Commission Regulation (EC) No 2049/2005 of  15 December 2005  laying down, pursuant to Regulation (EC) No 726/2004 of the European Parliament and of the Council, rules regarding the payment of fees to, and the receipt of administrative assistance from, the European Medicines Agency by micro, small and medium-sized enterprises Text with EEA relevance
Date: 2005-12-15
Institutions: European Commission
Subjects: European Medicines Agency, administrative cooperation, market approval, medicinal product, payment, small and medium-sized enterprises, veterinary drug

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Official Journal of the European Union

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COMMISSION REGULATION (EC) No 2049/2005

of 15 December 2005

laying down, pursuant to Regulation (EC) No 726/2004 of the European Parliament and of the
Council, rules regarding the payment of fees to, and the receipt of administrative assistance from,
the European Medicines Agency by micro, small and medium-sized enterprises

(Text with EEA relevance)

THE COMMISSION OF THE EUROPEAN COMMUNITIES,

sectors and should aim at promoting innovation and the
development of new medicinal products by SMEs.

Having regard to the Treaty
Community,

establishing the European

(4)

Having regard to European Parliament and Council Regulation
(EC) No 726/2004 of 31 March 2004 laying down Community
procedures for the authorisation and supervision of medicinal
products for human and veterinary use and establishing a
European Medicines Agency (1), and in particular Article 70(2)
thereof,

Whereas:

(1)

(2)

(3)

Regulation (EC) No 726/2004, which replaces Council
Regulation (EEC) No 2309/93 of 22 July 1993 laying
down Community procedures for the authorisation and
supervision of medicinal products
for human and
veterinary use and establishing a European Agency for
the Evaluation of Medicinal Products (2), provides that the
revenue of the European Medicines Agency (hereinafter
referred to as the Agency) must consist of a contribution
from the Community and fees paid by companies.

the system established by Regula-
In the context of
tion (EEC) No 2309/93, Council Regulation (EC) No
297/95 (3) provides for fees payable to the Agency.

Pursuant to Regulation (EC) No 726/2004, the situation
of micro, small and medium-sized enterprises (SMEs) has
to be considered separately. In order to reduce the cost
for SMEs of marketing medicinal products authorised via
the
that Regulation therefore
foresees the adoption of specific provisions allowing a
reduction of
fees, and
providing administrative
assistance. Such provisions
should apply equally to the human and veterinary

fees, deferring the payment of

centralised procedure,

(1) OJ L 136, 30.4.2004, p. 1.
(2) OJ L 214, 24.8.1993, p. 1.
(3) 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).

(5)

(6)

(7)

provided

The definition of micro, small and medium-sized enter-
prises
in Commission Recommendation
2003/361/EC (4) should apply, for reasons of coherence
and transparency.

Experience gained since the adoption of Regulation (EEC)
No 2309/93 shows that the main financial and admin-
istrative entry hurdles for SMEs are the various steps
involved in pre-marketing authorisation procedures,
such as the seeking of scientific advice, the submission
of
the marketing authorisation application, and the
undergoing of inspections. Provisions laid down in this
Regulation should therefore be focused on these aspects.

The fees for the marketing authorisation application and
the related inspections conducted for the purpose of
assessing the application could constitute a significant
financial constraint for SMEs. Consequently, in order to
avoid a weakening of the financial situation of under-
takings during the assessment of the marketing author-
isation application, it is appropriate to defer the payment
of these fees until the end of the procedure.

SMEs operating in the pharmaceutical sector are often
innovative companies, such as those active in the fields
of gene or somatic cell
therapy, which can notably
benefit
from the pooling of scientific expertise at a
Community level. Furthermore, the scientific evaluation
of a marketing authorisation application is more likely to
be favourable in the case of medicinal products which
have obtained scientific advice. Therefore, access to the
Agency’s scientific advice for SMEs seeking marketing
authorisation should be facilitated through fee reductions.
As an additional incentive, a conditional fee exemption
should be given to applicants who have requested such
advice and who have actually taken it into account for
the development of their medicinal product.

(8)

Another incentive should also be provided, in the form
of a fee reduction, for the establishment of maximum
residue limits (MRL) for veterinary medicinal products
in order to further support the establishment of such
limits.

(4) OJ L 124, 20.5.2003, p. 36.

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(9)

Translations can constitute a significant administrative
burden for SMEs. The Agency should therefore make
appropriate arrangements to provide for the translations
the granting of
of certain documents
draft
the
marketing
authorisation,
summary of
the product characteristics and the draft
text of the labelling and package leaflet.

required for

particular

in

(10) A lack of experience with the centralised procedure and
the Agency as an administrative organisation should not
impair the development and marketing of new medicinal
products. Consequently,
it is appropriate to create an
SME office, with the sole remit of offering administrative
assistance to SMEs. The SME office should provide a
single interface between the applicant SME and the
Agency,
to facilitate communication and to
answer practical or procedural enquiries.

so as

Article 2

Scope

1.
This Regulation shall apply to SMEs within the meaning
of Recommendation 2003/361/EC in the version of 6 May
2003 which are established in the Community.

Unless otherwise specified,

this Regulation shall apply
2.
for
both to applications
veterinary
human
to
use
medicinal
of Directives
2001/83/EC (1) and 2001/82/EC (2) of the European Parliament
and of the Council respectively.

concerning medicinal products
applications

products, within

the meaning

concerning

and

Article 3

Definition

(11)

In order to provide practical guidance to applicant SMEs,
the Agency should publish a user guide on the adminis-
trative and procedural aspects linked to the centralised
procedure which are of particular relevance for SMEs.

For the purposes of this Regulation, applicant means an under-
taking seeking to benefit from the application of the provisions
laid down in Chapters II and III.

(12)

The Agency should report annually on the operation of
the provisions laid down in this Regulation, so that
feedback on their practical application is available.

Article 4

Submission of information

(13)

In order to ensure that SMEs benefit, to the largest extent
possible, from the derogation provided for in this Regu-
lation it should enter into force immediately.

An SME wishing to benefit from the provisions of this Regu-
lation shall submit to the Agency the information necessary to
demonstrate
criteria mentioned in
Article 2(1).

compliance with the

(14)

The measures provided for in this Regulation are in
accordance with
Standing
Committee for Medicinal Products for Human Use and
of
the Standing Committee for Veterinary Medicinal
Products,

opinion

the

the

of

CHAPTER II

FEE DEFERRALS AND REDUCTIONS

Article 5

Fee deferrals

HAS ADOPTED THIS REGULATION:

The payment of the following fees shall be deferred until
1.
the notification of the final decision on the marketing author-
isation is issued, or the application is withdrawn:

CHAPTER I

GENERAL PROVISIONS

Article 1

Subject matter

This Regulation establishes the circumstances in which, by dero-
gation from the relevant provisions of Regulation (EC) No
297/95, micro, small and medium-sized enterprises (SMEs)
may pay reduced fees, defer payment of fees, or receive admin-
istrative assistance when submitting applications under Regu-
lation (EC) No 726/2004 to the European Medicines Agency,
hereinafter ‘the Agency’.

(a)

the fee for an application for a marketing authorisation of a
medicinal product, as referred to in points (a) and (b) of
Article 3(1) and points (a) and (b) of Article 5(1) of Regu-
lation (EC) No 297/95;

(b) the fee for

inspections undertaken for
assessing a marketing authorisation application for
medicinal product, as
Article 5(4) of Regulation (EC) No 297/95.

the purpose of
a
referred to in Article 3(4) and

(1) OJ L 311, 28.11.2001, p. 67.
(2) OJ L 311, 28.11.2001, p. 1.

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The fees referred to in paragraph 1 shall be payable within
2.
45 days of the date of the notification of the final decision on
the marketing authorisation, or within 45 days of the date of
the notification of withdrawal of the application.

Article 6

Conditional fee exemption

Without prejudice to Article 5, where an application for
marketing authorisation is submitted for a medicinal product
on which scientific advice has already been given by the
Agency, the fee payable to the Agency for the examination of
that application shall be due only if a marketing authorisation is
granted.

Article 7

Fee reductions

1.

The following reductions shall apply:

(a)

in the case of inspections a 90 % reduction to the inspection
fee, as referred to in Article 3(4) and Article 5(4) of Regu-
lation (EC) No 297/95;

(b) in the case of scientific advice a 90 % reduction to the
scientific advice fee, as referred to in Article 8(1) of Regu-
lation (EC) No 297/95;

(c)

in the case of scientific services a 90 % reduction to the
scientific service fee, as referred to in Article 8(2) of Regu-
lation (EC) No 297/95.

The administrative services, as referred to in Article 8(3) of
2.
Regulation (EC) No 297/95, shall be provided free of charge,
except where those services concern the parallel distribution of
medicinal products, as referred to in Article 57(1)(o) of Regu-
lation (EC) No 726/2004.

3.
By derogation from points (b) and (c) of paragraph 1,
scientific advice and scientific services for designated orphan
referred to in Regulation (EC) No
medicinal products as
141/2000 of the European Parliament and of the Council (1)
shall be provided free of charge.

Article 8

Fee reduction for the establishment of maximum residue
limits for veterinary medicinal products

1.
A 90 % reduction shall apply to the full and additional
maximum residue limits (MRL) fees, as referred to in Article 7
of Regulation (EC) No 297/95.

(1) OJ L 18, 22.1.2000, p. 1.

The reduction referred to in paragraph 1 shall not be
2.
taken into account when calculating the deduction of
the
MRL fees from the fee payable for an application for a
an application to extend a
marketing
for a medicinal product containing
marketing authorisation,
the substance for which the MRL concerned has been set,
where such applications are submitted by the same applicant.

authorisation or

However, this deduction shall not exceed one half of the fee to
which it applies.

Article 9

Multiple fee reductions

By derogation from Articles 7 and 8, where the applicant could,
in respect of the same fee, also benefit from other reductions
provided for in Community legislation, the provisions which are
the most favourable to the applicant shall apply.

Cumulative fee reductions for a given fee and a given applicant
shall not be allowed.

CHAPTER III

ADMINISTRATIVE ASSISTANCE

Article 10

Translations

The Agency shall provide for the translations of the documents
referred to in points (a) to (d) of Article 9(4) and points (a) to
(e) of Article 34(4) of Regulation (EC) No 726/2004 that are
required for the purpose of granting a Community marketing
authorisation.

Article 11

SME Office

The Executive Director of

1.
set up
dedicated administrative structures and specific procedures for
the establishment of an SME Office.

the Agency shall

2.

The SME Office shall have the following tasks:

(a)

to give advice to applicants on the administrative and
procedural steps necessary to comply with the requirements
laid down in Regulation (EC) No 726/2004;

(b) to ensure the appropriate monitoring of all requests and
applications submitted by the same applicant and related
to a particular medicinal product;

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(c)

to organise workshops and training sessions for applicants
on the administrative and procedural steps necessary to
comply with the requirements laid down in Regulation
(EC) No 726/2004.

Article 12

User Guide

The Agency shall, upon agreement of the Commission, publish
a detailed User Guide on the administrative and procedural
aspects of
the provisions laid down in Regulation (EC) No
726/2004, which are of particular relevance for SMEs. The
User Guide shall be kept updated.

The User Guide shall also contain references to existing national
provisions for SMEs applicable to the pharmaceutical sector.

CHAPTER IV

FINAL PROVISIONS

Article 13

Report

The Agency shall include in the Annual Report of its activities a
section on the experience acquired as a result of the application
of this Regulation.

Article 14

Transitional provision

This Regulation shall not apply to valid applications pending at
the date of its entry into force.

Article 15

Entry into force

For the purposes of the second paragraph, the Member States
shall communicate those references to the Agency.

This Regulation shall enter into force on the day of its publi-
cation 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, 15 December 2005.

For the Commission

Günter VERHEUGEN
Vice-President