Proposal for 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 Agency for the Evaluation of Medicinal Products
Date: 2001-11-26
Institutions: European Commission
Subjects: European Medicines Agency, drug surveillance, market approval, medicinal product, pharmaceutical legislation, veterinary drug

26.3.2002

EN

Official Journal of the European Communities

C 75 E/189

Proposal for 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 Agency for the Evaluation of Medicinal Products

(2002/C 75 E/12)

COM(2001) 404 final (cid:151) 2001/0252(COD)

(Submitted by the Commission on 26 November 2001)

THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE
EUROPEAN UNION,

Union. It also emerges from the report that the general
principles previously
established which govern the
centralised procedure should be maintained.

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,

Having regard to the opinion of
Committee,

the Economic and Social

Having regard to the opinion of the Committee of the Regions,

In accordance with the procedure referred to in Article 251 of
the Treaty,

Whereas:

(1) 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 and establishing a European Agency for
the Evaluation of Medicinal Products (1) provides,
in
Article 71, that within six years of the entry into force
of the Regulation the Commission is to publish a general
report on the experience acquired as a result of
the
operation of the procedures laid down in the Regulation.

(2) 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 for
the Evaluation of Medicinal
Products.

for

(4) Moreover, since the European Parliament and the Council
have adopted Directive 2001/83/EC of 23 October 2001
on the Community code relating to medicinal products
for human use and Directive 2001/82/EC of 23 October
2001 on the Community code relating to veterinary
medicinal products,
the references
contained in Regulation (EEC) No 2309/93 to the
codified directives has to be undertaken.

the updating of all

(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.

is

compulsory

(7) Experience gained since the adoption of Council Directive
87/22/EEC (2) of 22 December 1986 has shown that it is
necessary to create a centralised authorisation procedure
for high-technology medicinal
that
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
is
particularly important in the context of the emergence
of new therapies, such as gene therapy and associated
cell
therapies, and xenogenic somatic therapy. This
approach should be maintained, particularly with a view
to ensuring the effective operation of the internal market
in the pharmaceutical sector.

evaluation. This

in the

(3) 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

(8) With a view to harmonising the internal market for new
medicinal products, this procedure should also be made
compulsory for any medicinal product which is intended
to be administered to humans or animals and contains an
entirely new active substance, that is, one that has not yet
been authorised in the Community.

(1) OJ L 214, 24.8.1993, p. 1; Regulation as amended by Commission

(2) OJ L 15, 17.1.1987, p. 38; Directive repealed by Directive 93/41/EEC

Regulation (EC) No 649/98 (OJ L 88, 24.3.1998, p. 7).

(OJ L 214, 24.8.1993, p. 40).

C 75 E/190

EN

Official Journal of the European Communities

26.3.2002

(9) As regards medicinal products for human use, optional
access
to the centralised procedure should also be
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 a therapeutic innovation. 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 cannot be supplied without a
medical prescription. This option may be extended to
generic medicinal products authorised by the Community,
the
provided that
harmonisation achieved when the reference medicinal
products were 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 provided for in order to take
account of the specific features of this field, particularly
those due to the regional distribution of certain diseases.
The field of application of
the centralised procedure
should also include medicinal products used within the
framework of Community provisions regarding prophy-
lactic measures for epizootic diseases.

safety and efficacy of

(11) In the interest of public health, it is necessary that auth-
orisation decisions under the centralised procedure be
taken on the basis of the objective scientific criteria of
quality,
the medicinal product
concerned,
to the exclusion of economic and other
considerations. However, Member States should be able
the use on their territory of
exceptionally to prohibit
medicinal products
for human use which infringe
objectively defined concepts of public policy and public
morality. Moreover, a veterinary medicinal product may
not be authorised by the Community if its use would
contravene the rules
laid down by the Community
within the framework of the common agricultural policy.

(12) Provision should be made whereby the quality, safety and
efficacy criteria provided for by Directives 2001/83/EC
and 2001/82/EC apply to medicinal products authorised
by the Community.

(13) The Community should have the means to carry out a
scientific assessment of the medicinal products presented
in accordance with the centralised 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 centralised author-
isation procedures,
to endow the
Community with the means to resolve disagreements
between Member States concerning the quality, safety
and efficacy of medicinal products.

is necessary

it

(14) It is thus appropriate to establish a European Agency for
the Evaluation of Medicinal Products (hereinafter referred
to as the (cid:145)Agency(cid:146)).

(15) The structure and operation of the set of 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 institutions, the need for adequate represen-
tation of civil society, and the future enlargement of the
European Union.

(16) The chief

task of

legislation
after

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
of medicinal
Community
in
products. Only
evaluation
procedure addressing the quality, safety and efficacy of
high-technology medicinal products has been conducted
by the Agency, applying the highest possible standards,
should marketing authorisation be granted by the
Community, by means of a rapid procedure ensuring
close cooperation between the Commission and Member
States.

field
scientific

the
single

a

(17) In order to ensure close cooperation between the Agency
and the scientists operating in Member States, provision
the Management Board is
should be made so that
composed in such a way as
the
to guarantee that
competent authorities of the Member States are closely
involved in the overall management of the Community
system for authorising medicinal products by creating
an Advisory Board responsible to the Executive Director
of the Agency.

(18) Exclusive

responsibility

Products. As

for preparing

vested in a Committee

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
medicinal products are concerned, such responsibility
for Veterinary
should be
orphan medicinal
Medicinal
products,
to the Committee on
Orphan Medicinal Products set up under Regulation (EC)
the
No 141/2000 of
Council of 16 December 2000 on orphan medicinal
products (1).
herbal medicinal
products,
responsibility should be vested in the
Committee on Herbal Medicinal Products set up under
Directive 2001/83/EC].

the European Parliament and of

the task should fall

regards

regards

[Lastly,

this

as

(19) The creation of

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

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

26.3.2002

EN

Official Journal of the European Communities

C 75 E/191

(20) The field of activity of the Scientific Committees should
be enlarged and their operating methods and composition
modernised. Scientific advice for future applicants seeking
be provided more
marketing
authorisation should
structures
generally and in greater depth. Similarly,
allowing the development of advice
companies
for
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 appeal
procedures
should be amended to provide a better
guarantee for applicants’ rights.

(21) The number of members of

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

(22) It is also necessary to reinforce the role of the Scientific
Committees in such a way as to enable the Agency to
have an active presence in the context of the international
scientific dialogue and to develop certain activities that
will be necessary,
in particular regarding international
scientific harmonisation and technical cooperation with
the World Health Organisation.

for

the Agency’s work,

(23) Furthermore, in order to create greater legal certainty it is
necessary to define the responsibilities regarding the trans-
to set certain
parency rules
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
implementing
them in the case of failure to observe the provisions of
this Regulation and the conditions contained in the auth-
orisations issued under the procedures it establishes.

to monitor

for

(24) 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
the
framework of Community pharmacovigilance activities,
so as to ensure the rapid withdrawal from the market
of any medicinal product presenting an unacceptable
level of risk under normal conditions of use.

products within

these medicinal

of

(25) 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

responsible

for

authority to take provisional
competent
allow the
emergency measures,
introduction of
including the
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.

(26) 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
execution of
supervisory responsibilities
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

States which have

(27) It is necessary to provide for the coordinated implemen-
tation of Community procedures for the authorisation of
the national procedures of
medicinal products, and of
Member
already been broadly
harmonised 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.

(28) 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
procedures should be set up,
reserved for medicinal
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.

(29) In line with the

any

current provisions of Directives
2001/83/EC and 2001/82/EC, the term of validity of a
Community marketing authorisation should be unlimited.
Furthermore,
two
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 linked to maintaining such authorisations.

authorisation not used for

of

or

consisting

(30) Environmental risks may arise from medicinal products
containing
genetically modified
organisms. It is thus necessary to subject such products
to an environmental 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

C 75 E/192

EN

Official Journal of the European Communities

26.3.2002

Directive 90/220/EEC (1), to be conducted in parallel with
the evaluation, under a single Community procedures, of
the quality, safety and efficacy of the product concerned.

3

for

in Article

(31) Since most of the measures necessary for the implemen-
tation of this Regulation are measures of individual scope,
they should be adopted by use of the advisory procedure
provided
of Council Decision
1999/468/EC of 28 June 1999 laying down the
procedures
implementing powers
conferred on the Commission (2), or else by use of the
management procedure provided for under Article 4 of
that Decision.
In respect of measures of general scope
within the meaning of Article 2 of that Decision, they
should be adopted by use of the regulatory procedure
provided for in Article 5 of that Decision,

the exercise of

for

HAVE ADOPTED THIS REGULATION:

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 Agency for the Evaluation of
Medicinal Products (hereinafter referred to as (cid:145)the Agency(cid:146)).

authorisation,

the

The provisions of this Regulation shall not affect the powers of
the Member States’ authorities as regards setting the prices of
medicinal products or their inclusion in the scope of
the
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 the medicinal
products covered by this Regulation should be established in
the Community. The holder shall be responsible for placing
those medicinal products on the market.

(1) OJ L 106, 17.4.2001, p. 1; Directive last amended by Regulation
(EC) No . . ./2002 of the European Parliament and of the Council
[of . . . concerning the traceability of genetically modified organisms
and the
intended for human
consumption, etc.].

food products

traceability of

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

Article 3

1.
No medicinal product appearing in Annex I 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.

the applicant shows that

2.
Any medicinal product not appearing in Annex I may be
granted a marketing authorisation by the Community in
accordance with the provisions of this Regulation, provided
is a
that
significant
innovation or
that
the granting of authorisation in accordance with this
Regulation is of interest to patients or to animal health at
Community level.

therapeutic, scientific or technical

the medicinal product

Immunological veterinary medicinal products for the treatment
of
to Community prophylactic
measures may also be granted such authorisation.

animal diseases

subject

A generic form of a medicinal product authorised by the
3.
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 characteristics of the product is in all
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.

4.
After consulting the competent committee of the Agency
set up under Article 49, Annex I may be re-examined in the
light of technical and scientific progress, with a view to making
any necessary amendments. Such amendments shall be adopted
according to the procedure referred to in Article 77(2).

Article 4

1.
In order to obtain the marketing authorisation referred to
in Article 3, an application shall be submitted to the Agency.

2.
The Community shall issue and supervise marketing auth-
orisations for medicinal products for human use in accordance
with Title II.

The Community shall issue and supervise marketing auth-
in

for medicinal products

for veterinary use

3.
orisations
accordance with Title III.

26.3.2002

EN

Official Journal of the European Communities

C 75 E/193

TITLE II

AUTHORISATION AND SUPERVISION OF MEDICINAL
PRODUCTS FOR HUMAN USE

(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

CHAPTER 1

of research or development.

SUBMISSION AND EXAMINATION OF APPLICATIONS (cid:151)
AUTHORISATIONS

Article 5

A Committee for Human Medicinal Products is hereby

1.
established. The Committee shall be part of the Agency.

2. Without prejudice to Article 50 or to other tasks which
Community law may confer on it, the Committee for Human
Medicinal Products shall be responsible for formulating the
opinion of the Agency on any matter concerning the admissi-
bility of the files submitted in accordance with the centralised
procedure, the granting, variation, suspension or withdrawal of
an authorisation to place a medicinal product for human use
on the market in accordance with the provisions of this Title
and pharmacovigilance.

At the request of the Executive Director of the Agency or
3.
the Commission representative,
the Committee for Human
Medicinal Products shall also draw up an opinion on any
scientific matter
evaluation of medicinal
products for human use.

concerning the

Article 6

1.
Each application for authorisation for a medicinal product
for human use shall specifically include all the information and
documents referred to in Articles 8(3), 10a and 11 of Directive
thereto. The information and
2001/83/EC, and Annex I
documents are to take account of
the unique, Community
nature of the authorisation requested, and particularly of 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:

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 Human Medicinal Products is given within
210 days of the receipt of a valid application.

the opinion of

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

for marketing

authorisations

applications

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

Article 7

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

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

specified in this Regulation for

(b) may ask for a State laboratory or a laboratory designated
for this purpose to test the medicinal product for human
use, its starting materials and, if need be, its 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;

release

(a) a copy of the the competent authorities’ written consent to
the
research and devel-
in Part B of
Part B of Directive

the deliberate
genetically modified organisms for
opment purposes where provided for
Directive
90/220/EEC (1);

environment of

2001/18/EC or

into the

in

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

(1) OJ L 117, 8.5.1990, p. 15.

(c) may, where

appropriate,

to
supplement the particulars accompanying the application
within a specific time period.

applicant

request

the

Where the Committee avails itself of
the option under
point (c) of the first paragraph, the time-limit laid down
in the first subparagraph of Article 6(3) shall be suspended
until such time as the supplementary information requested
shall be
has been provided. Likewise,
suspended for
to
prepare oral or written explanations.

this
the time allowed to the applicant

time-limit

C 75 E/194

EN

Official Journal of the European Communities

26.3.2002

Article 8

1.
Upon receipt of a written request from the Committee for
Human Medicinal Products, a Member State shall forward the
information showing that
the manufacturer of a medicinal
product or the importer from a non-member 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

the
together with a report describing the assessment of
medicinal product by the Committee and stating the reasons
for its conclusions.

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

2. Where it considers it necessary in order to complete its
examination of an application,
the Committee for Human
Medicinal Products may require the applicant to submit to a
specific inspection of the manufacturing site of the medicinal
product concerned.

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,
who may be accompanied by a rapporteur or an expert
appointed by the Committee.

(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
concerned,
including the conditions under which the
medicinal product may be made available to patients,
having regard to the criteria laid down in Title VI of
Directive 2001/83/EC;

(c)

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

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

(d) the assessment report.

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

isation set out in this Regulation;

(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;

Article 10

1. Within 30 days of receipt of the opinion referred to in
Article 5(2),
the
decision to be taken in respect of the application.

the Commission shall prepare a draft of

In the event of a draft decision granting marketing author-
include or make reference to the
isation,
documents mentioned in points (a),
(b) and (c) of the first
subparagraph of Article 9(4).

the draft shall

(d) the authorisation needs

to be granted subject

to the

conditions provided for in Article 13(4) and (5).

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.

2. Within 15 days of receipt of the opinion referred to in
the applicant may give written notice to the
paragraph 1,
Agency that he/she wishes
the
for his/her
applicant
appeal to the Agency within 60 days of receipt of the opinion.

forward the detailed grounds

In that case,

to appeal.

shall

the grounds for appeal,

Within 60 days of receipt of
the
Committee for Human Medicinal Products shall re-examine
its opinion in accordance with the conditions laid down in
the second subparagraph of Article 55(1). The reasons for
the conclusion reached on the appeal shall be annexed to the
final opinion.

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

The Commission shall take a final decision in accordance
if the draft

2.
with the procedure referred to in Article 77(3)
decision accords with the Agency’s opinion.

The Commission shall take a final decision in accordance with
the procedure referred to in Article 77(4) if the draft decision
does not accord with the Agency’s opinion.

3. Within 30 days of its adoption, the Agency shall send the
final opinion of the Committee for Human Medicinal Products
to the Commission, to the Member States and to the applicant,

3.
for
The Standing Committee on Medicinal Products
Human Use referred to in Article 77(1) shall adjust its rules
of procedure so as to take account of the tasks incumbent
upon it under this Regulation.

26.3.2002

EN

Official Journal of the European Communities

C 75 E/195

These adjustments shall provide that:

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

writing;

(b) each Member State is to be allowed 15 days to forward
written observations on the draft decision to the
to be taken
Commission. However,
urgently,
the
set by
a
Chairman according the degree of urgency involved;

if a decision has
time-limit may be

shorter

(c) each Member State is to be permitted to require in writing
that
the draft decision referred to in paragraph 1 be
discussed by a plenary meeting of the Standing Committee,
giving its reasons in detail.

4. Where, in the opinion of the Commission, the written
observations of a Member State raise important new questions
of a scientific or
technical nature which have not been
addressed in the opinion of the Agency, 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 3 in accordance with the
procedure referred to in Article 77(2).

The Agency shall disseminate the documents referred to

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

Article 11

1.
The marketing authorisation shall be refused if, after
verification of the information and particulars submitted in
accordance with Article 6,
the
safety or the efficacy of the medicinal product have not been
properly or sufficiently demonstrated by the applicant.

it appears that

the quality,

likewise be refused if the particulars and
Authorisation shall
in accordance with
documents provided by the applicant
Article 6 are incorrect or if the labelling and package leaflets
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.

Article 12

4(4)

prejudice

to Article

of Directive
1. Without
a marketing authorisation which has been
2001/83/EC,
granted in accordance with the procedure laid down in 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.

The 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.

2.
Notification of marketing authorisation shall be published
in the Official Journal of the European Communities, quoting in
particular the date of authorisation and the registration number
in the Community Register.

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

After marketing authorisation has been granted,

4.
holder of the authorisation shall
dates of actual marketing of
human use in the Member States,
various presentations authorised.

the
inform the Agency of the
for
the

the medicinal product
taking into account

The holder shall also inform the Agency if the product ceases
to be marketed.

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 or prescriptions for the medical product concerned
at Community level.

Article 13

1. Without prejudice to paragraphs 2 and 3, authorisation
shall be valid for an unlimited period.

2.
Any authorisation which is not followed by the actual
placing of the medicinal product for human use authorised
on the Community market within two years of authorisation
shall cease to be valid.

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

4.
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, the authorisation shall
be valid for one year, on a renewable basis.

The arrangements for granting such authorisation shall be
determined by a Commission regulation adopted according to
the procedure referred to in Article 77(2).

C 75 E/196

EN

Official Journal of the European Communities

26.3.2002

In exceptional circumstances, when one of the grounds
5.
referred to in Annex I to Directive 2001/83/EC applies to an
application, and following consultation with the applicant,
authorisation may be granted only under specific conditions.
Continuation of the authorisation shall be linked to the annual
reassessment of these conditions.

6. When an application is lodged for a marketing author-
isation 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.
Due reasons are to be given for the request.

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

7. When adopting its opinion, the Committee for Human
Medicinal Products shall
include a proposal concerning the
criteria for the prescription or use of the medicinal products
in accordance with Article 70 of Directive 2001/83/EC.

8. Medicinal products for human use which have been auth-
orised in accordance with the provisions of this Regulation
shall benefit from the ten-year period of protection referred
to in Article 10(1) of Directive 2001/83/EC.

Article 14

The granting of authorisation shall not affect the civil and
criminal liability borne by the manufacturer or the holder of
the marketing authorisation by virtue of the prevailing national
law of the Member States.

CHAPTER 2

SUPERVISION AND SANCTIONS

Article 15

in respect of

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

2.
The holder of the marketing authorisation shall forthwith
supply to the Agency, to the Commission and to the Member
States any new information which might entail the amendment
of the particulars and documents referred to in Articles 8(3),

10a and 11 of Directive 2001/83/EC, or in Annex I thereto, or
Article 9(4) of this Regulation.

In particular, he/she 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
is
marketed and of any other new information which might
the
influence the evaluation of
veterinary medicinal product concerned.

veterinary medicinal product

the benefits and risks of

If

the holder of

3.
the authorisation for placing the
medicinal product for human use on the market proposes to
make any alteration to the information and particulars referred
to in paragraph 2, he/she shall submit the relevant application
to the Agency.

4.
The Commission shall, after consulting the Agency, make
appropriate arrangements for the examination of variations to
the terms of a marketing authorisation.

The Commission shall adopt these arrangements in the form of
a regulation in accordance with the procedure referred to in
Article 77(2).

Article 16

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
authorisation
provided for in Article 40 of Directive 2001/83/EC in respect
of the medicinal product concerned.

States which have

granted

the

In the

case of medicinal products

imported from
2.
non-member countries,
the supervisory authorities shall be
the competent authorities of the Member States in which the
controls referred to in Article 51(1)(b) of Directive 2001/83/EC
are carried out, unless appropriate arrangements 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 17

The supervisory authorities shall have responsibility 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 from a non-member
country satisfies the requirements laid down in Titles IV and
XI of Directive 2001/83/EC.

26.3.2002

EN

Official Journal of the European Communities

C 75 E/197

in

122

accordance Article

of Directive
2. Where,
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
the
marketing authorisation holder,
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
Human Medicinal Products.

the manufacturer or

the requirements

Subject

between

to any arrangements which may have been
3.
concluded
non-member
the Community
countries in accordance with Article 16(2), the Commission
may, following a reasoned request from a Member State, or
from the Committee for Human Medicinal Products, or on its
own initiative,
established in a
non-member country to submit to an inspection.

a manufacturer

require

and

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 medicinal product for human use
which has been authorised 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
the
immediately
procedure provided for in paragraphs 2 and 3.

it shall

initiate

shall

The suspensive measures referred to in paragraph 4 may
5.
be maintained in force until such time as a definitive decision
has been reached in accordance with the procedures referred to
in Article 10(2).

The Agency shall, upon request,

6.
concerned of the final decision.

inform any person

The inspection shall be undertaken by inspectors from the
Member State who possess the appropriate qualifications and
who may be accompanied by a rapporteur or expert appointed
by the Committee for Human Medicinal Products. The report
of the inspectors shall be made available to the Commission,
the Member States and the Committee for Human Medicinal
Products.

CHAPTER 3

PHARMACOVIGILANCE

Article 19

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

Article 18

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 on Community territory
is no longer fulfilling the obligations laid down in Title IV of
forthwith inform the
Directive 2001/83/EC,
Committee and the Commission,
in
detail and indicating the course of action proposed.

stating their

reasons

shall

they

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
the medicinal product concerned or where the
respect of
Committee for Human Medicinal Products has delivered an
opinion to that effect in accordance with Article 5 of this
Regulation.

the matter,

The Commission shall request the opinion of the Agency
2.
within a time-limit which it shall determine in the light of the
to examine the reasons
urgency of
in order
advanced. Whenever practicable,
the author-
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

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 about suspected adverse reactions to medicinal
products for human use which have been authorised by the
Community in accordance with this Regulation. If necessary,
in
the Committee
accordance with Article 5 of
formulate
opinions on the measures necessary.

for Human Medicinal Products may,

this Regulation,

These measures may include amendments to the marketing
authorisation granted in accordance with Article 10. They
shall be adopted in accordance with the procedures referred
to in Article 10(2).

The holder of the marketing authorisation and the competent
authorities of the Member States shall ensure that all relevant
information about 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.

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 procedures referred to in Article 10(2).

in

Article 21

The holder of an authorisation to place a medicinal product for
human use on the market granted by the Community in
accordance with the provisions of this Regulation shall have
permanently and continuously at his/her disposal an appro-
priately qualified person responsible for pharmacovigilance.

C 75 E/198

EN

Official Journal of the European Communities

26.3.2002

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

that

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

representatives,

(b) the preparation of the reports referred to in Article 22(3)
for the competent authorities of the Member States and the
Agency in accordance with the requirements of this Regu-
lation;

(c) ensuring that any request from the competent authorities
information necessary for
the benefits and risks of a medicinal
including the
the volume of sales or

for the provision of additional
the evaluation of
product
provision of
prescriptions for the medicinal product concerned;

is answered fully and promptly,

information about

(d) providing the

competent

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

to the evaluation of

Article 22

1.
The holder of an authorisation to place a medicinal
product for human use on the market shall ensure that all
suspected serious adverse reactions occurring within the
Community to a medicinal product authorised in accordance
with the provisions of this Regulation which are brought to
his/her attention by a health-care professional, are recorded and
reported immediately to the Member States in whose territory
the incident occurred, and in no case later than 15 days
following the receipt of the information.

The holder of an authorisation to place a medicinal product on
the market shall be obliged to record any other suspected
serious adverse reactions which meet the notification criteria,
in accordance with the guidelines referred to in Article 24, of
which he/she may reasonably be expected to be aware, and to
notify immediately the competent authority of the Member
State on whose territory the incident occurred, no later than
15 days following receipt of the information.

territory of

The holder of

a non-member

the authorisation to place the medical
2.
product for human use on the market shall ensure that all
suspected serious unexpected adverse reactions occurring in
the
reported
immediately to Member States and the Agency and in no
case
the
information. The arrangements for the reporting of suspected
unexpected adverse reactions which are not serious, whether in
the Community or in a non-member country, shall be adopted
in accordance with the procedure set out in Article 77(2).

than 15 days

following the

receipt of

country

later

are

these reactions shall be
Save in exceptional circumstances,
communicated in the form of a report
transmitted elec-
tronically and in accordance with the guidelines referred to
in Article 24.

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

the granting of

Unless other requirements have been laid down as a condition
of
the marketing authorisation by the
Community, these records shall be submitted, in the form of
an updated periodical report on safety, 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 records
shall be submitted at
three-yearly intervals, or immediately
upon request.

These records shall be accompanied by a scientific evaluation.

Article 23

reactions occurring within their

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

The Agency shall
systems
2001/83/EC.

inform the national pharmacovigilance
in accordance with Article 102 of Directive

Article 24

The Commission in consultation with the Agency, Member
States, and interested parties, shall draw up guidance on the
collection, verification and presentation of adverse reaction
reports.

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

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 medicinal products authorised in
accordance with Article 6 of Directive 2001/83/EC.

between

the

of

26.3.2002

EN

Official Journal of the European Communities

C 75 E/199

Article 25

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 non-member countries;
it shall send a copy
thereof to the Commission and the Member States.

Article 26

Any amendment which may be necessary to update the
provisions of this Chapter to take account of scientific and
technical progress shall be adopted in accordance with the
procedure referred to in Article 77(2).

TITLE III

AUTHORISATION AND SUPERVISION OF VETERINARY
MEDICINAL PRODUCTS

nature of the authorisation requested, and particularly of 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 any written consent or consents of the competent
authorities to the deliberate release into the environment of
the genetically modified organisms for research and devel-
opment purposes, where provided for in Part B of Directive
2001/18/EC or in Part B of Directive 90/220/EEC;

(b) the complete technical

file supplying the information
requested in Annexes III and IV to Directive 2001/18/EC;

(c)

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

CHAPTER 1

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

of research or development.

SUBMISSION AND EXAMINATION OF APPLICATIONS (cid:151)
AUTHORISATIONS

Article 27

A Committee for Veterinary Medicinal Products is hereby

1.
established. The Committee shall be part of the Agency.

2. Without prejudice to Article 50 and other tasks which
Community law may confer on it, in particular under Council
Regulation (EEC) No 2377/90 (1), the Committee for Veterinary
Medicinal Products shall be responsible for formulating the
the Agency on any question concerning the
opinion of
the files submitted in accordance with the
admissibility of
centralised procedure, the granting, variation, suspension or
withdrawal of
veterinary
an authorisation to place
medicinal product on the market arising in accordance with
the provisions of this Title and pharmacovigilance.

a

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 Veterinary Medicinal Products is given within
210 days of the receipt of a valid application.

the opinion of

the

shall

respect

environmental

In the case of a veterinary medicinal product containing or
consisting of genetically modified organisms, the opinion of
the Committee
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
set up by the
held by the rapporteur with the bodies
in accordance with
Community or
Directive 2001/18/EC.

the Member States

3.
At the request of the Executive Director of the Agency or
the Commission representative, the Committee for Veterinary
shall also draw up any opinions on
Medicinal Products
scientific matters concerning the evaluation of medicinal
products for veterinary use.

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

Article 29

Article 28

1.
Each application for authorisation for a medicinal product
for veterinary use shall specifically include all the information
and documents referred to in Articles 12(3), 13a and 14 of
Directive 2001/82/EC, and Annex I thereto. The information
and documents are to take account of the unique, Community

(1) OJ L 224, 18.8.1990, p. 1.

In order

1.
Veterinary Medicinal Products:

to prepare its opinion,

the Committee for

(a) shall verify that the particulars and documents submitted in
accordance with Article 28 comply with the requirements
the
of Directive 2001/82/EC and examine whether
conditions
issuing a
marketing authorisation are satisfied;

specified in this Regulation for

C 75 E/200

EN

Official Journal of the European Communities

26.3.2002

(b) may ask for a State laboratory or a laboratory designated
for this purpose to test the veterinary medicinal product, its
starting materials and, if need be, 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;

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

the maximum residue

level

(d) may request the applicant to supplement the particulars
accompanying the application within a specific time-limit.

Where the Committee avails itself of the option contained
in point (d) of the first subparagraph, the time-limit laid
down in the first subparagraph of Article 28(3) shall be
supplementary
suspended
time
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.

until

such

the

as

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

Article 30

Upon receipt of a written request from the Committee for
1.
Veterinary Medicinal Products, a Member State shall forward
the manufacturer of a
the information establishing that
veterinary medicinal product or
from a
the
non-member country is able to manufacture the veterinary
medicinal product concerned and/or carry out the necessary
control
and
documents supplied pursuant to Article 28.

in accordance with the particulars

importer

tests

undertaken by inspectors from the Member State who possess
the appropriate qualifications and who may be accompanied by
a rapporteur or expert appointed by the Committee.

Article 31

1.
The Agency shall forthwith inform the applicant if the
opinion of the Committee for Veterinary Medicinal Products 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 35(4).

2. Within 15 days of receipt of the opinion referred to in
paragraph 1, the applicant may provide written notice to the
Agency that he/she wishes to appeal. In that case the applicant
shall forward the detailed grounds for his/her appeal to the
Agency within 60 days of receipt of the opinion.

Within 60 days of receipt of
the
Committee for Veterinary Medicinal Products shall re-examine
its opinion in accordance with the conditions laid down in the
second subparagraph of Article 55(1). The conclusions reached
on the appeal shall be annexed to the final opinion.

the grounds for appeal,

3. Within 30 days of its adoption, the Agency shall forward
the final opinion of the Committee for Veterinary Medicinal
Products to the Commission, to the 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.

In the event of an opinion in favour of granting the
4.
relevant
veterinary
medicinal product on the market, the following documents
shall be annexed to the opinion:

authorisation to place

relevant

the

2. Where it considers it necessary in order to complete its
examination of the application, the Committee for Veterinary
Medicinal Products may require the applicant to submit to a
specific inspection of the manufacturing site of the veterinary
medicinal product concerned.

The inspection, which shall be completed within the time-limit
referred to in the first subparagraph of Article 28(3), shall be

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

shall

(b) 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

26.3.2002

EN

Official Journal of the European Communities

C 75 E/201

(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;

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

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

The provisions necessary for

5.
the implementation of
paragraph 3 shall be adopted by the Commission in accordance
with the procedure referred to in Article 77(2).

(e)

the assessment report.

The Agency shall disseminate the documents referred to

6.
in points (a) to (d) of Article 31(4).

Article 32

1. Within 30 days of receipt of the opinion referred to in
the
Article 27(2), the Commission shall prepare a draft of
decision to be taken in respect of the application.

In the event of a draft decision which envisages the granting of
marketing authorisation, the draft shall include the documents
mentioned in points (a) to (d) of Article 31(4), or shall make
reference to them.

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 the Member States and
the applicant.

The Commission shall take a final decision in accordance
if the draft

2.
with the procedure referred to in Article 77(3)
decision accords with the Agency’s opinion.

Article 33

The marketing authorisation shall be refused if, after
1.
verification of the information and particulars submitted in
accordance with Article 28, it appears that:

(a) the quality,

the safety or the efficacy of

the veterinary
medicinal product have not been properly or sufficiently
demonstrated by the applicant;

(b) in the case of zootechnical veterinary medicinal products
and growth promoters, when the safety and welfare of the
animals and/or consumer safety and benefits in terms of
health have not been sufficiently taken into account;

(c)

the waiting time 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 insufficiently substan-
tiated;

The Commission shall take a final decision in accordance with
the procedure referred to in Article 77(4) if the draft decision
does not accord with the Agency’s opinion.

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

prohibited under other Community provisions.

The

Standing Committee

3.
for Veterinary Medicinal
Products referred to in Article 77(1) shall adjust its rules of
procedure so as to take account of the tasks assigned to it by
this Regulation.

These adjustments shall provide that:

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

writing;

(b) each Member State is allowed 15 days to forward 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;

(c) each Member State shall be permitted to request in writing
that
the draft decision referred to in paragraph 1 be
discussed at a plenary meeting of the Standing Committee;
that request shall give reasons in detail.

likewise be refused if the particulars and
Authorisation shall
in accordance with
documents provided by the applicant
the labelling and package
if
Article 28 are incorrect or
leaflets proposed by the applicant are not in accordance with
Title V of Directive 2001/82/EC.

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

concerned throughout

Article 34

1. Without prejudice to Article 71 of Directive 2001/82/EC,
a marketing authorisation which has been issued 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.

C 75 E/202

EN

Official Journal of the European Communities

26.3.2002

The 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.

If the Committee for Veterinary Medicinal Products accepts the
application, the time-limits laid down in the first subparagraph
of Article 28(3) shall be reduced to 150 days.

Notification of marketing authorisation shall be published
2.
in the Official Journal of the European Communities, quoting in
particular the date of authorisation and the number in the
Community Register.

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

After marketing authorisation has been granted,

the
4.
inform the Agency of the
holder of the authorisation shall
dates of actual marketing of the veterinary medicinal product
in the Member States, taking into account the various presen-
tations authorised.

The holder shall also inform the Agency if the product ceases
to be marketed.

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 or prescriptions
at
for
Community level, broken down by Member State.

the medical product

6. When adopting its opinion, the Committee for Veterinary
include a proposal concerning the
Medicinal Products shall
conditions
the veterinary
for
medicinal products.

the prescription or use of

7.
Veterinary medicinal products which have been auth-
orised in accordance with the provisions of this Regulation
shall enjoy the periods of protection referred to in Articles
13 and 13a of Directive 2001/82/EC.

Article 36

The granting of authorisation shall not affect the civil and
criminal liability borne by the manufacturer or the holder of
the marketing authorisation by virtue of the prevailing national
law of the Member States.

CHAPTER 2

SUPERVISION AND SANCTIONS

Article 37

Article 35

1. Without prejudice to paragraphs 2 and 3, authorisation
shall be valid for unlimited duration.

2.
Any authorisation which is not followed by the actual
placing of the veterinary medicinal product authorised on the
Community market within two years of authorisation shall
cease to be valid.

in points

1.
After an authorisation has been issued in accordance with
this Regulation, the holder of the marketing authorisation shall,
in respect of the methods of production and control provided
for
(d) and (i) of Article 12(3) of Directive
2001/82/EC, take account of technical and scientific progress
and make any amendments that may be required to enable the
medicinal products to be manufactured and checked by means
of generally accepted scientific methods. He/she shall apply for
approval for these amendments in accordance with this Regu-
lation.

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

4.
In exceptional circumstances and following consultation
with the applicant, authorisation may be granted only under
specific conditions. Continuation of the authorisation shall be
linked to the annual reassessment of these conditions. Such
exceptional decisions may be adopted only for objective and
verifiable reasons.

5. When an application is lodged for a marketing author-
isation 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.
Due reasons are to be given for the request.

innovation,

therapeutic

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

At the request of the competent authority of a Member
3.
State or the Agency, the holder of the marketing authorisation
shall provide his 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
appointed in accordance with Council Directive
96/23/EC (1).

(1) OJ L 125, 23.5.1996, p. 10.

26.3.2002

EN

Official Journal of the European Communities

C 75 E/203

The holder of the marketing authorisation shall forthwith
4.
supply to the Agency, the Commission and the Member States
any new information which might entail the amendment of the
particulars and documents referred to in Articles 12(3), 13a and
14 of Directive 2001/82/EC, and in Annex I thereto, and in
Article 31(4) of this Regulation.

He/she 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 medicinal product is marketed and of any other
new information which might influence the evaluation of the
benefits
the veterinary medicinal product
concerned.

and risks of

If

the holder of

5.
the authorisation for placing the
veterinary product on the market proposes to make any
alteration to the information and documents referred to in
paragraph 4, he/she shall submit the relevant application to
the Agency.

The Commission shall, after consulting the Agency, make
6.
appropriate arrangements for the examination of variations to
the terms of a marketing authorisation.

The Commission shall adopt these arrangements in the form of
a regulation in accordance with the procedure laid down in
Article 77(2).

Article 38

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
authorisation
provided for in Article 44 of Directive 2001/82/EC in respect
of the manufacture of the medicinal product concerned.

States which have

granted

the

controls

2.
In the case of veterinary medicinal products imported
from non-member countries, the supervisory authorities shall
be the competent authorities of the Member States in which
the
referred to in Article 55(2) of Directive
2001/82/EC are carried out unless appropriate arrangements
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 39

The supervisory authorities shall have responsibility for
1.
verifying on behalf of the Community that the holder of the
marketing authorisation for the veterinary medicinal product
or the manufacturer or importer established on Community
territory satisfies the requirements laid down in Titles IV and
VIII of Directive 2001/82/EC.

in

90

of Directive
accordance Article
2. Where,
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 marketing auth-
the
the manufacturer or
orisation holder,
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.

the importer;

Subject

between

to any arrangements which may have been
3.
concluded
non-member
the Community
countries in accordance with Article 38(2), the Commission
from a Member
may, upon receipt of a reasoned request
State,
the Committee for Veterinary Medicinal Products, or
on its own initiative, require a manufacturer established in a
non-member country to submit to an inspection.

and

The inspection shall be undertaken by inspectors from the
Member State who possess the appropriate qualifications and
who may,
if need be, be accompanied by a rapporteur or
expert appointed by the Committee for Veterinary Medicinal
Products. The report of the inspectors shall be made available
to the Commission, the Member States and the Committee for
Veterinary Medicinal Products.

Article 40

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 on Community territory
is no longer fulfilling the obligations laid down in Title VII of
forthwith inform the
Directive 2001/82/EC,
in
Committee and the Commission,
detail and indicating the course of action proposed.

stating their

reasons

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
Committee for Veterinary Medicinal Products has delivered an
opinion to that effect in accordance with Article 27 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
to examine the reasons
urgency of
in order
advanced. Whenever practicable,
the author-
isation for placing the medicinal product on the market shall
be invited to provide oral or written explanations.

the holder of

the matter,

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

C 75 E/204

EN

Official Journal of the European Communities

26.3.2002

in
A final decision shall be adopted within six months,
accordance with the procedures referred to in Article 32(2).

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.

Article 43

The holder of an authorisation to place a veterinary medicinal
product on the market 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 be resident in the Community and
shall be responsible for the following:

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
the
immediately
procedure provided for in paragraphs 2 and 3.

it shall

initiate

shall

5.
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 procedures referred to in
Article 32(2).

The Agency shall, upon request,

6.
concerned of the final decision.

inform any person

CHAPTER 3

PHARMACOVIGILANCE

Article 41

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

Article 42

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. If necessary
in
the Committee for Veterinary Medicinal Products may,
accordance with Article 27 of
formulate
opinions on the measures necessary.

this Regulation,

These measures may include amendments to the marketing
authorisation. They shall be adopted in accordance with the
procedures referred to in Article 32(2).

The holder of
the marketing authorisation to place the
medicinal product on the market and the competent authorities
of the Member States shall ensure that all relevant information
about suspected adverse reactions to the veterinary medicinal
products authorised under this Regulation are brought to the
attention of the Agency in accordance with the provisions of
this Regulation.

that

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

representatives

(b) the preparation of the reports referred to in Article 44(3)
for the competent authorities of the Member States and the
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 benefits and risks of a veterinary
medicinal product
and promptly,
including the provision of information about the volume
the veterinary medicinal
for
of
product concerned;

sales or prescriptions

answered fully

is

(d) providing the

competent

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

to the evaluation of

Article 44

The holder of the authorisation for placing a veterinary
1.
medicinal product on the market shall ensure that all suspected
serious adverse
reactions, and adverse human reactions,
occurring within the Community to a veterinary medicinal
product authorised in accordance with the provisions of this
Regulation which are brought to his attention by a health-care
professional are recorded and reported immediately to the
Member States in whose territory the incident occurred, and
in no case later than 15 days following the receipt of the
information.

The holder of the marketing authorisation shall be obliged to
record any other suspected serious adverse reactions which
meet the notification criteria, in accordance with the guidelines
referred to in Article 46, of which he may reasonably be
expected to be aware, and to notify immediately the Member
States on whose territory the incident occurred and the
Agency, no later
the
information.

following receipt of

than 15 days

26.3.2002

EN

Official Journal of the European Communities

C 75 E/205

territory of

The holder of

the marketing authorisation for

the
2.
veterinary medicinal product shall ensure that all suspected
serious unexpected adverse reactions, and adverse human
reactions, occurring in the
a non-member
country, are reported immediately to the Member States and
the Agency and in no case later than 15 days following the
receipt of the information. The arrangements for the reporting
suspected unexpected adverse reactions which are not
of
serious, whether
in a
non-member country, shall be adopted in accordance with
the procedure referred to in Article 77(2).

in the Community or

arising

Save in exceptional circumstances,
these reactions shall be
communicated in the form of an electronically transmitted
report and in accordance with the guidance referred to in
Article 46.

In addition, the holder of the authorisation to place a
3.
veterinary medicinal product on the market shall be required
to maintain detailed records of all suspected adverse reactions
occurring within or outside the Community which are reported
to him/her by a health-care professional.

the granting of

Unless other requirements have been laid down as a condition
of
the marketing authorisation by the
Community, these records shall be submitted, in the form of
to the Agency and
a updated periodical report on safety,
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 records
shall be submitted at
three-yearly intervals, or immediately
upon request.

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

Article 47

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

Article 48

Any amendment necessary to update the provisions of this
Chapter to take account of scientific and technical progress
shall be adopted in accordance with the procedure referred
to in Article 77(2).

TITLE IV

THE EUROPEAN AGENCY FOR THE EVALUATION OF
MEDICINAL PRODUCTS RESPONSIBILITIES AND
ADMINISTRATIVE STRUCTURE

CHAPTER 1

TASKS OF THE AGENCY

Article 49

These records shall be accompanied by a scientific evaluation.

A European Agency for the Evaluation of Medicinal Products is
hereby established.

Article 45

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 immediately
to the Agency and the holder of the authorisation for placing
the veterinary medicinal product on the market, and in no case
later than 15 days following the 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 46

The Commission in consultation with the Agency, Member
States, and interested parties, shall draw up guidance on the
collection, verification and presentation of adverse reaction
reports.

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

Article 50

1.

The Agency shall comprise:

(a)

the Committee for Human Medicinal Products, which shall
be responsible for preparing the opinion of the Agency on
any question relating to the evaluation of medicinal
products for human use;

(b) the Committee for Veterinary Medicinal Products, which
shall be responsible for preparing the opinion of
the
Agency on any question relating to the evaluation of
medicinal products for veterinary use;

(c)

the Committee on Orphan Medicinal Products;

(d) the Committee on Herbal Medicinal Products;

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

(e) a Secretariat, which shall provide technical and adminis-
trative support for the Committees and ensure appropriate
coordination between them;

C 75 E/206

EN

Official Journal of the European Communities

26.3.2002

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

bilities set out in Article 57;

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

bilities set out in Articles 58, 59, and 60;

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 phar-
macovigilance obligations and the monitoring of
this
implementation;

(h) an Advisory Board, the functions of which are laid down in

Article 59.

The Committees referred to in points (a)

2.
to (d) of
paragraph 1 may each establish working parties and expert
groups. For this purpose they shall adopt, in accordance with
their rules of procedure, precise arrangements for delegating
certain tasks to these working parties and groups.

The Executive Director,

for Human Medicinal

in close consultation with the
3.
Committee
the
Products
Committee for Veterinary Medicinal Products, shall set up the
administrative structures and procedures allowing the devel-
opment of advice for companies, as referred to in point (1)
of Article 51, particularly regarding the development of new
therapies.

and

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

The Committee for Human Medicinal Products and the
they
important

4.
Committee for Veterinary Medicinal Products may,
consider
on
questions of a general scientific or ethical nature.

appropriate,

guidance

seek

it

if

(d) assuring the dissemination of

to medicinal products

reactions
Community, by means of
accessible to all Member States;

information on adverse
authorised in the
a database permanently

(e) distributing appropriate pharmacovigilance information to

the general public;

(f)

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;

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

(h) upon request, providing technical and scientific support
for steps to improve cooperation between the Community,
and
its Member
organisations
international
issues
non-member countries on scientific and technical
relating to the evaluation of medicinal products,
in
particular in the context of discussions organised in the
framework of international conferences on harmonisation;

States,

Article 51

1.
The Agency shall provide the Member States and the
institutions of the Community with the best possible scientific
advice on any question relating to the evaluation of the quality,
the safety, and the 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.

(i)

(j)

recording the status of marketing authorisations
medicinal
granted
Community procedures;

for
accordance with

products

in

creating a database on medicinal products, to be accessible
to the general public, and giving technical assistance for its
maintenance;

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

the Agency, acting particularly through its

(a)

(b)

(c)

the 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;

the coordination of
the supervision, under practical
conditions of use, of medicinal products which have
the
been

authorised within

the Community

and

(k) 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;

(l)

advising companies on the conduct of the various tests
and trials necessary to demonstrate the quality, safety
and efficacy of medicinal products and, in particular, on
the observance of good manufacturing practices;

(m) 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

26.3.2002

EN

Official Journal of the European Communities

C 75 E/207

(n) 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.

The database provided for in point (j) of paragraph 1
2.
shall
the
include the summaries of product characteristics,
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 Regu-
lation and those authorised under Chapters IV (Title III) of
Directive 2001/83/EC and Directive 2001/82/EC respectively.
The database shall subsequently be extended to include other
medicinal products.

Article 52

for

The Agency may give a scientific opinion, in the context of
cooperation with the World Health Organisation,
the
for human use
assessment of certain medicinal products
intended exclusively for the markets of non-member countries.
For this purpose, on the recommendation of the World Health
Organisation, a request shall be submitted to the Agency, in
accordance with the provisions of Article 6. The Committee for
Human Medicinal Products shall be responsible for drawing up
the Agency’s opinion,
in accordance with the provisions of
Articles 6 to 9. The provisions of Article 10 shall not apply.

Article 53

The Agency shall take care to ensure early identification
1.
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.

it shall contact

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

the body concerned in order

the

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 solve the conflict or to submit a joint
document to the Commission clarifying the scientific points of
conflict.

Save as otherwise provided for 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 solve

the conflict or to prepare a joint document clarifying the
scientific points of conflict.

Article 54

1.
Each Member State shall appoint, for a three-year term
which shall be renewable, one member to the Committee for
Human Medicinal Products and one member to the Committee
for Veterinary Medicinal Products. Members shall be chosen for
their
role and experience in the evaluation of medicinal
products for human and veterinary use as appropriate and
shall maintain relevant contacts with the competent national
authorities.

five additional
The committees may coopt a maximum of
specific scientific
members chosen on the basis of
competence. These members shall be appointed for a term of
three years which shall be renewable.

their

The members of each Committee may be accompanied by
experts in specific scientific or technical fields.

The Executive Director of the Agency or his/her representative
the Commission shall be entitled to
and representatives of
attend all
the Committees and working
parties convened by the Agency or its committees.

the meetings of

In addition to their task of providing objective scientific
2.
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
national
bodies
concerned with the marketing authorisation.

consultative

authorities,

including

the

The members of

scientific assessment and resources available

3.
the Committees and the experts
responsible for evaluating medicinal products shall rely on
the
to the
national marketing authorisation bodies. Each competent
national authority shall monitor the scientific level and inde-
pendence of
the evaluation carried out and facilitate the
activities of the Committee members and experts nominated.
The Member States shall refrain from giving the Committee
members and experts any instruction which is incompatible
with their own individual tasks or with the tasks and respon-
sibilities of the Agency.

4. 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 the divergent
positions, with their grounds.

Each Committee

5.
procedure.

shall

establish its own rules of

C 75 E/208

EN

Official Journal of the European Communities

26.3.2002

in particular lay down the procedures for
These rules shall
appointing and replacing the Chairman, the procedures for
delegating certain tasks to working parties and the estab-
lishment of a procedure for the urgent adoption of opinions,
particularly in relation to the provisions on market surveillance
and pharmacovigilance laid down in this Regulation.

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

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

The Agency or any of

the committees referred to in
5.
points (a)
to (d) of Article 50(1) may use the services of
experts for the discharge of other specific tasks for which
they are responsible.

Article 55

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

If there is an appeal against one of its opinions, the Committee
concerned shall appoint a different rapporteur and, where
necessary, a different co-rapporteur from those appointed for
the initial opinion. This appeal procedure may deal only with
the points of the opinion initially identified by the applicant
and may be based only on the scientific data available at the
time the Committee adopted the initial opinion.

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

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

3.
The provision of services by rapporteurs or experts shall
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/her employer, shall be remun-
erated 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 duties of the Agency,
in particular the need to provide a high level of public health
protection.

in a call

Article 56

1.
The membership of the committees referred to in points
(a) to (d) of Article 50(1) shall be made public. When each
appointment
the professional qualifications of
each member shall be specified.

is published,

the Management Board, members of

the
2. Members of
Advisory Board, 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. All indirect interests which could relate to
this industry shall be entered in a register held by the Agency
which the public may consult.

Members of the Management Board, members of the Advisory
Board, members of the Committees, rapporteurs and experts
who participate 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 points on the agenda.

Article 57

The Executive Director

1.
shall be appointed by the
Management Board, on a proposal from the Commission, for
a period of five years, which shall be renewable.

The Executive Director shall be the legal representative of

2.
the Agency. He/she 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
points (a) to (d) of Article 50(1), including making available
appropriate scientific and technical support;

(c)

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

(d) for

ensuring

coordination between the
committees referred to in points (a) to (d) of Article 50(1);

appropriate

26.3.2002

EN

Official Journal of the European Communities

C 75 E/209

(e)

for the preparation of the statement of revenue and expen-
diture and the execution of the budget of the Agency;

(f)

for all staff matters;

(g) for requesting the opinion of the Advisory Board on any
regarding the

point concerning the Agency’s activities
procedures for authorising medicinal products;

(h) for providing the secretariat for the Management Board and

the Advisory Board.

Each year,

3.
the
the Executive Director
following to the Management Board for approval, while
making
activities
between
concerning medicinal products
for human use and those
concerning veterinary medicinal products:

the Agency’s

distinction

submit

shall

a

(a) a draft report covering the activities of the Agency in the
previous year, including information about the number of
applications evaluated within the Agency, the time taken
for completion of
the evaluation and the medicinal
products authorised, rejected or withdrawn;

(b) a draft programme of work for the coming year;

(c)

the draft annual accounts;

(d) the draft forecast budget for the coming year.

The Executive Director shall approve all financial expen-

4.
diture of the Agency.

Article 58

the Member States,

The Management Board shall consist of four represen-
1.
tatives of
the
European Parliament, four representatives of the Commission,
and four representatives of patients and industry, appointed by
the Commission.

representatives of

four

The full members of the Management Board may arrange to be
replaced by alternates.

The term of office of the representatives shall be three

2.
years. It shall be renewable.

The Management Board shall elect its Chairman for a
3.
term of three years and shall adopt its rules of procedure.
Decisions of the Management Board shall be adopted by a
majority of two-thirds of its members.

4.
Before 31 January each year, the Management Board shall
adopt the general report on the activities of the Agency for the
previous year and its programme of work for the coming year
and forward them to the Member States,
the European
Parliament, the Council, and the Commission.

Article 59

The Advisory Board shall consist of one representative from
each of the national authorities competent in the authorisation
of human and veterinary medicinal products. The Executive
Director or his representative and the representatives of the
Commission shall have the right to attend the meetings of
the Advisory Board.

The Commission may submit
Community procedures for
products to the Advisory Board.

any question concerning
the authorisation of medicinal

The opinions of the Advisory Board shall not be binding in any
way.

the Executive
The Management Board, on the proposal of
Director
favourable opinion from the
Commission, shall draw up the provisions necessary for the
implementation of this Article.

and following a

CHAPTER 2

FINANCIAL PROVISIONS

Article 60

The

revenues of

1.
a
contribution from the Community and the fees paid by under-
takings for obtaining and maintaining a marketing author-
isation and for other services provided by the Agency.

the Agency

consist of

shall

The expenditure of the Agency shall

2.
include the staff,
infrastructure and operational expenses and
administrative,
expenses resulting from contracts entered into with third
parties.

By 15 February of each year at the latest, the Director
3.
shall draw up a preliminary draft budget covering the oper-
ational expenditure and the programme of work anticipated for
the following financial year, and shall forward this preliminary
draft to the Management Board together with an establishment
plan.

4.

Revenue and expenditure shall be in balance.

The Management Board shall adopt the draft budget and
5.
to the Commission, which on that basis shall
forward it
establish the relevant estimates
in the preliminary draft
general budget of the European Communities, which it shall
lay before the Council pursuant to Article 272 of the Treaty.

6.
The Management Board shall adopt the Agency’s final
budget before the beginning of the financial year, adjusting it
where necessary to the Community subsidy and the Agency’s
other resources.

7.

The Director shall implement the Agency’s budget.

C 75 E/210

EN

Official Journal of the European Communities

26.3.2002

8. Monitoring of the commitment and payment of all the
Agency’s expenditure and of the establishment and recovery of
all the Agency’s revenue shall be carried out by the financial
controller of the Commission.

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

9.
By 31 March of each year at the latest, the Director shall
forward to the Commission, the Management Board and the
Court of Auditors the accounts for all the Agency’s revenue
and expenditure in respect of the preceding financial year. The
Court of Auditors shall examine them in accordance with
Article 248 of the Treaty.

The Management Board, on a recommendation by the
10.
European Parliament, shall give a discharge to the Director in
respect of the implementation of the budget.

11.
After the Court of Auditors has delivered its opinion, the
Management Board shall adopt the internal financial provisions
specifying, in particular, the detailed rules for establishing and
implementing the Agency’s budget.

Article 61

The structure and the amount of the fees referred to in Article
60(1) shall be established by the Council acting under the
conditions provided for by the Treaty on a proposal
from
the Commission, following the latter’s consultation of organi-
sations
the pharmaceutical
industry at Community level.

representing the

interests of

CHAPTER 3

GENERAL PROVISIONS GOVERNING THE AGENCY

Article 62

The Agency shall have legal personality. In all Member States it
shall benefit from the widest powers granted by law to legal
persons.
In particular it may acquire and dispose of real
property and chattels and institute legal proceedings.

Article 63

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

The Court of
relating to compensation for such damages.

Justice shall have jurisdiction in any dispute

Article 64

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

Article 65

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 66

Members of the Management Board, members of the Advisory
Board, members of the Committees referred to in points (a) to
(d) of Article 50(1), and experts and officials and other servants
of the Agency, shall be required, even after their duties have
ceased, not to disclose information of the kind covered by the
duty of professional secrecy.

Article 67

in agreement with the Management
The Commission may,
invite representatives of
Board and the relevant Committee,
international organisations with interests in the harmonisation
of regulations applicable to medicinal products to participate as
the Agency. The conditions for
observers in the work of
participation
the
beforehand
Commission.

determined

shall

by

be

Article 68

in agreement with the
The Management Board shall,
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.

Article 69

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 administrative
measures to provide help to pharmaceutical companies at the
time of submission of their applications These administrative
measures shall include, in particular, the taking over responsi-
bility for some translations by the Agency.

26.3.2002

EN

Official Journal of the European Communities

C 75 E/211

Article 70

of

level

ensure

transparency,

an appropriate

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

TITLE V

GENERAL AND FINAL PROVISIONS

Article 71

a marketing

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

authorisation which are

state in detail

this Regulation, which is potentially of major
and (2) of
interest
from the point of view of public health, may be
made available to certain patients for compassionate reasons.

Before any decision is taken concerning the compas-
2.
sionate use of
falling within the
categories referred to in Article 3(1) and (2), the manufacturer
or the person applying for a marketing authorisation shall
notify the Agency.

the medicinal products

3. Where a compassionate use is envisaged, the Committee
for Human Medicinal Products, after consulting the manu-
facturer or the applicant, may adopt recommendations on
the conditions for use, the conditions for distribution and the
patients targeted. The Member States shall take any appropriate
measures to ensure that the recommendations may be imple-
mented under the applicable national legislation.

4.
The Agency shall keep an up-to-date list of the medicinal
products referred to in paragraph 1 made available for compas-
sionate use. Article 22(1) and Article 23 shall apply mutatis
mutandis.

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

5.
The recommendations referred to in paragraph 3 do not
affect the civil or criminal liability of the manufacturer or the
applicant for marketing authorisation.

Article 72

Only one authorisation may be granted to a particular

1.
applicant for a specific medicinal product.

However for objective verifiable reasons relating to public
health or
the availability of medicinal products to health
professionals and/or patients, the Commission may authorise
the same applicant to submit more than one application to the
Agency for that medicinal product.

As

regards medicinal products

the
2.
provisions of Article 98(3) of Directive 2001/83/EC apply to
medicinal products authorised under this Regulation.

for human use,

3. Without prejudice to the unique, Community nature of
the content of the documents referred to in points (a), (b) and
(c) of Article 9(4) and in points (a) to (d) of Article 31(4), this
Regulation shall not prohibit
two or more
commercial designs for a given medicinal product covered by
a single authorisation.

the use of

Article 73

1.
By way of derogation from Article 6 of Directive
2001/83/EC, a medicinal product not authorised for human
use belonging to the categories referred to in Article 3(1)

6.
No medicinal product administered for compassionate
reasons may be the subject of a paid transaction, except in
special cases determined beforehand in national legislation.

7.
The actual placing on the market of a medicinal product
previously administered for compassionate reasons, following
the granting of a marketing authorisation or a negative opinion
by the Committee for Human Medicinal Products within the
meaning of Article 9(2), shall render paragraphs 3 and 6 of
this Article invalid.

8.
This Article shall be without prejudice to Directive
2001/20/EC of the European Parliament and of the Council (1).

Article 74

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 the infringement
of the provisions of this Regulation or the regulations adopted
pursuant to it and shall take every measure necessary for their
implementation. The penalties shall be effective, proportionate
and dissuasive.

shall

inform the Commission of

Member States
these
provisions no later than 31 December 2004 of the penalties
laid down in accordance with the above subparagraph. They
shall send notification of any subsequent alterations as soon as
possible.

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

C 75 E/212

EN

Official Journal of the European Communities

26.3.2002

2. Member States shall inform the Commission immediately
of the institution of any litigation concerning the infringement
of this Regulation.

2. Where reference is made to this paragraph, the regulatory
procedure laid down in Article 5 of Decision 1999/468/EC
shall apply, in compliance with Article 7 and Article 8 thereof.

At the Agency’s request, the Commission may impose
3.
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 these penalties shall be laid down by the
Commission in accordance with the procedure foreseen in
Article 77(2).

Article 75

The period provided for
1999/468/EC shall be three months.

in Article 5(6) of Decision

3. Where reference is made to this paragraph, the advisory
procedure laid down in Article 3 of Decision 1999/468/EC
shall apply, in compliance with Article 7 and Article 8 thereof.

reference

4. Where
the
management procedure laid down in Article 4 of Decision
in compliance with Article 7 and
1999/468/EC shall apply,
Article 8 thereof.

to this paragraph,

is made

This Regulation shall not affect the competences vested in the
European Food Authority created by Regulation (EC) No . . . of
the Parliament and of the Council.

The period provided for
1999/468/EC shall be one month.

in Article 4(3) of Decision

Article 76

Article 78

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 [relating to medicinal
products for human use] and in Chapter 4 of Title III of
for
Directive 2001/82/EC [relating to medicinal products
veterinary use].

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

References to the repealed Regulation shall be construed as
references to this Regulation and shall be read in accordance
with the correlation table in Annex II.

Article 77

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

Article 79

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

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

26.3.2002

EN

Official Journal of the European Communities

C 75 E/213

ANNEX I

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

(cid:151) recombinant DNA technology;

(cid:151) controlled expression of genes coding for biologically active proteins in prokaryotes and eukaryotes including

transformed mammalian cells;

(cid:151) hybridoma and monoclonal antibody methods.

2. Veterinary medicinal products,

intended primarily for use as
including those not derived from biotechnology,
performance enhancers in order to promote the growth of treated animals or to increase yields from treated animals.

3. Medicinal products intended for administration to human beings, containing a new active substance which was not
included in the composition of any medicinal product for human use authorised in the Community prior to the date
of entry into force of this Regulation.

4. Medicinal products intended for veterinary use, containing a new active substance which was not included in the
composition of any medicinal product for veterinary use authorised in the Community prior to the date of entry into
force of this Regulation.

ANNEX II

CORRELATION TABLE

Present Regulation

Regulation (EEC) No 2309/93

Article 1

Article 2

Article 3

Article 4

Article 5

Article 6

Article 7

Article 8

Article 9

Article 10

Article 11

Article 12

Article 13

Article 14

Article 15

Article 16

Article 17

Article 18

Article 1

Article 2

Article 3

Article 4

Article 5

Article 6

Article 7

Article 8

Article 9

Article 10

Article 11

Article 12

Article 13

Article 14

Article 15

Article 16

Article 17

Article 18

C 75 E/214

EN

Official Journal of the European Communities

26.3.2002

Present Regulation

Regulation (EEC) No 2309/93

Article 19

Article 20

Article 21

Article 22

Article 23

Article 24

Article 25

Article 26

Article 27

Article 28

Article 29

Article 30

Article 31

Article 32

Article 33

Article 34

Article 35

Article 36

Article 37

Article 38

Article 39

Article 40

Article 41

Article 42

Article 43

Article 44

Article 45

Article 46

Article 47

Article 48

Article 49

Article 50

Article 51

Article 52

Article 53

Article 54

Article 55

Article 56

Article 19

Article 20

Article 21

Article 22

Article 23

Article 24

Article 25

Article 26

Article 27

Article 28

Article 29

Article 30

Article 31

Article 32

Article 33

Article 34

Article 35

Article 36

Article 37

Article 38

Article 39

Article 40

Article 41

Article 42

Article 43

Article 44

Article 45

Article 46

Article 47

Article 48

Article 49

Article 50

Article 51

New

New

Article 52

Article 53

Article 54

26.3.2002

EN

Official Journal of the European Communities

C 75 E/215

Present Regulation

Regulation (EEC) No 2309/93

Article 57

Article 58

Article 59

Article 60

Article 61

Article 62

Article 63

Article 64

Article 65

Article 66

Article 67

Article 68

Article 69

Article 70

Article 71

Article 72

Article 73

Article 74

Article 75

Article 76

Article 77

Article 78

Article 79

Annex I

Article 55

Article 56

New

Article 57

Article 58

Article 59

Article 60

Article 61

Article 62

Article 63

Article 64

Article 65

Article 66 (deleted)

New

New

Articles 67 and 68

New

New

Article 69

Article 70 (deleted)

New

Article 71

Articles 72 and 73

New

Article 74

Annex (Parts A and B)