Commission Regulation (EC) No 249/2009 of 23 March 2009 amending Council Regulation (EC) No 297/95 as regards the adjustment of the fees of the European Medicines Agency to the inflation rate
Date: 2009-03-23
Institutions: European Commission
Subjects: European Medicines Agency, inflation, quasi-fiscal charge, type of business

L 79/34

EN

Official Journal of the European Union

25.3.2009

COMMISSION REGULATION (EC) No 249/2009

of 23 March 2009

amending Council Regulation (EC) No 297/95 as regards the adjustment of the fees of the European
Medicines Agency to the inflation rate

THE COMMISSION OF THE EUROPEAN COMMUNITIES,

is therefore appropriate that this Regulation enters into
force as a matter of urgency and applies from that date,

Having regard to the Treaty
Community,

establishing the European

HAS ADOPTED THIS REGULATION:

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), and in particular
Article 12 thereof,

Whereas:

Article 67(3) of Regulation (EC) No 726/2004 of the
European Parliament and of the Council of 31 March
2004 laying down Community procedures for the au-
thorisation and supervision of medicinal products for
human and veterinary use and establishing a European
Medicines Agency (2), stipulates that the revenue of the
European Medicines Agency (hereinafter
the Agency)
shall consist of a contribution from the Community
and fees paid by undertakings to the Agency. Regulation
(EC) No 297/95 lays down the categories and levels of
such fees.

Article 12 of Regulation (EC) No 297/95 lays down that
the Commission shall review the fees of the Agency by
reference to the inflation rate and update them, with
effect from 1 April of each year.

Those fees should therefore be updated by reference to
the inflation rate of 2008. The inflation rate in the
Community, as published by the Statistical Office of
the European Communities
(Eurostat), was 3,7 % in
2008.

For the sake of simplicity, the adjusted levels of the fees
should be rounded to the nearest EUR 100.

Article 1

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

1. Article 3 is amended as follows:

(a) paragraph 1 is amended as follows:

(i) point (a) is amended as follows:

— in the first

subparagraph,
replaced by ‘EUR 251 600’,

‘EUR 242 600’

is

— in the second subparagraph,
replaced by ‘EUR 25 200’,

‘EUR 24 300’

is

— in the

third subparagraph,

replaced by ‘EUR 6 300’;

(ii) point (b) is amended as follows:

— in the

first

subparagraph,

replaced by ‘EUR 97 600’,

‘EUR 6 100’

is

‘EUR 94 100’

is

— in the second subparagraph,
replaced by ‘EUR 162 600’,

‘EUR 156 800’

is

— in the

third subparagraph,

replaced by ‘EUR 9 700’,

‘EUR 9 400’

is

— in the fourth subparagraph,
replaced by ‘EUR 6 300’;

‘EUR 6 100’

is

Regulation (EC) No 297/95 should therefore be amended
accordingly.

(iii) point (c) is amended as follows:

For reasons for legal certainty this Regulation should not
apply to valid applications which are pending on 1 April
2009.

Pursuant to Article 12 of Regulation (EC) No 297/95 the
update has to be made with effect from 1 April 2009. It

— in the

first

subparagraph,

replaced by ‘EUR 75 500’,

‘EUR 72 800’

is

— in the second subparagraph,

‘EUR 18 200 to
is replaced by ‘EUR 18 900 to

EUR 54 600’
EUR 56 600’,

(1) OJ L 35, 15.2.1995, p. 1.
(2) OJ L 136, 30.4.2004, p. 1.

— in the

third subparagraph,

replaced by ‘EUR 6 300’;

‘EUR 6 100’

is

(1)

(2)

(3)

(4)

(5)

(6)

(7)

25.3.2009

EN

Official Journal of the European Union

L 79/35

(b) paragraph 2 is amended as follows:

— the fourth subparagraph is amended as follows:

(i) the first subparagraph of point (a)

is amended as

follows:

— ‘EUR 2 600’ is replaced by ‘EUR 2 700’,

— ‘EUR 6 100’ is replaced by ‘EUR 6 300’;

(ii) point (b) is amended as follows:

— ‘EUR 60 600’ is replaced by ‘EUR 62 800’

— ‘EUR 6 100’ is replaced by ‘EUR 6 300’;

(ii) point (b) is amended as follows:

— in the

first

subparagraph,

replaced by ‘EUR 62 800’,

‘EUR 60 600’

is

— in the

first

subparagraph,

replaced by ‘EUR 75 500’,

‘EUR 72 800’

is

— in the second subparagraph,
replaced by ‘EUR 106 300’,

‘EUR 102 500’

is

— in the third subparagraph,
replaced by ‘EUR 12 500’,

‘EUR 12 100’

is

— in the fourth subparagraph,
replaced by ‘EUR 6 300’,

‘EUR 6 100’

is

— the fifth subparagraph is amended as follows:

— in the second subparagraph, ‘EUR 18 200 to EUR
is replaced by ‘EUR 18 900 to EUR

54 600’
56 600’;

‘EUR 12 100’

is replaced by ‘EUR

(c)

in paragraph 3,
12 500’;

(d) in paragraph 4,

18 900’;

‘EUR 18 200’

is replaced by ‘EUR

— ‘EUR 30 300’ is replaced by ‘EUR 31 400’

(e)

in paragraph 5, ‘EUR 6 100’ is replaced by ‘EUR 6 300’;

(f) paragraph 6 is amended as follows:

(i) in the first subparagraph, ‘EUR 87 000’ is replaced by

‘EUR 90 200’;

(ii) in the second subparagraph,

‘EUR 21 700 to EUR
65 200’ is replaced by ‘EUR 22 500 to EUR 67 600’.

2.

in Article 4, ‘EUR 60 600’ is replaced by ‘EUR 62 800’.

— ‘EUR 6 100’ is replaced by ‘EUR 6 300’;

(iii) point (c) is amended as follows:

— in the

first

subparagraph,

replaced by ‘EUR 31 400’,

‘EUR 30 300’

is

— in the second subparagraph ‘EUR 7 500 to EUR
is replaced by ‘EUR 7 800 to EUR

22 700’
23 500’,

— in the

third subparagraph,

replaced by ‘EUR 6 300’,

‘EUR 6 100’

is

3. Article 5 is amended as follows:

(a) paragraph 1 is amended as follows:

(b) Paragraph 2 is amended as follows:

(i) in point (a) ‘EUR 2 600’ is replaced by ‘EUR 2 700’

and ‘EUR 6 100’ is replaced by ‘EUR 6 300’;

(i) point (a) is amended as follows:

(ii) point (b) is amended as follows:

— in the first

subparagraph,
replaced by ‘EUR 125 800’,

‘EUR 121 300’

is

— in the second subparagraph,
replaced by ‘EUR 12 500’,

‘EUR 12 100’

is

— in the

first

subparagraph,

replaced by ‘EUR 37 700’,

‘EUR 36 400’

is

— in the second subparagraph, ‘EUR 9 100 to EUR
replaced by ‘EUR 9 400 to EUR

is

27 300’
28 300’,

— in the

third subparagraph,

‘EUR 6 100’

is

replaced by ‘EUR 6 300’,

— in the

third subparagraph,

replaced by ‘EUR 6 300’;

‘EUR 6 100’

is

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EN

Official Journal of the European Union

25.3.2009

(c)

in paragraph 3, ‘EUR 6 100’ is replaced by ‘EUR 6 300’;

(d) in paragraph 4,

18 900’;

‘EUR 18 200’

is replaced by ‘EUR

(e)

in paragraph 5, ‘EUR 6 100’ is replaced by ‘EUR 6 300’;

(f) paragraph 6 is amended as follows:

(i) in the first subparagraph, ‘EUR 29 000’ is replaced by

‘EUR 30 100’;

(ii) in the second subparagraph ‘EUR 7 200 to EUR
21 700’ is replaced by ‘EUR 7 500 to EUR 22 500’;

4.

in Article 6, ‘EUR 36 400’ is replaced by ‘EUR 37 700’;

5. Article 7 is amended as follows:

(a)

in the first paragraph,
‘EUR 62 800’;

‘EUR 60 600’

is replaced by

(b) in the second paragraph,

‘EUR 18 900’;

‘EUR 18 200’

is replaced by

6. Article 8 is amended as follows:

(a) paragraph 1 is amended as follows:

(iii) in the fourth subparagraph,

‘EUR 18 200 to EUR
54 600’ is replaced by ‘EUR 18 900 to EUR 56 600’;

(iv) in the fifth subparagraph,

‘EUR 9 100 to EUR
27 300’ is replaced by ‘EUR 9 400 to EUR 28 300’;

(b) paragraph 2 is amended as follows:

(i) in the second subparagraph,
replaced by ‘EUR 251 600’;

‘EUR 242 600’

is

(ii) in the third subparagraph, ‘EUR 121 300’ is replaced

by ‘EUR 125 800’;

(iii) in the fifth subparagraph,
is

‘EUR 2 600 to EUR
replaced by ‘EUR 2 700 to EUR

209 100’
216 800’;

(iv) in the sixth subparagraph, ‘EUR 104 600’ is replaced

by ‘EUR 108 500’;

(c)

in paragraph 3, ‘EUR 6 100’ is replaced by ‘EUR 6 300’.

Article 2

This Regulation shall not apply to valid applications pending on
1 April 2009.

(i) in the

second subparagraph,

replaced by ‘EUR 75 500’;

‘EUR 72 800’

is

Article 3

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

(ii) in the third subparagraph, ‘EUR 36 400’ is replaced

by ‘EUR 37 700’;

It shall apply from 1 April 2009.

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

Done at Brussels, 23 March 2009.

For the Commission

Günter VERHEUGEN
Vice-President