council supports the principle behind this amendment, but
considers that there is a need for a corresponding recital and has introduced some redrafting to
clarify both the scope and that any third party should have expressed an intention to continue
marketing the product. Also the Council considers that there should be a dead-line for informing
the Agency of the intention to discontinue placing a product on the market.

Title V — Rewards and incentives

54. Article 36 deals with the requirements that must be met in order for a Supplementary Protection

Certificate (SPC) to be prolonged six months.

One objective of the proposed Regulation is to ensure that safe and effective authorised medicines
are available for children. Therefore, one of the criteria for granting an extension of the period set
out in the SPC should be that the product must be authorised in all Member States. The same
principle applies to the reward of market exclusivity provided for in the Regulation on orphan
medicinal products. For this reason, the Council cannot agree to Amendment 51. In addition, the
proposed Regulation requires that the information from the completed paediatric investigation
plan must be included in the summary of product characteristics before SPC extension can be
granted. Marketing authorisation procedures, therefore, must be completed before the SPC exten-
sion can be granted. For the same reasons, the associated Amendment 14 to recital 26 has also
been rejected.

Article 36(4) states which products are entitled to a six month prolongation of the SPC. Here, the
second part of Amendment 52 has been accepted in principle. The Council supports the principle
of avoiding double rewards gained on the basis of the same research in the following particular
situation. The new Article 10(1) of Directive 2001/83/EC as amended by Directive 2004/27/EC,
provides that the period of market protection shall be extended by one year if the marketing
authorisation holder obtains an authorisation for a new indication which is judged to bring signif-
icant clinical benefit in comparison with existing therapies. In the case of a new paediatric indica-
tion, this additional year of market protection should not be granted together with the six-month
extension when based on the same research. To avoid this cumulative reward, the Council has
introduced a new paragraph in Article 36.

The Council cannot agree to the first part of the amendment, which relates to patents. A basic
patent (protecting the molecule) covers all medicinal uses of the substance, hence it covers also
any paediatric medicinal use. A specific paediatric patent only exists in the case of a so-called
‘usage patent’. The Commission proposal prolongs the basic patent;
in such circumstances it
would be difficult to operate the ‘non-cumulative’ test set out in the first part of the amendment
and it would go against the objective of stimulating innovation and research. However, consistent

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with the spirit of the amendment, the Council considers that there is a need to clarify that the
rewards and incentives which resulted from completion of an agreed paediatric investigation plan
should only be available if at least some significant research was completed after the entry into
force of the Regulation. Amendments have therefore been introduced into Articles 28(3) and
45(3).

Amendment 53 proposes to introduce a new paragraph stating that the prolongation should only
be admissible once per medicinal product. The Council does not consider that this amendment is
necessary since this provision is already provided for in Article 52,
indent 7, which amends
Article 13 of Regulation (EEC) No 1768/92 (the SPC Regulation).

55. The Council is unable to support Amendment 54 proposed to Article 37 since orphan medicinal
products are subject to the same authorisation procedures as other medicinal products. There are
already provisions in EC pharmaceutical legislation to allow, where necessary, the early authorisa-
tion of orphan medicinal products, such as the provisions for accelerated assessment or condi-
tional marketing authorisation set out in Regulation (EC) No 726/2004 (Article 14).

56. Article 39(3) deals with an inventory of incentives provided by the Community and Member
States to support research into, and the development and availability of, medicinal products for
paediatric use. In Amendment 55, the European Parliament proposes to make this publicly avail-
able. The Council agrees to this and has included the amendment with some minor redrafting to
improve clarity.

57. Like the European Parliament, the Council strongly supports the inclusion of a specific reference
to the funding of studies on the paediatric use of off-patent medicinal products, in form of a new
Article 40, but suggests redrafting compared to Amendments 56, 63 and 64. The Council
considers that the specific name of the programme should not be given in the Regulation. Also
the funding should be delivered through the Community Framework Programmes or any other
Community initiatives for the funding of research. Furthermore, the Council considers that the
reference to the study programme should be included only in Article 40, and not in Article 48.

Title VI — Communication and coordination

58. Article 41(1) deals with a European database on clinical trials. Like the European Parliament, the
Council supports the introduction of transparency into the paediatric clinical trials database, but
agrees that clarification is needed regarding what is to be included and how the details would be
entered into the database. Amendment 57 has therefore been included in paragraph 1 and a new
paragraph 2, with some redrafting, as has Amendment 58 on guidance.

59. The Council has introduced deadlines in Article 42 on collection of existing data on use of medic-

inal products in the paediatric population.

60. Article 43 deals with the inventory of paediatric needs. The Council agrees with the ideas behind
the amendments to the text as set out in the first and second parts of the new Article 2b proposed
in Amendment 19 by the European Parliament, and has redrafted Articles 43(2) and 43(3). The
deadline has been extended to three years to ensure that there is sufficient time to complete all
phases of the work involved. The Council cannot agree to the amendments to the text set out in
the other new articles of Amendment 19 because they either involve duplication of work or are
incomplete. The Council does not support the proposal to change the structure of the Regulation,
since it considers the structure of the Commission proposal to be more coherent.

61. Article 45 deals with paediatric studies completed prior to the entry into force of the Regulation
on Paediatric Medicines. The Council has clarified the scope of this Article. Here and in Article
46, the wording has been changed to make it clear that the Competent Authority has the discre-
tion to decide whether or not to vary a marketing authorisation. It should be noted that the
Competent Authority, when deciding on the action to take, is subject to pharmacovigilance provi-
sions in Community law. The Council shares the intentions behind Amendments 62 and 69, but
considers that both amendments should be included in Article 45(2) and not in Article 56. In
response to parts of Amendment 52, the Council decided to modify Article 45(3) (compare
Article 36 above).

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Title VII — General and final provisions

62. Article 48 deals with the Community contribution to the European Medicines Agency. The
Council agrees in principle to Amendment 63. The first part has been included in Article 48 with
minor redrafting. For the second part, the Council considers that the reference to the study
programme should be included in Article 40, and not in Article 48.

63. Article 49 deals with penalties for infringements of the Regulation. The Council supports the
intentions behind Amendment 66, and has included it, with some minor redrafting. The Council
considers that the harmonisation of national measures proposed in Amendment 65 would require
the adoption of Community legislation to this aim, and can therefore not support this amend-
ment.

64. Article 50 of the common position deals with reports to be prepared by the European Commis-
sion. The Council discussed in detail the necessary analysis of the impact of the reward mechan-
isms. It agrees, in principle, to Amendment 67 and has included it in Article 50(3) with some
redrafting. The Council fully supports a provision for the Commission to carry out detailed
analyses of the economic impact resulting from the application of the Regulation. However, the
Council wishes to ensure that there are sufficient data available to make robust analyses. Since
this might not be the case already after six years, the analysis of economic impact could take
place later, but within ten years. In addition the Council decided that there should be an analysis
of the estimated consequences for public health.

65. The Council decided to delete Article 50 of the Proposal, since it considers that the provisions in
Article 6 of the common position are sufficient as a basis for rules of procedure for the Paediatric
Committee, which should be decided within EMEA in order guarantee flexibility.

66. Article 51 on comitology has been adapted to correspond to standard wording.

67. Article 52 contains amendments necessary to Regulation (EEC)1768/92, the SPC Regulation. In
particular, a new paragraph 4 is inserted into Article 7 of Regulation (EEC)1768/92, stating that
the application for an SPC prolongation shall be lodged no later than two years before the expira-
tion of the SPC. The Council considers that the two-year deadline in the Proposal is necessary to
ensure transparency for generic competition. The Council can therefore not support Amendment
68, which shortens the deadline to six months.

Following detailed ‘technical’ examination of the proposed amendments to the SPC Regulation,
the Council has decided to change some of the provisions of the Proposal and has also introduced
some new amendments to this Regulation.

68. The Council has inserted a new Article 53 in order to introduce an amendment to Directive
2001/20/EC aiming at making public part of the information on paediatric clinical trials entered
in the European database on clinical trials.

69. Article 57 deals with the entry into force of the provisions of the proposed regulation. Since there
is no legal basis in current legislation nor any sufficiently empowered existing committee to agree
paediatric investigation plans in advance of the entry into force of the Regulation, applications
submitted before that date cannot include findings from studies which are part of an agreed
paediatric investigation plan. Therefore, the Council cannot support Amendment 70. But research
in advance of the entry into force of the Regulation is not discouraged. In accordance with Article
45(2) (Amendment 62), existing and on-going studies at the time of entry into force of the Regu-
lation shall be eligible to be included in a paediatric investigation plan once the Regulation is
adopted.

The Council also considers that the suggested time-limits in Amendment 71 would not allow
sufficient time for the necessary prior steps to be taken e.g. establishment of the Paediatric
Committee or agreement of paediatric investigation plans, and can therefore not support this
amendment.

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IV. CONCLUSION

70. The Council has incorporated a considerable number of the European Parliament's amendments
in its common position, which is fully in line with the objectives of the Commission proposal.

The common position of the Council has the special health care needs of children as its main
objective and strives to strike a balance between different considerations. The Commission has
acknowledged the overall balance of the Council's common position and welcomed the Political
Agreement at the Council (EPSCO) on 9 December 2005.