Common Position (EC) No 60/2003 of 29 September 2003 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 laying down Community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European Medicines Agency (Text with EEA relevance)
Date: 2003-09-29
Institutions: Council of the European Union
Subjects: European Medicines Agency, drug surveillance, market approval, marketing standard, medicinal product, veterinary drug

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I

(Information)

COUNCIL

COMMON POSITION (EC) No 60/2003

adopted by the Council on 29 September 2003

with a view to the adoption of a Regulation (EC) No . . ./2003 of the European Parliament and of
the Council of . . . laying down Community procedures for the authorisation and supervision of
medicinal products for human and veterinary use and establishing a European Medicines Agency

(2003/C 297 E/01)

(Text with EEA relevance)

(2)

(3)

THE EUROPEAN PARLIAMENT AND THE COUNCIL OF
THE EUROPEAN UNION,

Having regard to the Treaty establishing the European
Community,
and in particular Article 95 and Article
152(4)(b) thereof,

Having regard to the proposal from the Commission (1),

Having regard to the Opinion of the European Economic and
Social Committee (2),

After consulting the Committee of the Regions,

In accordance with the procedure laid down in Article 251 of
the Treaty (3),

In the light of the Commission's report on the experience
gained, it has proved necessary to improve the operation
the placing of
of
the authorisation procedures
in the Community
medicinal products on the market
and to amend certain administrative aspects of
the
European Agency
the Evaluation of Medicinal
Products. In addition, the name of that Agency should
be simplified and changed to the European Medicines
Agency, (hereinafter referred to as the ‘Agency’).

for

for

It emerges from the conclusions of that report that the
amendments to be made to the centralised procedure set
up by Regulation (EEC) No 2309/93 consist of corrections
to some of the operating procedures and adaptations to
take account of the probable development of science and
technology and the future enlargement of the European
Union. It also emerges from the report that the general
principles previously
established which govern the
centralised procedure should be maintained.

Whereas:

(1) Article 71 of Council Regulation (EEC) No 2309/93 of
22 July 1993 laying down Community procedures for
the authorisation and supervision of medicinal products
for human and veterinary use
a
the Evaluation of Medicinal
European Agency
Products (4) provides that, within six years of the entry
into force of
to
publish a general report on the experience acquired as a
result of the operation of the procedures laid down in the
Regulation.

the Commission is

and establishing

the Regulation,

for

(1) OJ C 75 E, 26.3.2002, p. 189.
(2) OJ C 61, 14.3.2003, p. 1.
(3) Opinion of the European Parliament of 23 October 2002 (not yet
published in the Official
Journal), Council Common Position of
29 September 2003 and Decision of the European Parliament of
. . . (not yet published in the Official Journal).

(4) Moreover, since the European Parliament and the Council
have adopted Directive 2001/83/EC of 6 November 2001
on the Community code relating to medicinal products for
human use (5) and Directive 2001/82/EC of 6 November
2001 on the Community code relating to veterinary
medicinal products (6), all the references to the codified
Directives in Regulation (EEC) No 2309/93 should be
updated.

(5)

For the sake of clarity, it is necessary to replace the said
Regulation with a new Regulation.

(6)

It is appropriate to preserve the Community mechanism
set up by the repealed Community legislation for concer-
tation prior to any national decision relating to a high-
technology medicinal product.

(5) OJ L 311, 28.11.2001, p. 67. Directive as last amended by Council

Directive 2003/. . ./EC (p. . . . of this Official Journal).

(4) OJ L 214, 24.8.1993, p. 1. Regulation as last amended by Regulation

(6) OJ L 311, 28.11.2001, p. 1. Directive as amended by Council

(EC) No 1647/2003 (OJ L 245, 29.9.2003, p. 19).

Directive 2003/. . ./EC (p. . . . of this Official Journal).

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it

is

for

compulsory

shown that

(7) Experience gained since the adoption of Council Directive
87/22/EEC of 22 December 1986 on the approximation
of national measures relating to the placing on the market
of high-technology medicinal products, particularly those
derived from biotechnology (1) has
is
necessary to create a centralised authorisation procedure
that
high-technology medicinal
products, particularly those resulting from biotechnical
processes, in order to maintain the high level of scientific
evaluation of these medicinal products in the European
Union and thus to preserve the confidence of patients
and the medical professions in the evaluation. This is
particularly important in the context of the emergence
of new therapies, such as gene therapy and associated
therapy. This
cell
approach should be maintained, particularly with a view
to ensuring the effective operation of the internal market
in the pharmaceutical sector.

and xenogenic

therapies,

somatic

(8) With a view to harmonising the internal market for new
medicinal products, this procedure should also be made
compulsory for any medicinal product
for human use
containing an entirely new active substance, i.e. one that
has not yet been authorised in the Community, and for
which the therapeutic indication is
the treatment of
acquired immune deficiency syndrome, cancer, neurode-
generative disorder or diabetes. It should be possible to
the Annex via a
review the provisions in point 3 of
simplified decision-making procedure not earlier
than
four years after the entry into force of this Regulation.

to the

(9) As regards medicinal products for human use, optional
access
should also be
centralised procedure
provided for in cases where use of a single procedure
produces added value for the patient. This procedure
for medicinal products which,
should remain optional
although not belonging to the abovementioned categories,
are nevertheless therapeutically innovative. It is also appro-
priate to allow access to this procedure for medicinal
products which, although not
innovative, may be of
benefit to society or to patients if they are authorised
from the outset at Community level, such as certain
medicinal products which can be supplied without a
medical prescription. This option may be extended to
generic medicinal products authorised by the Community,
provided that
the
harmonisation achieved when the reference medicinal
product was evaluated or the results of that evaluation.

this in no way undermines either

(10) In the field of veterinary medicinal products, adminis-
trative measures should be laid down in order to take
account of the specific features of this field, particularly
those due to the regional distribution of certain diseases. It
should be possible to use the centralised procedure for the
authorisation of veterinary medicinal products used within
the
regarding
prophylactic measures for epizootic diseases. Optional
access to the centralised procedure should be maintained
for veterinary medicinal products containing a new active
substance.

framework of Community provisions

(1) OJ L 15, 17.1.1987, p. 38. Directive repealed by Directive

93/41/EEC (OJ L 214, 24.8.1993, p. 40).

the

(11) For medicinal products for human use, the period for
protection of data relating to pre-clinical
tests and
clinical trials should be the same as that provided for in
Directive 2001/83/EC, except for medicinal products for
is
which
compulsory. These latter products should benefit from a
longer period of data protection. For medicinal products
for veterinary use,
the period for protection of data
relating to pre-clinical tests and clinical trials as well as
safety and residue tests should be the same as that
provided for in Directive 2001/82/EC.

authorisation

centralised

procedure

(12) In order to reduce the cost for small and medium-sized
enterprises of marketing medicinal products authorised via
the centralised procedure, provisions should be adopted to
allow for a reduction of fees, deferring the payment of fees
and offering administrative assistance in respect of theses
enterprises.

(13) In the interest of public health, authorisation decisions
under the centralised procedure should be taken on the
basis of the objective scientific criteria of quality, safety
and efficacy of the medicinal product concerned, to the
exclusion of economic and other considerations. However,
Member States should be able exceptionally to prohibit the
use in their territory of medicinal products for human use
which infringe objectively defined concepts of public
policy and public morality. Moreover,
a veterinary
medicinal product
to be authorised by the
Community if
its use would contravene the rules laid
down within the framework of the Common Agricultural
Policy or if presented for a use prohibited under other
Community provisions,
alia Council Directive
inter
96/22/EC of 29 April 1996 concerning the prohibition
on the use in stockfarming of certain substances having
a hormonal or thyrostatic action and of β-agonists, and
repealing Directives
and
88/299/EEC (2).

81/602/EEC,

88/146/EEC

is not

(14) Provision should be made for the quality, safety and
efficacy criteria in Directives 2001/83/EC and 2001/82/EC
to apply to medicinal products
authorised by the
Community and it should be possible to assess the risk-
benefit balance of all medicinal products when they are
placed on the market, at the time of the renewal of the
authorisation and at any other
time the competent
authority deems appropriate.

(15) There

is

for

the

also a need to provide

ethical
requirements of Directive 2001/20/EC of 4 April 2001
of the European Parliament and of the Council on the
approximation of the laws, regulations and administrative
provisions of the Member States relating to the implemen-
tation of good clinical practice in the conduct of clinical
trials on medicinal products for human use (3) to apply to
In
medicinal products authorised by the Community.
conducted
particular, with respect

to clinical

trials

(2) OJ L 125, 23.5.1996, p. 3. Directive as amended by Directive
2003/74/EC of the European Parliament and of the Council (OJ L
262, 14.10.2003, p. 17).
(3) OJ L 121, 1.5.2001, p. 34.

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outside the Community on medicinal products destined to
be authorised within the Community, at the time of the
evaluation of the application for authorisation, it should
be verified that these trials were conducted in accordance
with the principles of good clinical practice and the ethical
requirements equivalent
the said
Directive.

to the provisions of

(16) The Community should have the means to carry out a
scientific assessment of the medicinal products presented
in accordance with the decentralised Community author-
isation procedures. Moreover, with a view to ensuring the
effective harmonisation of administrative decisions taken
by Member States with regard to medicinal products
presented in accordance with decentralised authorisation
is necessary to endow the Community
procedures,
with the means
to resolve disagreements between
Member States concerning the quality, safety and efficacy
of medicinal products.

it

(17) The structure and operation of the various bodies making
up the Agency should be designed in such a way as to
take into account the need constantly to renew scientific
expertise, the need for cooperation between Community
and national bodies, the need for adequate involvement of
civil society, and the future enlargement of the European
Union. The various bodies of the Agency should establish
and develop appropriate
contacts with the parties
concerned,
in particular representatives of patients and
health-care professionals.

(18) The chief

after

task of

the Agency should be to provide
Community institutions and Member States with the best
possible scientific opinions so as to enable them to
exercise the powers regarding the authorisation and super-
vision of medicinal products conferred on them by
Community legislation in the field of medicinal products.
Only
evaluation procedure
scientific
addressing the quality, safety and efficacy of high-tech-
nology medicinal products has been conducted by the
Agency, applying the highest possible standards, should
marketing authorisation be granted by the Community,
and this should be done by means of a rapid procedure
ensuring close cooperation between the Commission and
Member States.

single

a

(19) In order to ensure close cooperation between the Agency
and scientists operating in Member States, the composition
of the Management Board should be such as to guarantee
that the competent authorities of the Member States are
closely involved in the overall management of
the
Community system for authorising medicinal products.

(20) Paragraph 25 of the Interinstitutional Agreement of 6 May
1999 between the European Parliament, the Council and
the Commission on budgetary discipline and improvement
of budgetary procedure (1) provides
the Financial
Perspective to be adjusted in order to cover the new
needs resulting from enlargement.

for

(21) Exclusive

responsibility

for preparing

the Agency's
opinions on all questions concerning medicinal products
for human use should be vested in a Committee for
Medicinal Products for Human Use. As far as veterinary
such responsibility
medicinal products are concerned,
should be vested in a Committee for Medicinal Products
for Veterinary Use. As regards orphan medicinal products,
to the Committee on Orphan
the task should fall
set up under Regulation (EC)
Medicinal
the
No 141/2000 of
Council of 16 December 1999 on orphan medicinal
products (2). Lastly, as regards herbal medicinal products,
this responsibility should be vested in the Committee on
Herbal Medicinal
set up under Directive
2001/83/EC.

the European Parliament and of

Products

Products

(22) The creation of

the Agency will make it possible to
reinforce the scientific role and independence of
the
committees, particularly through the setting-up of a
permanent technical and administrative secretariat.

for

future

Scientific

(23) The field of activity of the Scientific Committees should be
enlarged and their operating methods and composition
modernised.
applicants
advice
seeking marketing authorisation should be provided
more generally and in greater depth. Similarly, structures
allowing the development of advice for companies,
in
particular small and medium-sized enterprises, should be
put in place. The committees should be able to delegate
some of their evaluation duties to standing working parties
open to experts from the scientific world appointed for
this purpose, whilst retaining total responsibility for the
scientific opinions issued. The re-examination procedures
should be amended to provide a better guarantee for
applicants' rights.

(24) The number of members of

the Scientific Committees
participating in the centralised procedure should be estab-
lished with a view to ensuring that the committees remain
of an efficient size after the enlargement of the European
Union.

(25) It is also necessary to reinforce the role of the Scientific
Committees in such a way as to enable the Agency to
scientific dialogue
participate actively in international
and to develop certain activities that will be necessary,
in particular
regarding international scientific harmon-
isation and technical cooperation with the World Health
Organisation.

for

the Agency's work,

(26) Furthermore, in order to create greater legal certainty it is
necessary to define the responsibilities regarding the trans-
parency rules
to set certain
conditions for the marketing of medicinal products auth-
to confer on the Agency
orised by the Community,
powers
distribution of medicinal
the
products authorised by the Community and to specify
the sanctions and the procedures for implementing them
in the event of failure to observe the provisions of this
Regulation and the conditions contained in the authoris-
ations granted under the procedures it establishes.

to monitor

(1) OJ C 172, 18.6.1999, p. 1.

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

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(27) It is also necessary to take measures for the supervision of
medicinal products authorised by the Community, and in
particular
for the intensive supervision of undesirable
effects of these medicinal products within the framework
to
of Community pharmacovigilance activities,
from the market of any
ensure the rapid withdrawal
medicinal product presenting a negative
risk-benefit
balance under normal conditions of use.

so as

in its Conclusions on medicinal products and
Council,
public health (1), adopted on 29 June 2000, emphasised
identifying medicinal products that
the importance of
presented an added therapeutic value. However
this
evaluation should not be conducted in the context of
the marketing authorisation, for which it is agreed that
the fundamental criteria should be retained. It is useful
in this respect to allow for the possibility of gathering
information on the methods used by the Member States
to determine the therapeutic benefit obtained by each new
medicinal product.

for

responsible

(28) In order to enhance the efficiency of market surveillance,
the Agency should be
coordinating
Member States' pharmacovigilance activities. A number
of provisions need to be introduced to put
in place
stringent and efficient pharmacovigilance procedures, to
to take provisional
authority
allow the
competent
emergency measures,
introduction of
the
including
amendments to the marketing authorisation and, finally,
to permit a reassessment to be made at any time of the
risk-benefit balance of a medicinal product.

(29) It is also appropriate to entrust the Commission, in close
cooperation with the Agency and after consultations with
the Member States, with the task of coordinating the
supervisory responsibilities
execution of
vested in the Member States, and in particular with the
tasks of providing information on medicinal products and
of checking the observance of good manufacturing,
laboratory and clinical practices.

the various

(30) It is necessary to provide for the coordinated implemen-
tation of Community procedures for the authorisation of
medicinal products, and of
the national procedures of
Member States which have already been harmonised to a
considerable
by Directives 2001/83/EC and
2001/82/EC. It is appropriate that the operation of the
procedures laid down by this Regulation be re-examined
by the Commission every ten years on the basis of
experience gained.

degree

should be set up,

(31) In order to meet, in particular, the legitimate expectations
of patients and to take account of the increasingly rapid
progress of science and therapies, accelerated assessment
reserved for medicinal
procedures
products of major therapeutic interest, and procedures
for obtaining temporary authorisations subject to certain
annually reviewable conditions. In the field of medicinal
products for human use, a common approach should also
be followed, whenever possible, regarding the criteria and
conditions for the compassionate use of new medicinal
products under Member States' legislation.

(33) In line with the

current provisions of Directives
2001/83/EC and 2001/82/EC, the term of validity of a
Community marketing authorisation should be limited
initially to a period of
five years, upon the expiry of
which it should be renewed. Thereafter the marketing
authorisation should normally be of unlimited validity.
Furthermore,
three
consecutive years, that is to say, one which has not led
to the placing on the market of a medicinal product in the
Community during that period, should be considered
invalid, in order, in particular, to avoid the administrative
burden of maintaining such authorisations. However, this
rule should be subject
to exemptions when these are
justified on public health grounds.

authorisation not used for

any

(34) Environmental risks may arise from medicinal products
containing or consisting of genetically modified organisms.
It is thus necessary to subject such products to an environ-
mental risk-assessment procedure similar to the procedure
under Directive 2001/18/EC of the European Parliament
and of the Council of 12 March 2001 on the deliberate
release into the environment of genetically modified
organisms and repealing Council Directive 90/220/EEC (2),
to be conducted in parallel with the evaluation, under a
single Community procedure, of the quality, safety and
efficacy of the product concerned.

(35) 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 (3).

(36) The provisions of Regulation (EC) No 1647/2003
amending Regulation (EC) No 2309/93 as regards the
budgetary and financial rules applicable to the Agency
and access to the Agency's documents should be fully
incorporated into this Regulation,

HAVE ADOPTED THIS REGULATION:

(32) Member States have developed an evaluation of

the
comparative efficacy of medicinal products aimed at posi-
tioning a new medicinal product with respect to those that
already exist in the same therapeutic class. Similarly, the

(1) OJ C 218, 31.7.2000, p. 10.
(2) OJ L 106, 17.4.2001, p. 1. Directive as last amended by Regulation

(EC) No 1830/2003 (OJ L 268, 18.10.2003, p. 24).

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

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TITLE I

DEFINITIONS AND SCOPE

Article 1

for

The purpose of this Regulation is to lay down Community
procedures
supervision and phar-
macovigilance of medicinal products for human and veterinary
use, and to establish a European Medicines Agency (hereinafter
referred to as ‘the Agency’).

authorisation,

the

The provisions of this Regulation shall not affect the powers of
Member States' authorities as regards setting the prices of
the
medicinal products or their inclusion in the scope of
national health system or social security schemes on the
basis of health, economic and social conditions. In particular,
Member States shall be free to choose from the particulars
shown in the marketing authorisation those therapeutic indi-
cations and pack sizes which will be covered by their social
security bodies.

Article 2

The definitions laid down in Article 1 of Directive 2001/83/EC
and those laid down in Article 1 of Directive 2001/82/EC shall
apply for the purposes of this Regulation.

The holder of a marketing authorisation for medicinal products
covered by this Regulation must be established in the
Community. The holder shall be responsible for the placing
on the market of those medicinal products, whether he does
it himself or via one or more persons designated to that effect.

Article 3

1.
No medicinal product appearing in the Annex may be
placed on the market within the Community unless a
marketing authorisation has been granted by the Community
in accordance with the provisions of this Regulation.

Immunological veterinary medicinal products for the treatment
of animal diseases that are subject to Community prophylactic
measures may also be granted such authorisation.

3.
A generic medicinal product of a reference medicinal
product authorised by the Community may be authorised by
the competent authorities of the Member States in accordance
with Directive 2001/83/EC and Directive 2001/82/EC under
the following conditions:

(a) the application for authorisation is submitted in accordance
with Article 10 of Directive 2001/83/EC or Article 13 of
Directive 2001/82/EC;

(b) the summary of the product characteristics is in all relevant
respects consistent with that of the medicinal product auth-
orised by the Community; and

(c)

the generic medicinal product is authorised under the same
name in all the Member States where the application has
been made. For the purposes of this provision, all the
linguistic versions of the INN (international non-proprietary
name) shall be considered to be the same name.

After the competent committee of the Agency has been
4.
the Annex may be re-examined in the light of
consulted,
technical and scientific progress, with a view to making any
necessary amendments without extending the scope of
the
centralised procedure. Such amendments shall be adopted in
accordance with the procedure referred to in Article 87(2).

5.
Not earlier than . . . (*), the Commission, having consulted
the Agency, may present any appropriate proposal modifying
point 3 of the Annex and the Council shall take a decision on
that proposal by qualified majority.

Any medicinal product not appearing in the Annex may
2.
be granted a marketing authorisation by the Community in
accordance with the provisions of this Regulation, if:

Article 4

Applications for the marketing authorisations referred to

1.
in Article 3 shall be submitted to the Agency.

(a) the medicinal product contains a new active substance
which, on the date of entry into force of this Regulation,
was not authorised in the Community; or

The Community shall grant and supervise marketing
for human use in

for medicinal products

2.
authorisations
accordance with Title II.

(b) the applicant shows that the medicinal product constitutes
a significant therapeutic, scientific or technical innovation
or that the granting of authorisation in accordance with
this Regulation is in the interests of patients or animal
health at Community level.

The Community shall grant and supervise marketing
3.
authorisations for veterinary medicinal products in accordance
with Title III.

(*) Four years after the entry into force of this Regulation.

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AUTHORISATION AND SUPERVISION OF MEDICINAL PRODUCTS FOR HUMAN USE

TITLE II

C h a p t e r 1

Submission and examination of applications — Authoris-
ations

(b) the complete technical dossier supplying the information
required by Annexes III and IV to Directive 2001/18/EC;

Article 5

(c)

the environmental risk assessment in accordance with the
principles set out in Annex II to Directive 2001/18/EC; and

1.
A Committee for Medicinal Products for Human Use is
hereby established. The Committee shall be part of the Agency.

2. Without prejudice to Article 56 or to other tasks which
Community law may confer on it, the Committee for Medicinal
Products for Human Use shall be responsible for drawing up
the Agency on any matter concerning the
the opinion of
admissibility of
the files submitted in accordance with the
centralised procedure, the granting, variation, suspension or
revocation of an authorisation to place a medicinal product
in accordance with the
for human use on the market
provisions of this Title, and pharmacovigilance.

3.
At the request of the Executive Director of the Agency or
the Commission representative, the Committee for Medicinal
Products for Human Use shall also draw up an opinion on any
evaluation of medicinal
scientific matter
products
take due
account of any requests by Member States for an opinion.

for human use. The Committee shall

concerning the

Article 6

for human use shall

Each application for the authorisation of a medicinal
1.
specifically and completely
product
referred to in
include the particulars and documents as
Articles 8(3), 10, 10a, 10b or 11 of, and Annex I
to,
Directive 2001/83/EC. These particulars and documents shall
take account of the unique, Community nature of the author-
isation requested and, otherwise than in exceptional cases
relating to the application of the law on trade marks, shall
include the use of a single name for the medicinal product.

The application shall be accompanied by the fee payable to the
Agency for the examination of the application.

In the case of a medicinal product

2.
for human use
containing or consisting of genetically modified organisms
within the meaning of Article 2 of Directive 2001/18/EC, the
application shall be accompanied by:

(a) a copy of the competent authorities' written consent to the
deliberate release into the environment of the genetically
modified organisms for research and development purposes
where provided for in Part B of Directive 2001/18/EC or in
Part B of Council Directive 90/220/EEC of 23 April 1990
environment of
on the deliberate
genetically modified organisms (1);

into the

release

(1) OJ L 117, 8.5.1990, p. 15. Directive repealed by Directive

2001/18/EC, but continues to have certain legal effects.

(d) the results of any investigations performed for the purposes

of research or development.

Articles 13 to 24 of Directive 2001/18/EC shall not apply to
medicinal products for human use containing or consisting of
genetically modified organisms.

The Agency shall ensure that

the
3.
Committee for Medicinal Products for Human Use is given
within 210 days after receipt of a valid application.

the opinion of

the

shall

respect

environmental

In the case of a medicinal product for human use containing or
consisting of genetically modified organisms, the opinion of the
said Committee
safety
requirements laid down by Directive 2001/18/EC. During the
process of evaluating applications for marketing authorisations
for medicinal products for human use containing or consisting
of genetically modified organisms, the rapporteur shall carry
out necessary consultations of bodies that the Community or
Member States have set up in accordance with Directive
2001/18/EC.

4.
The Commission shall, in consultation with the Agency,
Member States and interested parties, draw up a detailed guide
regarding the form in which applications for authorisation are
to be presented.

Article 7

In order to prepare its opinion, the Committee for Medicinal
Products for Human Use:

(a) shall verify that the particulars and documents submitted in
accordance with Article 6 comply with the requirements of
Directive 2001/83/EC, and shall examine whether
the
conditions specified in this Regulation for granting a
marketing authorisation are satisfied;

(b) may request that an Official Medicines Control Laboratory
or a laboratory that a Member State has designated for that
its
purpose test
starting materials
intermediate
products or other constituent materials in order to ensure
that the control methods employed by the manufacturer
and described in the application documents are satisfactory;

the medicinal product

for human use,

if need be,

and,

its

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(c) may request that the applicant supplement the particulars
accompanying the application within a specific time period.
Where the said Committee avails itself of this option, the
time-limit laid down in Article 6(3),
first subparagraph,
shall be suspended until such time as the supplementary
information requested has been provided. Likewise,
this
time-limit shall be suspended for the time allowed for the
applicant to prepare oral or written explanations.

Article 8

1.
Upon receipt of a written request from the Committee for
Medicinal Products for Human Use, a Member State shall
forward the information showing that the manufacturer of a
medicinal product or the importer from a third country is able
to manufacture the medicinal product concerned and/or carry
out
in accordance with the
tests
particulars and documents supplied pursuant to Article 6.

the necessary control

2. Where it considers it necessary in order to complete its
examination of an application, the said Committee may require
the applicant to undergo a specific inspection of the manu-
facturing site of
the medicinal product concerned. Such
inspections may be made unannounced.

The inspection shall be carried out within the time-limit laid
down in the first subparagraph of Article 6(3) by inspectors
from the Member State holding the appropriate qualifications;
they may be accompanied by a rapporteur or an expert
appointed by the Committee.

subparagraph of Article 62(1). The reasons for the conclusion
reached shall be annexed to the final opinion.

3. Within 15 days after its adoption, the Agency shall send
the final opinion of the said Committee to the Commission, to
the Member States and to the applicant, together with a report
describing the assessment of the medicinal product by the
Committee and stating the reasons for its conclusions.

4.
If an opinion is favourable to the granting of the relevant
authorisation to place the medicinal product concerned on the
market,
the following documents shall be annexed to the
opinion:

(a) a draft summary of the product characteristics, as referred

to in Article 11 of Directive 2001/83/EC;

(b) details of any conditions or restrictions which should be
imposed on the supply or use of the medicinal product
including the conditions under which the
concerned,
medicinal product may be made available to patients,
in
accordance with the criteria laid down in Title VI of
Directive 2001/83/EC;

(c) details of any recommended conditions or restrictions with
the medicinal

regard to the safe and effective use of
product;

(d) the draft text of the labelling and package leaflet proposed
by the applicant, presented in accordance with Title V of
Directive 2001/83/EC;

Article 9

(e)

the assessment report.

1.
The Agency shall forthwith inform the applicant if the
opinion of the Committee for Medicinal Products for Human
Use is that:

Article 10

(a) the application does not satisfy the criteria for author-

isation set out in this Regulation;

1. Within 15 days after receipt of the opinion referred to in
the
Article 5(2),
decision to be taken in respect of the application.

the Commission shall prepare a draft of

(b) the summary of the product characteristics proposed by the

applicant needs to be amended;

(c) the labelling or package leaflet of the product is not in

compliance with Title V of Directive 2001/83/EC;

(d) the authorisation needs to be granted subject
conditions provided for in Article 14(7) and (8).

to the

2. Within 15 days after receipt of the opinion referred to in
paragraph 1, the applicant may give written notice to the
Agency that he wishes to request a re-examination of the
opinion.
forward to the
Agency the detailed grounds for the request within 60 days
after receipt of the opinion.

the applicant shall

In that case,

Where a draft decision envisages the granting of a marketing
include or make reference to the
authorisation,
documents mentioned in Article 9(4)(a), (b), (c) and (d).

shall

it

Where the draft decision is not in accordance with the opinion
of the Agency, the Commission shall annex a detailed expla-
nation of the reasons for the differences.

The draft decision shall be forwarded to Member States and the
applicant.

The Commission shall take a final decision in accordance
the procedure

2.
with, and within 15 days after the end of,
referred to in Article 87(3).

Within 60 days following receipt of
the grounds for the
request, the said Committee shall re-examine its opinion in
accordance with the conditions laid down in the fourth

3.
for
The Standing Committee on Medicinal Products
Human Use referred to in Article 87(1) shall adjust its rules
of procedure so as to take account of the tasks incumbent
upon it under this Regulation.

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The adjustments shall provide that:

Article 13

(a) the opinion of the said Standing Committee is to be given

in writing;

(b) Member States shall have 22 days to forward their written
observations on the draft decision to the Commission.
However, if a decision has to be taken urgently, a shorter
time-limit may be set by the Chairman according to the
degree of urgency involved. This time-limit shall not,
otherwise than in exceptional circumstances, be shorter
than 5 days;

(c) Member States may request

the draft
decision referred to in paragraph 1 be discussed by a
plenary meeting of the said Standing Committee, stating
their reasons in detail.

in writing that

4. Where,
in the opinion of the Commission, a Member
State's written observations raise important new questions of
a scientific or technical nature which the opinion delivered by
the Agency has not addressed, the Chairman shall suspend the
procedure and refer the application back to the Agency for
further consideration.

5.
The Commission shall adopt the provisions necessary for
the implementation of paragraph 4 in accordance with the
procedure referred to in Article 87(2).

The Agency shall disseminate the documents referred to

6.
in Article 9(4)(a), (b), (c) and (d).

Article 11

If an applicant withdraws an application for a marketing auth-
orisation submitted to the Agency before an opinion has been
given on the application, the applicant shall communicate its
reasons for doing so to the Agency. The Agency shall make
this information publicly accessible and shall publish the
assessment report, if available, after deletion of all information
of a commercially confidential nature.

Article 12

The marketing authorisation shall be refused if, after
1.
the particulars and documents submitted in
verification of
accordance with Article 6,
it appears that the applicant has
not properly or sufficiently demonstrated the quality, safety
or efficacy of the medicinal product.

likewise be refused if particulars or
Authorisation shall
documents provided by the applicant
in accordance with
Article 6 are incorrect or if the labelling and package leaflet
proposed by the applicant are not in accordance with Title V
of Directive 2001/83/EC.

2.
The refusal of a Community marketing authorisation shall
constitute a prohibition on the placing on the market of the
medicinal product concerned throughout the Community.

4(4)

prejudice

to Article

1. Without
of Directive
2001/83/EC, a marketing authorisation which has been
granted in accordance with this Regulation shall be valid
throughout the Community. It shall confer the same rights
and obligations in each of the Member States as a marketing
authorisation granted by that Member State in accordance with
Article 6 of Directive 2001/83/EC.

Authorised medicinal products for human use shall be entered
in the Community Register of Medicinal Products and shall be
given a number, which shall appear on the packaging.

Journal of

Notification of marketing authorisation shall be published
2.
the European Union, quoting in
in the Official
the date of authorisation and the registration
particular
number
International
Non-proprietary Name (INN) of the active substance of the
medicinal
any
its
Anatomical Therapeutic Chemical Code (ATC).

in the Community Register,

pharmaceutical

product,

form,

and

any

The Agency shall

immediately publish the assessment
3.
report on the medicinal product for human use drawn up by
the Committee for Medicinal Products for Human Use and the
reasons for its opinion in favour of granting authorisation, after
deletion of any information of a commercially confidential
nature.

The European Public Assessment Report (EPAR) shall include a
summary written in a manner that is understandable to the
public. The summary shall contain in particular a section
relating to the conditions of use of the medicinal product.

After a marketing authorisation has been granted, the
4.
inform the Agency of the
holder of the authorisation shall
dates of actual marketing of
for
human use in the Member States, taking into account the
various presentations authorised.

the medicinal product

The holder shall also notify the Agency if the product ceases to
be placed on the market, either temporarily or permanently.
Such notification shall, otherwise than in exceptional circum-
stances, be made no less than 2 months before the interruption
in the placing on the market of the product.

Upon request by the Agency, particularly in the context of
pharmacovigilance,
the marketing authorisation holder shall
provide the Agency with all data relating to the volume of
sales of the medicinal product at Community level, broken
down by Member State, and any data in the holder's possession
relating to the volume of prescriptions.

Article 14

1. Without prejudice to paragraphs 4, 5 and 7 a marketing
authorisation shall be valid for five years.

Information about all refusals and the reasons for them

3.
shall be made publicly accessible.

2.
The marketing authorisation may be renewed after five
years on the basis of a re-evaluation by the Agency of the
risk-benefit balance.

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To this end, the marketing authorisation holder shall provide
the Agency with a consolidated version of the file in respect of
quality, safety and efficacy, including all variations introduced
since the marketing authorisation was granted, at
least six
months before the marketing authorisation ceases to be valid
in accordance with paragraph 1.

3.
Once renewed, the marketing authorisation shall be valid
for an unlimited period, unless the Commission decides, on
to proceed
justified grounds relating to pharmacovigilance,
with one additional
in accordance with
paragraph 2.

five-year

renewal

4.
Any authorisation which is not followed by the actual
for human use on the
placing of
Community market within three years after authorisation
shall cease to be valid.

the medicinal product

11. Medicinal products for human use which have been
authorised in accordance with the provisions of this Regulation
shall benefit from the provisions on protection in Article 10 of
Directive 2001/83/EC.

Notwithstanding the first subparagraph, medicinal products for
human use appearing in the Annex to this Regulation shall
benefit from a ten-year period of protection, which shall be
extended to a maximum of 11 years if, during the first eight
years of those ten years, the marketing authorisation holder
obtains an authorisation for one or more new therapeutic
indications which, during the scientific evaluation prior to
their authorisation, are held to bring a significant clinical
benefit in comparison with existing therapies.

Article 15

5. When an authorised medicinal product previously placed
on the market is no longer actually present on the market for
three consecutive years, the authorisation shall cease to be
valid.

the civil or
The granting of authorisation shall not affect
criminal liability of the manufacturer or of the holder of the
marketing authorisation pursuant to the applicable national law
in Member States.

In exceptional

circumstances and on public health
6.
grounds
from
paragraphs 4 and 5. Such exemptions must be duly justified.

the Commission may

exemptions

grant

7.
Following consultation with the applicant, an author-
isation may be granted subject to certain specific obligations,
to be reviewed annually by the Agency.

By way of derogation from paragraph 1, such authorisation
shall be valid for one year, on a renewable basis.

The provisions for granting such authorisation shall be laid
down in a Commission Regulation adopted in accordance
with the procedure referred to in Article 87(2).

requirement

to introduce

the
for
in particular

applicant
concerning the

8.
In exceptional circumstances and following consultation
with the applicant, the authorisation may be granted subject to
specific
a
procedures,
the
medicinal product, notification to the competent authorities
of any incident relating to its use, and action to be taken.
This authorisation may be granted only for objective, verifiable
reasons and must be based on one of the grounds set out in
Annex I to Directive 2001/83/EC. Continuation of the author-
isation shall be linked to the annual reassessment of these
conditions.

safety of

9. When an application is submitted for a marketing auth-
orisation in respect of medicinal products for human use which
are of major interest from the point of view of public health
and in particular from the viewpoint of therapeutic innovation,
the applicant may request an accelerated assessment procedure.
The request shall be duly substantiated.

If
the Committee for Medicinal Products for Human Use
accepts the request, the time-limit laid down in Article 6(3),
first subparagraph, shall be reduced to 150 days.

its opinion,

10. When adopting
Medicinal Products for Human Use shall
concerning the criteria for the prescription or use of
medicinal products
Directive 2001/83/EC.

for
include a proposal
the
in accordance with Article 70(1) of

the Committee

C h a p t e r 2

Supervision and penalties

Article 16

1.
After an authorisation has been granted in accordance
with this Regulation, the holder of the marketing authorisation
for a medicinal product for human use shall, in respect of the
methods of manufacture and control provided for in Article
8(3)(d) and (h) of Directive 2001/83/EC,
take account of
technical and scientific progress and make any variations that
may be required to enable the medicinal products to be manu-
factured and checked by means of generally accepted scientific
methods. He shall apply for approval of such variations in
accordance with this Regulation.

The holder of the marketing authorisation shall forthwith
2.
supply to the Agency, to the Commission and to the Member
States any new information which might entail the variation of
the particulars or documents referred to in Articles 8(3), 10,
10a, 10b and 11 of Directive 2001/83/EC, in Annex I thereto,
or in Article 9(4) of this Regulation.

forthwith inform the Agency,

In particular, he shall
the
Commission and the Member States of any prohibition or
restriction imposed by the competent authorities of any
country in which the medicinal product for human use is
marketed and of any other new information which might
influence the evaluation of
the
medicinal product for human use concerned.

the benefits and risks of

In order that the risk-benefit balance may be continuously
assessed, the Agency may at any time ask the holder of the
marketing authorisation to forward data demonstrating that the
risk-benefit balance remains favourable.

If the holder of the authorisation for a medicinal product
3.
for human use proposes
the
particulars and documents referred to in paragraph 2, he
shall submit the relevant application to the Agency.

to make any variation of

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The Commission shall, after consulting the Agency, adopt
4.
appropriate provisions for the examination of variations to
marketing authorisations
in the form of a regulation in
accordance with the procedure referred to in Article 87(2).

Article 17

The applicant or the holder of a marketing authorisation shall
be responsible for the accuracy of the documents and of the
data submitted.

Article 18

In the case of medicinal products for human use manu-
1.
factured within the Community, the supervisory authorities
shall be the competent authorities of the Member State or
Member States which granted the manufacturing authorisation
provided for in Article 40(1) of Directive 2001/83/EC in
respect of the medicinal product concerned.

2.
In the case of medicinal products imported from third
countries, the supervisory authorities shall be the competent
authorities of the Member State or Member States that granted
the authorisation provided for in Article 40(3) of Directive
2001/83/EC to the importer, unless appropriate agreements
have been made between the Community and the exporting
country to ensure that those controls are carried out in the
exporting country and that the manufacturer applies standards
of good manufacturing practice at least equivalent to those laid
down by the Community.

A Member State may request assistance from another Member
State or from the Agency.

Article 19

The supervisory authorities

shall be responsible for
1.
verifying on behalf of the Community that the holder of the
marketing authorisation for the medicinal product for human
use or the manufacturer or importer established within the
Community satisfies the requirements laid down in Titles IV,
IX and XI of Directive 2001/83/EC.

2. Where,
in accordance with Article 122 of Directive
2001/83/EC, the Commission is informed of serious differences
of opinion between Member States as to whether the holder of
the marketing authorisation for the medicinal product
for
human use or a manufacturer or importer established within
the Community satisfies
referred to in
paragraph 1,
the Commission may, after consultation with
the Member States concerned, request an inspector from the
supervisory authority to undertake a new inspection of the
marketing authorisation holder,
the
importer; the inspector in question shall be accompanied by
two inspectors from Member States which are not party to the
dispute or by two experts nominated by the Committee for
Medicinal Products for Human Use.

the manufacturer or

the requirements

The inspection shall be undertaken by inspectors from the
Member States who possess the appropriate qualifications;
they may be
expert
appointed by the said Committee. The report of the inspectors
shall be made available to the Commission, the Member States
and the said Committee.

accompanied by a

rapporteur or

Article 20

1. Where the supervisory authorities or the competent auth-
orities of any other Member State are of the opinion that the
manufacturer or importer established within the Community
territory is no longer fulfilling the obligations laid down in
Title IV of Directive 2001/83/EC, they shall forthwith inform
the Committee for Medicinal Products for Human Use and the
Commission, stating their reasons in detail and indicating the
course of action proposed.

shall

same

apply where

a Member State or

the
The
Commission considers that one of the measures envisaged in
Titles IX and XI of Directive 2001/83/EC should be applied in
respect of the medicinal product concerned or where the said
Committee has delivered an opinion to that
in
accordance with Article 5 of this Regulation.

effect

the matter,

2.
The Commission shall request the opinion of the Agency
within a time-limit which it shall determine in the light of the
urgency of
to examine the reasons
in order
the author-
advanced. Whenever practicable,
isation for placing the medicinal product for human use on
the market shall be invited to provide oral or written expla-
nations.

the holder of

3.
Following an opinion by the Agency, the Commission
shall adopt the necessary provisional measures, which shall
be applied immediately.

A final decision shall be adopted within six months,
accordance with the procedure referred to in Article 87(3).

in

4. Where urgent action is essential to protect human health
or the environment, a Member State may, on its own initiative
or at the Commission's request, suspend the use in its territory
of a medicinal product for human use which has been auth-
orised in accordance with this Regulation.

When it does so on its own initiative,
inform the
Commission and the Agency of the reasons for its action at
the latest on the next working day following the suspension.
inform the other Member States without
The Agency shall
delay. The Commission shall
the
immediately
procedure provided for in paragraphs 2 and 3.

it shall

initiate

case,

In this

the Member State

that
5.
health-care professionals are rapidly informed of
its action
and the reasons for the action. Networks set up by professional
associations may be used to this effect. The Member States
shall
inform the Commission and the Agency of actions
taken for this purpose.

ensure

shall

Subject

3.
to any agreements which may have been
concluded between the Community and third countries in
accordance with Article 18(2),
the Commission may,
following a reasoned request from a Member State or from
the said Committee, or on its own initiative, require a manu-
facturer established in a third country to submit
to an
inspection.

6.
The suspensive measures referred to in paragraph 4 may
be maintained in force until such time as a definitive decision
has been reached in accordance with the procedure referred to
in Article 87(3).

The Agency shall, upon request,

7.
concerned of the final decision.

inform any person

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C h a p t e r 3

Pharmacovigilance

Article 21

For the purposes of this Chapter, Article 106(2) of Directive
2001/83/EC shall apply.

Article 22

The Agency, acting in close cooperation with the national
pharmacovigilance systems established in accordance with
Article 102 of Directive 2001/83/EC, shall receive all relevant
information concerning
to
suspected
medicinal products for human use which have been authorised
by the Community in accordance with this Regulation. Where
appropriate, the Committee for Medicinal Products for Human
Use shall, in accordance with Article 5 of this Regulation, draw
up opinions on the measures necessary.

reactions

adverse

These measures may include amendments to the marketing
authorisation granted in accordance with Article 10. They
shall be adopted in accordance with the procedure referred
to in Article 87(3).

The holder of the marketing authorisation and the competent
authorities of Member States shall ensure that all relevant
information concerning suspected adverse reactions to the
medicinal products authorised under
this Regulation are
brought to the attention of the Agency in accordance with
the provisions of this Regulation. Patients shall be encouraged
to
health-care
adverse
professionals.

communicate

reaction

any

to

Article 23

The holder of an authorisation for a medicinal product for
human use granted in accordance with the provisions of this
Regulation shall have permanently and continuously at his
disposal an appropriately qualified person responsible for phar-
macovigilance.

That qualified person shall reside in the Community and shall
be responsible for the following:

(a) establishing and managing a system which ensures that
information concerning all
suspected adverse reactions
which are reported to the personnel of the company and
is collected, evaluated and
to medical
collated so that
it may be accessed at a single point
within the Community;

representatives

(b) preparing the reports referred to in Article 24(3) for the
the Member States and the
competent authorities of
Agency in accordance with the requirements of this Regu-
lation;

(c) ensuring that any request from the competent authorities
for the provision of additional
information necessary for
the evaluation of the risks and benefits of a medicinal
product
including the
provision of information regarding the volume of sales or
prescriptions for the medicinal product concerned;

is answered fully and promptly,

(d) providing the

competent

authorities with any other
information relevant
to the evaluation of the risks and
benefits of a medicinal product, particularly information
concerning post-authorisation safety studies.

Article 24

reactions

1.
The holder of the marketing authorisation for a medicinal
product for human use shall ensure that all suspected serious
adverse
to a medicinal product authorised in
accordance with this Regulation occurring within the
Community which a health-care professional brings to his
attention are recorded and reported promptly to Member
States within the territory of which the incident occurred,
and no later
the
information.

than 15 days following the receipt of

The holder of the marketing authorisation shall record any
other suspected serious adverse reactions occurring within
the Community, in accordance with the guide referred to in
Article 26, of which he may reasonably be expected to be
aware, and promptly notify the competent authority of
incident
in the
Member States
occurred and the Agency, and no later
than 15 days
following receipt of the information.

territory of which the

2.
The holder of the marketing authorisation for a medicinal
product for human use shall ensure that all suspected serious
unexpected adverse reactions and any suspected transmission
via a medicinal product of any infectious agent occurring in
the territory of a third country are reported promptly to
Member States and the Agency, and no later than 15 days
following receipt of the information. The provisions for the
reporting of suspected unexpected adverse reactions which
are not serious, whether occurring in the Community or in a
third country,
shall be adopted in accordance with the
procedure referred to in Article 87(2).

Save in exceptional circumstances,
these reactions shall be
transmitted electronically in the form of a report and in
accordance with the guide referred to in Article 26.

3.
The holder of the marketing authorisation for a medicinal
product for human use shall maintain detailed records of all
suspected adverse reactions within or outside the Community
which are reported to him by a health-care professional.

the granting of

Unless other requirements have been laid down as a condition
for
the marketing authorisation by the
Community, these records shall be submitted, in the form of
a periodic safety update report, to the Agency and Member
States immediately upon request or at least every six months
during the first two years following authorisation and once a
year for the following two years. Thereafter, the reports shall
be submitted at three-yearly intervals, or immediately upon
request.

These reports shall be accompanied by a scientific evaluation,
particularly of
the medicinal
the risk-benefit balance of
product.

4.
The Commission may lay down provisions to amend
paragraph 3 in view of experience gained with its operation.
The Commission shall adopt any such provisions in accordance
with the procedure referred to in Article 87(2).

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information relating

The holder of a marketing authorisation may not
5.
communicate
to pharmacovigilance
concerns to the general public in relation to its authorised
medicinal product without giving prior or simultaneous notifi-
cation to the Agency.

In any case, the marketing authorisation holder shall ensure
that such information is presented objectively and is not
misleading.

Member States shall take the necessary measures to ensure that
a marketing authorisation holder who fails to discharge these
obligations is subject to effective, proportionate and dissuasive
penalties.

Article 25

reactions occurring within their

Each Member State shall ensure that all suspected serious
territory to a
adverse
medicinal product for human use authorised in accordance
with this Regulation which are brought to their attention are
recorded and reported promptly to the Agency and the
marketing authorisation holder, and no later than 15 days
following receipt of the information.

The Agency shall forward the information to the national phar-
macovigilance systems set up in accordance with Article 102
of Directive 2001/83/EC.

Article 26

The Commission,
in consultation with the Agency, Member
States and interested parties, shall draw up a guide on the
collection, verification and presentation of adverse-reaction
reports. This guide shall contain, in particular, for the benefit
of health-care professionals, recommendations concerning the
communication of information on adverse reactions.

In accordance with this guide, holders of marketing authoris-
ations shall use the medical terminology accepted at inter-
national level for the transmission of adverse-reaction reports.

transmission

in consultation with Member States and the
The Agency,
Commission, shall set up a data-processing network for the
rapid
competent
Community authorities in the event of an alert relating to
faulty manufacture, serious adverse reactions and other phar-
macovigilance data regarding medicinal products authorised in
accordance with Article 6 of Directive 2001/83/EC.

information

the

to

of

For a period of five years following the initial placing on the
market in the Community, the Agency may request that the
marketing authorisation holder arrange for
specific phar-
macovigilance data to be collected from targeted groups of
patients. The Agency shall state the reasons for the request.
The marketing authorisation holder shall collate and assess the
data collected and submit it to the Agency for evaluation.

Article 27

The Agency shall collaborate with the World Health Organi-
sation in matters of international pharmacovigilance and shall
take the necessary steps to submit to it, promptly, appropriate
and adequate information regarding the measures taken in the
Community which may have a bearing on public health
protection in third countries; it shall send a copy thereof to
the Commission and the Member States.

Article 28

The Agency and Member States' competent authorities shall
cooperate to continuously develop pharmacovigilance systems
capable of achieving high standards of public health protection
for all medicinal products, regardless of routes of authorisation,
including the use of collaborative approaches, to maximise use
of resources available within the Community.

Article 29

Any amendment which may be necessary to update the
provisions of this Chapter in order to take account of scientific
and technical progress shall be adopted in accordance with the
procedure referred to in Article 87(2).

AUTHORISATION AND SUPERVISION OF VETERINARY MEDICINAL PRODUCTS

TITLE III

C h a p t e r 1

Submission and examination of applications — Authoris-
ations

Article 30

1.
A Committee for Medicinal Products for Veterinary Use is
hereby established. The Committee shall be part of the Agency.

Community procedure for the establishment of maximum
residue limits of veterinary medicinal products in foodstuffs
of animal origin (1),
the Committee for Medicinal Products
for Veterinary Use shall be responsible for drawing up the
the Agency on any question concerning the
opinion of
admissibility of
submitted in accordance with the
centralised procedure, the granting, variation, suspension or
revocation of an authorisation to place a veterinary medicinal
product on the market arising in accordance with the
provisions of this Title, and pharmacovigilance.

files

2. Without prejudice to Article 56 and other tasks which
Community law may confer on it, in particular under Council
Regulation (EEC) No 2377/90 of 26 June 1990 laying down a

(1) OJ L 224, 18.8.1990, p. 1. Regulation as last amended by
L 275,

Commission Regulation (EC) No 1873/2003 (OJ
25.10.2003, p. 9).

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At the request of the Executive Director of the Agency or
3.
the Commission representative, the Committee for Medicinal
Products for Veterinary Use shall also draw up opinions on any
scientific matters concerning the evaluation of veterinary
medicinal products. The Committee shall take due account of
any requests from Member States for an opinion.

Article 31

Each application for the authorisation of a medicinal
1.
product for veterinary use shall specifically and exhaustively
referred to in
include the particulars and documents as
Articles 12(3), 13, 13a, 13b and 14 of, and Annex I
to,
Directive 2001/82/EC. These particulars and documents shall
take account of the unique, Community nature of the author-
isation requested and, otherwise than in exceptional cases
relating to the application of the law on trade marks, shall
include the use of a single name for the medicinal product.

The application shall be accompanied by the fee payable to the
Agency for the examination of the application.

2.
In the case of a veterinary medicinal product containing
or consisting of genetically modified organisms within the
meaning of Article 2 of Directive 2001/18/EC, the application
shall also be accompanied by:

(a) a copy of the written consent of the competent authorities
to the deliberate release into the environment of
the
genetically modified organisms for research and devel-
opment purposes, as provided for in Part B of Directive
2001/18/EC or in Part B of Directive 90/220/EEC;

(b) the complete technical

required
2001/18/EC;

under Annexes

file supplying the information
IV to Directive

and

III

(c) the environmental risk assessment in accordance with the
principles set out in Annex II to Directive 2001/18/EC; and

(d) the results of any investigations performed for the purposes

of research or development.

Articles 13 to 24 of Directive 2001/18/EC shall not apply to
veterinary medicinal products containing or consisting of
genetically modified organisms.

The Agency shall ensure that

3.
the
Committee for Medicinal Products for Veterinary Use is given
within 210 days after the receipt of a valid application.

the opinion of

In the case of a veterinary medicinal product containing or
consisting of genetically modified organisms, the opinion of
the said Committee must respect
the environmental safety
requirements laid down by Directive 2001/18/EC. During the
process of evaluating applications for marketing authorisations
for veterinary medicinal products containing or consisting of
genetically modified organisms, necessary consultations shall be
held by the rapporteur with the bodies
set up by the
Community or
in accordance with
Directive 2001/18/EC.

the Member States

4.
The Commission shall, in consultation with the Agency,
Member States and interested parties, draw up a detailed guide
regarding the form in which applications for authorisation are
to be presented.

Article 32

In order

1.
Medicinal Products for Veterinary Use:

to prepare its opinion,

the Committee for

(a) shall verify that the particulars and documents submitted in
accordance with Article 31 comply with the requirements
of Directive 2001/82/EC and examine whether
the
conditions specified in this Regulation for granting a
marketing authorisation are satisfied;

(b) may request that an Official Medicines Control Laboratory
or a laboratory that a Member State has designated for that
purpose test the veterinary medicinal product, its starting
materials and, where appropriate, its intermediate products
or other constituent materials in order to ensure that the
control methods employed by the manufacturer and
described in the application are satisfactory;

that

laboratory

(c) may request a Community reference laboratory, Official
Medicines Control Laboratory or
a
Member State has designated for that purpose to verify,
using samples provided by the applicant, that the analytical
detection method proposed by the applicant
the
purposes of Article 12(3)(j), second indent, of Directive
2001/82/EC is satisfactory and is suitable for use to
the presence of residue levels, particularly those
reveal
above
accepted by the
the maximum residue
Community in accordance with the provisions of Regu-
lation (EEC) No 2377/90;

level

for

(d) may request the applicant to supplement the particulars
accompanying the application within a specific time-limit.
Where the said Committee avails itself of this option, the
time-limit laid down in Article 31(3), first subparagraph
shall be suspended until such time as the supplementary
information requested has been provided. Likewise,
the
time-limit shall be suspended for the time allowed to the
applicant to prepare oral or written explanations.

2.
In those cases where the analytical method has not been
subject to verification by one of the abovementioned labora-
tories under the procedures established by Regulation (EEC)
No 2377/90, the verification shall be carried out within the
framework of this Article.

Article 33

1.
Upon receipt of a written request from the Committee for
Medicinal Products for Veterinary Use, a Member State shall
forward the information establishing that the manufacturer of a
veterinary medicinal product or the importer from a third
country is able to manufacture the veterinary medicinal
product concerned and/or carry out
the necessary control
tests
in accordance with the particulars and documents
supplied pursuant to Article 31.

2. Where it considers it necessary in order to complete its
examination of
the said Committee may
require the applicant to undergo a specific inspection of the
manufacturing site of
the veterinary medicinal product
concerned. Such inspections may be made unannounced.

the application,

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The inspection, which shall be completed within the time-limit
subparagraph,
referred to in Article 31(3),
shall be
from the Member State who
undertaken by inspectors
possess the appropriate qualifications;
they may be accom-
panied by a rapporteur or expert appointed by the said
Committee.

first

(d) details of any recommended conditions or restrictions with
the medicinal

regard to the safe and effective use of
product;

(e)

the draft text of the labelling and package leaflet proposed
by the applicant, presented in accordance with Title V of
Directive 2001/82/EC;

Article 34

(f)

the assessment report.

The Agency shall forthwith inform the applicant if the
for

for Medicinal Products

the Committee

1.
opinion of
Veterinary Use is that:

(a) the application does not satisfy the criteria for author-

isation set out in this Regulation;

(b) the summary of

the product characteristics should be

amended;

(c) the labelling or package leaflet of the product is not in

compliance with Title V of Directive 2001/82/EC;

(d) the

authorisation should be granted subject

to the

conditions provided for in Article 39(7).

2. Within 15 days after receipt of the opinion referred to in
paragraph 1, the applicant may provide written notice to the
Agency that he wishes to request a re-examination of the
forward to the
opinion.
Agency the detailed grounds for the request within 60 days
after receipt of the opinion.

In that case the applicant shall

Within 60 days after receipt of the grounds for the request, the
said Committee shall re-examine its opinion in accordance with
the conditions laid down in Article 62(1), fourth subparagraph.
The reasons for the conclusion reached shall be annexed to the
final opinion.

the Agency shall
3. Within 15 days after its adoption,
forward the final opinion of
the said Committee to the
Commission, to Member States and to the applicant, together
with a report describing the assessment of
the veterinary
medicinal product by the Committee and stating the reasons
for its conclusions.

4.
If an opinion is favourable to the granting of the relevant
authorisation to place the relevant veterinary medicinal product
on the market, the following documents shall be annexed to
the opinion:

(a) a draft summary of the product characteristics, as referred
to in Article 14 of Directive 2001/82/EC; where appro-
priate, this draft shall reflect differences in the veterinary
conditions in the Member States;

(b) in the case of a veterinary medicinal product intended for
administration to food-producing animals, a statement of
the maximum residue level which may be accepted by the
Community
(EEC)
No 2377/90;

accordance with Regulation

in

(c) details of any conditions or restrictions which should be
imposed on the supply or use of the veterinary medicinal
product concerned, including the conditions under which
the veterinary medicinal product may be made available to
users, in conformity with the criteria laid down in Directive
2001/82/EC;

Article 35

1. Within 15 days after receipt of the opinion referred to in
Article 30(2), the Commission shall prepare a draft of the
decision to be taken in respect of the application.

Where a draft decision envisages the granting of marketing
include or make reference to the
authorisation,
documents mentioned in Article 34(4)(a) to (e).

shall

it

Where the draft decision is not in accordance with the opinion
of the Agency, the Commission shall annex a detailed expla-
nation of the reasons for the differences.

The draft decision shall be forwarded to Member States and the
applicant.

The Commission shall take a final decision in accordance
the procedure

2.
with, and within 15 days after the end of,
referred to in Article 87(3).

The

Standing Committee

for Veterinary Medicinal
3.
Products referred to in Article 87(1) shall adjust its rules of
procedure so as to take account of the tasks assigned to it by
this Regulation.

The adjustments shall provide that:

(a) the opinion of the said Standing Committee is to be given

in writing;

(b) Member States shall have 22 days to forward their written
observations on the draft decision to the Commission;
however, if a decision has to be taken urgently, a shorter
time-limit may be set by the Chairman according to the
degree of urgency involved. This time-limit shall not,
otherwise than in exceptional circumstances, be shorter
than 5 days;

(c) Member States may request

the draft
decision referred to in paragraph 1 be discussed at a
plenary meeting of the said Standing Committee, stating
their reasons in detail.

in writing that

in the opinion of the Commission, the written
4. Where,
observations of a Member State raise important new questions
technical nature which have not been
of a scientific or
addressed in the opinion delivered by the Agency,
the
Chairman shall suspend the procedure and refer the application
back to the Agency for further consideration.

The provisions necessary for

5.
paragraph 4 shall be
accordance with the procedure referred to in Article 87(2).

the implementation of
adopted by the Commission in

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The Agency shall disseminate the documents referred to

6.
in Article 34(4)(a) to (e).

Authorised veterinary medicinal products shall be entered in
the Community Register of Medicinal Products and shall be
given a number which shall appear on the packaging.

Article 36

If an applicant withdraws an application for a marketing auth-
orisation submitted to the Agency before an opinion has been
given on the application, the applicant shall communicate its
reasons for doing so to the Agency. The Agency shall make
this information publicly accessible and shall publish the
assessment report, if available, after deletion of all information
of a commercially confidential nature.

Article 37

The marketing authorisation shall be refused if, after
the particulars and documents submitted in

1.
verification of
accordance with Article 31, it appears that:

(a) the applicant has not properly or sufficiently demonstrated
the quality, safety or efficacy of the veterinary medicinal
product;

(b) in the case of zootechnical veterinary medicinal products
and performance enhancers, when the safety and welfare of
safety have not been
the animals and/or
sufficiently taken into account;

consumer

(c) the withdrawal period recommended by the applicant is
not long enough to ensure that foodstuffs obtained from
treated animals do not contain residues which might
constitute a health hazard for the consumer or is insuf-
ficiently substantiated;

(d) the veterinary medicinal product is presented for a use

prohibited under other Community provisions.

likewise be refused if particulars or
Authorisation shall
in accordance with
documents provided by the applicant
Article 31 are incorrect or
the labelling and package
if
leaflets proposed by the applicant are not in accordance with
Title V of Directive 2001/82/EC.

2.
The refusal of a Community marketing authorisation shall
constitute a prohibition on the placing on the market of the
veterinary medicinal product
the
Community.

concerned throughout

Information about all refusals and the reasons for them

3.
shall be made publicly accessible.

Article 38

1. Without prejudice to Article 71 of Directive 2001/82/EC,
a marketing authorisation which has been granted in
accordance with this Regulation shall be valid throughout the
Community. It shall confer the same rights and obligations in
each of
the Member States as a marketing authorisation
granted by that Member State in accordance with Article 5
of Directive 2001/82/EC.

Journal of

Notification of marketing authorisation shall be published
2.
in the Official
the European Union, quoting in
particular the date of authorisation and the number in the
Community Register, any International Non-proprietary Name
(INN) of the active substance of the medicinal product,
its
any Anatomical Therapeutic
pharmaceutical
Chemical Veterinary Code (ATC Vet Code).

form,

and

The Agency shall

3.
immediately publish the assessment
report on the veterinary medicinal product drawn up by the
Committee for Medicinal Products for Veterinary Use and the
reasons for its opinion in favour of granting authorisation, after
deletion of any information of a commercially confidential
nature.

The European Public Assessment Report (EPAR) shall include a
summary written in a manner that is understandable to the
public. The summary shall contain in particular a section
relating to the conditions of use of the medicinal product.

After a marketing authorisation has been granted, the
4.
inform the Agency of the
holder of the authorisation shall
dates of actual placing on the market of
the veterinary
medicinal product in Member States, taking into account the
various presentations authorised.

The holder shall also notify the Agency if the product ceases to
be placed on the market, either temporarily or permanently.
than in exceptional circum-
Such notification shall, other
stances, be made no less than two months before the inter-
ruption in the placing of the product on the market.

Upon request by the Agency, particularly in the context of
pharmacovigilance,
the marketing authorisation holder shall
provide the Agency with all data relating to the volume of
sales of the medicinal product at Community level, broken
down by Member State, and any data in the holder's possession
relating to the volume of prescriptions.

Article 39

1. Without prejudice to paragraphs 4 and 5, a marketing
authorisation shall be valid for five years.

2.
The marketing authorisation may be renewed after five
years on the basis of a re-evaluation by the Agency of the
risk-benefit balance.

To this end, the marketing authorisation holder shall provide
the Agency with a consolidated version of the file in respect of
quality, safety and efficacy, including all variations introduced
since the marketing authorisation was granted, at
least six
months before the marketing authorisation ceases to be valid
in accordance with paragraph 1.

3.
Once renewed, the marketing authorisation shall be valid
for an unlimited period, unless the Commission decides, on
justified grounds relating to pharmacovigilance,
to proceed
with one additional
in accordance with
paragraph 2.

five-year

renewal

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Any authorisation which is not followed by the actual
4.
placing of the medicinal product for veterinary use on the
Community market within three years after authorisation
shall cease to be valid.

5. When an authorised medicinal product previously placed
on the market is no longer actually present on the market for
three consecutive years, the authorisation shall cease to be
valid.

6.
In exceptional circumstances and on public and/or animal
health grounds the Commission may grant exemptions from
the provisions of paragraphs 4 and 5. Such exemptions must
be duly justified.

7.
In exceptional circumstances and following consultation
with the applicant, authorisation may be granted subject to a
requirement for the applicant to introduce specific procedures,
in particular concerning product safety, notification to the
relevant authorities of any incident relating to its use, and
action to be taken. This authorisation may be granted only
for objective, verifiable reasons. Continuation of the author-
isation shall be linked to the annual reassessment of these
conditions.

8. When an application is submitted for a marketing auth-
orisation in respect of veterinary medicinal products of major
interest, particularly from the point of view of animal health
and from the viewpoint of
the
applicant may request an accelerated assessment procedure.
The request shall be duly substantiated.

innovation,

therapeutic

If the Committee for Medicinal Products for Veterinary Use
accepts the request, the time-limit laid down in Article 31(3),
first subparagraph, shall be reduced to 150 days.

9. When adopting its opinion,
include
for
concerning
prescription or use of the veterinary medicinal products.

the said Committee shall
the
the

a proposal

conditions

10.
Veterinary medicinal products which have been auth-
orised in accordance with the provisions of this Regulation
shall benefit from the provisions on protection in Articles 13
and 13a of Directive 2001/82/EC.

Article 40

the civil or
The granting of authorisation shall not affect
criminal
liability of the manufacturer or the holder of the
marketing authorisation pursuant to the applicable national
law in Member States.

in Article 12(3)(d)

shall, in respect of the methods of manufacture and control
provided for
and (i) of Directive
2001/82/EC, take account of technical and scientific progress
and make any variations that may be required to enable the
medicinal products to be manufactured and checked by means
of generally accepted scientific methods. He shall apply for
approval of these variations in accordance with this Regulation.

The competent authority of a Member State or the
2.
Agency may require the holder of the marketing authorisation
to provide
the
performance of tests to detect the presence of residues of the
veterinary medicinal products concerned in foodstuffs of
animal origin.

in sufficient

substances

quantities

for

3.
At the request of the competent authority of a Member
State or the Agency, the holder of the marketing authorisation
shall provide technical expertise to facilitate the implemen-
tation of
the analytical method for detecting residues of
veterinary medicinal products by the Community reference
laboratory or, where appropriate, national reference labora-
tories designated in accordance with Council Directive
96/23/EC of 29 April 1996 on measures to monitor certain
substances and residues thereof
in live animals and animal
products and repealing Directives 85/358/EEC and 86/469/EEC
and Decisions 89/187/EEC and 91/664/EEC (1).

4.
The holder of the marketing authorisation shall forthwith
supply to the Agency, the Commission and the Member States
any new information which might entail the variation of the
particulars or documents referred to in Articles 12(3), 13, 13a,
13b and 14 of Directive 2001/82/EC, in Annex I thereto, or in
Article 34(4) of this Regulation.

He shall forthwith inform the Agency, the Commission and the
Member States of any prohibition or restriction imposed by the
competent authorities of any country in which the veterinary
is marketed and of any other new
medicinal product
the
influence the evaluation of
information which might
benefits
the veterinary medicinal product
concerned.

and risks of

In order that the risk-benefit balance may be continuously
assessed, the Agency may at any time ask the holder of the
marketing authorisation to forward data justifying that the risk-
benefit balance remains favourable.

If

the holder of

5.
the marketing authorisation for the
veterinary medicinal product proposes to make any variation
of the particulars and documents referred to in paragraph 4, he
shall submit the relevant application to the Agency.

C h a p t e r 2

Supervision and sanctions

Article 41

6.
The Commission shall, after consulting the Agency, adopt
appropriate provisions for the examination of variations to
in the form of a regulation in
marketing authorisations
accordance with the procedure referred to in Article 87(2).

1.
After an authorisation has been granted in accordance
with this Regulation, the holder of the marketing authorisation

(1) OJ L 125, 23.5.1996, p. 10. Directive as amended by Regulation

(EC) No 806/2003 (OJ L 122, 16.5.2003, p. 1).

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Article 42

The applicant or the holder of a marketing authorisation shall
be responsible for the accuracy of the documents and of the
data submitted.

Article 43

In the case of veterinary medicinal products manu-
1.
factured within the Community, the supervisory authorities
shall be the competent authorities of the Member State or
Member States which granted the manufacturing authorisation
provided for in Article 44(1) of Directive 2001/82/EC in
respect of the manufacture of the medicinal product concerned.

2.
In the case of veterinary medicinal products imported
from third countries, the supervisory authorities shall be the
competent authorities of the Member State or Member States
that granted the authorisation provided for in Article 44(3) of
Directive 2001/82/EC to the importer, unless appropriate
agreements have been made between the Community and the
exporting country to ensure that those controls are carried out
in the exporting country and that the manufacturer applies
standards of good manufacturing practice at least equivalent
to those laid down by the Community.

A Member State may request assistance from another Member
State or the Agency.

Article 44

The supervisory authorities

1.
shall be responsible for
verifying on behalf of the Community that the holder of the
marketing authorisation for the veterinary medicinal product or
the manufacturer
the
importer
Community satisfies the requirements laid down in Titles IV,
VII and VIII of Directive 2001/82/EC.

established within

or

2. Where,
in accordance with Article 90 of Directive
2001/82/EC, the Commission is informed of serious differences
of opinion between Member States as to whether the holder of
the marketing authorisation for
the veterinary medicinal
product or a manufacturer or importer established within the
Community satisfies the requirements referred to in paragraph
1, the Commission may, after consultation with the Member
States concerned, request an inspector from the supervisory
authority to undertake a new inspection of the holder of the
marketing authorisation, the manufacturer or the importer; the
inspector in question shall be accompanied by two inspectors
from Member States which are not party to the dispute and/or
by two experts nominated by the Committee for Medicinal
Products for Veterinary Use.

Subject

to any agreements which may have been
3.
concluded between the Community and third countries in
accordance with Article 43(2), the Commission may, upon
receipt of a reasoned request from a Member State or from
the said Committee, or on its own initiative, require a manu-
to an
facturer established in a third country to submit
inspection.

accompanied by a

expert
they may be
appointed by the said Committee. The report of the inspectors
shall be made available to the Commission, the Member States
and the said Committee.

rapporteur or

Article 45

1. Where the supervisory authorities or the competent auth-
orities of any other Member State are of the opinion that the
manufacturer or importer established within the Community is
no longer fulfilling the obligations laid down in Title VII of
Directive 2001/82/EC,
forthwith inform the
Committee for Medicinal Products for Veterinary Use and the
Commission, stating their reasons in detail and indicating the
course of action proposed.

shall

they

shall

same

apply where

a Member State or

The
the
Commission considers that one of the measures envisaged in
Title VIII of Directive 2001/82/EC should be applied in respect
of the veterinary medicinal product concerned or where the
said Committee has delivered an opinion to that effect
in
accordance with Article 30 of this Regulation.

2.
The Commission shall request the opinion of the Agency
within a time-limit which it shall determine in the light of the
urgency of
to examine the reasons
in order
advanced. Whenever practicable, the holder of the marketing
authorisation for the medicinal product shall be invited to
provide oral or written explanations.

the matter,

3.
Following an opinion by the Agency, the Commission
shall adopt the necessary provisional measures, which shall
be applied immediately.

A final decision shall be adopted within six months,
accordance with the procedure referred to in Article 87(3).

in

4. Where urgent action is essential to protect human or
animal health or the environment, a Member State may, on
its own initiative or at the Commission's request, suspend the
use on its territory of a veterinary medicinal product which has
been authorised in accordance with this Regulation.

When it does so on its own initiative, the Member State shall
inform the Commission and the Agency of the reasons for its
action at the latest on the next working day following the
inform the other Member
suspension. The Agency shall
States without delay. The Commission shall
immediately
initiate the procedure provided for in paragraphs 2 and 3.

case,

In this

the Member State

that
5.
health-care professionals are rapidly informed of
its action
and the reasons for the action. Networks set up by professional
associations may be used to this effect. Member States shall
inform the Commission and the Agency of actions taken for
this purpose.

ensure

shall

6.
The suspensive measures referred to in paragraph 4 may
be maintained until such time as a definitive decision has been
reached in accordance with the procedure referred to in Article
87(3).

The inspection shall be undertaken by inspectors from the
Member State who possess the appropriate qualifications;

The Agency shall, upon request,

7.
concerned of the final decision.

inform any person

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C h a p t e r 3

Pharmacovigilance

Article 46

For the purpose of this Chapter, Article 77(2) of Directive
2001/82/EEC shall apply.

Article 47

The Agency, acting in close cooperation with the national
pharmacovigilance systems established in accordance with
Article 73 of Directive 2001/82/EC, shall receive all relevant
information about suspected adverse reactions to veterinary
medicinal products which have been authorised by the
Community in accordance with this Regulation. Where appro-
priate the Committee for Medicinal Products for Veterinary Use
shall, in accordance with Article 30 of this Regulation, draw up
opinions on the measures necessary.

These measures may include amendments to the marketing
authorisation granted in accordance with Article 35. They
shall be adopted in accordance with the procedure referred
to in Article 87(3).

The holder of the marketing authorisation and the competent
authorities of
the Member States shall ensure all relevant
information about suspected adverse reactions to the veterinary
medicinal products authorised under this Regulation is brought
to the attention of
the Agency in accordance with the
provisions of this Regulation. Animal owners and breeders
shall be encouraged to communicate any adverse reaction to
health-care professionals or to the competent national auth-
orities responsible for pharmacovigilance.

Article 48

The holder of the marketing authorisation for a veterinary
medicinal product granted in accordance with the provisions
of this Regulation shall have permanently and continuously at
his disposal an appropriately qualified person responsible for
pharmacovigilance.

That qualified person shall reside in the Community and shall
be responsible for the following:

(a) establishing and managing a system which ensures that
information about all suspected adverse reactions which
are reported to the personnel of
the company and to
medical representatives is collected, evaluated and collated
so that it may be accessed at a single point within the
Community;

(b) preparing the reports referred to in Article 49(3) for the
the Member States and the
competent authorities of
Agency in accordance with the requirements of this Regu-
lation;

(c) ensuring that any request from the competent authorities
information necessary for
for the provision of additional
the evaluation of the risks and benefits of a veterinary
medicinal product
and promptly,
including the provision of information about the volume
of
the veterinary medicinal
for
product concerned;

sales or prescriptions

answered fully

is

(d) providing the

competent

authorities with any other
information relevant
to the evaluation of the risks and
benefits of a veterinary medicinal product, particularly
information concerning post-authorisation safety studies,
including information regarding the validity of the with-
drawal period or lack of expected efficacy or potential
environmental problems.

Article 49

The holder of

the marketing authorisation for

1.
a
veterinary medicinal product shall ensure that all suspected
serious adverse reactions, and adverse human reactions to a
veterinary medicinal product authorised in accordance with
the provisions of
this Regulation occurring within the
Community which a health-care professional brings to his
attention are recorded and reported promptly to the Member
States in the territory of which the incident occurred no later
than 15 days following receipt of the information.

The holder of the marketing authorisation shall record any
other suspected serious adverse reactions and human adverse
reactions occurring within the Community, in accordance with
the guidelines referred to in Article 51, of which he may
reasonably be expected to be aware, and promptly notify
Member States
incident
in the
occurred and the Agency, and no later
than 15 days
following receipt of the information.

territory of which the

The holder of

the marketing authorisation for

2.
a
veterinary medicinal product shall ensure that all suspected
serious unexpected adverse reactions, and adverse human
reactions, and any suspected transmission via a medicinal
product of any infectious agent occurring in the territory of
a third country are reported promptly to the Member States
and the Agency, and no later than 15 days following receipt of
the information. The provisions for the reporting of suspected
unexpected adverse reactions which are not serious, whether
occurring in the Community or in a third country, shall be
adopted in accordance with the procedure referred to in Article
87(2).

Save in exceptional circumstances,
these reactions shall be
transmitted electronically in the form of a report and in
accordance with the guide referred to in Article 51.

The holder of

the marketing authorisation for

3.
a
veterinary medicinal product shall maintain detailed records
of all suspected adverse reactions occurring within or outside
the Community which are reported to him.

the granting of

Unless other requirements have been laid down as a condition
for
the marketing authorisation by the
Community, these records shall be submitted, in the form of
a periodic safety update report, to the Agency and Member
States immediately upon request or at least every six months
during the first two years following authorisation and once a
year for the following two years. Thereafter, the reports shall
be submitted at three-yearly intervals, or immediately upon
request.

These reports shall be accompanied by a scientific evaluation,
particularly of
the medicinal
the risk-benefit balance of
product.

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The Commission may lay down provisions to amend
4.
paragraph 3 in view of experience gained with its operation.
The Commission shall adopt any such provisions in accordance
with the procedure referred to in Article 87(2).

information relating

The holder of a marketing authorisation may not
5.
communicate
to pharmacovigilance
concerns to the general public in relation to its authorised
medicinal product without giving prior or simultaneous notifi-
cation to the Agency.

In any case, the marketing authorisation holder shall ensure
that such information is presented objectively and is not
misleading.

Member States shall take the necessary measures to ensure that
a marketing authorisation holder who fails to discharge these
obligations is subject to effective, proportionate and dissuasive
penalties.

Article 50

Each Member State shall ensure that all suspected serious
adverse reactions, and adverse human reactions, occurring
within its territory to a veterinary medicinal product authorised
in accordance with the provisions of this Regulation which are
brought to its attention are recorded and reported promptly to
the Agency and the holder of the marketing authorisation for
the veterinary medicinal product, and no later than 15 days
following receipt of the information.

The Agency shall forward the information to the national phar-
macovigilance systems set up in accordance with Article 73 of
Directive 2001/82/EC.

Article 51

In accordance with this guide, holders of marketing authoris-
ations shall use the medical terminology accepted at inter-
national level for the transmission of adverse-reaction reports.

of

transmission

The Agency, in consultation with the Member States and the
Commission, shall set up a data-processing network for the
rapid
competent
data
Community authorities in the event of an alert relating to
faulty manufacture, serious adverse reactions and other phar-
macovigilance data regarding veterinary medicinal products
authorised in accordance with Article 5 of Directive
2001/82/EC.

between

the

For a period of five years following the initial placing on the
market in the Community, the Agency may request that the
marketing authorisation holder arrange for
specific phar-
macovigilance data to be collected from targeted groups of
animals. The Agency shall state the reasons for the request.
The marketing authorisation holder shall collate and assess
the data collected and submit it to the Agency for evaluation.

Article 52

The Agency shall cooperate with international organisations
concerned with veterinary pharmacovigilance.

Article 53

The Agency and the Member States' competent authorities shall
cooperate to continuously develop pharmacovigilance systems
capable of achieving high standards of public health protection
for all medicinal products, regardless of routes of authorisation,
including the use of collaborative approaches, to maximise use
of resources available within the Community.

in consultation with the Agency, Member
The Commission,
States and interested parties, shall draw up a guide on the
collection, verification and presentation of adverse-reaction
reports. This guide shall contain, in particular, for the benefit
of health-care professionals, recommendations concerning the
communication of information on adverse reactions.

Article 54

Any amendment which may be necessary to update the
provisions of this Chapter in order to take account of scientific
and technical progress shall be adopted in accordance with the
procedure referred to in Article 87(2).

THE EUROPEAN MEDICINES AGENCY — RESPONSIBILITIES AND ADMINISTRATIVE STRUCTURE

TITLE IV

C h a p t e r 1

Article 56

Tasks of the Agency

1.

The Agency shall comprise:

Article 55

A European Medicines Agency is hereby established.

(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;

The Agency shall be responsible for coordinating the existing
scientific resources put at its disposal by Member States for the
evaluation, supervision and pharmacovigilance of medicinal
products.

(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;

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(c) the Committee on Orphan Medicinal Products;

(d) the Committee on Herbal Medicinal Products;

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

administrative support
appropriate coordination between them;

for

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

bilities set out in Article 64;

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

bilities set out in Articles 65, 66 and 67.

2.
The committees referred to in paragraph 1(a) to (d) may
each establish standing and temporary working parties. The
committees
referred to in paragraph 1(a) and (b) may
establish scientific advisory groups in connection with the
evaluation of
types of medicinal products or
treatments, to which the committee concerned may delegate
certain tasks associated with drawing up the scientific opinions
referred to in Articles 5 and 30.

specific

When establishing working parties and scientific advisory
groups,
in their rules of procedures
the committees shall
referred to in Article 61(8) provide for:

(a) the appointment of members of these working parties and
scientific advisory groups on the basis of the lists of experts
referred to in the second subparagraph of Article 62(2);
and

(b) consultation of these working parties and scientific advisory

groups.

The Executive Director,

in close consultation with the
3.
Committee for Medicinal Products for Human Use and the
Committee for Medicinal Products for Veterinary Use, shall
set up the administrative structures and procedures allowing
the development of advice for undertakings, as referred to in
Article 57(1)(m), particularly regarding the development of new
therapies.

Each committee shall establish a standing working party with
the sole remit of providing scientific advice to undertakings.

4.
The Committee for Medicinal Products for Human Use
and the Committee for Medicinal Products for Veterinary Use
may,
seek guidance on
important questions of a general scientific or ethical nature.

it appropriate,

they consider

if

Article 57

The Agency shall provide the Member States and the
1.
institutions of the Community with the best possible scientific
advice on any question relating to the evaluation of the quality,
safety and efficacy of medicinal products
for human or
veterinary use which is referred to it in accordance with the
provisions of Community legislation relating to medicinal
products.

To this end,
committees, shall undertake the following tasks:

the Agency, acting particularly through its

(a)

(b)

(c)

coordination of the scientific evaluation of the quality,
safety and efficacy of medicinal products which are
subject to Community marketing authorisation procedures;

transmitting on request and making available assessment
reports, summaries of product characteristics,
labels and
package leaflets or inserts for these medicinal products;

coordination of the supervision, under practical conditions
of use, of medicinal products which have been authorised
within the Community and the provision of advice on the
measures necessary to ensure the safe and effective use of
these products, in particular by evaluation, coordination of
the implementation of pharmacovigilance obligations and
the monitoring of such implementation;

(d) ensuring the dissemination of

to medicinal products

information on adverse
authorised in the
reactions
Community, by means of
a database permanently
accessible to all Member States; health-care professionals,
marketing authorisation holders and the public shall have
appropriate levels of access
to these databases, with
personal data protection being guaranteed;

(e)

assisting Member States with the rapid communication of
information concerning pharmacovigilance to health-care
professionals.

(f)

distributing appropriate pharmacovigilance information to
the general public;

(g) advising on the maximum limits for residues of veterinary
medicinal products which may be accepted in foodstuffs of
animal origin in accordance with Regulation (EEC)
No 2377/90;

(h) coordinating the verification of compliance with the prin-
ciples of good manufacturing practice, good laboratory
practice, good clinical practice and the verification of
compliance with pharmacovigilance obligations;

(i)

(j)

upon request, providing technical and scientific support in
order to improve cooperation between the Community, its
international organisations and third
Member States,
countries on scientific and technical issues relating to the
evaluation of medicinal products,
in the
context of discussions organised in the framework of inter-
national conferences on harmonisation;

in particular

recording the status of marketing authorisations
medicinal
granted
Community procedures;

for
accordance with

products

in

(k) creating a database on medicinal products, to be accessible
to the general public, and giving technical assistance for its
maintenance; the information provided to the public shall
be worded in an appropriate and comprehensible manner;

(l)

assisting the Community and Member States
in the
provision of information to health-care professionals and
the general public about medicinal products evaluated by
the Agency;

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(m) advising undertakings on the conduct of the various tests
and trials necessary to demonstrate the quality, safety and
efficacy of medicinal products;

(n) checking that the conditions laid down in Community
legislation on medicinal products and in the marketing
case of parallel
authorisations
distribution
in
accordance with this Regulation;

are observed in the

of medicinal

authorised

products

(o) drawing up, at

the Commission's request, any other
scientific opinion concerning the evaluation of medicinal
products or the starting materials used in the manufacture
of medicinal products;

(p) with a view to the protection of public health, compilation
of scientific information concerning pathogenic agents
which might be used in biological warfare, including the
existence of vaccines
and other medicinal products
available to prevent, or to treat, the effects of such agents;

(q) coordination of the supervision of the quality of medicinal
products placed on the market by requesting testing of
compliance with their authorised specifications by an
Official Medicines Control Laboratory or by a laboratory
that a Member State has designated for that purpose;

(r)

forwarding annually to the budgetary authority any
to the outcome of the evaluation
information relevant
procedures.

The database provided for in paragraph 1(k) shall include
2.
the summaries of product characteristics, the patient or user
package leaflet and the information shown on the labelling.
The database shall be developed in stages, priority being
given to medicinal products authorised under this Regulation
and those authorised under Chapter 4 of Title III of Directive
2001/83/EC and of Directive 2001/82/EC respectively. The
database shall
subsequently be extended to include any
medicinal product placed on the market within the
Community.

Article 58

The Agency may give a scientific opinion, in the context
1.
of cooperation with the World Health Organisation, for the
evaluation of certain medicinal products
for human use
intended exclusively for markets outside the Community. For
this purpose, an application shall be submitted to the Agency
in accordance with the provisions of Article 6. The Committee
for Medicinal Products for Human Use may, after consulting
the World Health Organisation, draw up a scientific opinion in
accordance with Articles 6 to 9. The provisions of Article 10
shall not apply.

2.
The said Committee shall establish specific procedural
rules for the implementation of paragraph 1, as well as for
the provision of scientific advice.

Article 59

1.
The Agency shall take care to ensure early identification
of potential sources of conflict between its scientific opinions
and those of other bodies established under Community law
carrying out a similar task in relation to issues of common
concern.

source of
2. Where the Agency identifies a potential
conflict,
the body concerned in order to
ensure that any relevant scientific information is shared and
to identify the scientific points which potentially conflict.

it shall contact

3. Where there is a fundamental conflict over scientific
points and the body concerned is a Community agency or a
scientific committee, the Agency and the body concerned shall
work together either to resolve the conflict or to submit a joint
document to the Commission clarifying the scientific points of
conflict. This document shall be published immediately after its
adoption.

Save as otherwise provided in this Regulation,

in
4.
Directive 2001/83/EC or
in Directive 2001/82/EC, where
there is a fundamental conflict over scientific points and the
body concerned is a body in a Member State, the Agency and
the national body concerned shall work together either to
resolve the conflict or to prepare a joint document clarifying
the scientific points of conflict. This document
shall be
published immediately after its adoption.

Article 60

authorised medicinal products,

At the request of the Commission, the Agency shall, in respect
of
available
information on methods that Member States' competent auth-
orities use to determine the added therapeutic value that any
new medicinal product provides.

collect

any

Article 61

1.
Each Member State shall appoint, for a three-year term
which may be renewed, one member and one alternate to the
Committee for Medicinal Products for Human Use and one
member and one alternate to the Committee for Medicinal
Products for Veterinary Use.

The alternates shall represent and vote for the members in their
absence and may act as rapporteurs in accordance with Article
62.

Members and alternates shall be chosen for their role and
experience
for
human and veterinary use as appropriate and shall represent
the competent national authorities.

evaluation of medicinal products

in the

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The

five
committees may co-opt
2.
additional members chosen on the basis of
their specific
scientific competence. These members shall be appointed for
a term of three years, which may be renewed, and shall not
have alternates.

a maximum of

With a view to the co-opting of such members, the committees
shall identify the specific complementary scientific competence
of
shall be
chosen among experts nominated by Member States or the
Agency.

the additional member(s). Co-opted members

The members of each Committee may be accompanied

3.
by experts in specific scientific or technical fields.

4.
The Executive Director of the Agency or his represen-
tative and representatives of the Commission shall be entitled
to attend all meetings of the committees, working parties and
scientific advisory groups and all other meetings convened by
the Agency or its committees.

Article 62

1. Where, in accordance with the provisions of this Regu-
lation, the Committee for Medicinal Products for Human Use
or the Committee for Medicinal Products for Veterinary Use is
required to evaluate a medicinal product, it shall appoint one
of its members to act as rapporteur for the coordination of the
evaluation. The Committee concerned may appoint a second
member to act as co-rapporteur.

report(s) drawn up by the rapporteur or

When consulting the scientific advisory groups referred to in
Article 56(2), the Committee shall forward to them the draft
assessment
the
co-rapporteur. The opinion issued by the scientific advisory
group shall be forwarded to the chairman of
the relevant
Committee in such a way as to ensure that the deadlines laid
down in Article 6(3) and Article 31(3) are met.

The substance of
assessment report published pursuant
Article 38(3).

the opinion shall be included in the
to Article 13(3) and

In addition to their task of providing objective scientific
5.
opinions
to the Community and Member States on the
questions which are referred to them, the members of each
committee shall ensure that there is appropriate coordination
between the tasks of the Agency and the work of competent
bodies
national
concerned with the marketing authorisation.

consultative

authorities,

including

the

shall

6. Members of the committees and experts responsible for
rely on the scientific
evaluating medicinal products
evaluation and resources available to national marketing auth-
orisation bodies. Each competent national authority shall
monitor the scientific level and independence of the evaluation
carried out and facilitate the activities of nominated committee
members and experts. Member States shall refrain from giving
committee members and experts any instruction which is
incompatible with their own individual
tasks or with the
tasks and responsibilities of the Agency.

7. When preparing the opinion, each committee shall use its
best endeavours to reach a scientific consensus.
If such a
consensus cannot be reached, the opinion shall consist of the
position of the majority of members and divergent positions,
with the grounds on which they are based.

8.

Each committee shall establish its own rules of procedure.

These rules shall, in particular, lay down:

(a) procedures for appointing and replacing the Chairman;

(b) procedures

relating to working parties and scientific

advisory groups; and

(c) a procedure

adoption of opinions,
particularly in relation to the provisions of this Regulation
on market surveillance and pharmacovigilance.

the urgent

for

They shall enter into force after receiving a favourable opinion
from the Commission and the Management Board.

for

the

initial opinion. The

If there is a request for re-examination of one of its opinions,
the Committee concerned shall appoint a different rapporteur
and, where necessary, a different co-rapporteur from those
appointed
re-examination
the opinion
procedure may deal only with the points of
initially identified by the applicant and may be based only
on the scientific data available when the Committee adopted
the initial opinion. The applicant may request
the
Committee consult a scientific advisory group in connection
with the re-examination.

that

2. Member States shall transmit to the Agency the names of
national experts with proven experience in the evaluation of
medicinal products who would be available to serve on
working parties
the
Committee for Medicinal Products for Human Use or the
Committee
for Veterinary Use,
together with an indication of their qualifications and specific
areas of expertise.

for Medicinal

groups of

scientific

Products

advisory

or

The Agency shall keep an up-to-date list of accredited experts.
include the experts referred to in the first
The list shall
subparagraph and other experts appointed directly by the
Agency. The list shall be updated.

The provision of services by rapporteurs or experts shall
3.
be governed by a written contract between the Agency and the
person concerned, or where appropriate between the Agency
and his employer.

The person concerned, or his employer, shall be remunerated
in accordance with a scale of
fees to be included in the
financial arrangements established by the Management Board.

The performance of scientific services for which there are
4.
for an
several potential providers may result
expression of interest,
if the scientific and technical context
allows, and if it is compatible with the tasks of the Agency,
in particular to ensure a high level of public health protection.

in a call

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The Management Board shall adopt the appropriate procedures
on a proposal from the Executive Director.

(c)

for ensuring that the time-limits laid down in Community
legislation for the adoption of opinions by the Agency are
complied with;

5.
The Agency or any of the committees referred to in
the
Article 56(1) may use
discharge of other specific tasks for which they are responsible.

services of experts

the

for

Article 63

The membership of the committees referred to in Article
is
shall be made public. When each appointment
the professional qualifications of each member

1.
56(1)
published,
shall be specified.

the Management Board, members of

2. Members of
the
committees, rapporteurs and experts shall not have financial
or other interests in the pharmaceutical industry which could
affect their impartiality. They shall undertake to act in the
public interest and in an independent manner, and shall
make an annual declaration of their financial
interests. All
indirect interests which could relate to this industry shall be
entered in a register held by the Agency which is accessible to
the public, on request, at the Agency's offices.

The Agency's code of conduct shall provide for the implemen-
tation of this Article with particular reference to the acceptance
of gifts.

rapporteurs

and experts who participate

the Management Board, members of

the
Members of
committees,
in
meetings or working groups of the Agency shall declare, at
each meeting, any specific interests which could be considered
to be prejudicial to their independence with respect to the
shall be made
items on the agenda. These declarations
available to the public.

(d) for

ensuring

appropriate

coordination between

the

committees referred to in Article 56(1);

(e)

for the preparation of the draft statement of estimates of
the Agency's revenue and expenditure, and execution of its
budget;

(f)

for all staff matters;

(g) for providing the secretariat for the Management Board.

3.
Each year the Executive Director shall submit a draft
work programme for the coming year to the Management
approval, making a distinction between the
Board for
Agency's activities concerning medicinal products for human
use and those concerning veterinary medicinal products.

Article 65

1.
The Management Board shall consist of one represen-
tative of each Member State and four representatives of the
Commission.

2.
The members of
appointed on the basis of
management and,
medicinal products for human or veterinary use.

the Management Board shall be
in
relevant
if appropriate, experience in the field of

expertise

their

Each Member State and the Commission shall appoint
3.
the Management Board as well as an
their members of
alternate who will replace the member in his absence and
vote on his behalf.

Article 64

The term of office of the representatives shall be three

4.
years. The term of office may be renewed.

The Executive Director

1.
shall be appointed by the
Management Board, on a proposal from the Commission, for
a period of five years on the basis of a list of candidates
proposed by the Commission following a call for expressions
of interest published in the Official Journal of the European Union
and elsewhere. Before appointment, the candidate nominated
by the Management Board shall be invited forthwith to make a
statement
to the European Parliament and to answer any
questions put by its Members. His mandate may be renewed
once. The Management Board may, upon a proposal from the
Commission, remove the Executive Director from his post.

The Executive Director shall be the legal representative of

2.
the Agency. He shall be responsible:

(a)

for the day-to-day administration of the Agency;

(b) for managing all

the Agency resources necessary for
conducting the activities of the committees referred to in
Article 56(1),
appropriate
scientific and technical support;

including making available

The Management Board shall elect its Chairman from

5.
among its members.

The term of office of the Chairman shall be three years and
shall expire when he
the
Management Board. The term of office may be renewed once.

to be a member of

ceases

Decisions of the Management Board shall be adopted by a

6.
majority of two-thirds of its members.

7.

The Management Board shall adopt its rules of procedure.

8.
The Management Board may invite the chairmen of the
scientific committees to attend its meetings, but they shall not
have the right to vote.

9.
The Management Board shall approve the annual work
programme of the Agency programme and forward it to the
European Parliament, the Council, the Commission and the
Member States.

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The Management Board shall adopt the annual report
10.
on the Agency's activities and forward it by 15 June at the
latest
the
Commission, the European Economic and Social Committee,
the Court of Auditors and the Member States.

the Council,

Parliament,

European

the

to

Article 66

The Management Board shall:

The Agency's revenue shall consist of a contribution from
3.
the Community and fees paid by undertakings for obtaining
and maintaining Community marketing authorisations and for
other services provided by the Agency.

‘the budgetary authority’)

The European Parliament and the Council (hereinafter referred
to as
re-examine, when
necessary, the level of the Community contribution on the
basis of an evaluation of needs and taking account of the
level of fees.

shall

(a) adopt an opinion on the rules of procedures of

the
Committee for Medicinal Products for Human Use and
the Committee for Medicinal Products for Veterinary Use
(Article 61);

4.
Activities relating to pharmacovigilance, to the operation
of communications networks and to market surveillance shall
receive adequate public funding.

(b) adopt procedures for the performance of scientific services

(Article 62);

(c) appoint the Executive Director (Article 64);

5.
The expenditure of the Agency shall include staff remun-
eration, administrative and infrastructure costs, and operating
expenses; and expenses resulting from contracts entered into
with third parties.

(d) adopt the annual work programme and forward it to the
European Parliament, the Council, the Commission and the
Member States (Article 65);

(e) adopt the annual report on the Agency's activities and
to the European
forward it by 15 June at
Parliament,
the Commission, the European
Economic and Social Committee, the Court of Auditors
and the Member States (Article 65);

the Council,

the latest

(f) adopt the budget of the Agency (Article 67);

(g) adopt the internal financial provisions (Article 67);

(h) adopt provisions
(Article 75);

implementing the Staff Regulations

(i) develop contacts with stakeholders and stipulate

the

conditions applicable (Article 78);

(j) adopt provisions for providing assistance to pharmaceutical

companies (Article 79);

(k) adopt rules to ensure the availability to the public of
information concerning the authorisation or supervision
of medicinal products (Article 80).

C h a p t e r 2

Financial Provisions

Article 67

Estimates of all

the revenue and expenditure of

1.
the
Agency shall be prepared for each financial year, corresponding
to the calendar year, and shall be shown in the budget of the
Agency.

The revenue and expenditure shown in the budget shall

2.
be in balance.

6.
Each year the Management Board, on the basis of a draft
drawn up by the Executive Director, shall produce an estimate
of revenue and expenditure for the Agency for the following
financial year. This estimate, which shall include a draft estab-
lishment plan, shall be forwarded by the Management Board to
the Commission by 31 March at the latest.

7.
The estimate shall be forwarded by the Commission to
the budgetary authority together with the preliminary draft
general budget of the European Union.

8.
On the basis of the estimate, the Commission shall enter
in the preliminary draft general budget of the European Union
the estimates it deems necessary for the establishment plan and
the amount of the subsidy to be charged to the general budget,
which it
the budgetary authority in
shall place before
accordance with Article 272 of the Treaty.

The budgetary authority shall authorise the appro-

9.
priations for the subsidy to the Agency.

The budgetary authority shall adopt the establishment plan for
the Agency.

10.
The budget shall be adopted by the Management Board.
It shall become final following final adoption of the general
budget of the European Union. Where appropriate, it shall be
adjusted accordingly.

11.
Any modification of the establishment plan and of the
budget shall be the subject of an amending budget, which is
forwarded for the purposes of information to the budgetary
authority.

The Management Board shall, as soon as possible, notify
12.
the budgetary authority of
its intention to implement any
project which may have significant financial implications for
the funding of its budget, in particular any projects relating to
property such as the rental or purchase of buildings. It shall
inform the Commission thereof.

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Where a branch of the budgetary authority has notified its
intention to deliver an opinion,
it shall forward its opinion
to the Management Board within a period of six weeks from
the date of notification of the project.

Article 68

The Executive Director shall implement the budget of the

1.
Agency.

2.
By 1 March at the latest following each financial year, the
Agency's accounting officer shall communicate the provisional
accounts to the Commission's accounting officer together with
a report on the budgetary and financial management for that
financial year. The Commission's accounting officer
shall
consolidate the provisional accounts of the institutions and
decentralised bodies
in accordance with Article 128 of
Council Regulation (EC, Euratom) No 1605/2002 of 25 June
2002 on the Financial Regulation applicable to the general
budget of the European Communities (1) (hereinafter referred
to as the ‘general Financial Regulation’).

3.
By 31 March at the latest following each financial year,
the Commission's accounting officer shall submit the Agency's
provisional accounts to the Court of Auditors, together with a
report on the budgetary and financial management for that
financial year. The report on the budgetary and financial
management for the financial year shall also be forwarded to
the European Parliament and the Council.

On receipt of the Court of Auditors' observations on the
4.
Agency's provisional accounts, pursuant to Article 129 of the
general Financial Regulation, the Executive Director shall draw
up the Agency's final accounts under his own responsibility
and submit them to the Management Board for an opinion.

The Management Board of the Agency shall deliver an

5.
opinion on the Agency's final accounts.

The Executive Director shall, by 1 July at

the latest
6.
following each financial year, forward the final accounts to
the European Parliament, the Council, the Commission and
the Court of Auditors, together with the Management Board's
opinion.

7.

The final accounts shall be published.

The Agency's Executive Director shall send the Court of
8.
Auditors a reply to its observations by 30 September at the
latest. He shall also send this reply to the Management Board.

The Executive Director shall submit

to the European
9.
Parliament, at the latter's request, any information required
for the smooth application of
the discharge procedure for
the financial year in question, as laid down in Article 146(3)
of the general Financial Regulation.

10.
The European Parliament, on a recommendation from
the Council acting by a qualified majority, shall, before 30 April

of year N+2, give a discharge to the Executive Director in
respect of the implementation of the budget for year N.

The financial rules applicable to the Agency shall be
11.
adopted by the Management Board after the Commission has
been consulted. They may not depart from Commission Regu-
lation (EC, Euratom) No 2343/2002 of 19 November 2002 on
the framework Financial Regulation for the bodies referred to
Euratom)
in Article 185 of Council Regulation (EC,
No 1605/2002 on the Financial Regulation applicable to the
the European Communities (2), unless
general budget of
specifically required for the Agency's operation and with the
Commission's prior consent.

Article 69

In order to combat fraud, corruption and other unlawful
1.
activities the provisions of Regulation (EC) No 1073/1999 of
the European Parliament and of the Council of 25 May 1999
concerning
European
Anti-Fraud Office (OLAF) (3) shall apply without restriction.

investigations

conducted

the

by

shall

The Agency

2.
Interinstitutional
accede
Agreement of 25 May 1999 concerning internal investigations
issue,
by the European Anti-Fraud Office (OLAF) and shall
without delay, the appropriate provisions applicable to all the
employees of the Agency.

to the

Article 70

1.
The structure and the level of the fees referred to in
Article 67(3) shall be established by the Council acting under
the conditions provided for by the Treaty on a proposal from
the Commission, once the Commission has consulted organi-
sations
the pharmaceutical
industry at Community level.

representing the

interests of

2.
However, provisions shall be adopted in accordance with
the procedure referred to in Article 87(2), establishing the
circumstances in which small and medium-sized enterprises
may pay reduced fees, defer payment of the fee, or receive
administrative assistance.

C h a p t e r 3

General Provisions governing the Agency

Article 71

The Agency shall have legal personality. In all Member States it
shall enjoy the most extensive legal capacity accorded to legal
persons under their laws.
It may in particular acquire or
dispose of movable and immovable property and may be a
party to legal proceedings.

(1) OJ L 248, 16.9.2002, p. 1.

(2) OJ L 357, 31.12.2002, p. 72.
(3) OJ L 136, 31.5.1999, p. 1.

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Article 72

1.
The contractual liability of the Agency shall be governed
by the law applicable to the contract in question. The Court of
Justice of the European Communities shall have jurisdiction
to any arbitration clause contained in a contract
pursuant
concluded by the Agency.

2.
In the case of non-contractual liability, the Agency shall,
in accordance with the general principles common to the laws
of the Member States, make good any damage caused by it or
by its servants in the performance of their duties.

The Court of
relating to compensation for any such damage.

Justice shall have jurisdiction in any dispute

3.
The personal liability of its servants towards the Agency
shall be governed by the relevant rules applying to the staff of
the Agency.

Article 73

Regulation (EC) No 1049/2001 of the European Parliament and
of the Council of 30 May 2001 regarding public access to
European Parliament, Council and Commission documents (1)
shall apply to documents held by the Agency.

The Management Board shall adopt
the arrangements for
implementing Regulation (EC) No 1049/2001 within six
months of entry into force of this Regulation.

Decisions taken by the Agency pursuant to Article 8 of Regu-
lation (EC) No 1049/2001 may give rise to the lodging of a
complaint with the Ombudsman or form the subject of an
action before the Court of Justice, under the conditions laid
down in Articles 195 and 230 of the Treaty respectively.

even after their duties have ceased, not to disclose information
of the kind covered by the obligation of professional secrecy.

Article 77

in agreement with the Management
The Commission may,
invite representatives of
Board and the relevant committee,
in the harmon-
international organisations with an interest
isation of regulations applicable to medicinal products to
participate as observers in the work of
the Agency. The
conditions for participation shall be determined beforehand
by the Commission.

Article 78

in agreement with the
The Management Board shall,
1.
contacts between the
Commission, develop appropriate
Agency and the representatives of
the industry, consumers
and patients and the health professions. These contacts may
include the participation of observers in certain aspects of the
Agency's work, under conditions determined beforehand by the
Management Board, in agreement with the Commission.

The committees referred to in Article 56(1) and any
2.
working parties and scientific advisory groups established in
accordance with that Article shall in general matters establish
contacts, on an advisory basis, with parties concerned with the
use of medicinal products, in particular patient organisations
and
associations. Rapporteurs
appointed by these committees may, on an advisory basis,
establish contacts with representatives of patient organisations
and health-care professionals' associations relevant to the indi-
cation of the medicinal product concerned.

professionals'

health-care

Article 74

Article 79

The Protocol on the Privileges and Immunities of the European
Communities shall apply to the Agency.

Article 75

The staff of the Agency shall be subject to the rules and regu-
lations applicable to officials and other staff of the European
Communities. In respect of its staff, the Agency shall exercise
the powers which have been devolved to the appointing
authority.

The Management Board, in agreement with the Commission,
shall adopt the necessary implementing provisions.

Article 76

the Management Board, members of

the
Members of
committees referred to in Article 56(1), and experts and
officials and other servants of the Agency, shall be required,

(1) OJ L 145, 31.5.2001, p. 43.

The Management Board shall,
in the case of veterinary
medicinal products which have limited markets, or in the
case of veterinary medicinal products intended for diseases
with a regional distribution, adopt the necessary measures to
provide assistance to companies at the time of submission of
their applications.

Article 80

level of

transparency,

an appropriate

To ensure
the
Management Board, on the basis of a proposal by the
Executive Director and in agreement with the Commission,
shall adopt rules to ensure the availability to the public of
regulatory, scientific or technical
information concerning the
authorisation or supervision of medicinal products which is not
of a confidential nature.

rules

internal

The
its
committees and its working groups shall be made available
to the public at the Agency and on the Internet.

and procedures of

the Agency,

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TITLE V

GENERAL AND FINAL PROVISIONS

Article 81

a marketing

All decisions to grant, refuse, vary, suspend, withdraw or
1.
taken in
revoke
the
accordance with this Regulation shall
reasons on which they are based. Such decisions shall be
notified to the party concerned.

authorisation which are

state in detail

An authorisation to place a medicinal product governed
2.
by this Regulation on the market shall not be granted, refused,
varied, suspended, withdrawn or revoked except through the
procedures and on the grounds set out in this Regulation.

3. When a Member State makes use of
provided for in paragraph 1 it shall notify the Agency.

the possibility

4. When compassionate use is envisaged, the Committee for
Medicinal Products for Human Use, after consulting the manu-
the applicant, may adopt opinions on the
facturer or
conditions for use,
the conditions for distribution and the
patients targeted. The opinions shall be updated on a regular
basis.

5. Member States
opinions.

shall

take account of any available

Article 82

Only one authorisation may be granted to an applicant

1.
for a specific medicinal product.

6.
The Agency shall keep an up-to-date list of the opinions
adopted in accordance with paragraph 4, which shall be
published on its website. Article 24(1) and Article 25 shall
apply mutatis mutandis.

However, the Commission shall authorise the same applicant to
submit more than one application to the Agency for that
medicinal product when there are objective verifiable reasons
relating to public health regarding the availability of medicinal
products to health-care professionals and/or patients, or for
co-marketing reasons.

2.
As regards medicinal products for human use, Article
98(3) of Directive 2001/83/EC shall apply to medicinal
products authorised under this Regulation.

3. Without prejudice to the unique, Community nature of
the content of the documents referred to in Article 9(4)(a), (b),
(c) and (d) and in Article 34(4)(a) to (e), this Regulation shall
not prohibit the use of two or more commercial designs for a
given medicinal product covered by a single authorisation.

Article 83

1.
By way of exemption from Article 6 of Directive
2001/83/EC Member States may make a medicinal product
for human use belonging to the categories referred to in
Article 3(1) and (2) of this Regulation available for compas-
sionate use.

For the purposes of this Article, ‘compassionate use’ shall
2.
mean making a medicinal product belonging to the categories
referred to in Article 3(1) and (2) available for compassionate
reasons to a group of patients with a chronically or seriously
debilitating disease or whose disease is considered to be life-
threatening, and who cannot be treated satisfactorily by an
authorised medicinal
product
concerned must either be the subject of an application for a
marketing authorisation in accordance with Article 6 of this
Regulation or must be undergoing clinical trials.

The medicinal

product.

The opinions referred to in paragraph 4 shall not affect
liability of the manufacturer or of the

7.
the civil or criminal
applicant for marketing authorisation.

8. Where a compassionate use programme has been set up,
the applicant shall ensure that patients taking part also have
access to the new medicinal product during the period between
authorisation and placing on the market.

This Article shall be without prejudice to Directive

9.
2001/20/EC and to Article 5 of Directive 2001/83/EC.

Article 84

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 regulations adopted
pursuant to it and shall take all measures necessary for their
implementation. The penalties shall be effective, proportionate
and dissuasive.

Member States
provisions no later
notify any subsequent alterations as soon as possible.

these
than 31 December 2004. They shall

inform the Commission of

shall

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

3.
At the Agency's request, the Commission may impose
financial penalties on the holders of marketing authorisations
granted under this Regulation if they fail to observe certain
obligations laid down in connection with the authorisations.
The maximum amounts as well as the conditions and methods
for collection of
shall be laid down in
accordance with the procedure referred to in Article 87(2).

these penalties

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The Commission shall publish the names of the marketing
authorisation holders
involved and the amounts of and
reasons for the financial penalties imposed.

The period laid down in Article 5(6) of Decision 1999/468/EC
shall be set at three months.

Article 85

This Regulation shall not affect the competences vested in the
European Food Safety Authority created by Regulation (EC)
No 178/2002 of the European Parliament and of the Council
of 28 January 2002 laying down the general principles and
requirements of
food law, establishing the European Food
Safety Authority and laying down procedures in matters of
food safety (1).

Article 86

At least every ten years, the Commission shall publish a general
report on the experience acquired as a result of the operation
of the procedures laid down in this Regulation, in Chapter 4 of
Title III of Directive 2001/83/EC and in Chapter 4 of Title III of
Directive 2001/82/EC.

Article 87

The Commission shall be assisted by the Standing
1.
Committee on Medicinal Products for Human Use set up by
Article 121 of Directive 2001/83/EC and by the Standing
Committee on Veterinary Medicinal Products
set up by
Article 89 of Directive 2001/82/EC.

3. Where reference is made to this paragraph, Articles 4 and
7 of Decision 1999/468/EC shall apply, having regard to the
provisions of Article 8 thereof.

The period laid down in Article 4(3) of Decision 1999/468/EC
shall be set at one month.

4.

The committees shall adopt their Rules of Procedure.

Article 88

Regulation (EEC) No 2309/93 is hereby repealed.

References to the repealed Regulation shall be construed as
references to this Regulation.

Article 89

This Regulation shall enter into force on the twentieth day
following that of its publication in the Official Journal of the
European Union.

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.

By way of derogation from the first subparagraph, Titles I, II, III
and V shall apply from . . . (*).

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

Done at . . .

For the European Parliament

The President

For the Council

The President

(1) OJ L 31, 1.2.2002, p. 1. Regulation as last amended by Regulation

(EC) No 1642/2003 (OJ L 245, 29.9.2003, p. 4).

(*) 18 months after the date of entry into force of this Regulation.

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MEDICINAL PRODUCTS TO BE AUTHORISED BY THE COMMUNITY

ANNEX

1. Medicinal products developed by means of one of the following biotechnological processes:

— recombinant DNA technology,

— controlled expression of genes coding for biologically active proteins in prokaryotes and eukaryotes including

transformed mammalian cells,

— hybridoma and monoclonal antibody methods.

2. Medicinal products for veterinary use intended primarily for use as performance enhancers in order to promote the

growth of treated animals or to increase yields from treated animals.

3. Medicinal products for human use containing a new active substance which, on the date of entry into force of this
Regulation, was not authorised in the Community, for which the therapeutic indication is the treatment of any of the
following diseases:

— acquired immune deficiency syndrome,

— cancer,

— neurodegenerative disorder,

— diabetes.

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STATEMENT OF THE COUNCIL'S REASONS

I. INTRODUCTION

1. On 26 November 2001, the Commission submitted a proposal for a Regulation relating to auth-
orisation and supervision of medicinal products for human and veterinary use and establishing a
European Agency for the Evaluation of Medicinal Products (1).

The proposal is based on Articles 95 and 152(4)(b) of the Treaty.

The proposal, together with two proposals for Directives, is part of the review of the Community
legislation on medicinal products.

2. The European Parliament adopted its Opinion at first reading on 23 October 2002 (2). Following

this Opinion, the Commission presented an amended proposal on 10 December 2002 (3).

3. The Economic and Social Committee adopted its Opinion on 18 September 2002 (4).

4. On 29 September 2003, the Council adopted its Common Position in accordance with Article 251

of the Treaty.

II. AIM

The principal objectives of the three proposals making up the review of Community legislation are:

— to ensure that Community legislation can respond to new challenges, particularly the development

of new therapies, and thus to safeguard a high level of health protection in Europe;

— to ensure the proper operation of the internal market both before and after the future enlargement

of the European Union;

— to enhance the competitiveness of the European pharmaceutical industry to enable it better to meet

the challenges of globalisation; and

— to improve the transparency of procedures and decisions.

III. ANALYSIS OF THE COMMON POSITION

1. The Council has been examining the proposal since the end of 2001. The Council's Common

Position is consistent with the aims of the Commission's proposal.

However, the Council has agreed on a number of changes to the Commission's proposal (5). Apart
from changes introduced following amendments by the European Parliament and other changes on
substance, the Council has agreed on a certain number of changes in order, in the first place, to
clarify the provisions of the text, update terminology and to align the human and veterinary
provisions to the largest extent possible. The more substantial changes are described below.

(1) OJ C 75 E, 26.3.2002, p. 189.
(2) Not yet published in the Official Journal.
(3) Document 15793/02.
(4) OJ C 61, 14.3.2003, p. 1.
(5) Changes include the introduction of a number of new Articles (11, 17, 28, 36, 42, 53, 60, 66, 68, 69 and 73) that

entail the renumbering of articles from Article 10 and onwards.

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2. The Council has simplified the name of the European Agency for the Evaluation of Medicinal

Products to ‘European Medicines Agency’ (hereinafter called the Agency).

3. The Council has delineated the extension of the compulsory use of the centralised procedure to
medicinal products for human use containing a new active substance for the treatment of 4 key
disease areas (HIV/AIDS, cancer, neuro-degenerative disorders and diabetes), cf. paragraph 3 of the
Annex. These disease areas are,
in addition, broadly aligned with the areas in which specialist
expertise is being developed at the Agency with the introduction of therapeutic advisory groups
(which are now to be called scientific advisory groups cf. Article 56).

In reaching agreement, the Council, in particular, had regard to the importance of maintaining
national expertise for the evaluation of new active substances and the fact that existing legislation
already allows the applicant to choose the centralised authorisation procedure for all medicinal
products containing a new active substance. This option has been maintained for those products
containing a new active substance that are not covered by paragraph 3 of the Annex.

In addition, the Council has inserted a review clause (Article 3(5)), which will provide for the
possibility to extend the range of products for which use of
the centralised procedure is
compulsory four years after the entry into force of the Regulation. The Council considers it
appropriate to set out an ad hoc procedure for adoption of such decisions based on the
Council's right to reserve implementing powers to itself in accordance with Article 202 of the
Treaty. According to this procedure, the Commission may after consultation of the Agency, submit
a proposal to the Council that shall act with a qualified majority.

For veterinary medicinal products, the Council has chosen to retain the applicant's possibility to
choose between the centralised procedure and the decentralised procedure to take account of the
considerable regional differences in markets and disease patterns, e.g. animal species that only live
in a limited part of the Community and some diseases only occurring in some geographical
regions in the Community. In this context Article 79 should be borne in mind, which offers
incentives to use the centralised procedure for veterinary products in order to improve availability.
In addition, the ‘cascade’ procedure set out in Articles 10 and 11 of Directive 2001/82/EC is aimed
at securing availability of veterinary products.

4. The provisions on the choice of Committee procedure in relation to decisions concerning
marketing authorisations (Articles 10(2) and 35(2)) have been changed as the Council does not
consider it consistent with Decision 1999/468/EC to have two different procedures for decisions
having the same object. The Council believes that the management procedure is the appropriate
procedure to apply for these decisions.

5. The Council has provided for the possibility of adopting amendments to the arrangements
concerning the periodic safety update reports (Articles 24(4) and 49(4)) through a Committee
procedure in the light of experience gained.

6. Article 59 on the setting up of an Advisory Board has been deleted. In view of the changes agreed
to the composition of the Management Board, there is no need for an Advisory Board (see also
Section VI).

7. The provisions of Title IV, in particular Chapter 2, have been amended and rearranged to take full
account of the adoption of the Regulation (EC) No 1647/2003 amending Regulation (EEC)
No 2309/93 as regards the financial rules governing the Agency. These amendments concern
Articles 64, 65, 67, 68 (new) and 73 (new).

8. As concerns Article 82 on the principle of one single authorisation for a medicinal product, the
exemptions from that rule have been clarified and now explicitly include the admission of more
than one application for co-marketing reasons.

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9. A number of changes have been made to Article 83 on compassionate use. Article 5 of Directive
2001/83/EC allows Member States to make unauthorised medicinal products available to individual
patients under the direct responsibility of a health care professional, e.g. for compassionate use
reasons. The Council has considered that this provision should not be affected by this Regulation
and has therefore chosen to provide for a complementary system based on making products
available to groups of patients, and also made it clear that compassionate use cannot be used
by pharmaceutical companies as an alternative to applying for and obtaining a marketing auth-
orisation. The paragraph on payment in relation to compassionate use products has been deleted
as the Council believes that, in line with the principle set out in Article 1(2), it should be up to
each Member State to decide on the arrangements for the financing of the distribution of compas-
sionate use products.

10. Other changes include:

— Adding the possibility for Member States to ask for an opinion of the scientific committees,

subject to the discretion of the relevant committee (Articles 5(3) and 30(3)).

— Adjusting some time-limits in relation to the evaluation procedure (Articles 10(3) and 35(3)).

— Strengthening the supervision of the Agency by providing it with the explicit right to request
the submission of data from the marketing authorisation holder at any time (Articles 16(2) and
41(4)).

— Extension of the duty of the marketing authorisation holder to report adverse reactions

occurring in the territory of a third country (Articles 24(2) and 49(2)).

— Clarification of the wording of Article 37, including the alignment with the Annex (consistent

use of the term ‘performance enhancers’).

IV. ACCEPTED AMENDMENTS OF THE EUROPEAN PARLIAMENT

The Council has accepted amendments 12, 13, 14, 28, 30, 32, 33, 36, 37, 40, 41, 60, 69, 72, 75, 77,
78, 90, 98, 99, 103, 106, 111, 112, 124, 126, 127, 135 and 146, subject to drafting changes in a few
cases.

As concerns amendment 106, the word ‘panels’ has been replaced with ‘scientific advisory groups’ (see
section V). In relation to amendments 124 and 126, adjustments have been made, cf. Articles 67(11)
and 68(10), to take account of the incorporation of the abovementioned Regulation regarding the
financial rules of the Agency.

V. AMENDMENTS OF THE EUROPEAN PARLIAMENT ACCEPTED PARTLY OR IN PRINCIPLE

1. The Council has accepted partly or in principle amendments 1, 4, 15, 18, 20, 22, 23, 24, 25, 31,
34, 38, 39, 43, 44, 46, 47, 49, 50, 51, 53, 54, 62, 63, 64, 66, 68, 73, 76, 79, 81, 82, 84, 86, 87,
88, 89, 91, 93, 95, 96, 100, 102, 104, 105, 107, 108, 109, 110, 113, 118, 120, 121, 123, 125,
128, 129, 130, 131, 134, 140, 141, 153, 155, 157, 163, 165 and 166.

2. The Council has accepted amendments 1 and 129 on the reduction of

fees for small and
the Council considers that more detailed
medium-sized enterprises in principle. However,
provisions are required, and that these should be set out via a Committee procedure cf. Article
70(2). The Council believes that the aforementioned provision covers the substance of a part of
amendment 130 (on the extension of Article 79 to medicinal products for human use).

3. As concerns amendments 15 and 47 dealing with Directive 89/105/EEC on national procedures for
the pricing and reimbursement of medicinal products, the Council has noted that the Commission
in its amended proposal has accepted the request of the Parliament to draw up a report on the
implementation of
the Council considers it
that Directive.
unnecessary to change the wording of the Regulation.

In line with the Commission,

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4. The essence of amendments 31 and 73 on conditions and restrictions in relation to the safe and
effective use of the medicinal product has been accepted. However, as these conditions and
restrictions should also be applied to third parties, the Council is of the opinion that a specific
legal instrument is necessary to produce this effect. Therefore, the new Articles 127a of Directive
2001/83/EC and 95a of Directive 2001/82/EC provide for adoption through comitology of
decisions requiring Member States to implement such conditions and restrictions,
including
vis-à-vis third parties. As the conditions and restrictions are part of the opinion of the scientific
committees that has to be implemented via subsequent decisions to take effect, the Council
considers it appropriate to use the term ‘recommendations’ instead of ‘details’ and to simplify
the wording of the provision.

5. The Council accepts the principle of amendments 43, 51, 53, 79, 81 and part of 87, 109 and 131
that proposes to refer to Regulation 1049/2001/EC on access to documents. The Council has
agreed on a new Article 73 which sets out that the aforementioned Regulation shall apply to
documents held by the Agency.

6. The Council has accepted amendment 46 in principle on setting out the same data protection
period for medicinal products for human use authorised centrally as for products authorised
nationally, except for those products where the use of the centralised procedure is compulsory.

In coming to agreement on the issue of data protection, the Council has considered both the need
to harmonise the widely differing data protection periods available in the Member States and the
period of 10 years' data protection currently available to products using the centralised procedure.
The Council therefore has decided that it is appropriate to retain the current 10 year's data
protection for products for which use of the centralised procedure is compulsory. Furthermore,
the Council has considered that offering an additional year's data protection for such products will
be in line with encouraging innovation for these products.

For products authorised nationally, the Council has considered that harmonising the period at 10
years would be difficult for some Member States but that a provision as the one agreed by
Parliament, that allows generic companies to undertake all development work in the last two
years of a ten year period (the ‘8+2’ provision (1)) would be acceptable. The Council felt that in
view of the significant increase in data exclusivity that the ‘8+2’ provision would be offering in a
number of Member States, there was no justification for adding a further year's data exclusivity for
nationally authorised products. Mindful of
the choice between the
centralised and the national procedure be influenced by differences in data protection periods,
the Council has decided to apply this data protection period to products that a company
voluntarily refers for centralised authorisation.

the need to avoid that

7. Amendment 50 on the

communication of pharmacovigilance

information to health-care
professionals has been partly accepted in principle by the Council which has agreed to the intro-
duction of Articles 20(5) and 45(5) as suggested by the Commission in its amended proposal with
the exception of making it compulsory to use the networks of professional associations. Although
these networks might be useful for this purpose, the Council believes that the provision should be
more flexible and thus allow Member States to use all relevant channels of communication for
such important information, in particular to ensure the efficiency of this communication.

8. The Council has accepted the part of amendment 54 on patients' reporting of adverse reactions that
relate to health-care professionals. On the other hand the Council does not believe that it,
in
general,
is appropriate to encourage patients to report directly to the marketing authorisation
holder without the intervention of a health-care professional, also taking into account the potential
for double reporting. In relation to medicinal products for veterinary use, the Council, having
regard to the specificity of the sector, considers it useful to encourage animal owners and breeders
also to report adverse reactions to the competent authorities, cf. Article 47.

(1) Cf. Article 10(1) of Directive 2001/83/EC on medicinal products for human use.

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9. The concept contained in amendment 64 of providing for increased surveillance in the first years
following a marketing authorisation via a collection of data from targeted groups of patients has
been welcomed by the Council. To make such a provision compulsory for all products seems
however not to be proportional. The Council prefers to reserve the possibility for collecting
specific data from targeted groups of patients in cases selected by the Agency and in return
extend the period of surveillance to five years from the placing on the market of the product.

10. The Council supports the aim of amendment 66, i.e. ensuring that pharmacovigilance systems of
the Member States and the Agency work together in a coordinated way. However, the concrete
organisation of national systems should continue to be the competence of Member States and
therefore the Council has agreed on new Articles 28 and 53, that focus on the obligation to
cooperate and make the best of the common resources. The role of the Agency in relation to
coordination is set out in Article 57(1) which also contains a reference to a database with phar-
macovigilance information.

11. Amendment 82 on a specific reference to residues of medicinal products in relation to the
evaluation of the risk/benefit balance is acceptable in principle. However, the Council considers
that the reference should be extended and made more precise by referring to ‘the validity of the
withdrawal period, lack of expected efficacy or potential environmental problems’ in Article 48,
second subparagraph, point d.

12. In relation to amendment 93, the Council agrees that it is useful to entrust some tasks to the
Agency in relation to bio-terrorism but as this area is related to national security concerns in
the
Member States and concrete information therefore is considered as potentially sensitive,
Council cannot agree to the elements of the amendment that would go beyond the Agency's
compilation of more general information as defined in the new point p in Article 57(1), second
subparagraph.

13. Amendments 95, 96 and 157 aimed at specifying the contents of the database of the Agency has
been accepted in principle, amendment 95 subject to a more precise wording cf. Article 57(2). A
database on information on clinical trials, cf. amendment 96, is already provided for in Directive
2001/20/EC on clinical trials and the provision proposed by the Parliament is therefore not
necessary. As concerns amendment 157 on pharmacovigilance information,
is now
provided for in Article 102 of Directive 2001/83/EC.

this

14. As regards the Scientific Committees, in addition to accepting amendments 103 and 106 (as set
out under section IV), the Council has in principle accepted amendments 84, 102 (partly), 104, 105
(partly), 107 (partly) and 108 (partly).

In relation to the setting up of ‘panels’, it should be recalled that similar ‘groups’ already exist on
an informal basis and called ‘therapeutic advisory groups’. The Council therefore prefers to use a
similar term in the context of formalising these groups, hence the term ‘scientific advisory groups’,
indicating that these groups are to be entrusted with broader tasks than giving advice in relation to
treatment of specific diseases. Further, the Council believes that it should be up to the Scientific
Committees to decide on setting up these groups thereby taking into account the committees'
responsibilities for the opinions as well as their independence. In relation to the rules of procedure,
the Council has rearranged and simplified the text. As concerns the part of amendments 102 and
105 referring to the establishment of contacts with interested parties, the Council has preferred to
set out provisions to that effect in Article 78, however making them more general and not linking
such contacts to specific pending applications, thereby ensuring that the scientific independence of
the committees and rapporteurs is not compromised.

15. The Council has accepted amendment 110 on the declaration of financial interests, except the first

part referring to ‘officials of the Agency’.

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16. Amendment 118 on participation of the chairman of the scientific committees in the meetings of
the Management Board is acceptable in principle. However, the Council shares the view expressed
by the Commission in its amended proposal in that it prefers to maintain the current practice
where the chairmen participate upon invitation by the Board.

17. Amendments 120 and 123 relating to the financial provisions of the Agency have been accepted in
principle, cf. Articles 67(3) and 67(6). The rearranging of provisions and redrafting is mainly due
to the complete integration of the abovementioned Regulation relating to the financial provisions
of the Agency.

18. Amendment 121 has been accepted partly by the Council

in that it can agree that the phar-
macovigilance activities of the Agency should receive adequate public funding as set out in
Article 67(4). However, the Council cannot agree to the implication that public funding is a
prerequisite or guarantee for independence in performing these activities as independence can
be ensured via other requirements and measures.

19. Amendment 125 on the publication by the Court of Auditors on an annual report on the Agency
has been accepted in principle but as the publication of reports is regulated elsewhere, including in
particular Article 248 of the Treaty, it is not necessary to set this out in the Regulation.

20. The first part of amendment 128 replacing ‘amount of fees’ with ‘level of fees’ has been accepted by

the Council.

21. Amendment 134 on continued supply of medicinal products for compassionate use has been
in order to align the provision to the changes made to
welcomed by the Council. However,
Article 83 on compassionate use, cf. section III, ‘manufacturer’ should be replaced with ‘applicant’.

22. As concerns the provisions on renewal of marketing authorisations, amendments 163, 165 and 166
have in principle been accepted by the Council in that it agrees to have one renewal after a
five-year period where after validity of the marketing authorisation should be unlimited. However,
the Council prefers to set the five-year period in relation to the granting of the authorisation as it
considers it administratively simpler to commence the five-year from the date of the marketing
authorisation, in particular as the date of the marketing will vary between Member States. The
Council has thus basically agreed to the drafting of Articles 14 and 39 as proposed by the
Commission in its amended proposal with some clarification of the wording and one important
addition, i.e. to provide for a possibility for the Agency to decide on one extra five-year renewal
based on justified pharmacovigilance grounds. The Council believes that this addition provides the
Agency with an extra tool in ensuring the effective surveillance of authorised products.

23. In relation to a number of amendments, the Council have accepted these in principle but prefers the
redrafting suggested by the Commission in its amended proposal as more precise and appropriate
for the same reasons as stated by the Commission. In some cases slight additions have been made
(indicated below). The following amendments are concerned:

— Amendments 4 (partly) and 100 on comparative efficacy and added therapeutic value, cf. the new

Recital 32 and the new Article 60 with some clarification of the wording.

— Part of amendments 4, 24 and 25 as concerns good clinical practice and clinical trials cf. the new

Recital 15.

— Amendments 18 and 22 on the name of generic medicinal products, cf. Article 3(3)(c), with a

slight redrafting.

— Part of amendment 24 referring to exceptions from the principle of a single name of a medicinal

product, cf. Articles 6(1) and 31(1).

— Amendments 38 and 76 on assessment reports, cf. Articles 13(3) and 38(3).

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— Amendment 44 on authorisation of medicinal products under exceptional circumstances, cf.

Articles 14(8) and 39(7).

— Amendment 49 on the responsibility of the applicant for the accuracy of the documents and the

data submitted, cf. the new Articles 17 and 42.

— Amendment 62 on guidance on adverse reactions, cf. Articles 26(1) and 51(1), the Council
considering the word ‘recommendations’ more appropriate than ‘rules’ which could give a
misleading impression as the provision does not concern binding rules.

— Amendments 63 and 88 on access to the database on pharmacovigilance, cf. Article 57(1)(d),
with the precision that a distinction should be made between marketing authorisation holders
and other companies, the latter belonging to the category ‘the public’.

— Amendments 89, 91 (partly) and 93 (partly) on the Agency's role in the communication of

pharmacovigilance information, cf. Article 57(1), point e).

— Part of amendment 91 on the information to the public contained in the database operated by

the Agency, cf. Article 57(1), point k).

— Amendment 113 on the procedure for the nomination of the Executive Director, cf. Article

64(1).

— Part of amendment 131 on making public the internal rules and procedures related to the

Agency and its bodies, cf. Article 80.

— Part of amendment 131 relating to the European Public Assessment Reports, cf. Articles 13(3)

and 38(3).

— Amendment 140 relating to responsibility for a medicinal product, cf. Article 2, with some

additional precision of the wording.

— Amendments 153 and 155 on information on withdrawals of applications for marketing auth-
orisation, cf. new Articles 11 and 36, with the addition that the published information should
in principle also include the assessment report (if available).

24. In relation to a number of amendments,

the
amendments, at least in principle but as provisions to their effect are already contained in
other parts of the text of Regulation,
it has been deemed unnecessary to reword the relevant
Articles as proposed by the Parliament. These are:

the Council has agreed with the content of

— Amendment 34 on an accelerated procedure for certain medicines is acceptable. This possibility

is contained in Article 14(9).

— Amendment 39 on marketing authorisation holders' obligation to provide the Agency with data
on adverse reactions upon request. Such obligation is already set out in the Regulation, cf.
Articles 16(2), 24(3), 41(4) and 49(3).

— Amendment 86 on minority views in the opinions of the Scientific Committees. This is provided

for in Article 61(7).

— Part of amendment 109 on the declaration of conflicts of interest. This is provided for in Article

63(2).

— Amendment 141 on notification on withdrawal. Such an obligation is contained in Articles

13(4), second subparagraph and 38(4), second subparagraph.

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25. As concerns some amendments, the Council agrees with the amendments, at least in principle as
provisions to their effect are already contained in the text of the Directive 2001/83/EC on
medicinal products for human use or/and Directive 2001/82/EC on medicinal products for
veterinary use,
it is deemed not necessary to reword the relevant Articles as proposed by the
Parliament. These are:

— Amendment 20 (on risk/benefit balance), see in particular Articles 1, points 28, 29 and 30 and

8(3)(g) of Directive 2001/83/EC.

— Amendments 23 and 68 (on opinions of the Scientific Committees in the context of the mutual

recognition procedure), cf. Title III, Chapter 4 of both Directives.

— Part of amendment 87 on the wording of the labels and leaflet packages, cf. Title V of both
Directives which apply also to products authorised centrally, and in particular Articles 59
(Directive 2001/83/EC) and 61(2001/82/EC).

VI. AMENDMENTS OF THE EUROPEAN PARLIAMENT REJECTED PARTLY OR IN TOTAL

1. The Council has rejected in total or partly amendments 2, 3, 5, 6, 7, 8, 10, 21, 25, 26, 27, 29, 42,
45, 48, 49, 52, 56, 57, 58, 59, 61, 65, 67, 70, 71, 80, 83, 85, 91, 92, 94, 97, 101, 102, 107,
108, 110, 114, 115, 116, 117, 119, 122, 128, 130, 132, 133, 145, 147, 148, 152, 162, 173,
174 and 175.

2. Amendments 52, 67 and 80 on the funding of pharmacovigilance activities have been rejected, 52
and 80 in as far as they seem to imply that public funding should be required for phar-
macovigilance activities of the competent authorities of the Member States which is an issue to
be decided upon by Member States themselves. For the same reasons amendment 57 that would
make a contribution from the marketing authorisation holder compulsory is not acceptable either.

3. As concerns amendments 56 and 58 on obliging the marketing authorisation holder to report
adverse reactions reported to him or her by a patient, the Council, as stated in relation to
amendment 54 (see Section V), does not believe that it, in general, is appropriate to encourage
patients to report directly to the marketing authorisation holder without the intervention of a
health-care professional, also taking into account the potential for double reporting. Consequently
the amendments have not been accepted by the Council.

4. Although the Council understands the aim of amendment 59 as concerns the periodic safety update
reports, it cannot accept the amendment as it considers it administratively simpler to relate the
period to the date of the authorisation, in particular as the date of the marketing will vary between
Member States. It should be noted that the Council has agreed on provisions (Articles 24(4) and
49(4)) whereby amendments to the arrangements concerning the periodic safety update reports
can be adopted through a Committee procedure in the light of experience gained.

5. The Council can agree with the aim of amendment 61 on communication of adverse reactions from
the marketing authorisation holder to ensure that such communication is correct and complete but
believes that the requirement of prior consent of the Agency is disproportionate and can therefore
not agree to the concrete wording proposed by the Parliament. Given that the marketing author-
isation holder is responsible for such information and thus has an interest in the accuracy and
objectivity of this information, the Council believes that a requirement to notify the Agency and
thereby giving the Agency the possibility to counter any misleading information, while underlining
the responsibility of the marketing authorisation holder, is sufficient to achieve the aim of the
amendment (Articles 24(5) and 49(5)).

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6. The Council has not been able to accept amendments 101, 102 (partly) and 114 on the appointment
of the members of the Scientific Committees. The Council believes that as the opinions of the
scientific committees form the basis for Commission decisions that lead to products being placed
on the markets of the Member States, and for which in many respects the Member States are
responsible, it is important that the members of the scientific committees should be appointed
directly by the Member States. However, as the Council shares the aim of ensuring that the
committees are sufficiently multidisciplinary, it has agreed to provide for co-opted members to
complement the expertise of existing members as well as for the possibility for members to be
advised and accompanied by experts. The provisions on setting up scientific advisory groups will
further ensure that expertise from different scientific areas and disciplines can be called upon to
advise the scientific committees whenever necessary.

7. Amendment 115 on making herbal medicinal products a separate category in relation to the draft
work programme of the Agency has not been accepted, as the Council prefers to maintain only the
two main categories: products for human use and products for veterinary use.

8. In relation to amendments 116 and 117 on the composition of the Management Board, the Council
cannot agree to change the composition of the Board to a model based on the European Food
Safety Authority (EFSA).

The availability and surveillance of medicinal products is an integrated part of national public
health systems, public health in general being a Member State competence. Thus decisions of the
Management Board have repercussions for the work and priorities of the authorities of Member
States and the Council therefore considers it essential that representation of each Member State on
the Management Board is guaranteed, also in an enlarged European Union. The Council has
reduced the number of representatives from two to one, which will mean that the size of the
Management after enlargement remains approximately the same as the present one.

in particular finds two
Without prejudice to the principle reasons set out above, the Council
elements in amendment 116 questionable. The Council believes that the inclusion of represen-
tatives of industry, would be in conflict with Article 63(2) according to which members of the
bodies of the Agency may not have financial interests in the pharmaceutical industry. As concerns
the
a representative of social security systems,
differences of these systems between Member States both in relation to their organisation and
financing.

is deemed unfeasible taking into account

it

Specifically, on amendment 117 on the non-renewability of the term of office, it seems inap-
propriate in the light of the Council's decision on the composition of the Management board.

Finally, it is recalled that the Council and the Parliament quite recently have adopted two Regu-
lations (Regulation (EC) No 1406/2002 on a European Maritime Safety Agency and Regulation
(EC) No 1592/2002 on a European Aviation Safety Agency (1)) in which an identical model for
their Management Boards as the one adopted by Council as regards the European Medicines
Agency were laid down.

9. Amendment 119 on widening the composition of the Advisory Board has not been accepted by the
Council, as it has chosen to delete the provision altogether (see Section III). Article 78 on contacts
with interested parties is recalled in this context.

10. The Council cannot agree to limiting the assistance offered in Article 79 to small and
medium-sized enterprises in case of veterinary medicinal products as such limitation could
hamper the aim of this provision which is to offer incentives in order to improve availability
of products that have limited markets. The part of amendment 130 referring to this limitation is
consequently rejected.

(1) OJ L 208, 5.8.2002, p. 1 (OJ L 240, 7.9.2002, p. 1).

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11. In relation to a number of amendments, the Council has rejected these for the same reasons as stated

by the Commission in its amended proposal. These are the following:

— Amendment 2 on mentioning the access of herbal medicinal products to the centralised

procedure in a recital.

— Amendment 3 on a specific regulation in relation to the issue of availability of medicinal

products for veterinary use.

— Amendments 5, 6, 10 and 83 on clinical trials and medicinal products for paediatric use.

— Amendments 7, 8 and 26 on medicines for export and in relation hereto incentives for

developing medicinal products for the treatment of tropical diseases.

— Amendment 21 on introducing an exception relating to patent protection to one of the

conditions set out in Article 3(3) on generic medicinal products.

— Part of amendment 25 referring to the inclusion in the application for a marketing authorisation

of a comparison with other medicinal products.

— Amendment 27 on introducing an explicit condition for a laboratory not to have an interest in

the authorisation of the medicinal product to be tested by that laboratory.

— Amendments 29 and 70 that would make the participation of rapporteurs or experts in

inspections compulsory.

— Amendment 42 on the inclusion of the phrase ‘newly authorised medicinal product’ on the

package leaflet.

— Amendment 45 on setting out a detailed procedure in relation to requests for the use of the

accelerated procedure in Article 14(9).

— Amendment 48 on a reference to Community law in Article 16(1).

— Part of amendment 49 on a detailed procedure in relation to the transmission of incorrect data.

— Amendment 57 requiring that reports on adverse reactions should be transmitted electronically.

— Amendment 65 providing for an annual report on adverse reaction to be drawn up by the

Agency.

— Amendments 71 and 107 (first part) on making new data admissible in an appeal against the

opinion of the scientific committees.

— Amendment 85 on the competence of the Committee for Herbal Medicinal Products and the

references to this committee contained in amendments 101, 105 and 108.

— The parts of amendment 91 relating to the database run by the Agency as concerns the issues of
independence from pharmaceutical companies, comparison of medicinal products and
medicinal products for paediatric use.

— Amendment 92 on giving the Parliament the right to request an opinion from the scientific

committees.

— Amendment 94 on entrusting the Agency with certain tasks in relation to developing countries.

— Amendment 97 on extending the cooperation with WHO to veterinary medicinal products via

the International Office of Epizooties.

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— Part of amendment 110 on including a reference to Officials of the Agency in Article 63(2).

— Amendment 122 on the financing of new tasks of the Agency.

— Part of amendment 128 on the adjustment of the level of fees.

— Amendment 132 and 133 relating to the provisions on compassionate use as regards phar-

macovigilance and financing of those products. See also Section III.

— Amendment 145 on the deletion of the requirement of one single authorisation for a medicinal

product.

— Amendments 147 and 148 on gender aspects.

— Amendment 152 on a recital relating to the financing of the tasks of the Agency.

— Amendment 162 on the definition of European patient groups.

— Amendment 173 on a recital declaring that the legislation on medicinal products involves

matters relating to public health.

— Amendment 174 on the obligation to publish evaluation reports containing confidential

information in certain cases.

— Amendment 175 on setting a minimum duration of the scientific evaluation period.