Council Regulation (EC) No 2743/98 of 14 December 1998 amending Regulation (EC) No 297/95 on fees payable to the European Agency for the Evaluation of Medicinal Products
Date: 1998-12-14
Institutions: Council of the European Union
Subjects: European Medicines Agency, market approval, payment, pharmaceutical legislation, public health, veterinary medicinal product

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Official Journal of the European Communities

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I

(Acts whose publication is obligatory)

COUNCIL REGULATION (EC) No 2743/98

of 14 December 1998

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

THE COUNCIL OF THE EUROPEAN UNION,

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) (here-
inafter referred to as the ‘Agency'), and in particular
Article 10 thereof,

Having regard to the proposal from the Commission,

Having regard to the opinion of the European Parlia-
ment (2),

Whereas under Article 57(1) of Council Regulation (EEC)
No 2309/93 of 22 July 1993 laying down Community
procedures for the authorisation and supervision of medi-
cinal products for human and veterinary use and estab-
lishing a European Agency for the Evaluation of Medi-
cinal Products (3), 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;

Whereas the amounts and structure of the fees established
by Regulation (EC) No 297/95 must be reviewed by 31
December 1997;

Whereas, in view of the experience gained since 1995, it
is appropriate to maintain the general principles and
overall structure of the fees as well as the main opera-
tional and procedural provisions established by the above-
mentioned Regulation;

Whereas for certain fees, however, the services to which
they relate should be specified so as to facilitate their
collection and improve the transparency and practical
implementation of this Regulation;

(1) OJ L 35, 15. 2. 1995, p. 1.
(2) OJ C 328, 26. 10. 1998.
(3) 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).

Whereas new fees must also be established to cover all the
services now provided by the Agency;

Whereas an annual fee must be introduced to ensure
coverage of the costs connected with the supervision of
authorised medicinal products; whereas a given part of
this fee will have to be allocated to the competent
national authorities required under the terms of Regula-
tion (EEC) No 2309/93 to supervise the market on behalf
of
the rules for
distribution amongst those authorities will have to be
adopted by the Agency’s Management Board in accord-
ance with the procedure laid down in this Regulation;

the Community; whereas, moreover,

Whereas in certain exceptional cases and for imperative
reasons of public or animal health it must be possible to
reduce the abovementioned fees; whereas,
therefore,
without prejudice
specific provisions of
Community law, any decision to reduce fees will have to
be taken by the Executive Director on the basis of a
critical examination of the situation specific to each case
after consultation of the competent scientific committee,

to more

HAS ADOPTED THIS REGULATION:

Article 1

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

1. Article 1 shall be replaced by the following:

‘Article 1

Scope

Fees for obtaining and maintaining a Community
authorisation to market medicinal products for human
and veterinary use and for other services supplied by
the Agency shall be levied in accordance with this
Regulation.

The amounts of these fees shall be laid down in ecus.'

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2. Articles 3 to 10 shall be replaced by the following:

‘Article 3

Medicinal products for human use covered by
the procedures laid down in Regulation (EEC)
No 2309/93

1. Authorisation to market a medicinal product

— where the extension is for a new strength, a
new pharmaceutical form, a new indication
or a new method of administration, the fee
shall be ECU 50 000,

— where the extension is for a new presenta-
tion of a strength, a pharmaceutical form
or of a method of administration which are
already authorised, the fee shall be ECU
10 000.

(a) F u l l

f e e

2. Variation

The fee for an application for authorisation to
market a medicinal product supported by a full
dossier is ECU 200 000. This fee covers a
single strength associated with one pharma-
ceutical form.

The fee shall be increased by ECU 20 000 for
each additional strength and/or pharmaceut-
ical form submitted at the same time as the
initial
authorisation. This
increase covers one additional strength and/or
pharmaceutical form.

application for

The fee shall be increased by ECU 5 000 for
the same
each additional presentation of
strength and pharmaceutical form, submitted
at the same time as the initial application for
authorisation.

(b) R e d u c e d f e e

A reduced fee of ECU 100 000 shall apply to
for authorisation to market a
applications
for which a full dossier
medicinal product
need not be presented, as provided for in
Article 4 of the third paragraph of point 8(a)(i)
and (iii) of Directive 65/65/EEC or when
recourse is had to point 8(a)(ii) of the third
paragraph of Article 4 of the same Directive.
This fee covers a single strength associated
with one pharmaceutical form.

The fee shall be increased by ECU 20 000 for
each additional strength and/or pharmaceut-
ical form submitted at the same time as the
initial
authorisation. This
increase covers one additional strength and/or
pharmaceutical form.

application for

The fee shall be increased by ECU 5 000 for
each additional presentation of
the same
strength and pharmaceutical form submitted at
the same time as the initial application for
authorisation.

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

is

This
the fee for each extension of a
marketing authorisation which has already
been granted:

(a) T y p e I v a r i a t i o n f e e

The fee for a variation of minor importance to
a marketing authorisation according to the
classification established by the Commission
Regulation applicable to the matter shall be
ECU 5 000.

In the event of the same variation being intro-
duced,
fee shall cover all authorised
strengths, pharmaceutical forms and presenta-
tions.

this

(b) T y p e I I v a r i a t i o n f e e

The fee for a variation of major importance to
a marketing authorisation according to the
classification established by the Commission
Regulation applicable to the matter shall be
ECU 60 000. It may be halved for certain Type
II variations which do not
involve detailed
scientific evaluation, a list of which shall be
drawn up in accordance with the procedure
laid down in Article 11(2).

In the event of the same variation being intro-
duced,
fee shall cover all authorised
strengths, pharmaceutical forms and presenta-
tions.

this

3. Renewal fee

The fee for examining information available at the
time of the five-yearly renewal of an authorisation
to market a medicinal product shall be ECU
10 000. It shall be charged for each strength asso-
ciated with a pharmaceutical form.

4. Inspection fee

The flat-rate fee for any inspection within or
outside the Community is ECU 15 000. For
inspections
travel
expenses shall be charged extra on the basis of
actual cost.

the Community,

outside

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5. Transfer fee

The fee for a change in the holder of
the
marketing authorisations to which the transfer
relates shall be ECU 5 000. This covers all author-
ised presentations of a given medicinal product.

6. Annual fee

The annual fee for each medicinal product which
has been granted a marketing authorisation shall
be ECU 60 000. This covers all authorised presen-
tations of a given medicinal product.

Article 4

Medicinal products for human use covered by
laid down in Directive 75/
the procedures
319/EEC (*)

Arbitration fee

A fee of ECU 10 000 shall be payable where the
procedures laid down in Articles 10(2), 11, 12 and 15
of Directive 75/319/EEC are initiated.

The fee shall be increased by ECU 40 000 where the
procedures
laid down in Articles 11 and 12 of
Directive 75/319/EEC are initiated at the instigation
of the applicant for or holder of the marketing author-
isation.

Article 5

Medicinal products for veterinary use covered by
the procedures laid down in Regulation (EEC)
No 2309/93

1. Authorisation to market a medicinal product

(a) F u l l

f e e

The fee for an application for authorisation to
market a medicinal product supported by a full
dossier shall be ECU 100 000. It covers a
single strength associated with one pharma-
ceutical form.

The fee shall be increased by ECU 10 000 for
each additional strength and/or pharmaceut-
ical form submitted at the same time as the
initial
authorisation. This
increase covers one additional strength and/or
pharmaceutical form.

application for

The fee shall be increased by ECU 5 000 for
the same
each additional presentation of
strength and pharmaceutical form, submitted
at the same time as the initial application for
authorisation.

In the case of vaccines, the full fee shall be
reduced to ECU 50 000, with each additional
strength and/or pharmaceutical form and/or
presentation entailing an increase of ECU
5 000.

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

(b) R e d u c e d f e e

A reduced fee of ECU 50 000 shall apply to
for authorisation to market a
applications
medicinal product
for which a full dossier
need not be presented, as provided for in point
10(a)(i) and (iii) of
the third paragraph of
Article 5 of Directive 81/851/EEC or when
recourse is had to point (ii) of the third para-
graph of Article 5 of the same Directive. This
fee covers a single strength associated with one
pharmaceutical form of the medicinal product.

The fee shall be increased by ECU 10 000 for
each additional strength and/or pharmaceut-
ical form submitted at the same time as the
initial
authorisation. This
increase covers one additional strength and/or
pharmaceutical form.

application for

The fee shall be increased by ECU 5 000 for
the same
each additional presentation of
strength and pharmaceutical form submitted at
the same time as the initial application for
authorisation.

In the case of vaccines,
the fee shall be
reduced to ECU 25 000, with each additional
strength and/or pharmaceutical form and/or
presentation entailing an increase of ECU
5 000.

For the purposes of this paragraph (b), the
number of target species is irrelevant.

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

is

the fee for each extension of a
This
marketing authorisation which has already
been granted:

— where the extension is for a new strength, a
new pharmaceutical form, a new species, a
new indication or a new method of admin-
istration, the fee shall be ECU 25 000,

— where the extension is for a new presenta-
tion of a strength, of a pharmaceutical form
or of a method of administration which are
already authorised, the fee shall be ECU
5 000,

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— in the case of vaccines, where the extension
is for a new strength, a new pharmaceutical
form, a new presentation or a new method
of administration, the fee shall be ECU
5 000.

2. Variation

(a) T y p e I v a r i a t i o n f e e

The fee for a variation of minor importance to
a marketing authorisation according to the
classification established by the Commission
Regulation applicable to the matter shall be
ECU 5 000. The same fee shall be charged in
respect of vaccines.

In the event of the same variation being intro-
duced,
fee shall cover all authorised
strengths, pharmaceutical forms and presenta-
tions.

this

(b) T y p e I I v a r i a t i o n f e e

The fee for a variation of major importance to
a marketing authorisation according to the
classification established by the Commission
Regulation applicable to the matter shall be
ECU 30 000. It may be halved for certain Type
II variations which do not
involve detailed
scientific evaluation, a list of which shall be
drawn up in accordance with the procedure
laid down in Article 11(2).

In the case of vaccines, the fee shall be ECU
5 000.

In the event of the same variation being intro-
duced,
fee shall cover all authorised
strengths, pharmaceutical forms and presenta-
tions.

this

3. Renewal fee

The fee for examining information available at the
time of the five-yearly renewal of an authorisation
to market a medicinal product shall be ECU
5 000. It shall be charged for each strength asso-
ciated with a pharmaceutical form.

4. Inspection fee

The flat-rate fee for any inspection within or
outside the Community shall be ECU 15 000. For
travel
inspections
expenses shall be charged extra on the basis of
actual cost.

the Community,

outside

5. Transfer fee

relates shall be ECU 5 000. This covers all author-
ised presentations of a given medicinal product.

6. Annual fee

The annual fee for each medicinal product which
has been granted a marketing authorisation shall
be ECU 20 000. This covers all authorised pre-
sentations of a given medicinal product.

Article 6

Medicinal products for veterinary use covered by
the procedures
laid down in Directive 81/
851/EEC

Arbitration fee

An arbitration fee of ECU 10 000 shall be payable
where the procedures laid down in Articles 18(2), 19,
20 and 23 of Directive 81/851/EEC are initiated.

The fee shall be increased by ECU 20 000 where the
procedures
laid down in Articles 19 and 20 of
Directive 81/851/EEC are initiated at the instigation
of the applicant for or holder of the marketing author-
isation.

Article 7

Establishment of maximum residue
(MRL) for veterinary medicinal products

limits

1. Fees for establishing MRL

A full MRL fee of ECU 50 000 shall be charged
for an application to set an initial MRL for a given
substance.

An additional MRL fee of ECU 15 000 shall be
payable for each application to amend or extend
an existing MRL, or to cover new species.

the medicinal

MRL fees shall be deducted from the fee payable
for an application for marketing authorisation or
an application to extend a marketing authorisation
for
the
substance for which an MRL has been set where
such applications are submitted by the same
applicant. However, this deduction may total no
more than one half of the fee to which it applies.

containing

product

2. MRL fee

A fee of ECU 15 000 shall be charged for any
application to set an MRL with a view to clinical
trials.

The fee for a change in the holder of
the
marketing authorisations to which the transfer

The fee shall be deducted from the amount of the
full MRL fee laid down in point 1.

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Article 8

Various fees

1. Fee for scientific advice

This fee shall be charged where an application is
made for scientific or technical advice concerning
the research and development of a medicinal
product with a view to the possible submission of
an application for marketing authorisation or an
application to extend a marketing authorisation.

— For medicinal products for human use the

maximum fee is set at ECU 60 000.

— For medicinal products for veterinary use the

maximum fee is set at ECU 30 000.

The detailed procedures for applying this point
shall be adopted in accordance with the procedure
laid down in Article 11(2).

2. Fees for administrative charges

Fees shall be payable for administrative charges
when documents or certificates are issued outside
the framework of services covered by another fee
provided for in this Regulation or upon conclu-
sion of the administrative validation of a dossier
resulting in rejection of the application for which
the dossier was submitted. The unit amount of
such fees may not exceed ECU 5 000. In accord-
ance with Article 11(2) of this Regulation, a classi-
fication shall be established and specified by the
Management Board of the Agency.

The arbitration fee shall be payable within 30 days
following referral to the Agency; the annual fee
shall be payable within 30 days of the first and
each subsequent anniversary of the notification of
the marketing authorisation decision.

The inspection fee shall be payable within 30 days
of the date on which the inspection was carried
out.

2. Where any fee payable under this Regulation
remains unpaid at its due date, and without preju-
dice to the Agency’s capacity to institute legal
proceedings conferred on it by Article 59 of Regu-
lation (EEC) No 2309/93, the Executive Director
of the Agency may decide either not to provide
the
the requested services or
services and procedures under way until the whole
of the relevant fee has been paid.

to suspend all

3. Fees shall be paid in ecus or in the national
currency of one of the Member States according to
the exchange rates in force, which are fixed daily
by the Commission. However, monthly conversion
rates based on the earlier rates may be fixed
according to a calculation established by the
Agency’s Management Board.

Article 11

Article 9

Implementing rules

Possible fee reductions

Without prejudice to more specific provisions of
Community law, in exceptional circumstances and for
imperative reasons of public or animal health, fee
reductions may be granted case by case by the Execu-
tive Director after consultation of
the competent
scientific committee. Any decision taken pursuant to
this Article shall state the reasons on which it is based.

A total or partial exemption may be granted, in par-
ticular for medicinal products for treating rare diseases
or diseases affecting minor species.

Article 10

Due date and belated payment

1. Fees shall be payable on the date of receipt of the
specific provisions

relevant application unless
stipulate otherwise.

1. On a proposal from the Executive Director and
following a favourable opinion from the Commis-
sion, the Agency’s Management Board shall fix the
rules for repaying a part of the resources deriving
from the annual fees to the competent national
authorities involved in Community market super-
vision.

2. Without prejudice to the provisions of this Regu-
lation or of Regulation (EEC) No 2309/93, the
Agency’s Management Board may, on a proposal
from the Executive Director, specify any other
provision proving necessary for the application of
this Regulation.

3.

In the event of disagreement as to the classi-
fication of an application in one of the fee cat-
egories laid down in this Regulation, the Executive
Director shall give a ruling after consultation of
the competent scientific committee.

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Article 12

Amendment

Any amendment to this Regulation shall be adopted
by the Council acting by a qualified majority after
consulting the European Parliament, on a proposal
from the Commission.

However, amendments to the amounts of the fees
established by this Regulation shall be adopted in
accordance with the procedure laid down in Article 73
of Regulation (EEC) No 2309/93.

Within three years of the entry into force of this
Regulation, the Commission will present a report on
its implementation, after consultation of the Agency’s
Management Board.

Future reviews of fees shall be based on a compre-
hensive evaluation of the Agency’s costs, including
expenditure relating to Member States’ rapporteurs.

(*) OJ L 147, 9.6.1975, p. 13. Directive as

last
amended by Directive 93/39/EEC (OJ L 214,
24.8.1993, p. 22).'

3. The existing Article 11 shall become Article 13.

Article 2

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

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

Done at Brussels, 14 December 1998.

For the Council

The President
W. MOLTERER