Commission Regulation (EC) No 312/2008 of 3 April 2008 amending Council Regulation (EC) No 297/95 as regards the adjustment of the fees of the European Medicines Agency to the inflation rate
Date: 2008-04-03
Institutions: European Commission
Subjects: European Medicines Agency, inflation, quasi-fiscal charge, type of business

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Official Journal of the European Union

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COMMISSION REGULATION (EC) No 312/2008

of 3 April 2008

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,

(8)

Having regard to the Treaty
Community,

establishing the European

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:

(1)

(2)

(3)

(4)

(5)

(6)

(7)

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.

the fees of

Since 2005,
the Agency have not been
adjusted to the inflation rate. It is therefore necessary
to review those fees by reference to the inflation rate
in the Community in the years 2006 and 2007.

The inflation rate in the Community, as published by the
Statistical Office of the European Communities (Eurostat),
was 2,2 % in 2006 and 2,3 % in 2007.

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

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

For reasons for legal certainty this Regulation should not
apply to valid applications which are pending on 1 April
2008.

(1) OJ L 35, 15.2.1995, p. 1. Regulation as last amended by Regulation

(EC) No 1905/2005 (OJ L 304, 23.11.2005, p. 1).

(2) OJ L 136, 30.4.2004, p. 1. Regulation as last amended by Regu-

lation (EC) No 1394/2007 (OJ L 324, 10.12.2007, p. 121).

Pursuant to Article 12 of Regulation (EC) No 297/95 the
update has to be made with effect from 1 April 2008, it
is therefore appropriate that this Regulation enter into
force as a matter of urgency and apply from that date,

HAS ADOPTED THIS REGULATION:

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 242 600’,

‘EUR 232 000’

is

— in the second subparagraph,
replaced by ‘EUR 24 300’,

‘EUR 23 200’

is

— in the

third subparagraph,

replaced by ‘EUR 6 100’;

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

— in the

first

subparagraph,

replaced by ‘EUR 94 100’,

‘EUR 5 800’

is

‘EUR 90 000’

is

— in the second subparagraph,
replaced by ‘EUR 156 800’,

‘EUR 150 000’

is

— in the

third subparagraph,

replaced by ‘EUR 9 400’,

‘EUR 9 000’

is

— in the fourth subparagraph,
replaced by ‘EUR 6 100’;

‘EUR 5 800’

is

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

— in the

first

subparagraph,

replaced by ‘EUR 72 800’,

‘EUR 69 600’

is

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— in the second subparagraph,

‘EUR 17 400 to
is replaced by ‘EUR 18 200 to

EUR 52 200’
EUR 54 600’,

— in the first

subparagraph,
replaced by ‘EUR 121 300’,

‘EUR 116 000’

is

— in the

third subparagraph,

replaced by ‘EUR 6 100’.

‘EUR 5 800’

is

— in the second subparagraph,
replaced by ‘EUR 12 100’,

‘EUR 11 600’

is

(b) Paragraph 2 is amended as follows:

(i) the first subparagraph of point (a)

is amended as

follows:

— ‘EUR 2 500’ is replaced by ‘EUR 2 600’,

— ‘EUR 5 800’ is replaced by ‘EUR 6 100’;

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

— in the

first

subparagraph,

replaced by ‘EUR 72 800’,

‘EUR 69 600’

is

— in the second subparagraph, ‘EUR 17 400 to EUR
is replaced by ‘EUR 18 200 to EUR

52 200’
54 600’.

— in the

third subparagraph,

replaced by ‘EUR 6 100’,

‘EUR 5 800’

is

— the fourth subparagraph is amended as follows:

— ‘EUR 58 000’

is replaced by ‘EUR 60 600’,

— ‘EUR 5 800’ is replaced by ‘EUR 6 100’;

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

— in the

first

subparagraph,

replaced by ‘EUR 60 600’,

‘EUR 58 000’

is

— in the second subparagraph,
replaced by ‘EUR 102 500’,

‘EUR 98 000’

is

— in the third subparagraph,
replaced by ‘EUR 12 100’,

‘EUR 11 600’

is

(c)

In paragraph 3,
12 100’.

(d) In paragraph 4,

18 200’.

‘EUR 11 600’

is replaced by ‘EUR

— in the fourth subparagraph,
replaced by ‘EUR 6 100’,

‘EUR 5 800’

is

‘EUR 17 400’

is replaced by ‘EUR

— the fifth subparagraph is amended as follows:

(e)

In paragraph 5, ‘EUR 5 800’ is replaced by ‘EUR 6 100’.

(f) Paragraph 6 is amended as follows:

(i) in the first subparagraph, ‘EUR 83 200’ is replaced by

‘EUR 87 000’;

(ii) in the second subparagraph,

‘EUR 20 800 to EUR
62 400’ is replaced by ‘EUR 21 700 to EUR 65 200’.

2. In Article 4, ‘EUR 58 000’ is replaced by ‘EUR 60 600’.

3. Article 5 is amended as follows:

(a) Paragraph 1 is amended as follows:

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

— ‘EUR 29 000’

is replaced by ‘EUR 30 300’,

— ‘EUR 5 800’ is replaced by ‘EUR 6 100’;

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

— in the

first

subparagraph,

replaced by ‘EUR 30 300’,

‘EUR 29 000’

is

— in the second subparagraph ‘EUR 7 200 to EUR
is replaced by ‘EUR 7 500 to EUR

21 700’
22 700’,

— in the

third subparagraph,

replaced by ‘EUR 6 100’.

‘EUR 5 800’

is

(b) Paragraph 2 is amended as follows:

(i) in point (a) ‘EUR 2 500’ is replaced by ‘EUR 2 600’

and ‘EUR 5 800’ is replaced by ‘EUR 6 100’;

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

— in the

first

subparagraph,

replaced by ‘EUR 36 400’,

‘EUR 34 800’

is

— in the second subparagraph, ‘EUR 8 700 to EUR
replaced by ‘EUR 9 100 to EUR

is

26 100’
27 300’,

— in the

third subparagraph,

replaced by ‘EUR 6 100’.

‘EUR 5 800’

is

(c)

In paragraph 3, ‘EUR 5 800’ is replaced by ‘EUR 6 100’.

(d) In paragraph 4,

18 200’.

‘EUR 17 400’

is replaced by ‘EUR

(e)

In paragraph 5, ‘EUR 5 800’ is replaced by ‘EUR 6 100’.

(f) Paragraph 6 is amended as follows:

(i) in the first subparagraph, ‘EUR 27 700’ is replaced by

‘EUR 29 000’;

(ii) in the second subparagraph ‘EUR 6 900 to EUR
20 800’ is replaced by ‘EUR 7 200 to EUR 21 700’.

4. In Article 6, ‘EUR 34 800’ is replaced by ‘EUR 36 400’.

5. Article 7 is amended as follows:

(a)

in the first paragraph, ‘EUR 58 000’ is replaced by ‘EUR
60 600’;

(b) in the second paragraph,

‘EUR 18 200’.

‘EUR 17 400’

is replaced by

6. Article 8 is amended as follows:

(i) in the

second subparagraph,

replaced by ‘EUR 72 800’;

‘EUR 69 600’

is

(ii) in the third subparagraph, ‘EUR 34 800’ is replaced

by ‘EUR 36 400’;

(iii) in the fourth subparagraph,

‘EUR 17 400 to EUR
52 200’ is replaced by ‘EUR 18 200 to EUR 54 600’;

(iv) in the fifth subparagraph,

‘EUR 8 700 to EUR
26 100’ is replaced by ‘EUR 9 100 to EUR 27 300’.

(b) Paragraph 2 is amended as follows:

(i) in the second subparagraph,
replaced by ‘EUR 242 600’;

‘EUR 232 000’

is

(ii) in the third subparagraph, ‘EUR 116 000’ is replaced

by ‘EUR 121 300’;

(iii) in the fifth subparagraph,
is

‘EUR 2 500 to EUR
replaced by ‘EUR 2 600 to EUR

200 000’
209 100’;

(iv) in the sixth subparagraph, ‘EUR 100 000’ is replaced

by ‘EUR 104 600’.

(c)

In paragraph 3, ‘EUR 5 800’ is replaced by ‘EUR 6 100’.

Article 2

This Regulation shall not apply to valid applications pending at
1 April 2008.

Article 3

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

(a) Paragraph 1 is amended as follows:

It shall apply from 1 April 2008.

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

Done at Brussels, 3 April 2008.

For the Commission

Günter VERHEUGEN
Vice-President