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19.6.2013 Official
Journal
of
the
European
Union L
167/17
COMMISSION IMPLEMENTING REGULATION (EU) No 564/2013
of 18 June 2013
on the fees and charges payable to the European Chemicals Agency pursuant to Regulation (EU) No
528/2012 of the European Parliament and of the Council concerning the making available on the
market and use of biocidal products
(Text with EEA relevance)
THE EUROPEAN COMMISSION,
biocides sector combined with the interest of avoiding
excessive fees for other enterprises while ensuring that
the Agency’s work is fully financed. For the purpose of
Having regard to the Treaty on the Functioning of the European
discouraging applications for products containing active
Union,
substances fulfilling one of the substitution criteria listed
in Article 10(1) of Regulation (EU) No 528/2012, as well
as of such active substances, reductions should not apply
Having regard to Regulation (EU) No 528/2012 of 22 May
to applications for such biocidal products or active
2012 of the European Parliament and of the Council
substances.
concerning the making available on the market and use of
biocidal products ( 1 ), and in particular Article 80(1) thereof,
(5) Taking into account the Agency’s work required to
handle an appeal lodged in accordance with Article 77
Whereas:
of Regulation (EU) No 528/2012, it is appropriate to levy
a fee for such appeals in accordance with the third
subparagraph of Article 77(1) of that Regulation.
(1) The
structure
and
amount
of
the
fees
payable
to
the
However, to avoid penalising persons launching
European Chemicals Agency, (hereinafter referred to as
justified appeals, it is appropriate to refund such fees
‘the Agency’), as well as the conditions for payment
where the appeal is well founded.
should be established.
(2) The
structure
and
amount
of
the
fees
should
take (6) Taking
into
account
the
reduced
work
required
by
the
account of the work required by Regulation (EU) No
Agency in cases where applications are rejected before or
528/2012 to be carried out by the Agency. Fees
during validation, or withdrawn during their assessment,
should be set at such a level as to ensure that the
it is appropriate to provide for partial refund of fees in
revenue derived from them, when combined with other
such cases.
sources of the Agency’s revenue, is sufficient to cover the
cost of the services delivered.
(7) For
the
purpose
of
encouraging
applications
for
approval
of active substances that are suitable alternatives to
(3) It
follows
from
Article
80(3)(d)
of
Regulation
(EU)
No
approved active substances fulfilling one of the
528/2012 that the structure and amount of fees is to
exclusion criteria listed in Article 5(1) of Regulation
take into account whether information has been
(EU) No 528/2012, it is appropriate to provide for
submitted jointly or separately. In order to reflect the
reimbursement of the fee for such applications.
actual work load of the Agency and to promote joint
submission of information, it is appropriate to only levy
one fee per application, in case several persons apply
jointly for the approval of an active substance or the
(8)
The fee for applications for inclusion in Annex I to
renewal of an approval of an active substance.
Regulation (EU) No 528/2012 of active substances that
do not give rise to concern should take into account the
estimated work required by the Agency to handle such
applications, as well as the public interest in allowing
(4) To
take
into
account
the
specific
needs
of
small
and
products containing such substances to be authorised.
medium-sized enterprises within the meaning of

Commission Recommendation 2003/361/EC of 6 May
2003 concerning the definition of micro, small and
medium sized enterprises ( 2 ) (hereinafter ‘SMEs’) estab
(9) For
the
purpose
of
discouraging
applications
for
approval
lished in the Union, reduced fees for active substance
or renewal of approval of active substances fulfilling one
approval, renewal of approval or inclusion in Annex I
of the substitution criteria listed in Article 10(1) of Regu
to Regulation (EU) No 528/2012 and biocidal product
lation (EU) No 528/2012 as well as applications for auth
authorisation or renewal should apply to such
orisation or renewal of products requiring a comparative
companies. The levels of the reductions should take
assessment in accordance with Article 23 of Regulation
into account the significant proportion of SMEs in the
(EU) No 528/2012, and of contributing to financing the
waivers and reductions provided for by this Regulation, it
( 1 ) OJ L 167, 27.6.2012, p. 1.
is appropriate to provide for increased fees for such
( 2 ) OJ L 124, 20.5.2003, p. 36.
applications.

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L 167/18
EN
Official Journal of the European Union
19.6.2013
(10) In
view
of
the
Agency’s
work
required
to
handle
a
should be fixed taking due account of the deadlines of
request for an opinion on the classification of a change
the procedures provided for in that Regulation.
in accordance with Commission Implementing Regu
lation (EU) No 354/2013 of 18 April 2013 on
changes of biocidal products authorised in accordance
(15) The
fees
set
out
in
this
Regulation
should
be
reviewed
at
with Regulation (EU) No 528/2012 of the European
appropriate intervals, with a view to aligning the fees
Parliament and of the Council ( 1 ), it is appropriate to
with the inflation rate and with the actual costs to the
levy a fee for such requests. However, to avoid, to the
Agency of the services provided. These reviews should
extent possible, penalising applicants whose requests to
take into account the Agency’s increased experience in
have a change classified as minor or administrative are
dealing with applications under the Regulation and the
justified, it is appropriate to grant a fee reduction to the
efficiencies thereby gained.
subsequent application for a change, where the request
leads to a recommendation to classify the change as an
administrative or minor change.
(16) The
Standing
Committee
on
Biocidal
Products
referred
to
in Article 82(1) of Regulation (EU) No 528/2012 did not
deliver an opinion on the measures provided for in this
(11) Given
the
Agency’s
work
required
to
treat
submissions
Regulation. Since an implementing act was deemed to be
for inclusion in the list of relevant persons referred to in
necessary, the chair submitted the draft implementing act
Article 95 of Regulation (EU) No 528/2012, it is appro
to the appeal committee for further deliberation. The
priate to levy a fee for such submissions. The amount of
appeal committee did not deliver an opinion,
work required for such submission will vary significantly
depending on whether the relevant person submits a
letter of access or a new dossier, since, in the latter
HAS ADOPTED THIS REGULATION:
case, the Agency will have to check that the dossier
complies with Annex II to Regulation (EU) No
528/2012 or, where appropriate, Annex IIA to
Directive 98/8/EC of the European Parliament and of
CHAPTER I
the Council of 16 February 1998 concerning the
FEES
placing on the market of biocidal products ( 2 ). It is
appropriate to differentiate the fee accordingly.
Article 1
Fees for work in relation to active substances
The Agency shall levy the fees provided for in Table 1 of Annex
(12) Given
the
Agency’s
work
required
to
handle
a
request
for
I for work required by Regulation (EU) No 528/2012 to be
confidentiality in accordance with Article 66(4) of Regu
carried out in relation to approval and renewal of approval of
lation (EU) No 528/2012, it is appropriate to levy a fee
active substances, as well as inclusion in Annex I to that Regu
for such requests.
lation.
(13) Since
the
Agency’s
budget
is
drawn
up
and
implemented
Article 2
in euro, and its accounts are also presented in euro in
accordance with Article 19 of Regulation (EU, Euratom)
Fees for work in relation to Union authorisation of
No 966/2012 of the European Parliament and of the
biocidal products
Council of 25 October 2012 on the financial rules
The Agency shall levy the fees provided for in Table 1 of Annex
applicable to the general budget of the Union and
II for work required by Regulation (EU) No 528/2012 to be
repealing Council Regulation (EC, Euratom) No
carried out in relation to Union authorisation of biocidal
1605/2002 ( 3 ), with Article 17 of Commission Regu
products.
lation (EC, Euratom) No 2343/2002 of 23 December
2002 on the framework Financial Regulation for the
bodies referred to in Article 185 of Council Regulation
(EC, Euratom) No 1605/2002 on the Financial Regu
Article 3
lation applicable to the general budget of the European
Other fees
Communities ( 4 ) and with Article 17 of the Financial
Regulation of the European Chemicals Agency of
1. The
Agency
shall
levy
the
fees
provided
for
in
Annex
III
24 September 2008 ( 5 ), it is appropriate to levy fees
for work required by Regulation (EU) No 528/2012 to be
only in euro.
carried out in relation to establishment of technical equivalence,
applications for mutual recognition, requests for inclusion in the
list of relevant persons, and requests for confidential treatment
of information submitted to the Agency.
(14) It
follows
from
Article
80(3)(f)
of
Regulation
(EU)
No
528/2012 that the deadlines for the payment of fees
2. The
Agency
shall
levy
the
annual
fees
provided
for
in
( 1 ) OJ L 109, 19.4.2013, p. 4.
Annex III for every biocidal product or biocidal product
( 2 ) OJ L 123, 24.2.1998, p. 1.
family authorised by the Union. The annual fee shall be due
( 3 ) OJ L 298, 26.10.2012, p. 1.
( 4 ) OJ L 357, 31.12.2002, p. 72.
on the first and each subsequent anniversary of the entry into
( 5 ) MB/53/2008 final.
force of the authorisation. It shall relate to the preceding year.

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EN
19.6.2013 Official
Journal
of
the
European
Union L
167/19
Article 4
(EU) No 528/2012, the question shall be determined by
reference to the active substance manufacturer that is repre
Fees for appeals against a decision of the Agency under
sented by the prospective applicant. In case of an application
Article 77 of Regulation (EU) No 528/2012
for product authorisation or renewal of product authorisation,
1. For
any
appeal
against
a
decision
of
the
Agency
under the question shall be determined by reference to the prospective
Article 77 of Regulation (EU) No 528/2012, the Agency shall
authorisation holder.
levy a fee as set out in Annex III.
3. The
Agency
shall
publish
a
list
of
the
relevant
elements
to
2. An
appeal
shall
not
be
considered
to
be
received
by
the be submitted in accordance with paragraph 1.
Board of Appeal until the relevant fee has been received by the
Agency.
4. Within
45
days
of
receipt
of
all
the
relevant
elements
referred to in paragraph 1, the Agency shall decide what SME
3. If the appeal is considered inadmissible by the Board of
status, if any, can be recognised.
Appeal, the fee shall not be refunded.
5. A
recognition
of
an
enterprise
as
an
SME
shall
be
valid
for
4. The
Agency
shall
refund
the
fee
levied
in
accordance
with applications submitted under Regulation (EU) No 528/2012 for
paragraph 1 if the Executive Director of the Agency rectifies a
two years.
decision in accordance with Article 93(1) of Regulation (EU) No
1907/2006 of the European Parliament and of the Council ( 1 ),
or if the appeal is decided in favour of the appellant.
6. An
appeal
may
be
brought,
in
accordance
with
Article
77
of Regulation (EU) No 528/2012 against a decision taken by
Article 5
the Agency under paragraph 4.
Reimbursement possibility for alternatives to approved
Article 7
active substances fulfilling one of the exclusion criteria
Fee Reductions
1. Upon submission of an application to the Agency for the
approval of an active substance, which may be a suitable alter
1. Reductions
of
fees
payable
to
the
Agency
as
set
out
in
native, within the meaning of the second subparagraph of
Table 2 of Annex I and Table 2 of Annex II shall be granted to
Article 5(2) of Regulation (EU) No 528/2012, to an approved
SMEs established in the Union.
active substance fulfilling one of the exclusion criteria pursuant
to Article 5(1) of that Regulation, an applicant may request
2. Reductions for applications for active substance approval,
reimbursement of the fee to be paid to the Agency.
renewal of approval or inclusion in Annex I to Regulation (EU)
No 528/2012 shall only be granted when the active substance
2. Upon receipt of the opinion from the Agency in
is not a candidate for substitution.
accordance with Article 8(4) of Regulation (EU) No
528/2012, which shall also include a recommendation on
3. Reductions for applications for biocidal product authori
whether the active substance is a suitable alternative within
sation or renewal of authorisation shall only be granted when
the meaning of the second subparagraph of Article 5(2) of
the product does not contain an active substance which is a
Regulation (EU) No 528/2012, the Commission shall decide
candidate for substitution.
on the request.
CHAPTER III
3. Where
the
Commission
decides
that
the
active
substance
is a suitable alternative, the Agency shall inform the applicant
PAYMENTS
thereof and fully reimburse the fee referred to in paragraph 1.
Article 8
CHAPTER II
Mode of payment
SUPPORT FOR SMEs
1. The fees provided for by this Regulation shall be paid in
Article 6
euro.
Recognition of SME status
2. Payments
shall
be
made
only
after
the
Agency
has
issued
1. Before
submission
of
an
application
to
the
Agency
for an invoice.
approval, renewal or inclusion in Annex I to Regulation (EU)
No 528/2012 of an active substance or for Union authorisation
3. By
derogation
from
paragraph
2,
payments
due
under
of a biocidal product or biocidal product family, submitted in
Article 4 shall be made at the time of the submission of the
accordance with Articles 7(1), 13(1), 28(4), 43(1) or 45(1) of
appeal.
that Regulation respectively, containing a claim for SME
reduction, the prospective applicant shall submit to the
4. Payments
shall
be
made
by
means
of
a
transfer
to
the
Agency the relevant elements proving entitlement to such
bank account of the Agency.
reduction by virtue of the status of SME in the meaning of
Recommendation 2003/361/EC.
Article 9
2. In
the
case
of
an
application
for
approval,
renewal
or
Identification of the payment
inclusion of an active substance in Annex I to Regulation
1. Every
payment,
with
the
exception
of
payments
referred
to in Article 8(3), shall indicate in the reference field the invoice
( 1 ) OJ L 396, 30.12.2006, p. 1.
number.

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L 167/20
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Official Journal of the European Union
19.6.2013
2. Payments
referred
to
in
Article
8(3)
shall
indicate,
in
the
Article 13
reference field, the identity of the appellant(s) and, if available,
the number of the decision that is being appealed against.
Refunds of amounts in case of applications rejected before
or during validation or withdrawn during the assessment
1. The
Agency
shall
reimburse
90
%
of
the
fee
collected
3. If
the
purpose
of
the
payment
cannot
be
established,
the where an application for active substance approval or biocidal
Agency shall set a deadline by which the paying party must
product authorisation, submitted in accordance with
notify it in writing of the purpose of the payment. If the Agency
respectively Article 7(1) or 43(1) of Regulation (EU) No
does not receive a notification of the purpose of the payment
528/2012, or an application for a minor or major change of
before expiry of that deadline, the payment shall be considered
a product, is rejected before or during the validation phase.
invalid and the amount concerned shall be refunded to the
paying party.
2. The
Agency
shall
reimburse
75
%
of
the
fee
collected
Article 10
where an application for active substance approval or biocidal
product authorisation, submitted in accordance with
Date of payment
respectively Article 7(1) or 43(1) of Regulation (EU) No
1. Unless
otherwise
provided,
fees
shall
be
paid
within
30 528/2012, or an application for a major change of a product,
days from the date on which the invoice is notified by the
is withdrawn before the evaluating Competent Authority has
Agency.
transmitted its assessment report to the Agency.
2. The date on which the full amount of the payment is
The fee collected shall not be reimbursed where an application
deposited in a bank account held by the Agency shall be
is withdrawn after the evaluating Competent Authority has
considered to be the date on which the payment has been
transmitted its assessment report to the Agency.
made.
3. The payment shall be considered to have been made in
3. The
arrangements
for
the
refund
of
the
remaining
amount
time where sufficient documentary evidence is produced to
to the paying party shall be fixed by the Executive Director of
show that the paying party ordered the transfer to the bank
the Agency and published on the website of the Agency.
account indicated on the invoice before expiry of the relevant
deadline. A confirmation of the transfer order issued by a
financial institution shall be regarded as sufficient evidence.
CHAPTER IV
FINAL PROVISIONS
Article 11
Article 14
Insufficient payment
Reimbursement of rapporteurs
1. A deadline for payment shall be considered to have been
Members of the Biocidal Product Committee acting as
observed only if the full amount of the fee has been paid in due
rapporteurs shall be reimbursed through the fees paid in
time.
accordance with Article 80(2) to the Member States’
competent authorities acting as evaluating competent authority.
2. When
an
invoice
relates
to
a
group
of
transactions,
the
Agency may attribute any under-payment to any of the relevant
transactions. The criteria for the attribution of payments shall
Article 15
be laid down by the Management Board of the Agency.
Charges
1. Subject
to
a
favourable
opinion
from
the
Commission,
the
Article 12
Agency may establish by decision of its Management Board
Refund of amounts paid in excess
charges for administrative or technical services that it provides
in accordance with Regulation (EU) No 528/2012 at the request
1. The arrangements for the refund to the paying party of
of a party in order to facilitate its implementation. The
amounts paid in excess of a fee shall be fixed by the Executive
Executive Director of the Agency may decide not to levy a
Director of the Agency and published on the website of the
charge on international organisations or countries that request
Agency.
assistance from the Agency.
However, where an amount paid in excess is below EUR 200
and the party concerned has not expressly requested a refund,
2. The
charges
shall
be
set
at
such
a
level
as
to
cover
the
the amount paid in excess shall not be refunded.
costs of the services delivered by the Agency and shall not
exceed what is necessary to cover those costs.
2. It shall not be possible to count any amount paid in
excess and not refunded as being made towards future
3.
The charge shall be paid within 30 calendar days from the
payments to the Agency.
date on which the invoice is notified by the Agency.

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19.6.2013 Official
Journal
of
the
European
Union L
167/21
Article 16
as published by Eurostat. A first review shall be carried out at
the latest by 1 January 2015.
Provisional estimate
The Management Board of the Agency shall, when producing
The Commission shall also keep this Regulation under continual
an estimate of the overall expenditure and income for the
review in the light of significant information becoming available
following financial year in accordance with Article 96(5) of
in relation to the underlying assumptions for anticipated
Regulation (EC) No 1907/2006 of the European Parliament
income and expenditure of the Agency. At the latest by
and of the Council ( 1 ), include a specific provisional estimate
1 January 2015, the Commission shall review this Regulation
of income from fees and charges from activities entrusted to the
with a view to amend it, if appropriate, taking into account in
Agency in accordance with Regulation (EU) No 528/2012
particular the resources required by the Agency and those
which is separate from income from any subsidy from the
required by the competent authorities of the Member States
Union.
for services of a similar nature. The review shall take into
consideration the impacts on the SMEs, and review the fee
reduction rates allowable to SMEs where appropriate.
Article 17
Review
Article 18
The Commission shall review the fees and charges provided for
This Regulation shall enter into force on the twentieth day
in this Regulation annually by reference to the inflation rate as
following that of its publication in the Official Journal of the
measured by means of the European Index of Consumer Prices
European Union.
This Regulation shall be binding in its entirety and directly applicable in all Member States.
Done at Brussels, 18 June 2013.
For the Commission
The President
José Manuel BARROSO
( 1 ) OJ L 396, 30.12.2006, p. 1.

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L 167/22
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Official Journal of the European Union
19.6.2013
ANNEX I
Fees relating to active substances
Table 1
Standard fees
General description of task; relevant provision
in Regulation (EU) No 528/2012
Specific condition or task description Fee
(EUR)
Approval of an active substance;
Fee for the first product-type for which that active
120 000
Article 7(2)
substance is approved
Additional fee per additional product-type 40
000
Additional fee per product-type (for both the first product-
20 000
type and any additional product-type) if the active substance
is a candidate for substitution in accordance with Article 10
of Regulation (EU) No 528/2012
Fee for the amendment of an approval, other than the
20 000
addition of a product-type.
Renewal of an approval; Article 13(3)
Fee for the first product-type for which renewal of that
15 000
active substance is sought
Additional fee per additional product-type 1
500
Additional fee for the first product-type for which renewal
25 000
of that active substance is sought in case a full evaluation is
found necessary in accordance with Article 14(1) of Regu
lation (EU) No 528/2012
Additional fee per additional product-type in case a full
2 500
evaluation is found necessary in accordance with
Article 14(1) of Regulation (EU) No 528/2012
Additional fee per product-type (for both the first product-
20 000
type and any additional product-type) if the active substance
is a candidate for substitution in accordance with Article 10
of Regulation (EU) No 528/2012
Inclusion in Annex I of an active
Fee for the first inclusion in Annex I of an active substance 10
000
substance; Article 28
Fee for the amendment of an inclusion of an active
2 000
substance in Annex I
Notification in accordance with Article 3a Fee per substance/product-type combination.
10 000
of Regulation (EC) No 1451/2007
The fee for the notification shall be deducted from the
subsequent application in accordance with Article 7 of
Regulation (EU) No 528/2012.
Table 2
Fee reductions for applications for the approval, renewal of approval, inclusion in Annex I of active substances
if the active substance manufacturer is an SME established in the Union, except where the active substance is a
candidate for substitution
Type of enterprise Reduction
(%
of
the
standard
fee)
Micro enterprise 60
Small enterprise 40
Medium enterprise 20

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EN
19.6.2013 Official
Journal
of
the
European
Union L
167/23
ANNEX II
Fees for Union authorisation of biocidal products
Table 1
Standard fees
General description of task; relevant provision
in Regulation (EU) No 528/2012
Specific condition or task description Fee
(EUR)
Granting of Union authorisation, single
Fee per product not identical with (one of) the represen
80 000
product; Article 43(2)
tative product(s) assessed for the purpose of the substance
approval
Fee per product identical with (one of) the representative
40 000
product(s) assessed for the purpose of the substance
approval
Additional fee per product when comparative assessment in
40 000
accordance with Article 23 of Regulation (EU) No
528/2012 is required
Additional fee per product when the requested authori
10 000
sation is provisional in accordance with Article 55(2) of
Regulation (EU) No 528/2012
Granting of Union authorisation, biocidal Fee per family 150
000
product family; Article 43(2)
Additional fee per family when comparative assessment in
60 000
accordance with Article 23 of Regulation (EU) No
528/2012 is required
Additional fee per family when the requested authorisation
15 000
is provisional in accordance with Article 55(2) of Regu
lation (EU) No 528/2012
Notification to the Agency of an
Fee per additional product 2
000
additional product within a biocidal
product family; Article 17(6)
Union authorisation of a same biocidal
Fee per product constituting a ‘same product’ within the
2 000
product; Article 17(7)
meaning of Commission Implementing Regulation (EU) No
414/2013 of 6 May 2013 specifying a procedure for the
authorisation of same biocidal products in accordance with
Regulation (EU) No 528/2012 of the European Parliament
and of the Council ( 1 )
Major change of an authorised product or Fee per application 40
000
product family; Article 50(2)
Minor change of an authorised product
Fee per application 15
000
or product family; Article 50(2)
Administrative change of an authorised
Fee per notification 2
000
product or product family; Article 50(2)
Recommendation on the classification of Fee per request in accordance with Regulation (EU) No
2 000
a change of an authorised product or
354/2013.
product family; Article 50(2)
If the recommendation is to classify the change as an
administrative or minor change, the fee for the request shall
be deducted from the subsequent application or notification
in accordance with Regulation (EU) No 354/2013.

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Official Journal of the European Union
19.6.2013
General description of task; relevant provision
in Regulation (EU) No 528/2012
Specific condition or task description Fee
(EUR)
Renewal of Union authorisation, single
Fee per product 5
000
product; Article 45(3)
Additional fee per product in case a full evaluation is found
15 000
necessary in accordance with Article 14(1) of Regulation
(EU) No 528/2012
Additional fee per product when comparative assessment in
40 000
accordance with Article 23 of Regulation (EU) No
528/2012 is required
Renewal of Union authorisation, biocidal Fee per product family 7
500
product family; Article 45(3)
Additional fee per product family in case a full evaluation is
22 500
found necessary in accordance with Article 14(1) of Regu
lation (EU) No 528/2012
Additional fee per product family when comparative
60 000
assessment in accordance with Article 23 of Regulation (EU)
No 528/2012 is required
( 1 ) OJ L 125, 7.5.2013, p. 4.
Table 2
Fee reductions for applications for the granting and renewal of Union authorisation of biocidal products or
biocidal product families, if the prospective authorisation holder is an SME established in the Union, except
where the product contains an active substance which is a candidate for substitution
Type of enterprise Reduction
(%
of
the
standard
fee)
Micro enterprise 30
Small enterprise 20
Medium enterprise 10

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19.6.2013 Official
Journal
of
the
European
Union L
167/25
ANNEX III
Other fees
General description of task; relevant provision
in Regulation (EU) No 528/2012)
Specific condition or task description Fee
(EUR)
Technical equivalence; Article 54(3) Fee,
when
difference
between
the
active
substance
sources
is
5 000
limited to a change in manufacturing location, and appli
cation is based solely on analytical data
Fee, when difference between the active substance sources
20 000
goes beyond a change in the manufacturing location, and
application is based solely on analytical data
Fee when previous conditions are not met. 40
000
Annual fee for biocidal products auth
Fee per Union authorisation of a biocidal product 10
000
orised by the Union; Article 80(1)(a)
Fee per Union authorisation of a biocidal product family 20
000
Mutual Recognition Submission fee;
Fee per product or product family concerned by an appli
700
Article 80(1)(a)
cation for mutual recognition, per Member State where
mutual recognition is sought
Appeal; Article 77(1) Fee
per
appeal 2
500
Submission for inclusion in the list of
Fee per submission of a letter of access to a dossier already
2 000
relevant persons; Article 95
found complete by the Agency or an evaluating Competent
Authority
Fee per submission of a letter of access to part of a dossier
20 000
already found complete by the Agency or an evaluating
Competent Authority, together with complementary data
Fee per submission of a new dossier 40
000
Requests under Article 66(4) submitted to Fee per item for which confidentiality is requested 1
000
the Agency

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Document Outline

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