Commission Regulation (EC) No 658/2007 of 14 June 2007 concerning financial penalties for infringement of certain obligations in connection with marketing authorisations granted under Regulation (EC) No 726/2004 of the European Parliament and of the Council
Date: 2007-06-14
Institutions: European Commission
Subjects: European Medicines Agency, drug surveillance, economic sanctions, infringement procedure (EU), market approval, medicinal product, veterinary drug

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COMMISSION REGULATION (EC) No 658/2007

of 14 June 2007

concerning financial penalties for infringement of certain obligations in connection with marketing
authorisations granted under Regulation (EC) No 726/2004 of the European Parliament and of the
Council

THE COMMISSION OF THE EUROPEAN COMMUNITIES,

(4)

Having regard to the Treaty
Community,

establishing the European

Having regard to Regulation (EC) No 726/2004 of the European
Parliament and of the Council of 31 March 2004 laying down
Community procedures for the authorisation and supervision of
medicinal products for human and veterinary use and estab-
lishing a European Medicines Agency (1), and in particular the
first subparagraph of Article 84(3) thereof,

Whereas:

(1)

(2)

(3)

In order to ensure the enforcement of certain obligations
connected with marketing authorisations for medicinal
products granted in accordance with Regulation (EC)
No 726/2004, Article 84 of that Regulation empowers
the Commission,
the European
Medicines Agency, hereinafter ‘the Agency’, to impose
financial penalties on the holders of marketing authori-
sations.

request of

the

at

Infringements of obligations laid down in connection
with marketing authorisations granted in accordance
with Regulation (EC) No 726/2004 which may lead to
the application of a financial penalty should concern the
content of a marketing authorisation and post-marketing
requirements
authorisation,
linked to a marketing
including the requirements of Community law relating
to pharmacovigilance and market surveillance.

Moreover, in view of the provision made by Article 84(1)
of Regulation (EC) No 726/2004, under which the
Member States are to determine the penalties to be
applied for infringement of the provisions of that Regu-
lation or the Regulations adopted pursuant to it and to
take the necessary measures for their implementation,
action at Community level should be taken only in
cases where
the Community are
involved. In that way, the effective enforcement of Regu-
lation (EC) No 726/2004 would be ensured by an appro-
priate management of
at
the
Community and national level.

interests of

resources

available

the

(5)

(6)

As a result of the system of parallel powers in relation to
supervision and enforcement by the Community and the
Member States with regard to marketing authorisations
granted
in accordance with Regulation (EC) No
726/2004, the provisions of this Regulation can be effec-
tively enforced only in a framework of close cooperation,
in accordance with Article 10 of the Treaty, between the
Member States, the Agency and the Commission. For that
purpose it is necessary to set up arrangements for consul-
tation and cooperation between them.

It is appropriate that, for the purposes of the initiation
and conduct of
the infringement procedure and the
quantification of financial penalties, the Agency and the
Commission should take into account any procedure by
a Member State against the same marketing authorisation
holder and based on the same legal grounds and the
same facts.

In order to ensure the effective conduct of the inquiry
the Agency and the
stage of alleged infringements,
Commission should have recourse to the competent
authorities of the Member States, designated as the super-
visory authorities of medicinal products
authorised
through the centralised procedure by Regulation (EC)
No 726/2004, to carry out the necessary measures of
inquiry and to obtain information relating to infringe-
ments falling within the scope of this Regulation. To
that end, it is appropriate that the supervisory authorities
conduct
the inspection and surveillance activities for
in accordance with the
which they are competent
provisions of Regulation (EC) No 726/2004, Directive
2001/82/EC of
the
Council of 6 November 2001 on the Community code
relating to veterinary medicinal products (2) and Directive
2001/83/EC of
the
Council of 6 November 2001 on the Community code
relating to medicinal products for human use (3) and
their implementing provisions.

the European Parliament and of

the European Parliament and of

(7)

The obligations connected with marketing authorisations
in accordance with Regulation (EC) No
granted
726/2004 falling within the scope of this Regulation
should be enforceable by means of
two types of
financial penalties: fines and periodic penalty payments.
Maximum amounts for both categories should be estab-
lished.

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

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

(1) OJ L 136, 30.4.2004, p. 1. Regulation as amended by Regulation

(3) OJ L 311, 28.11.2001, p. 67. Directive as last amended by Regu-

(EC) No 1901/2006 (OJ L 378, 27.12.2006, p. 1).

lation (EC) No 1901/2006.

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(8)

(9)

The decision to initiate an infringement procedure under
this Regulation should be taken by the Agency, which
should first inform the Commission and the Member
States. In the course of an inquiry, the Agency should
be empowered to require such information to be
supplied as is necessary to detect any infringement. It
should also be able to rely on the cooperation of
national competent authorities. Any supervisory powers
entrusted to the Agency by Community law as regards
marketing authorisations for medicinal products granted
in accordance with Regulation (EC) No 726/2004 may
be used by it in the course of the investigation of an
infringement.

The decisions by the Commission imposing penalties
should be based on the inquiry by the Agency, the obser-
vations of the marketing authorisation holder subject to
the infringement procedure and, where appropriate, other
information submitted to it. Any supervisory powers
entrusted to the Commission by Community law as
regards marketing authorisations for medicinal products
in accordance with Regulation (EC) No
granted
726/2004 may be used by it
the
in the course of
decision-making stage of an infringement procedure.

relating to a
necessary information and documents
presumed infringement, the right to silence in situations
where the holder would be compelled to provide answers
which may involve an admission on its part of
the
existence of an infringement, as developed by the
Court of Justice, should also be respected.

(14)

the purposes of ensuring legal certainty in the
For
it is necessary
conduct of the infringement procedure,
to lay down detailed rules
the computation of
time-limits and limitation periods for the imposition
and enforcement of penalties.

for

(15) Decisions

imposing penalties are to be enforced in
the Treaty and are

accordance with Article 256 of
subject to review by the Court of Justice.

(16)

rights and
This Regulation respects the fundamental
observes the principles recognised in particular by the
Charter of Fundamental Rights of the European Union.

(10)

It
is appropriate that decisions imposing penalties be
based exclusively on objections on which the marketing
to
authorisation holder
comment.

concerned has been able

(17)

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

Standing Committee

opinion

the

the

of

(11)

The penalties imposed should be effective, proportionate
and dissuasive, having regard to the circumstances of the
specific case.

HAS ADOPTED THIS REGULATION:

(12)

It appears appropriate to provide for a specific procedure
in cases where the Commission intends to impose a fine
for failure by a marketing authorisation holder subject to
an infringement procedure to comply with a request for
information from the Agency or the Commission.

(13) When carrying out an infringement procedure,

the
Agency and the Commission must ensure the respect
of the rights of defence and of the principle of confiden-
tiality in accordance with the general principles of law,
and the case-law of the Court of Justice of the European
Communities. In particular, the marketing authorisation
holder subject to the infringement procedure should have
the right to be heard by the Agency during the inquiry
stage and by the Commission once it has been notified a
statement of objections, as well as to access the file
compiled by the Agency and the Commission. While
compel
the Commission
the
marketing

entitled
to

be
holders

authorisation

provide

should

to

CHAPTER I

GENERAL PROVISIONS

Article 1

Subject-matter and scope

This Regulation lays down rules concerning the application of
financial penalties to the holders of marketing authorisations,
granted under Regulation (EC) No 726/2004,
in respect of
infringements of the following obligations, in cases where the
infringement concerned may have significant public health
implications in the Community, or where it has a Community
dimension by taking place or having its effects in more than
one Member State, or where interests of the Community are
involved:

1. the completeness and the accuracy of the particulars and
documents contained in an application for marketing
authorisation under Regulation (EC) No 726/2004, or of
any other documents and data submitted to the European
Medicines Agency established by that Regulation, here-
inafter ‘the Agency’, in response to obligations laid down
in that Regulation;

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2. conditions or restrictions included in the market authori-
sation and concerning the supply or use of the medicinal
product, as referred to in Article 9(4)(b), the second sub-
paragraph of Article 10(1), Article 34(4)(c) and the second
(EC)
subparagraph
No 726/2004;

of Article 35(1)

of Regulation

3. conditions or restrictions included in the marketing author-
isation with regard to the safe and effective use of the
medicinal product, as referred to in Article 9(4)(c), Article
10(1), Article 34(4)(d) and Article 35(1) of Regulation (EC)
No 726/2004;

4. the introduction of any necessary variations to the terms of
the marketing authorisation to take account of technical
and scientific progress and enable the medicinal products
to be manufactured and checked by means of generally
accepted scientific methods, as referred to in Article 16(1)
and Article 41(1) of Regulation (EC) No 726/2004;

5. the supply of any new information which may entail a
variation to the terms of the marketing authorisation, the
notification of any prohibition or restriction imposed by
the competent authorities of any country in which the
medicinal product is marketed, or the supply of any infor-
mation that may influence the evaluation of the risks and
benefits of the product, as referred to in Article 16(2) and
Article 41(4) of Regulation (EC) No 726/2004;

6. the supply at the request of the Agency of any data demon-
strating that the risk-benefit balance remains favourable, as
referred to in Article 16(2) and Article 41(4) of Regulation
(EC) No 726/2004;

7. the detection of residues in the case of veterinary medicinal
products, as referred to in Article 41(2) and (3) of Regu-
lation (EC) No 726/2004;

8. placing on the market in accordance with the content of
the product characteristics and the
in the

the summary of
labelling
and package
marketing authorisation;

contained

leaflet

as

9. the specific obligations referred to in Article 14(7) of Regu-
in any other provisions

lation (EC) No 726/2004 or
adopted pursuant thereto;

10. the specific procedures referred to in Article 14(8) and

Article 39(7) of Regulation (EC) No 726/2004;

11. notification to the Agency of the dates of actual marketing
and of the date when the product ceases to be on the
market, and provision to the Agency of data relating to
the volume of sales and the volume of prescriptions of
the product, as referred to in Article 13(4) and Article
38(4) of Regulation (EC) No 726/2004;

12. the appropriately qualified person responsible for pharma-
covigilance, as referred to in Article 23 and Article 48 of
Regulation (EC) No 726/2004;

13. recording and reporting of
and,

suspected serious adverse
veterinary medicinal
referred to in
and Article 49(1) of Regulation (EC)

reactions
in the
products, human adverse reactions, as
Article 24(1)
No 726/2004;

case of

14. reporting of suspected serious unexpected adverse reactions,
suspected transmission of infectious agents and, in the case
of veterinary medicinal products, human adverse reactions,
as referred to in Article 24(2) and Article 49(2) of Regu-
lation (EC) No 726/2004;

15. detailed recording of all suspected adverse reactions and
submission of such records in the form of periodic safety
update reports, as referred to in Article 24(3) and Article
49(3) of Regulation (EC) No 726/2004;

16. communication of

information relating to pharmacov-
igilance concerns to the general public, as referred to in
Article 24(5)
and Article 49(5) of Regulation (EC)
No 726/2004;

17. collation and assessment of

specific pharmacovigilance
data, as referred to in the fourth paragraph of Article 26
and the fourth paragraph of Article 51 of Regulation (EC)
No 726/2004.

Article 2

Complementarity of procedures

For the purposes of the initiation and conduct of the infringe-
ment procedure provided for in Chapter II, the Agency and the
Commission shall take into account any infringement procedure
by a Member State against the same marketing authorisation
holder and based on the same legal grounds and the same facts.

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Article 3

Cooperation by the competent authorities of the
Member States

The competent authorities of

the Member States shall
1.
cooperate with the Agency and the Commission to enable
them to carry out their duties under this Regulation.

Information provided by the national competent autho-
2.
the
in response to a request
rities
Commission under
this Regulation shall be used by the
Agency and the Commission only for the following purposes:

from the Agency or

(a) as evidence for the purposes of applying this Regulation;

(b) for carrying out the tasks entrusted to them for the author-
isation and supervision of medicinal products under Regu-
lation (EC) No 726/2004.

Article 4

Burden of proof

In any infringement procedure under
burden of proving
an infringement
Commission.

this Regulation,
shall

the
rest on the

CHAPTER II

INFRINGEMENT PROCEDURE

SECTION 1

Inquiry

S u b s e c t i o n 1

I n i t i a t i o n o f p r o c e d u r e

Article 5

Initiation of the infringement procedure

The Agency may initiate the infringement procedure on its
1.
own initiative or following a request from the Commission or a
Member State.

The Agency shall
initiate the infringement procedure.

inform the Commission that it intends to

The Agency shall initiate the infringement procedure only

2.
after informing the Member States.

Article 6

Request for information

The Agency shall state the purpose of the request and the fact
that it is made under this Regulation, and indicate a time-limit
for the submission of the reply by the marketing authorisation
holder, which shall be at least four weeks.

Where the request is in response to a request from a Member
State under Article 5(1), that Member State shall be informed by
the Agency.

Article 7

Notification

The Agency shall send written notification of the initiation of
an infringement procedure to the marketing authorisation
and to the
to the Member
holder
Commission.

concerned,

States

set out

the
The notification shall
marketing
the provision
allegedly infringed, and the evidence on which those allegations
are founded.

the allegations against

authorisation holder,

specifying

It shall give notice to the marketing authorisation holder that
fines or periodic penalty payments may be imposed.

S u b s e c t i o n 2

M e a s u r e s o f i n q u i r y

Article 8

Requests by the Agency

The Agency may request

the marketing authorisation
1.
holder to provide written or oral explanations, or particulars
or documents.

Requests shall be addressed in writing to the marketing author-
isation holder. The Agency shall state the legal basis and the
purpose of the request, fix a time-limit by which the infor-
mation is to be provided, which shall be at least four weeks,
the fines
and inform the marketing authorisation holder of
provided for in Article 19(1)(a) and (b) for failing to comply
with the request or for supplying incorrect or misleading infor-
mation.

The Agency may request national competent authorities to

2.
cooperate in the investigation in the following ways:

Prior to initiating an infringement procedure, the Agency may
request from the marketing authorisation holder concerned any
information relating to the alleged infringement.

(a) by performing any of the tasks entrusted to the supervisory
authorities by Articles 19(1) and 44(1) of Regulation (EC)
No 726/2004;

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(b) by performing inspections or other supervisory measures in
accordance with Articles 111 to 115 of Directive
2001/83/EC and Articles 80, 81 and 82 of Directive
2001/82/EC.

Requests shall be addressed in writing and shall state the legal
basis and the purpose of the request. The time-limit for the
the measure of
the reply or the conduct of
submission of
inquiry shall be determined by agreement between the Agency
and the national competent authority to which the request is
addressed, having regard to the specific circumstances of the
case.

The Agency may ask any natural or legal persons to

3.
provide information relating to the alleged infringement.

Requests shall be addressed in writing and shall state the legal
basis and the purpose of the request, and shall fix a time-limit
by which the information should be provided, which shall be at
least four weeks.

Article 9

Right to be heard

Before adoption of the report provided for in Article 10, the
Agency shall
to
submit written observations.

invite the marketing authorisation holder

It shall do so in writing,
the
submission of those observations, which shall be at least four
weeks.

indicating a time-limit

for

S u b s e c t i o n 3

R e p o r t

Article 10

Content and time-limits

its report no later

The Agency shall adopt

than 18
3.
months after notification of
the procedure in
accordance with Article 7 or one year after notification by
the Commission of the return of the file in accordance with
Article 15.

initiation of

SECTION 2

Decision-making stage

S u b s e c t i o n 1

P r o c e d u r e

Article 11

Statement of objections

1. Where, following a request from the Agency pursuant to
Article 10(2), the Commission decides to continue with the
infringement procedure,
shall notify in writing to the
marketing authorisation holder a statement of objections
containing the following:

it

(a) the allegations against the marketing authorisation holder,
including a precise indication of which provision has
allegedly been infringed, and the evidence on which those
allegations are founded;

(b) notice that
imposed.

fines or periodic penalty payments may be

2. Where, within 18 months of receiving the request from
the Agency, the Commission has not notified a statement of
objections, it shall provide the marketing authorisation holder
with an explanatory statement.

Article 12

Right to reply

1. When notifying
the
Commission shall set a time-limit within which the marketing
authorisation holder may submit to the Commission his written
observations on the statement of objections.

of objections,

statement

the

1.
The Agency shall provide the Commission, the Member
States and the marketing authorisation holder with a report
summarising its findings in the light of
the inquiry carried
out in accordance with this Section.

That time-limit shall be at least four weeks.

2. Where the Agency considers that the marketing author-
isation holder has committed an infringement as referred to in
Article 1, the report shall also include an assessment of the
circumstances of
the specific case in accordance with the
criteria set out in Article 18(2) and a request to the Commission
for application of financial penalties.

The Commission shall not be obliged to take into account
written observations received after the expiry of that time-limit.

2.
The marketing authorisation holder may annex to his
written observations, statements from other persons who may
corroborate any aspect of those written observations.

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Article 13

Oral hearing

Article 15

New period of inquiry

1. Where the marketing authorisation holder so requests in
his written observations, the Commission shall give him an
opportunity to develop his arguments at an oral hearing.

The date for the oral hearing shall be set by the Commission.

1. Where, having regard to the report of the Agency, the
observations of the marketing authorisation holder and, as the
case may be, other information submitted to it, the Commission
information is needed in order to
considers that additional
continue the procedure,
it may return the case-file to the
Agency for a new period of inquiry.

2. Where necessary, the Commission may invite the national
competent authorities or any other persons to take part in the
oral hearing.

The Commission shall clearly indicate to the Agency the points
if appropriate,
of fact which it should further examine and,
suggest possible measures of inquiry to that effect.

3.
The oral hearing shall not be public. Each person may be
heard separately or in the presence of other persons invited to
attend, having regard to the legitimate interest of marketing
authorisation holders and other persons in the protection of
their business secrets and other confidential information.

Article 14

Subsections 2 and 3 of Section 1 shall apply to the

2.
conduct of the new period of inquiry.

S u b s e c t i o n 2

D e c i s i o n a n d f i n a n c i a l p e n a l t i e s

Article 16

Requests for information

Forms of financial penalty and maximum amounts

1.
After receipt of a request from the Agency pursuant to
Article 10(2) and before adoption of the decision referred to in
the
Article 16,
marketing authorisation holder to provide written or oral expla-
nations, or particulars or documents, relating to the alleged
infringement.

the Commission may at any time request

Requests shall be addressed in writing to the marketing author-
isation holder. The Commission shall state the legal basis and
the purpose of the request, fix a time-limit by which the infor-
mation is to be provided, which shall be at least four weeks,
and inform the marketing authorisation holder of
the fines
provided for in Article 19(1)(c) and (d) for failing to comply
with the request or supplying incorrect or misleading infor-
mation.

2.
The Commission may request the Agency, the national
competent authorities or any other natural or legal persons to
provide information relating to the alleged infringement.

Requests shall be addressed in writing and shall state the legal
basis and the purpose of the request. Where the request is
addressed to the Agency or a national competent authority,
the time-limit by which the information is to be provided
shall be determined by the Commission after consultation of
the Agency or the national competent authority to which the
request is addressed, having regard to the specific circumstances
of the case. Where the request is addressed to other natural or
legal persons, it shall fix a time-limit by which the information
is to be provided, which shall be at least four weeks.

the

following

procedure

1. Where,
in
Subsection 1, the Commission finds that the marketing author-
intentionally or negligently, an
isation holder has committed,
infringement as referred to in Article 1, it may adopt a decision
imposing a fine not exceeding 5 % of the holder’s Community
turnover in the preceding business year.

provided

for

the marketing authorisation holder has not
2. Where
in the
terminated the infringement,
impose periodic penalty
decision referred to in paragraph 1,
payments per day not exceeding 2,5 % of the holder’s average
daily Community turnover in the preceding business year.

the Commission may,

Periodic penalty payments may be imposed for a period
running from the date of notification of that decision until
the infringement has been brought to an end.

3.
For the purposes of paragraphs 1 and 2, the preceding
business year refers to the business year preceding the date of
the decision referred to in paragraph 1.

Article 17

Decision

1.
The decision provided for in Article 16 shall be based
exclusively on grounds on which the marketing authorisation
holder has been able to comment.

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The Commission shall inform the marketing authorisation

2.
holder of the judicial remedies available.

The Commission shall communicate the adoption of the

3.
decision to the Agency and to the Member States.

4. When publishing details of its decision in accordance with
the second subparagraph of Article 84(3) of Regulation (EC)
No 726/2004,
the Commission shall have regard to the
legitimate interest of marketing authorisation holders and
other persons in the protection of their business secrets.

Article 18

Principles governing the application and quantification of
financial penalties

In determining whether to impose a financial penalty and
1.
in
the
determining
appropriate
Commission shall be guided by the principles of effectiveness,
proportionality and dissuasiveness.

financial

penalty,

the

the infringement and the application of
detection of
corrective action, or during the course of the infringement
procedure or, on the other hand, any obstruction by the
marketing authorisation holder of the detection of an infrin-
gement and the conduct of an infringement procedure, or
any non-compliance by the marketing authorisation holder
with requests made by the Agency, the Commission or a
national competent authority in application of this Regu-
lation;

(d) the turnover of the medicinal product concerned;

(e) the need to adopt provisional measures by the Commission
or urgent action by a Member State in accordance with
Articles 20 or 45 of Regulation (EC) No 726/2004 as a
result of an infringement;

(f)

the repetition, frequency or duration of the infringement by
that marketing authorisation holder;

In each case,

2.
eration, where relevant, the following circumstances:

the Commission shall

take into consid-

(a) the seriousness and the effects of the infringement, and, in

particular, the following:

(g) prior sanctions,

including penalties,

imposed on the same

marketing authorisation holder.

(i) the way in which the infringement adversely affects the

rights, safety or well-being of patients;

In determining the amount of the financial penalty, the
3.
Commission shall
take into account any penalties already
imposed on the marketing authorisation holder at national
level on the basis of the same legal grounds and the same facts.

(ii) its effects on animal health and welfare and the impact

on animal owners;

(iii) whether it poses or could pose a risk to public health,

animal health or the environment;

(iv) the gravity of the infringement in relation to public

health, animal health and the environment;

(b) on the one hand, the good faith of the marketing author-
isation holder in the interpretation and fulfilment of the
obligations
authorisations
granted in accordance with Regulation (EC) No 726/2004
or, on the other hand, any evidence of wilful deceit on the
part of the marketing authorisation holder;

connected with marketing

SECTION 3

Non-cooperation

Article 19

Financial penalties

The Commission may by decision impose on marketing
1.
authorisation holders
their
Community turnover in the preceding business year where,
intentionally or negligently:

exceeding 0,5 % of

fines not

(a) they do not comply with a measure of inquiry adopted

pursuant to Article 8(1);

(c) on the one hand, the degree of diligence and cooperation
in the

shown by the marketing authorisation holder

(b) they supply incorrect or misleading information in response
to a measure of inquiry adopted pursuant to Article 8(1);

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(c) they do not comply with a request for information pursuant

to Article 14;

Article 22

Legal representation

(d) they supply incorrect or misleading information in response

to a request for information pursuant to Article 14.

2. Where the non-cooperation of
the marketing authori-
sation holder continues, the Commission may, in the decision
referred to in paragraph 1, impose periodic penalty payments
the holder’s average daily
per day not exceeding 0,5 % of
Community turnover in the preceding business year.

Periodic penalty payments may be imposed for a period
running from the date of notification of that decision until
the non-cooperation has ceased.

The marketing authorisation holder shall have the right to legal
representation during the infringement procedure.

Article 23

Confidentiality and professional secrecy

1. Without prejudice to the exchange and to the use of
information foreseen in Article 3, an infringement procedure
shall be carried out subject to the principles of confidentiality
and of professional secrecy. The Agency and the Commission,
their officials, servants and other persons working under their
supervision shall not
information acquired or
exchanged by them pursuant to this Regulation and of the
kind covered by the obligation of professional secrecy and
confidentiality.

disclose

3.
For the purposes of paragraphs 1 and 2, the preceding
business year refers to the business year preceding the date of
the decision referred to in paragraph 1.

2. Without prejudice to the right to access the case-file, the
marketing authorisation holder shall not have access to business
secrets, confidential information or internal documents held by
the Agency, the Commission or a Member State.

Article 20

Procedure

When the Commission intends to adopt a decision as referred
to in Article 19(1), it shall first notify in writing the marketing
authorisation holder, setting a time-limit within which the
marketing authorisation holder may submit to the Commission
his written observations. That time-limit shall be at least four
weeks.

The Commission shall not be obliged to take into account
written observations received after the expiry of that time-limit.

CHAPTER III

ACCESS TO THE FILE, REPRESENTATION, CONFIDENTIALITY
AND TEMPORAL PROVISIONS

Article 21

Access to the file

Following notification under Article 7, the marketing authori-
sation holder shall have the right, on request, to access the
documents and other materials compiled by the Agency
and the Commission which serve as evidence of an alleged
infringement.

Any person who submits information or observations
3.
pursuant to Articles 8, 9, 12 or 14 shall clearly identify any
material considered to be confidential, giving reasons, and
provide a separate non-confidential version by the date set by
the Agency or the Commission.

4. Without prejudice to paragraph 3, the Agency and the
Commission may require persons who submit information or
observations pursuant
to this Regulation to identify the
documents or parts of documents which they consider to
contain business
information
belonging to them.

secrets or other confidential

The Agency and the Commission may also require marketing
authorisation holders and other persons to identify any part of a
report by the Agency, of a statement of objections or of a
decision adopted by the Commission which in their view
contains business secrets.

The Agency and Commission may set a time-limit within which
the marketing authorisation holder and other persons are to:

Documents obtained through access to the file shall be used
only for the purposes of judicial or administrative proceedings
for the application of this Regulation.

(a) substantiate their claim for confidentiality with regard to

each individual document or part of document;

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(b) provide the Commission with a non-confidential version of
in which the confidential passages are

the documents,
deleted;

In the case of the financial penalties provided for in Article 19,
the right of the Commission to adopt a decision imposing such
a penalty shall expire after three years.

(c) provide a concise description of each piece of deleted infor-

mation.

The time-limit referred to in the third subparagraph shall be at
least two weeks.

5.
If the marketing authorisation holder or other persons fail
to comply with paragraphs 3 and 4, the Commission may
the information or observations concerned do
assume that
not contain confidential information.

Article 24

Application of time-limits

1.
The time-limits laid down in this Regulation shall run
from the day following receipt of a communication or
delivery thereof by hand.

it shall be sufficient

In the case of a communication from the marketing authori-
sation holder,
for the purposes of the
the communication to have been
relevant
dispatched by registered post before the relevant
time-limit
has expired.

time-limits

for

2. Where the time-limit falls to expire on a Saturday, Sunday
it shall be extended up to the end of the
or public holiday,
following working day.

In setting the time-limits provided for in Articles 6, 8(1),
3.
12(1) and 14(1), the Agency and the Commission, as the case
may be, shall have regard both to the time required for
preparation of the submission and to the urgency of the case.

4. Where appropriate and upon reasoned request made
before the expiry of the original time-limit, time-limits may
be extended.

Article 25

Limitation periods for the imposition of financial penalties

The right of

1.
imposing a financial penalty pursuant
expire after five years.

the Commission to adopt a decision
to Article 16 shall

Time shall begin to run on the day on which the infringement
is committed. However, in the case of continuing or repeated
infringements, time shall begin to run on the day on which the
infringement ceases.

Any action taken by the Agency or the Commission for
2.
the purpose of the investigation or infringement procedure shall
interrupt the limitation periods laid down in paragraph 1. The
limitation period shall be interrupted with effect from the date
on which the action is notified to the marketing authorisation
holder.

3.
Each interruption shall start time running afresh. However,
the limitation period shall expire at the latest on the day on
which a period equal to twice the limitation period has elapsed
without the Commission having imposed a financial penalty.
The period shall be extended by the time during which
limitation is suspended pursuant to paragraph 4.

The limitation period for

4.
financial
penalties shall be suspended for as long as the decision of the
Commission is the subject of proceedings pending before the
Court of Justice of the European Communities.

the imposition of

Article 26

Limitation periods for the collection of financial penalties

1.
The right to start a recovery procedure shall expire one
year after the decision pursuant to Article 16 or Article 19 has
become final.

The

limitation period for

2.
financial
penalties shall be interrupted by any action of the Commission
or of a Member State, acting at the request of the Commission,
designed to enforce payment of the penalty.

recovery of

the

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3.

Each interruption shall start time running afresh.

The limitation period for

4.
penalties shall be suspended for so long as:

the

recovery of

(a) time to pay is allowed;

financial

CHAPTER IV

FINAL PROVISIONS

Article 27

Transitional provision

In the case of infringements which began before its entry into
force, this Regulation shall apply to the part of the infringement
which takes place after that date.

Article 28

Entry into force

(b) enforcement of payment is suspended pursuant to a decision
of the Court of Justice of the European Communities.

This Regulation shall enter into force on the 20th day following
its publication 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, 14 June 2007.

For the Commission

Günter VERHEUGEN
Vice-President