Proposal for a Council Regulation amending Regulation (EC) No 2309/93 as regards the budgetary and financial rules applicable to the European Agency for the Evaluation of Medicinal Products and access to the Agency's documents
Date: 2002-07-17
Institutions: European Commission
Subjects: European Medicines Agency, access to information, administrative transparency, appointment of staff, approximation of laws, financial regulation, general budget (EU)

31.12.2002

EN

Official Journal of the European Communities

C 331 E/61

Proposal for a Council Regulation amending Regulation (EEC) No 2309/93 as regards the budgetary
and financial rules applicable to the European Agency for the Evaluation of Medicinal Products and
access to the Agency's documents

(2002/C 331 E/09)

COM(2002) 406 final — 2002/0170(CNS)

(Submitted by the Commission on 17 July 2002)

THE COUNCIL OF THE EUROPEAN UNION,

1. Article 55(1) is replaced by the following:

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

Having regard to the proposal from the Commission,

Having regard to the opinion of the European Parliament,

Whereas:

The Agency shall be under

‘1.
the authority of an
Executive Director appointed by the Management Board,
on a proposal from the Commission, for a period of five
years, which, on a proposal from the Commission, may be
extended for one further period not exceeding five years.’

(a)

in paragraph 2,
following:

the fifth indent

is replaced by the

(1) The provisions of Council Regulation (EEC) No 2309/93 of
22 July 1993 laying down Community procedures for the
authorisation and supervision of medicinal products for
human and veterinary use and establishing a European
the Evaluation of Medicinal Products (1)
Agency for
should be harmonised with Council Regulation (EC,
. . . on the Financial Regulation
Euratom) No . . . of
applicable
the European
Communities, and in particular Article 185 thereof.

general budget of

to the

(2) 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 1049/2001
of the European Parliament and of the Council of 30 May
2001 regarding public access to European Parliament,
Council and Commission documents (2).

(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 in
line with that Regulation.

(4) Appropriate provisions should therefore be included in
Regulation (EEC) No 2309/92 to make Regulation (EC)
No 1049/2001 applicable to the European Agency for
the Evaluation of Medicinal Products, as should a clause
guaranteeing a right of appeal against a refusal of access
to documents.

(5) It would be useful to clarify the rules for the conditions and
procedures applying to the renewal of the term of office of
the Executive Director and to harmonise the rules for all
is
the Community bodies
possible,

for which re-appointment

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

accordingly,

HAS ADOPTED THIS REGULATION:

Article 1

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

(1) 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).

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

‘— for

the preparation of

statement of
estimates of the Agency's revenue and expenditure,
and execution of its budget,’

the draft

(b) paragraph 3 is 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

coming

those

year

and

(c) Paragraph 4 is deleted.

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

‘The Management Board shall adopt the annual report on
the Agency's activities and transmit it by 15 June at the
the
latest
the
Commission,
Court of Auditors and the Member States.’

the Council,
the Economic and Social Committee,

to the European Parliament,

3. Article 57 is replaced by the following:

‘Article 57

1.
Estimates of all the revenue and expenditure of the
Agency shall be prepared for each financial year, corre-
sponding to the calendar year, and shall be shown in the
budget of the Agency.

The revenue and expenditure shown in the budget shall be
in balance.

2.
The Agency's revenues shall consist of a contribution
from the Community and fees paid by undertakings for
obtaining and maintaining Community marketing authoris-
ations and for other services provided by the Agency. The
expenditure of the Agency shall include staff remuneration,
administrative
and operating
expenses, and expenses resulting from contracts entered
into with third parties.

and infrastructure

costs,

C 331 E/62

EN

Official Journal of the European Communities

31.12.2002

at

the

latest,

Each year, by 15 February

the
3.
Management Board, on the basis of a draft drawn up by
the Executive Director,
shall produce a statement of
estimates of revenue and expenditure for the Agency for
the following financial year. This statement of estimates,
which shall
include a draft establishment plan, shall be
transmitted by the Management Board to the Commission
by 31 March at the latest.

The statement of estimates shall be transmitted by the
Commission to the European Parliament and the Council
“budgetary authority”)
(hereinafter
together with the preliminary draft budget of
the
Communities.

referred to as

the

The budgetary authority shall determine the appro-

4.
priations available for the subsidy to the Agency.

The budgetary authority shall adopt the establishment

5.
plan for the Agency.

The Management Board shall adopt

6.
the Agency's
definitive budget before the beginning of the budget year,
adjusting it as necessary to the Community subsidy and the
Agency's other resources.

The Executive Director shall implement the budget of

7.
the Agency.

The Commission's internal auditor shall exercise the
the Agency as over Commission

8.
same powers over
departments.

accounts

to the Commission's

9.
By 1 March at the latest following each financial year,
the Agency's accounting officer shall communicate the
provisional
accounting
together with a report on the budgetary and
officer
year. The
financial management
that
Commission's accounting officer
the
provisional accounts of the institutions and decentralised
bodies within the meaning of Article 128 of Regulation
(EC, Euratom) No . . . (*) (hereinafter “the general Financial
Regulation”).

financial
shall

consolidate

for

By 31 March at the latest following each financial
10.
year, the Commission's accounting officer shall transmit the
Agency's provisional accounts to the Court of Auditors,
together with a report on the budgetary and financial
financial year. The report on the
management
budgetary and financial management for the financial year
shall also be transmitted to the European Parliament and the
Council.

for that

On receipt of the Court of Auditors' observations on
11.
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 transmit them to the Management Board
for an opinion.

The Executive Director shall, by 1 July at the latest
13.
following each financial year, transmit the final accounts to
the European Parliament, the Council, the Commission and
the Court of Auditors,
together with the Management
Board's opinion.

14.

The final accounts shall be published.

15.
The Agency's Executive Director shall send the Court
of Auditors a reply to its observations by 30 September at
the latest. He shall also send this reply to the Management
Board.

16.
The European Parliament, on a recommendation
from the Council acting by a qualified majority, shall,
before 30 April of year N + 2, give a discharge to the
Executive Director in respect of the implementation of the
budget for year N.

17.
The financial rules applicable to the Agency shall be
adopted by the Management Board after the Commission
has been consulted. They may not depart
from the
framework Financial Regulation adopted by the Commission
under Article 185 of the Financial Regulation applicable to
the general budget of the European Communities unless
specifically required for the Agency's operation and with
the Commission's prior consent.
___________
(*) OJ L . . .’

4. A new Article 63a is inserted:

‘Article 63a

Regulation (EC) No 1049/2001 of the European Parliament
and of the Council (*) shall apply to documents held by the
Agency.

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

Decisions taken by the Agency under Article 8 of Regu-
lation (EC) No 1049/2001 may be appealed by means of
a complaint to the Ombudsman or an action before the
the European Communities, under
Court of
Articles 195 and 230 of the EC Treaty respectively.
___________
(*) OJ L 145, 31.5.2001, p. 43.’

Justice of

Article 2

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

The Management Board of the Agency shall deliver

12.
an opinion on the Agency's final accounts.

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