Council Regulation (EC) No 1647/2003 of 18 June 2003 amending Regulation (EEC) No 2309/93 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: 2003-06-18
Institutions: Council of the European Union
Subjects: European Medicines Agency, access to EU information, financial regulation

29.9.2003

EN

Official Journal of the European Union

L 245/19

COUNCIL REGULATION (EC) No 1647/2003

of 18 June 2003

amending Regulation (EEC) No 2309/93 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

THE COUNCIL OF THE EUROPEAN UNION,

(4)

Having regard to the Treaty establishing the European
Community, and in particular Article 308 thereof,

Appropriate provisions should therefore be included in
Regulation (EEC) No 2309/93 to make Regulation (EC)
No 1049/2001 applicable to the European Agency for
the Evaluation of Medicinal Products, as
should a
provision for appeals against a refusal of access to
documents.

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

(5)

Regulation (EEC) No 2309/93 should therefore be
amended accordingly,

Having regard to the opinion of the European Parliament (2),

Having regard to the opinion of the Court of Auditors (3),

Whereas:

HAS ADOPTED THIS REGULATION:

Article 1

(1)

(2)

Certain provisions of Council Regulation (EEC) No
2309/93 of 22 July 1993 laying down Community
the authorisation and supervision of
procedures for
medicinal products for human and veterinary use and
establishing a European Agency for the Evaluation of
Medicinal Products (4) should be brought into line with
Council Regulation (EC, Euratom) No 1605/2002 of 25
June 2002 on the Financial Regulation applicable to the
European Communities (5)
general budget of
(hereinafter
Financial
general
Regulation'), and in particular Article 185 thereof.

referred to as

‘the

the

The general principles and limits governing right of
access to documents provided for in Article 255 of the
Treaty have been laid down by Regulation (EC) No
the
1049/2001 of
Council of 30 May 2001 regarding public access to
European
Commission
documents (6).

the European Parliament and of

Parliament,

Council

and

(3) When Regulation (EC) No 1049/2001 was adopted, the
three institutions agreed in a joint declaration that the
agencies and similar bodies should implement rules
conforming to those of that Regulation.

(1) OJ C 331 E, 31.12.2002, p. 61.
(2) Opinion delivered on 27.3.2003 (not yet published in the Official

Journal).

(3) OJ C 285, 21.11.2002, p. 4.
(4) OJ L 214, 24.8.1993, p. 1. Regulation as amended by Commission

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

(5) OJ L 248, 16.9.2002, p. 1, with Corrigendum in OJ L 25,

30.1.2003, p. 43.

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

Regulation (EEC) No 2309/93 is hereby amended as follows.

1.

In Article 55:

(a)

the fifth indent of paragraph 2 shall be replaced by the
following:

‘— for

the preparation of

estimates
expenditure, and execution of its budget,'

the Agency's

of

the draft statement of
and

revenue

(b) paragraph 3 shall be replaced by the following:

for

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

for human use

and those

coming

year

(c) paragraph 4 shall be deleted.

2. Article 56(5) shall be replaced by the following:

The Management Board shall adopt

‘5.
the annual
report on the Agency's activities and forward it by 15 June
at the latest to the European Parliament, the Council, the
Commission,
Social
Committee, the Court of Auditors and the Member States.

Economic

European

and

the

6.
The Agency shall forward annually to the budgetary
authority any information relevant to the outcome of the
evaluation procedures.'

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EN

Official Journal of the European Union

29.9.2003

3. Article 57 shall be replaced by the following:

‘Article 57

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

Estimates of all the revenue and expenditure of the
1.
Agency
year,
corresponding to the calendar year, and shall be shown in
the budget of the Agency.

shall be prepared for

each financial

The revenue and expenditure shown in the budget

2.
shall be in balance.

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

and maintaining

The expenditure of

include staff
4.
remuneration,
costs,
operating expenses and expenses resulting from contracts
entered into with third parties.

and infrastructure

the Agency shall

administrative

5.
Each year the Management Board, on the basis of a
draft drawn up by the Executive Director, shall produce an
estimate of revenue and expenditure for the Agency for the
following financial year. This estimate, which shall include
a draft establishment plan, shall be forwarded by the
Management Board to the Commission by 31 March at the
latest.

6.
The estimate shall be forwarded by the Commission
to the European Parliament and the Council (hereinafter
referred to as the ‘budgetary authority') together with the
preliminary draft general budget of the European Union.

On the basis of the estimate, the Commission shall
7.
enter
the
in the preliminary draft general budget of
European Union the estimates it deems necessary for the
establishment plan and the amount of the subsidy to be
charged to the general budget, which it shall place before
the budgetary authority in accordance with Article 272 of
the Treaty.

The

8.
appropriations for the subsidy to the Agency.

budgetary

authority

shall

authorise

the

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

9.
The budget of the Agency shall be adopted by the
Management Board. It shall become final following final
adoption of the general budget of the European Union.
Where appropriate, it shall be adjusted accordingly.

the budgetary

any project which may have

The Management Board shall, as soon as possible,
10.
intention to
authority of
notify
significant
implement
financial
in
particular any projects relating to property such as the
inform the
rental or purchase of buildings.
Commission thereof.

implications for the funding of

its budget,

shall

its

It

4. The following Article shall be inserted:

‘Article 57a

The Executive Director shall implement the budget of

1.
the Agency.

2.
By 1 March at the latest following each financial year,
the Agency's accounting officer shall communicate the
provisional accounts
to the Commission's accounting
together with a report on the budgetary and
officer
year. The
that
financial management
financial
Commission's accounting officer
shall consolidate the
provisional accounts of the institutions and decentralised
bodies in accordance with Article 128 of
the general
Financial Regulation.

for

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

for that

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

The Management Board of the Agency shall deliver

5.
an opinion on the Agency's final accounts.

The Executive Director shall, by 1 July at the latest
6.
following each financial year, forward the final accounts to
the European Parliament, the Council, the Commission and
the Court of Auditors,
together with the Management
Board's opinion.

7.

The final accounts shall be published.

The Executive Director

send the Court of
8.
Auditors a reply to its observations by 30 September at the
latest. He shall also send this reply to the Management
Board.

shall

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

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Official Journal of the European Union

L 245/21

The European Parliament, on a recommendation
10.
from the Council acting by a qualified majority, shall,
before 30 April of year N + 2, give a discharge to the
Executive Director in respect of the implementation of the
budget for year N.

been

depart

consulted. They may not

11.
The financial rules applicable to the Agency shall be
adopted by the Management Board after the Commission
has
from
Commission Regulation (EC, Euratom) No 2343/2002 of
19 November 2002 on the framework Financial Regulation
for
the bodies referred to in Article 185 of Council
Regulation (EC, Euratom) No 1605/2002 on the Financial
Regulation applicable
the
European Communities (*) unless specifically required for
the Agency's operation and with the Commission's prior
consent.

to the general budget of

(*) OJ L 357, 31.12.2002, p. 72, with Corrigendum in

OJ L 2, 7.1.2003, p. 39.'

5. The following Article shall be inserted:

‘Article 63a

Regulation (EC) No 1049/2001 of

1.
the European
Parliament and of the Council of 30 May 2001 regarding
and
public

to European Parliament, Council

access

Commission documents (*) shall apply to documents held
by the Agency.

for

The Management Board shall adopt

the practical
2.
arrangements
implementing Regulation (EC) No
1049/2001 within six months of entry into force of
Council Regulation (EC) No 1647/2003 of 18 June 2003
amending Regulation (EEC) No 2309/93 laying down
Community
and
for
procedures
for human and
supervision of medicinal products
veterinary use and establishing a European Agency for the
Evaluation of Medicinal Products (**).

authorisation

the

3.
Decisions taken by the Agency pursuant to Article 8
of Regulation (EC) No 1049/2001 may form the subject of
a complaint to the Ombudsman or of an action before the
Court of Justice, under the conditions laid down in Articles
195 and 230 of the Treaty respectively.

(*) OJ L 145, 31.5.2001, p. 43.
(**) OJ L 245, 29.9.2003, p. 19.'

Article 2

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

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

Done at Luxembourg, 18 June 2003.

For the Council

The President

G. DRYS