1995R0297 — EN — 20.03.2003 — 002.001 — 1
This document is meant purely as a documentation tool and the institutions do not assume any liability for its contents
►B COUNCILREGULATION(EC)No297/95
of10February1995
onfeespayabletotheEuropeanAgencyfortheEvaluationofMedicinal Products
(OJ L 35, 15.2.1995, p. 1)
Amended by:
Official Journal
No page date
►M1Council Regulation (EC) No 2743/98 of 14 December 1998 L 345 3 19.12.1998
►M2Commission Regulation (EC) No 494/2003 of 18 March 2003 L 73 6 19.3.2003
Corrected by:
►C1Corrigendum, OJ L 75, 4.4.1995, p. 29 (297/95)
NB: This consolidated version contains references to the European unit of account and/or the ecu, which from 1 January 1999
should be understood as references to the euro — Council Regulation (EEC) No 3308/80 (OJ L 345, 20.12.1980, p. 1) andCouncil Regulation (EC) No 1103/97 (OJ L 162, 19.6.1997, p. 1).
▼B
COUNCILREGULATION(EC)No297/95
of10February1995
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, inparticular Article 235 thereof,
Having regard to the proposal from the Commission,
►
C1Having regard to the European Parliament (1)◄,
WhereasArticle 58 of Council Regulation (EEC) No 2309/93 of 22
July 1993 laying down Community proceduresfor the authorizationand supervision of medicinal products for human and veterinary useand establishing a European Agency for the Evaluation of MedicinalProducts(
2), hereinafter referred to as‘the Agency’, requiresthe
Council to establish the structure and the amount of fees referred to in
Article 57 (1);
Whereas Article 57 (1) of the Regulation establishes that the revenues
of the Agency shall consist of a contribution from the Community, andthe feespaid by undertakingsfor obtaining and maintaining a Commu-nity marketing authorization and for other services provided by the
Agency;
WhereasArticles6 (3) and 28 (3) res pectively of Regulation (EEC)
No 2309/93 require that any application for authorization for a medic-inal product or any application for a variation be accompanied by thefee payable to the Agency for the examination of the application;
Whereasthe calculation of the amount of the feescharged by the
Agency must be based on the principle of the service actually
provided;
Whereasthe amount of the feeslaid down in thisRegulation s hould
not be a determining factor for the applicant for an authorization wherethere isa choice between a centralized procedure and a national proce-dure;
Whereas the basic fee should be defined as the fee charged for the
initial application for an authorization for a medicinal product plusafee for each different strength and/or pharmaceutical form; whereas,however, a ceiling should be established;
Whereas to the same end, an extension fee should be laid down for
subsequent applications regarding a medicinal product which has
already been authorized in order to take account of the additional
work and expenditure where an applicant chooses to submit the appli-cations gradually and subsequently;
Whereas provision should be made for a reduced fee for applications
which may be sustained by a less detailed dossier pursuant to point 8of the second paragraph of Article 4 of Council Directive 65/65/EEC of
26 January 1965 on the approximation of provisions laid down by law,
regulation or administrative action relating to medicinal products (
3)
and point 8 of the second paragraph of Article 5 of Council Directive81/851/EEC of 28 September 1981 on approximation of the lawsof theMember Statesrelating analytical, pharmaco-toxicological and clinicalstandards protocols in respect of the testing of veterinary medicinal1995R0297 — EN — 20.03.2003 — 002.001 — 2
(1) Opinion delivered on 19 January 1995 (not yet published in the Official
Journal).
(2) OJ No L 214, 24. 8. 1993, p. 1.
(3) OJ No 22, 9. 2. 1965, p. 369/65. Directive aslas t amended by Directive 93/
39/EEC (OJ No L 214, 24. 8. 1993, p. 22).
▼B
products(1) respectively and for applications concerning a medicinal
product for use in non-food producing animals;
Whereasthe examination of variationsto the termsof exis ting author-
izationsnot requiring full evaluation of the product'squality, s afety andefficacy should be charged according to the complexity of the varia-tionsand the real workload linked to them, and therefore at a rate far
lower than for a standard application;
Whereasthe work involved in the mandatory five-yearly renewal of a
Community marketing authorization justified the charging of a fee;
Whereas a fee should be laid down for arbitration services in the event
of disagreement between Member States on applications for authoriza-tionss ubmitted under the decentralized procedure;
Whereas a fee should be levied on a flat-rate basis for any inspection
made successively to a marketing authorization at the request or in theinterest of its holder;
Whereasthe market for a veterinary medicinal product differsfrom that
of a medicinal product for human use and therefore justifies a generalreduction of the fee; whereas it should furthermore be possible to takeaccount of the particular situation linked to the marketing of certain
veterinary medicinal products on an individual basis; whereas this aim
can best be achieved by means of special provisions such as a clausefor reductionsand waivers ;
Whereas, as regards the evaluation of applications to establish
maximum residue limits (MRLs), it is up to the applicant to decidewhether to apply separately for the establishment of MRLs or to do sotogether with hisapplication for a Community marketing authorizationin which case the fee incurred for the evaluation of the application forauthorization should cover the one for the establishment of MRLs;
whereas, however, if the applicant deliberately chooses to apply sepa-
rately for the establishment of MRLs, the additional work andexpenditure should be recouped by means of an isolated MRL fee;
Whereasall other feesfor the evaluation of veterinary medicinal
products should follow the principles described above;
Whereas provision should be made for waivers or reductions of the
fees stated above under exceptional circumstances for essential public
health or animal health reasons; whereas any decision upon those casesshould be taken by the Director after hearing the competent committeeand on the basis of general criteria laid down by the Agency's Manage-ment Board;
Whereas a provisional period of three years should be laid down after
which the experience gained will enable the financial needsof theAgency to be re-assessed; whereas for practical reasons provisionshould also be made for machinery to permit rates to be updated over
shorter periods;
Whereas the Treaty does not provide the necessary powers for fixing
feesat Community level, within the framework of a Community
system; whereas it is therefore appropriate to have recourse to Article
235 of the Treaty,
HAS ADOPTED THIS REGULATION:
Article 1
Scope
Feesfor obtaining and maintaining a Community authoris ation to
market medicinal productsfor human and veterinary us e and for other1995R0297 — EN — 20.03.2003 — 002.001 — 3
(1) OJ No L 317, 6. 11. 1981, p. 1. Directive aslas t amended by Directive 93/
40/EEC (OJ No L 214, 24. 8. 1993, p. 31).▼M1
▼M1
services supplied by the Agency shall be levied in accordance with this
Regulation.
The amounts of these fees shall be laid down in ecus.
Article 2
The Agency shall indicate in its annual estimate intended for the estab-
lishment of the preliminary draft budget of the Commission the
estimates concerning the fees for the following financial year, and thisshall be done separately from the estimating of the overall expenditureand the possible contribution by the Community.
Article 3
Medicinal products for human use covered by the procedures laid
downinRegulation(EEC)No2309/93
1.Authorisation to market a medicinal product
(a) Full fee
The fee for an application for authorisation to market a medic-
inal product supported by a full dossier is
►
M2EUR 232 000 ◄. This fee covers a single strength asso-
ciated with one pharmaceutical form.
The fee shall be increased by ►M2EUR 23 200 ◄for each
additional strength and/or pharmaceutical form submitted at the
same time as the initial application for authorisation. Thisincrease covers one additional strength and/or pharmaceuticalform.
The fee shall be increased by ►
M2EUR 5 800 ◄for each
additional presentation of the same strength and pharmaceuticalform, submitted at the same time as the initial application forauthorisation.
(b) Reduced fee
A reduced fee of ►
M2EUR 116 000 ◄shall apply to applica-
tionsfor authoris ation to market a medicinal product for which afull dossier 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 para-graph of Article 4 of the same Directive. This fee covers asingle strength associated with one pharmaceutical form.
The fee shall be increased by ►
M2EUR 23 200 ◄for each
additional strength and/or pharmaceutical form submitted at thesame time as the initial application for authorisation. Thisincrease covers one additional strength and/or pharmaceuticalform.
The fee shall be increased by ►
M2EUR 5 800 ◄for each
additional presentation of the same strength and pharmaceuticalform submitted at the same time as the initial application forauthorisation.
(c) Extension fee
This is the fee for each extension of a marketing authorisation
which hasalready been granted:
— where the extension is for a new strength, a new pharmaceu-
tical form, a new indication or a new method ofadministration, the fee shall be ►
M2EUR 58 000 ◄,
— where the extension is for a new presentation of a strength, a
pharmaceutical form or of a method of administration whichare already authorised, the fee shall be►
M2EUR 11 600 ◄.1995R0297 — EN — 20.03.2003 — 002.001 — 4
▼B
▼M1
▼M1
2.Variation
(a) Type I variation fee
The fee for a variation of minor importance to a marketing
authorisation according to the classification established by theCommission Regulation applicable to the matter shall be►
M2EUR 5 800 ◄.
In the event of the same variation being introduced, this fee
shall cover all authorised strengths, pharmaceutical forms andpresentations.
(b) Type II variation fee
The fee for a variation of major importance to a marketing
authorisation according to the classification established by theCommission Regulation applicable to the matter shall be►
M2EUR 69 600 ◄. It may be halved for certain Type II
variationswhich do not involve detailed s cientific 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 introduced, this fee
shall cover all authorised strengths, pharmaceutical forms and
presentations.
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 ►M2EUR 11 600 ◄. It shall be charged for each
strength associated with a pharmaceutical form.
4.Inspection fee
The flat-rate fee for any inspection within or outside the Community
is►M2EUR 17 400 ◄. For inspections outside the Community,
travel expenses shall be charged extra on the basis of actual cost.
5.Transfer fee
The fee for a change in the holder of the marketing authorisations to
which the transfer relates shall be ►M2EUR 5 800 ◄. This
covers all authorised presentations of a given medicinal product.
6.Annual fee
The annual fee for each medicinal product which hasbeen granted a
marketing authorisation shall be ►M2EUR 75 600 ◄. Thiscovers
all authorised presentations of a given medicinal product.
Article 4
Medicinal products for human use covered by the procedures laid
downinDirective 75/319/EEC (1)
Arbitration fee
A fee of ►M2EUR 11 600 ◄shall be payable where the procedures
laid down in Articles10(2), 11, 12 and 15 of Directive 75/319/EEC areinitiated.
The fee shall be increased by ►
M2EUR 46 400 ◄where the proce-
dureslaid down in Articles11 and 12 of Directive 75/319/EEC are
initiated at the instigation of the applicant for or holder of themarketing authorisation.1995R0297 — EN — 20.03.2003 — 002.001 — 5
(1) OJ L 147, 9. 6. 1975, p. 13. Directive aslas t amended by Directive 93/39/
EEC (OJ L 214, 24. 8. 1993, p. 22).
▼M1
Article 5
Medicinal products for veterinary use covered by the procedures
laiddowninRegulation(EEC)No2309/93
1.Authorisation to market a medicinal product
(a)Full fee
The fee for an application for authorisation to market a medic-
inal product supported by a full dossier shall be►
M2EUR 116 000 ◄. It covers a single strength associated
with one pharmaceutical form.
The fee shall be increased by ►M2EUR 11 600 ◄for each
additional strength and/or pharmaceutical form submitted at thesame time as the initial application for authorisation. This
increase covers one additional strength and/or pharmaceutical
form.
The fee shall be increased by ►
M2EUR 5 800 ◄for each
additional presentation of the same strength and pharmaceuticalform, submitted at the same time as the initial application forauthorisation.
In the case of vaccines, the full fee shall be reduced to
►
M2EUR 58 000 ◄, with each additional strength and/or
pharmaceutical form and/or presentation entailing an increaseof►
M2EUR 5 800 ◄.
For the purposes of this point (a), the number of target species is
irrelevant.
(b) Reduced fee
A reduced fee of ►M2EUR 58 000 ◄shall apply to applica-
tionsfor authoris ation to market a medicinal product for which afull 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 thirdparagraph of Article 5 of the same Directive. This fee covers asingle strength associated with one pharmaceutical form of themedicinal product.
The fee shall be increased by ►
M2EUR 11 600 ◄for each
additional strength and/or pharmaceutical form submitted at the
same time as the initial application for authorisation. Thisincrease covers one additional strength and/or pharmaceuticalform.
The fee shall be increased by ►
M2EUR 5 800 ◄for each
additional presentation of the same strength and pharmaceuticalform submitted at the same time as the initial application for
authorisation.
In the case of vaccines, the fee shall be reduced to
►
M2EUR 29 000 ◄, with each additional strength and/or
pharmaceutical form and/or presentation entailing an increaseof►
M2EUR 5 800 ◄.
For the purposes of this paragraph (b), the number of target
species is irrelevant.
(c) Extension fee
This is the fee for each extension of a marketing authorisation
which hasalready been granted:
— where the extension is for a new strength, a new pharmaceu-
tical form, a new species, a new indication or a new methodof administration, the fee shall be ►
M2EUR 29 000 ◄,
— where the extension is for a new presentation of a strength,
of a pharmaceutical form or of a method of administration
which are already authorised, the fee shall be
►M2EUR 5 800 ◄,
— in the case of vaccines, where the extension is for a new
strength, a new pharmaceutical form, a new presentation or1995R0297 — EN — 20.03.2003 — 002.001 — 6
▼M1
a new method of administration, the fee shall be
►M2EUR 5 800 ◄.
2.Variation
(a) Type I variation fee
The fee for a variation of minor importance to a marketing
authorisation according to the classification established by theCommission Regulation applicable to the matter shall be
►
M2EUR 5 800 ◄. The same fee shall be charged in respect
of vaccines.
In the event of the same variation being introduced, this fee
shall cover all authorised strengths, pharmaceutical forms andpresentations.
(b) Type II variation fee
The fee for a variation of major importance to a marketing
authorisation according to the classification established by theCommission Regulation applicable to the matter shall be►
M2EUR 34 800 ◄. It may be halved for certain Type II
variationswhich do not involve detailed s cientific 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 ►M2EUR 5 800 ◄.
In the event of the same variation being introduced, this fee
shall cover all authorised strengths, pharmaceutical forms andpresentations.
3.Renewal fee
The fee for examining information available at the time of the five-
yearly renewal of an authorisation to market a medicinal productshall be►
M2EUR 5 800 ◄. It shall be charged for each strength
associated with a pharmaceutical form.
4.Inspection fee
The flat-rate fee for any inspection within or outside the Community
shall be ►M2EUR 17 400 ◄. For inspections outside the
Community, travel expenses shall be charged extra on the basis of
actual cost.
5.Transfer fee
The fee for a change in the holder of the marketing authorisations to
which the transfer relates shall be ►M2EUR 5 800 ◄. This
covers all authorised presentations of a given medicinal product.
6.Annual fee
The annual fee for each medicinal product which hasbeen granted a
marketing authorisation shall be ►M2EUR 25 200 ◄. Thiscovers
all authorised presentations of a given medicinal product.
Article 6
Medicinal products for veterinary use covered by the procedures
laiddowninDirective 81/851/EEC
Arbitration fee
An arbitration fee of ►M2EUR 11 600 ◄shall be payable where the
procedureslaid down in Articles18(2), 19, 20 and 23 of Directive 81/851/EEC are initiated.
The fee shall be increased by ►
M2EUR 23 200 ◄where the proce-
dureslaid down in Articles19 and 20 of Directive 81/851/EEC areinitiated at the instigation of the applicant for or holder of themarketing authorisation.1995R0297 — EN — 20.03.2003 — 002.001 — 7
▼M1
Article 7
Establishment of maximum residue limits (MRL) for veterinary
medicinal products
1.Fees for establishing MRL
A full MRL fee of ►M2EUR 58 000 ◄shall be charged for an
application to set an initial MRL for a given substance.
An additional MRL fee of ►M2EUR 17 400 ◄shall be payable
for each application to amend or extend an existing MRL, or tocover new species.
MRL feess hall be deducted from the fee payable for an application
for marketing authorisation or an application to extend a marketingauthorisation for the medicinal product containing the substance forwhich an MRL has been set where such applications are submittedby the same applicant. However, this deduction may total no morethan one half of the fee to which it applies.
2.MRL fee
A fee of►
M2EUR 17 400 ◄shall be charged for any application
to set an MRL with a view to clinical trials.
The fee shall be deducted from the amount of the full MRL fee laid
down in point 1.
Article 8
Variousfees
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 anapplication for marketing authorisation or an application to extenda marketing authorisation.
— For medicinal products for human use the maximum fee is set at
►
M2EUR 69 600 ◄.
— For medicinal products for veterinary use the maximum fee is set
at►M2EUR 34 800 ◄.
The detailed proceduresfor applying thispoint s hall 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 thisRegulation or upon conclus ion ofthe administrative validation of a dossier resulting in rejection ofthe application for which the dossier was submitted. The unitamount of such fees may not exceed ►
M2EUR 5 800 ◄.I n
accordance with Article 11(2) of this Regulation, a classification
shall be established and specified by the Management Board of theAgency.
Article 9
Possiblefeereductions
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 theExecutive Director after consultation of the competent scientificcommittee. Any decision taken pursuant to this Article shall state thereasons on which it is based.
A total or partial exemption may be granted, in particular for medicinal
products for treating rare diseases or diseases affecting minor species.1995R0297 — EN — 20.03.2003 — 002.001 — 8
▼M1
Article 10
Duedateandbelatedpayment
1. Feess hall be payable on the date of receipt of the relevant applica-
tion unless specific provisions stipulate otherwise.
The arbitration fee shall be payable within 30 days following
referral to the Agency; the annual fee shall be payable within 30days of the first and each subsequent anniversary of the notificationof 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 thisRegulation remainsunpaid at its
due date, and without prejudice to the Agency'scapacity to ins titute
legal proceedingsconferred on it by Article 59 of Regulation (EEC)No 2309/93, the Executive Director of the Agency may decideeither not to provide the requested services or to suspend all theservices and procedures under way until the whole of the relevantfee hasbeen paid.
3. Feess hall be paid in ecusor in the national currency of one of the
Member Statesaccording to the exchange ratesin force, which are
fixed daily by the Commission. However, monthly conversion ratesbased on the earlier rates may be fixed according to a calculationestablished by the Agency's Management Board.
Article 11
Implementingrules
1. On a proposal from the Executive Director and following a favour-
able opinion from the Commission, the Agency's ManagementBoard shall fix the rules for repaying a part of the resources derivingfrom the annual feesto the competent national authoritiesinvolved
in Community market supervision.
2. Without prejudice to the provisions of this Regulation or of Regula-
tion (EEC) No 2309/93, the Agency'sManagement Board may, on aproposal from the Executive Director, specify any other provisionproving necessary for the application of this Regulation.
3. In the event of disagreement as to the classification of an application
in one of the fee categorieslaid down in thisRegulation, the Execu-
tive Director shall give a ruling after consultation of the competent
scientific committee.
Article 12
Amendment
Any amendment to thisRegulation s hall 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 yearsof the entry into force of thisRegulation, the
Commission will present a report on its implementation, after consulta-
tion of the Agency'sManagement Board.
Future reviews of fees shall be based on a comprehensive evaluation of
the Agency's costs, including expenditure relating to Member States'
rapporteurs.
Article►
M113◄
Entryintoforce andlegaleffect
ThisRegulation s hall enter into force on the day following itspublica-
tion in the Official Journal of the European Communities .1995R0297 — EN — 20.03.2003 — 002.001 — 9
▼B
▼B
ThisRegulation s hall be binding in itsentirety and directly applicable
in all Member States.1995R0297 — EN — 20.03.2003 — 002.001 — 10