Commission Regulation (EC) No 494/2003 of 18 March 2003 amending Council Regulation (EC) No 297/95 on the fees payable to the European Agency for the Evaluation of Medicinal Products
Date: 2003-03-18
Institutions: European Commission
Subjects: European Medicines Agency, marketing standard, payment, pharmaceutical legislation, veterinary medicinal product

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Official Journal of the European Union

19.3.2003

COMMISSION REGULATION (EC) No 494/2003

of 18 March 2003

amending Council Regulation (EC) No 297/95 on the fees payable to the European Agency for the
Evaluation of Medicinal Products

THE COMMISSION OF THE EUROPEAN COMMUNITIES,

Having regard to the Treaty establishing the European
Community,

Having regard to Council Regulation (EC) No 297/95 of 10
February 1995 on fees payable to the European Agency for the
Evaluation of Medicinal Products (1), as amended by Regulation
(EC) No 2743/98 (2), and in particular Article 12 thereof,

(7)

(8)

The general principles and overall structure of the fees
will be reviewed in the context of a general reflection on
the fee system, and in particular, on the basis of the
modification of Council Regulation (EEC) No 2309/93,
once adopted. These new amounts will
therefore be
applied during a limited period of time.

The measures provided for in this Regulation are in
accordance with the opinion of the Standing Commit-
tees,

Whereas:

(1)

(2)

(3)

(4)

(5)

(6)

On the basis of Article 57(1) of Council Regulation
(EEC) No 2309/93 of 22 July 1993,
laying down
Community procedures for the authorisation and super-
vision of medicinal products for human and veterinary
use and establishing a European Agency for the Evalua-
tion of Medicinal Products (3), as
last amended by
Commission Regulation (EC) No 649/98 (4), the revenues
of the Agency consist of a contribution and the fees paid
by undertakings
for obtaining and maintaining a
Community marketing authorisation and for other
services provided by the Agency.

The Agency derives the majority of its revenue from
fees.

Since the 1998 reform of the fee system, the Agency has
faced a relative decline in fee revenue due to inflation,
while the prevailing market conditions have led to a rise
in its expenditure.

the European
Figures from the Statistical Office of
Communities (Eurostat) support
the necessity for an
increase in all fees by 10 % in order to arrive at the same
level of purchasing power as was the case for the fees
set in 1998.

In view of the difficult economic conditions that the
Agency has had to face and which are affecting its
its
revenue and putting at risk the maintenance of
resource infrastructure and therefore its ability to carry
out its tasks, an additional adjustment of all fees, except
the annual fee, of 6 % is necessary.

In view of the growing importance of post-authorisation
surveillance activities in the work of the Agency and in
order to improve the capacity of the Community to
identify and manage risks arising from the use of,
in
particular, innovative medicines, the annual fee should
be adjusted by 16 %.

(1) OJ L 35, 15.2.1995, p. 1.
(2) OJ L 345, 19.12.1998, p. 3.
(3) OJ L 214, 24.8.1993, p. 1.
(4) OJ L 88, 24.3.1998, p. 7.

HAS ADOPTED THIS REGULATION:

Article 1

Regulation (EC) No 297/95 is amended as follows:

1. Article 3 is amended as follows:

(a) in the first subparagraph of paragraph 1(a),

‘ECU

200 000’ is replaced by ‘EUR 232 000’;

(b) in the second subparagraph of paragraph 1(a),

‘ECU

20 000’ is replaced by ‘EUR 23 200’;

(c) in the third subparagraph of paragraph 1(a),

‘ECU

5 000’ is replaced by ‘EUR 5 800’;

(d) in the first subparagraph of paragraph 1(b),

‘ECU

100 000’ is replaced by ‘EUR 116 000’;

(e) in the second subparagraph of paragraph 1(b),

‘ECU

20 000’ is replaced by ‘EUR 23 200’;

(f) in the third subparagraph of paragraph 1(b),

‘ECU

5 000’ is replaced by ‘EUR 5 800’;

(g) in the first subparagraph of paragraph 1(c),

‘ECU

50 000’ is replaced by ‘EUR 58 000’;

(h) in the second subparagraph of paragraph 1(c),

‘ECU

10 000’ is replaced by ‘EUR 11 600’;

(i) in the first subparagraph of paragraph 2(a), ‘ECU 5 000’

is replaced by ‘EUR 5 800’;

(j) in the first subparagraph of paragraph 2(b),

‘ECU

60 000’ is replaced by ‘EUR 69 600’;

(k) in paragraph 3,
‘EUR 11 600’;

(l) in paragraph 4,
‘EUR 17 400’;

‘ECU 10 000’

is

replaced by

‘ECU 15 000’

is

replaced by

(m) in

paragraph

5,

‘ECU 5 000’

is

replaced

by

‘EUR 5 800’;

(n) in paragraph 6,
‘EUR 75 600’.

‘ECU 60 000’

is

replaced by

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2. Article 4 is amended as follows:
(a) in the first subparagraph,

‘ECU 10 000’ is replaced by

‘EUR 11 600’;

(b) in the second subparagraph, ‘ECU 40 000’ is replaced by

‘EUR 46 400’.

3. Article 5 is amended as follows:

(a) in the first subparagraph of paragraph 1(a),

‘ECU

100 000’ is replaced by ‘EUR 116 000’;

(b) in the second subparagraph of paragraph 1(a),

‘ECU

10 000’ is replaced by ‘EUR 11 600’;

(c) in the third subparagraph of paragraph 1(a),

‘ECU

5 000’ is replaced by ‘EUR 5 800’;

(d) in the fourth subparagraph of paragraph 1(a),

‘ECU
50 000’ is replaced by ‘EUR 58 000’ and ‘ECU 5 000’
is replaced by ‘EUR 5 800’;

(e) in the first subparagraph of paragraph 1(b),

‘ECU

50 000’ is replaced by ‘EUR 58 000’;

(f) in the second subparagraph of paragraph 1(b),

‘ECU

10 000’ is replaced by ‘EUR 11 600’;

(g) in the third subparagraph of paragraph 1(b),

‘ECU

5 000’ is replaced by ‘EUR 5 800’;

(h) in the fourth subparagraph of paragraph 1(b),

‘ECU
25 000’ is replaced by ‘EUR 29 000’ and ‘ECU 5 000’
is replaced by ‘EUR 5 800’;

(i) in paragraph 1(c), first subparagraph,

‘ECU 25 000’ is

replaced by ‘EUR 29 000’;

(j) in paragraph 1(c), second subparagraph, ‘ECU 5 000’ is

replaced by ‘EUR 5 800’;

(k) in paragraph 1(c), third subparagraph,

‘ECU 5 000’ is

replaced by ‘EUR 5 800’;

(l) in the first subparagraph of paragraph 2(a) ‘ECU 5 000’

is replaced by ‘EUR 5 800’;

(n) in the second subparagraph of paragraph 2(b),

‘ECU

5 000’ is replaced by ‘EUR 5 800’;
‘ECU 5 000’
3,

paragraph

(o) in

is

replaced

by

‘EUR 5 800’;
(p) in paragraph 4,
‘EUR 17 400’;
paragraph

(q) in

5,

‘EUR 5 800’;
(r) in paragraph 6,
‘EUR 25 200’.

‘ECU 15 000’

is

replaced by

‘ECU 5 000’

is

replaced

by

‘ECU 20 000’

is

replaced by

4. Article 6 is amended as follows:
(a) in the first subparagraph,

‘ECU 10 000’ is replaced by

‘EUR 11 600’;

(b) in the second subparagraph, ‘ECU 20 000’ is replaced by

‘EUR 23 200’.

5. Article 7 is amended as follows:

(a) in the first subparagraph of paragraph 1, ‘ECU 50 000’

is replaced by ‘EUR 58 000’;

(b) in the second subparagraph of paragraph 1,

‘ECU

15 000’ is replaced by ‘EUR 17 400’;

(c) in the first subparagraph of paragraph 2, ‘ECU 15 000’

is replaced by ‘EUR 17 400’.

6. Article 8 is amended as follows:

(a) in the first

indent of paragraph 1,

‘ECU 60 000’

is

replaced by ‘EUR 69 600’;

(b) in the second indent of paragraph 1,

‘ECU 30 000’ is

replaced by ‘EUR 34 800’;

(c) in paragraph 2, ‘ECU 5 000’ is replaced by ‘EUR 5 800’.

Article 2

(m) in the first subparagraph of paragraph 2(b),

‘ECU

30 000’ is replaced by ‘EUR 34 800’;

This Regulation shall enter into force on the day 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 Brussels, 18 March 2003.

For the Commission

Erkki LIIKANEN

Member of the Commission