Council Regulation (EC) No 1905/2005 of 14 November 2005 amending Regulation (EC) No 297/95 on fees payable to the European Medicines Agency
Date: 2005-11-14
Institutions: Council of the European Union
Subjects: European Medicines Agency, market approval, payment, pharmaceutical industry, trade licence

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I

(Acts whose publication is obligatory)

COUNCIL REGULATION (EC) No 1905/2005

of 14 November 2005

amending Regulation (EC) No 297/95 on fees payable to the European Medicines Agency

THE COUNCIL OF THE EUROPEAN UNION,

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,

(3)

Having regard to the proposal from the Commission,

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

Whereas:

(4)

(1)

for

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
the
authorisation, supervision and surveillance of medicinal
products for human and veterinary use and establishing a
European Medicines Agency (3),
the
revenue of the European Medicines Agency (hereinafter
referred to as the Agency) shall consist of a contribution
from the Community and fees paid by undertakings for
obtaining
and maintaining Community marketing
authorisations and for other services provided by the
Agency.

stipulates

that

to
have also been changed following amendments
Directive 2001/82/EC of the European Parliament and
the Council of 6 November 2001 on the
of
to veterinary medicinal
Community
products (4)
the
of 6
European Parliament
November 2001 on the Community code relating to
medicinal products for human use (5).

code
and to Directive 2001/83/EC of
of

the Council

relating

and

In particular,

In view of the experience gained since 1995, it is appro-
priate to maintain the general principles and overall
structure of the fees, as well as the main operational
and procedural provisions established by Regulation
(EC) No 297/95.
the
level of fees charged by the Agency should be based
on the principle of the service actually provided and
should be related to specific medicinal products. The
proportionality between the fees and the assessment
as well
related costs of
the
each application,
provision of
should also be
the service requested,
ensured.

the calculation of

as

products

authorised

of medicinal

Regulation (EC) No 726/2004 lays down provisions for
new post-authorisation activities to be carried out by the
Agency. These tasks include the recording of the actual
in
marketing
accordance with Community procedures,
the main-
tenance of marketing authorisation dossiers and of the
various databases managed by the Agency, as well as the
the risk-benefit balance of
continuous
authorised medicinal products.
is
In addition,
necessary to reduce the Agency’s dependence on fees
fee should
related to new applications. The annual
therefore be increased by 10 % to accommodate those
changes.

follow-up of

it

(2)

Regulation (EC) No 726/2004 also provides for new
the existing tasks
tasks for the Agency. Furthermore,

(5)

New categories of fees have to be created to cover new,
specific tasks now provided by the Agency, such as new
types of
related to a medicinal
product.

scientific opinions

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

last amended by
Commission Regulation (EC) No 494/2003 (OJ L 73, 19.3.2003,
p. 6).

(2) Not yet published in the Official Journal.
(3) OJ L 136, 30.4.2004, p. 1.

(4) OJ L 311, 28.11.2001, p. 1. Directive as last amended by Directive

2004/28/EC (OJ L 136, 30.4.2004, p. 58).

(5) OJ L 311, 28.11.2001, p. 67. Directive as last amended by Directive

2004/27/EC (OJ L 136, 30.4.2004, p. 34).

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(6)

(7)

the Agency should be
The Management Board of
competent to specify provisions necessary for the appli-
cation of
from the
this Regulation, on a proposal
Executive Director and following a favourable opinion
from the Commission. In particular, since the levels of
fees laid down in this Regulation are set as maximum
fees, the Management Board should establish, for certain
services for which this is laid down in the Regulation,
detailed classifications and lists of reduced fees.

The Executive Director should also keep the competence
to decide, in exceptional circumstances, on reductions of
the fees, in particular as regards certain cases related to
specific medicinal products and where a reduction is
necessary for imperative reasons of public or animal
health. Likewise, the Executive Director should have the
possibility to decide on exemptions from the obligation
to pay a fee in the case of medicinal products for the
treatment of rare diseases, for the treatment of diseases
affecting minor animal species and for the addition of
animal species in the case of
the determination of
in accordance with the
maximum residue
procedure laid down in Council Regulation (EEC) No
2377/90 of 26 June 1990 laying down a Community
procedure for the establishment of maximum residue
limits of veterinary medicinal products in foodstuffs of
animal origin (1).

limits

(8)

In accordance with Article 70(2) of Regulation (EC) No
726/2004,
the circumstances under which small and
medium-sized enterprises may pay reduced fees, defer
payment of the fee or receive administrative assistance
are not to be covered by this Regulation.

(9)

In order to allow an immediate budgetisation, the fees
should be due on the date of validation but should be
payable within a certain number of days.

lation (EC) No 726/2004. It should not apply to valid
applications pending at the time of its application.

(13)

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

HAS ADOPTED THIS REGULATION:

Article 1

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

1. the second paragraph of Article 1 shall be replaced by the

following:

‘The amounts of these fees shall be laid down in euro.’;

2. Article 3 is amended as follows:

(a) the title shall be replaced by the following:

‘Medicinal products for human use covered by the
laid down in Regulation (EC) No
procedures
726/2004 (*)

___________
(*) OJ L 136, 30.4.2004, p. 1.’;

(b) paragraph 1 is amended as follows:

(10)

Provisions should be laid down to report on the imple-
mentation of this Regulation after experience has been
gained and to review, if necessary, the level of the fees.

(i)

in point (a) the first and second subparagraph shall
be replaced by the following:

(11)

It is appropriate to include an indexation mechanism for
automatically adjusting the fees in relation to official
inflation rates indices.

(12)

For the sake of consistency, this Regulation should apply
at the same time as the full entering into force of Regu-

(1) OJ L 224, 18.8.1990, p. 1. Regulation as

(EC) No 1518/2005 (OJ

last amended by
L 244,

Commission Regulation
20.9.2005, p. 11).

‘A full fee of EUR 232 000 shall apply for an appli-
cation for a marketing authorisation supported by a
full dossier. That fee shall cover a single strength
associated with one pharmaceutical form and one
presentation.

strength and/or pharmaceutical

The fee shall be increased by EUR 23 200 for each
additional
form
submitted at the same time as the initial application
increase shall cover one
for authorisation. That
additional
form and
one presentation.’;

strength or pharmaceutical

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(ii) points (b) and (c) shall be replaced by the following:

‘(b) R e d u c e d f e e

for

A reduced fee of EUR 90 000 shall apply to
applications
a marketing authorisation
pursuant to Article 10(1) and (3), and Article
10c of Directive 2001/83/EC of the European
Parliament and of the Council of 6 November
2001 on the Community code relating to
medicinal products for human use (*). That
fee shall cover a single strength associated
with one pharmaceutical form and one presen-
tation.

A specific reduced fee of EUR 150 000 shall
apply to applications for a marketing authori-
sation pursuant to Article 10(4) of Directive
fee shall cover a single
2001/83/EC. That
strength associated with one pharmaceutical
form and one presentation.

The reduced fees referred to in the first and
second subparagraph shall be increased by
EUR 9 000 for each additional strength or
pharmaceutical
the same
time as the initial application for authorisation.
additional
That
strength or pharmaceutical
form and one
presentation.

form submitted at

cover one

increase

shall

The reduced fees referred to in the first and
second subparagraph shall be increased by
EUR 5 800 for each additional presentation
strength and pharmaceutical
of
form,
the
the same time as
initial application for authorisation.

submitted at

same

the

(c) E x t e n s i o n f e e

An extension fee of EUR 69 600 shall apply
for each extension of a marketing authorisation
within the meaning of Annex II to Commission
Regulation (EC) No 1085/2003 of 3 June 2003
concerning the examination of variations to the
for
of
terms
medicinal products
and
veterinary medicinal products
falling within
the scope of Council Regulation (EEC) No
2309/93 (**), which has already been granted.

a marketing
for

authorisation
human use

certain extensions. Those extensions shall be
included in a list, which shall be drawn up in
accordance with Article 11(2) of
this Regu-
lation.

The extension fee and the reduced extension
fee shall be increased by EUR 5 800 for each
additional presentation of the same extension
submitted at the time of the extension appli-
cation.

___________
(*) OJ L 311, 28.11.2001, p. 67. Directive as last
amended by Directive 2004/27/EC (OJ L 136,
30.4.2004, p. 34).

(**) OJ L 159, 27.6.2003, p. 24.’;

(c) paragraph 2 is amended as follows:

(i)

in point (a) the first subparagraph shall be replaced
by the following:

‘A Type I variation fee shall apply for a minor
variation to a marketing authorisation, as defined
in Article 3(2) of Regulation (EC) No 1085/2003.
For Type IA variations, the fee shall be EUR 2 500.
For Type IB variations, the fee shall be EUR 5 800.’;

(ii) in point (b) the first subparagraph shall be replaced

by the following:

‘A Type II variation fee of EUR 69 600 shall apply
for a major variation to a marketing authorisation,
as defined in Article 3(3) of Regulation (EC) No
1085/2003.

first

By derogation from the
subparagraph, a
reduced Type II variation fee falling within the
range of EUR 17 400 to EUR 52 200 shall apply
for certain variations. Those variations shall be
included in a list, which shall be drawn up in
accordance with Article 11(2) of this Regulation.’;

(d) paragraph 4 is amended as follows:

(i)

the sole subparagraph shall be replaced by the
following:

By derogation from the first subparagraph, a
reduced extension fee falling within the range
of EUR 17 400 to EUR 52 200 shall apply for

‘A fee of EUR 17 400 shall apply for any inspection
within or outside the Community. For inspections
outside the Community,
travel expenses shall be
charged extra on the basis of actual cost.’;

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(ii) the following subparagraph shall be added:

(b) paragraph 1 is amended as follows:

‘By derogation from the first
subparagraph, a
reduced inspection fee shall apply for certain
inspections, according to the extent and nature of
the inspection and on the basis of the conditions
laid down in accordance with Article 11(2).’;

(i) point (a) shall be amended as follows:

— the first and second subparagraph shall be

replaced by the following:

(e) paragraph 6 shall be replaced by the following:

‘6. Annual fee

An annual fee of EUR 83 200 shall apply for each
marketing authorisation of a medicinal product.
That fee shall cover all authorised presentations of
a given medicinal product.

first

subparagraph,

By derogation from the
a
reduced annual fee falling within the range of EUR
20 800 to EUR 62 400 shall apply for certain types
of medicinal products. Those medicinal products
shall be included in a list, which shall be drawn
up in accordance with Article 11(2).’;

3. Article 4 shall be replaced by the following:

‘Article 4

Medicinal products for human use covered by the
procedures laid down in Directive 2001/83/EC

Referral fee

A referral
fee of EUR 58 000 shall apply where the
procedures laid down in Article 30(1) and Article 31 of
Directive 2001/83/EC are initiated by the applicant of a
marketing authorisation or
the holder of an existing
marketing authorisation.

Where more than one applicant of marketing authori-
sations or holder of existing marketing authorisations are
concerned by the procedures referred to in the first subpar-
agraph, the applicants or holders may be grouped for the
If
purpose of
however,
the same procedure concerns more than ten
different applicants or holders, the fee shall be charged
by the application of the abovementioned referral fee.’;

the payment of one single referral

fee.

4. Article 5 is amended as follows:

(a)

the title shall be replaced by the following:

‘Medicinal products for veterinary use covered by
the procedures laid down in Regulation (EC) No
726/2004’;

‘A full fee of EUR 116 000 shall apply for an
authorisation
application for
fee shall
supported by a full dossier. That
cover a single strength associated with one
pharmaceutical form and one presentation.

a marketing

The fee shall be increased by EUR 11 600 for
each additional strength and/or pharmaceutical
form submitted at the same time as the initial
application for authorisation. That
increase
shall cover one additional strength or pharma-
ceutical form and one presentation.’;

— the fourth subparagraph shall be replaced by

the following:

case of

immunological
fee

‘In the
veterinary
medicinal products,
shall be
the
reduced to EUR 58 000, with each additional
strength and/or pharmaceutical
form and/or
presentation entailing an increase of EUR
5 800.’;

full

(ii) point (b) shall be replaced by the following:

‘(b) R e d u c e d f e e

A reduced fee of EUR 58 000 shall apply to
applications
for a marketing authorisation
pursuant to Article 13(1) and (3), and Article
13c of Directive 2001/82/EC of the European
Parliament and of the Council of 6 November
2001 on the Community code relating to
veterinary medicinal products (*). That
fee
shall cover a single strength associated with
form and one presen-
one pharmaceutical
tation.

A specific reduced fee of EUR 98 000 shall
apply to applications for a marketing author-
isation pursuant to Article 13(4) of Directive
2001/82/EC. That
fee shall cover a single
strength associated with one pharmaceutical
form and one presentation.

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The reduced fees referred to in the first and
second subparagraph shall be increased by
EUR 11 600 for each additional strength or
pharmaceutical
the same
time as the initial application for authori-
sation. That increase shall cover one additional
strength or pharmaceutical
form and one
presentation.

form submitted at

The reduced fees referred to in the first and
second subparagraph shall be increased by
EUR 5 800 for each additional presentation
the same strength and pharmaceutical
of
form, submitted at
the same time as the
initial application for authorisation.

case of

In the
immunological veterinary
medicinal products, the fee shall be reduced
additional
to
EUR 29 000, with
strength and/or pharmaceutical
form and/or
presentation entailing an increase of EUR
5 800.

each

accordance with Article 11(2) of
lation.

this Regu-

The extension fee and the reduced extension fee
shall be increased by EUR 5 800 for each addi-
tional presentation of
extension
submitted at the time of the extension appli-
cation.’;

same

the

(c) paragraph 2 is amended as follows:

(i)

in point (a) the first subparagraph shall be replaced
by the following:

‘A Type I variation fee shall apply for a minor
variation to a marketing authorisation, as defined
in Article 3(2) of Regulation (EC) No 1085/2003.
For Type IA variations, the fee shall be EUR 2 500.
For Type IB variations, the fee shall be EUR 5 800.’;

For the purposes of this point, the number of
target species is irrelevant.

(ii) point (b) shall be replaced by the following:

___________
(*) OJ L 311, 28.11.2001, p. 1. Directive as last
amended by Directive 2004/28/EC (OJ L 136,
30.4.2004, p. 58).’;

(iii) point (c) shall be replaced by the following:

‘(c) E x t e n s i o n f e e

An extension fee of EUR 29 000 shall apply for
each extension of a marketing authorisation
within the meaning of Annex II to Regulation
(EC) No 1085/2003, which has already been
granted.

‘T y p e I I v a r i a t i o n f e e

A Type II variation fee of EUR 34 800 shall apply
for a major variation to a marketing authorisation,
as defined in Article 3(3) of Regulation (EC) No
1085/2003.

first

By derogation from the
subparagraph, a
reduced Type II variation fee falling within the
range of EUR 8 700 to EUR 26 100 shall apply
for certain variations. Those variations shall be
included in a list, which shall be drawn up in
accordance with Article 11(2) of this Regulation.

In the case of immunological veterinary medicinal
products, the fee shall be EUR 5 800.

By derogation from the first subparagraph, a
reduced extension fee falling withn the range
of EUR 7 200 to EUR 21 700 shall apply for
certain extensions. Those extensions shall be
included in a list, which shall be drawn up in

In the event of the same variation being introduced,
the fee referred to in the first, second and third
subparagraph shall cover all authorised strengths,
pharmaceutical forms and presentations.’;

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(d) paragraph 4 is amended as follows:

(i)

the sole subparagraph shall be replaced by the
following:

Where more than one applicant of marketing authori-
sations or holder of existing marketing authorisations are
concerned by the procedures referred to in the first subpa-
ragraph, the applicants or holders may be grouped for the
If
purpose of
however,
the same procedure concerns more than ten
different applicants or holders, the fee shall be charged
fee.’;
by the application of

the payment of one single referral

the abovementioned referral

fee.

‘A fee of EUR 17 400 shall apply for any inspection
within or outside the Community. For inspections
outside the Community, travel expenses shall be
charged extra on the basis of actual cost.’;

6. Article 7 is amended as follows:

(ii) the following subparagraph shall be added:

(a)

the title shall be replaced by:

‘By derogation from the first
subparagraph, a
reduced inspection fee shall apply for certain
inspections, according to the extent and nature of
the inspection and on the basis of the conditions
laid down in accordance with Article 11(2).’;

(e) paragraph 6 shall be replaced by the following:

‘6. Annual fee

‘Establishment of maximum residue limits (MRL)
for veterinary medicinal products in accordance
with the procedures
laid down in Regulation
(EEC) No 2377/90 (*)

___________
(*) OJ L 224, 18.8.1990, p. 1. Regulation as last
amended by Commission Regulation (EC) No
1518/2005 (OJ L 244, 20.9.2005, p. 11).’;

(b) in paragraph 1 the second subparagraph shall be

replaced by the following:

An annual fee of EUR 27 700 shall apply for each
marketing authorisation of a medicinal product.
That fee shall cover all authorised presentations of
a given medicinal product.

‘An additional fee of EUR 17 400 shall apply for each
application to modify an existing MRL, as included in
one of the Annexes to Regulation (EEC) No 2377/90.’;

first

subparagraph, a
By derogation from the
reduced annual
fee falling within the range of
EUR 6 900 to EUR 20 800 shall apply for certain
types of medicinal products. Those medicinal
products shall be included in a list, which shall be
drawn up in accordance with Article 11(2).’;

(c) paragraph 2 shall be deleted and the numbering of

paragraph 1 shall be deleted;

7. Article 8 shall be replaced by the following:

5. Article 6 shall be replaced by the following:

‘Article 6
Veterinary medicinal
procedures laid down in Directive 2001/82/EC

products

covered

by

Referral fee

‘Article 8
Various Fees

1. Fee for scientific advice

the

The scientific advice fee shall apply where an application
is made for scientific advice concerning the conduct of
the various tests and trials necessary to demonstrate the
quality, safety and efficacy of medicinal products.

A referral
fee of EUR 34 800 shall apply where the
procedures laid down in Article 34(1) and Article 35 of
Directive 2001/82/EC are initiated by the applicant of a
marketing authorisation or
the holder of an existing
marketing authorisation.

When it concerns medicinal products for human use,
the fee shall be EUR 69 600.

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When it concerns veterinary medicinal products, the fee
shall be EUR 34 800.

opinions or services concerning medicinal products for
human use.

By derogation from the second subparagraph, a reduced
scientific advice fee falling within the range of EUR
17 400 to EUR 52 200 shall apply for certain scientific
advice concerning medicinal products for human use.

By derogation from the third subparagraph, a reduced
scientific service fee falling within the range of EUR
2 500 to EUR 100 000 shall apply for certain scientific
opinions or services concerning veterinary medicinal
products.

By derogation from the third subparagraph, a reduced
scientific advice fee falling within the range of EUR
8 700 to EUR 26 100 shall apply for certain scientific
advice concerning veterinary medicinal products.

The scientific opinions or services referred to in the fifth
and sixth subparagraph shall be included in a list, which
shall be drawn up in accordance with Article 11(2).

The scientific advice referred to in the fourth and fifth
subparagraph shall be included in a list, which shall be
drawn up in accordance with Article 11(2).

2. Fee for scientific services not covered by Articles 3 to 7 or by

Article 8(1)

A scientific service fee shall apply where an application
is made for any scientific advice or opinion by a
scientific Committee, which is not covered by Articles
3 to 7 or by Article 8(1). This includes any evaluation of
traditional herbal medicinal products, any opinion on
medicinal products for compassionate use, any consul-
including blood deri-
tation on ancillary substances,
and any
incorporated in medical devices,
vatives,
evaluation of plasma master files and vaccine antigen
master files.

When it concerns medicinal products for human use,
the fee shall be EUR 232 000.

When it concerns veterinary medicinal products, the fee
shall be EUR 116 000.

3. Fee for administrative services

A fee falling within the range of EUR 100 to EUR 5 800
shall apply for administrative services where documents
or certificates are issued outside the framework of
services covered by another fee provided for in this
Regulation or where
rejected
following the conclusion of the administrative validation
of the related dossier or where the information required
in the case of parallel distribution has to be checked.

an application is

A classification of the services and fees shall be included
in a list, which shall be drawn up in accordance with
Article 11(2).’;

8.

in Article 9 the second paragraph shall be replaced by the
following:

‘A total or partial exemption from payment of the fees laid
down in this Regulation may be granted, in particular for
medicinal products for treating rare diseases or diseases
extension of
affecting minor
existing MRL
for
medicinal products available for compassionate use.

to additional

species or

species or

animal

animal

for

Article 3 of this Regulation shall apply to any scientific
opinion for the evaluation of medicinal products for
human use intended exclusively for markets outside
the Community pursuant to Article 58 of Regulation
(EC) No 726/2004.

The detailed conditions for the application of the total or
partial exemption shall be determined in accordance with
Article 11(2).

By derogation from the second subparagraph, a reduced
scientific service fee falling within the range of EUR
2 500 to EUR 200 000 shall apply for certain scientific

The fee payable for an opinion on a medicinal product for
compassionate use shall be deducted from the fee payable
for an application for a marketing authorisation of the
same medicinal product, where
such application is
submitted by the same applicant.’;

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9. Article 10 shall be replaced by the following:

10. Article 11(2) shall be replaced by the following:

‘Article 10
Due date and deferral of the payment

the

relevant

1.
Fees shall be due on the date of the administrative
validation of
specific
stipulate otherwise. They shall be payable
provisions
within 45 days of the date of the notification of the admin-
istrative validation to the applicant. They shall be paid in
euro.

application unless

The annual
the
subsequent
marketing authorisation decision.
within 45 days of
relate to the preceding year.

fee shall be due on the first and each
the
anniversary
shall be payable
fee shall

the due date. The annual

notification
It

of

of

The inspection fee shall be payable within 45 days from the
date on which the inspection is carried out.

The payment of

the fee for an application for a
2.
to be
marketing authorisation of a medicinal product
used in a human pandemic situation shall be deferred
until the pandemic situation is duly recognised, either by
the World Health Organisation or by the Community in
the
the
framework of Decision No 2119/98/EC of
European Parliament and of the Council of 24 September
1998 setting up a network for
epidemiological
surveillance and control of communicable diseases in the
Community (*). Such deferral shall not exceed five years.

the

3. Where any fee payable under this Regulation remains
unpaid at
its due date and without prejudice to the
Agency’s capacity to institute legal proceedings conferred
on it by Article 71 of Regulation (EC) No 726/2004, the
Executive Director may decide not to provide the requested
services or to suspend all the services and procedures under
including the relevant
way until the fee has been paid,
interest as provided for in Article 86 of Commission Regu-
lation (EC, Euratom) No 2342/2002 of 23 December 2002
laying down detailed rules for
the implementation of
Council Regulation (EC, Euratom) No 1605/2002 on the
Financial Regulation applicable to the general budget of the
European Communities (**).

___________
(*) OJ L 268, 3.10.1998, p. 1. Decision as last amended
by Regulation (EC) No 1882/2003 (OJ L 284,
31.10.2003, p. 1).

(**) OJ L 357, 31.12.2002, p. 1. Regulation as amended by
Regulation (EC, Euratom) No 1261/2005 (OJ L 201,
2.8.2005, p. 3).’;

‘2. Without prejudice to the provisions of Regulation
(EC) No 726/2004, the Management Board of the Agency
may, on a proposal
from the Executive Director and
following a favourable opinion from the Commission,
specify any provision necessary for the application of this
shall be made publicly
Regulation. Those provisions
available.’;

11. Article 12 is amended as follows:

(a)

second paragraph shall be

the
following:

replaced by the

‘However, amendments to the amounts of
the fees
established by this Regulation shall be adopted in
accordance with the procedure laid down in Article
(EC) No 726/2004, with
87(2)
exception of
the updating provided for in the fifth
paragraph of this Article.’;

of Regulation

(b) the third and fourth paragraphs shall be replaced by the

following:

‘By 24 November 2010, the Commission shall present
a report on its implementation to the Council, this
report
the need for
including a dispute settlement procedure into this Regu-
lation.

shall contain an analysis of

Any review of the fees shall be based on an evaluation
of the Agency’s costs and on the basis of the related
costs of the services provided for by the Member States.
Those costs shall be calculated in accordance with
costing methods,
international
generally
which shall be adopted in accordance with Article
11(2).’;

accepted

(c)

the following paragraph shall be added:

‘With effect from 1 April of each year, the Commission
shall review the fees by reference to the inflation rate as
published in the Official Journal of the European Union
and update them.’

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This Regulation shall not apply to valid applications pending at 20 November 2005.

Article 2

Transitional period

Article 3

Entry into force

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

It shall apply from 20 November 2005.

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

Done at Brussels, 14 November 2005.

For the Council
The President

T. JOWELL