Commission Regulation (EC) No 507/2006 of  29 March 2006  on the conditional marketing authorisation for medicinal products for human use falling within the scope of Regulation (EC) No 726/2004 of the European Parliament and of the Council   (Text with EEA relevance)
Date: 2006-03-29
Institutions: European Commission
Subjects: drug surveillance, market approval, medicinal product, pharmaceutical legislation

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Official Journal of the European Union

30.3.2006

COMMISSION REGULATION (EC) No 507/2006

of 29 March 2006

on the conditional marketing authorisation for medicinal products for human use falling within the
scope of Regulation (EC) No 726/2004 of the European Parliament and of the Council

(Text with EEA relevance)

THE COMMISSION OF THE EUROPEAN COMMUNITIES,

lation (EC) No 141/2000 of the European Parliament and
of
the Council of 16 December 1999 on orphan
medicinal products (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
Article 14(7) thereof,

Whereas:

(1)

(2)

Before a medicinal product for human use is authorised
for placing on the market of one or more Member States,
it generally has to undergo extensive studies to ensure
that it is safe, of high quality and effective for use in the
target population. The rules and procedures for obtaining
a marketing authorisation are laid down in Directive
2001/83/EC of
the
Council of 6 November 2001 on the Community code
relating to medicinal products for human use (2) and in
Regulation (EC) No 726/2004.

the European Parliament and of

categories

In the case of certain categories of medicinal products,
however,
in order to meet unmet medical needs of
patients and in the interests of public health, it may be
necessary to grant marketing authorisations on the basis
less complete data than is normally the case and
of
to specific obligations, hereinafter ‘conditional
subject
marketing authorisations’. The
concerned
should be medicinal products which aim at
the
treatment, prevention or medical diagnosis of seriously
life-threatening diseases, or medicinal
debilitating or
products
in
response to public health threats recognised either by
the World Health Organisation or by the Community
in the framework of Decision No 2119/98/EC of the
the Council of 24
and of
European Parliament
September 1998 setting up a network for the epidemio-
logical surveillance and control of communicable diseases
in the Community (3), or medicinal products designated
as orphan medicinal products in accordance with Regu-

to be used in emergency

situations

(1) OJ L 136, 30.4.2004, p. 1.
(2) OJ L 311, 28.11.2001, p. 67. Directive as last amended by Directive

2004/27/EC (OJ L 136, 30.4.2004, p. 34).

(3) OJ L 268, 3.10.1998, p. 1. Decision as last amended by Regulation

(EC) No 1882/2003 (OJ L 284, 31.10.2003, p. 1).

(3)

Although the data upon which an opinion on a condi-
tional marketing authorisation is based may be less
complete, the risk-benefit balance, as defined in Article
1(28a) of Directive 2001/83/EC should be positive.
Furthermore,
the benefits to public health of making
the medicinal product concerned immediately available
on the market should outweigh the risk inherent in the
fact that additional data are still required.

(4) Where conditional marketing authorisations are granted,
they should be restricted to situations where only the
clinical part of the application dossier is less complete
than normal. Incomplete pre-clinical or pharmaceutical
data should be accepted only in the case of a product
to be used in emergency situations, in response to public
health threats.

(5)

(6)

to medicines

to ensure that

the right balance is struck
In order
between facilitating access
for patients
with unmet medical needs and preventing the authori-
sation of medicines with an unfavourable risk-benefit
profile, it is necessary to make those marketing author-
isations subject to specific obligations. The holder should
be required to complete or initiate certain studies with a
view to confirming that
the risk-benefit balance is
positive and resolving any questions relating to the
quality, safety and efficacy of the product.

In the case of

Conditional marketing authorisations are distinct from
marketing authorisations granted in exceptional circum-
stances in accordance with Article 14(8) of Regulation
(EC) No 726/2004.
the conditional
marketing authorisation, authorisation is granted before
all data are available. The authorisation is not intended,
however, to remain conditional indefinitely. Rather, once
the missing data are provided, it should be possible to
replace it with a marketing authorisation which is not
conditional, that is to say, which is not subject to specific
obligations. In contrast, it will normally never be possible
to assemble a full dossier in respect of a marketing
authorisation granted in exceptional circumstances.

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

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(7)

(8)

(9)

(10)

(11)

(12)

It should also be made clear that applications containing
requests for conditional marketing authorisations may be
the subject of an accelerated assessment procedure in
accordance with Article 14(9) of Regulation (EC)
No 726/2004.

(13)

advice should be an additional service to the existing
scientific advice provided by the Agency.

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

opinion

the

the

of

Since the provisions of Regulation (EC) No 726/2004
apply to conditional marketing authorisations unless
otherwise
the
procedure for evaluating a conditional marketing author-
isation is the normal procedure laid down in Regulation
(EC) No 726/2004.

this Regulation,

provided

for

in

In accordance with Regulation (EC) No 726/2004, condi-
tional marketing authorisations will be valid for one year
on a renewable basis. The deadline for submission of a
renewal application should be six months prior to the
expiry of the marketing authorisation, and the opinion of
the European Medicines Agency (hereinafter the Agency)
on the application should be adopted within 90 days of
its receipt. To ensure that medicinal products are not
removed from the market except for reasons related to
the conditional marketing authorisation
public health,
should, as long as a renewal application is submitted
within the deadline, remain valid until the Commission
reaches a decision based on the renewal assessment
procedure.

Clear information should be provided to patients and
healthcare professionals on the conditional nature of
is therefore necessary that such
the authorisations.
summary of
information be
product
product
concerned as well as on the package leaflet.

clearly stated in the

the medicinal

characteristics

of

It

a

authorisation

conditional marketing

for medicinal products
Enhanced pharmacovigilance
granted
is
important and is already adequately provided for in
Directive
(EC) No
and
726/2004. However, the time schedule for submitting
periodic safety update reports should be adapted to
accommodate
conditional
marketing authorisations.

2001/83/EC

Regulation

renewal

annual

the

of

The planning of studies and of the submission of an
application for a marketing authorisation occurs at an
early stage in the development of medicinal products.
Such planning will critically depend on whether a condi-
tional marketing authorisation is a possibility. For this
reason it is necessary to provide a mechanism for the
Agency to give companies advice on whether a medicinal
product falls within the scope of this Regulation. Such

HAS ADOPTED THIS REGULATION:

Article 1

Subject matter

This Regulation lays down rules on the granting of a marketing
authorisation subject to specific obligations in accordance with
Article 14(7) of Regulation (EC) No 726/2004, hereinafter
‘conditional marketing authorisation’.

Article 2

Scope

This Regulation shall apply to medicinal products for human
use that fall under Article 3(1) and (2) of Regulation (EC) No
726/2004 and belong to one of the following categories:

1. medicinal products which aim at

the
prevention or the medical diagnosis of seriously debilitating
diseases or life-threatening diseases;

treatment,

the

2. medicinal products to be used in emergency situations,

in
response to public health threats duly recognised either by
the World Health Organisation or by the Community in the
framework of Decision No 2119/98/EC;

3. medicinal products designated as orphan medicinal products
(EC)

accordance with Article

of Regulation

3

in
No 141/2000.

Article 3

Requests or proposals

1.
A request for a conditional marketing authorisation may
be presented by the applicant together with an application in
accordance with Article 6 of Regulation (EC) No 726/2004. The
request shall be accompanied by details showing that
the
product falls within the scope of this Regulation and satisfies
the requirements laid down in Article 4(1).

The Agency shall immediately inform the Commission of appli-
cations containing a request for a conditional marketing author-
isation.

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The Committee for Medicinal Products for Human Use,
2.
hereinafter ‘the Committee’, may,
in its opinion on an appli-
cation submitted in accordance with Article 6 of Regulation
(EC) No 726/2004, propose a conditional marketing autho-
risation, after having consulted the applicant.

Article 4

Requirements

1.
A conditional marketing authorisation may be granted
where the Committee finds
that, although comprehensive
the
clinical data referring to the safety and efficacy of
medicinal product have not been supplied, all the following
requirements are met:

(a)

the risk-benefit balance of the medicinal product, as defined
in Article 1(28a) of Directive 2001/83/EC, is positive;

that the risk-benefit balance is positive and providing the addi-
tional data referred to in Article 4(1).

In addition, specific obligations may be imposed in relation to
the collection of pharmacovigilance data.

2.
The specific obligations referred to in paragraph 1 and the
timeframe for their completion shall be clearly specified in the
conditional marketing authorisation.

The Agency shall make the specific obligations and the

3.
timeframe for their completion publicly available.

Article 6

Renewal

(b) it is likely that the applicant will be in a position to provide

the comprehensive clinical data;

After its period of validity of one year the conditional

1.
marketing authorisation may be renewed annually.

(c) unmet medical needs will be fulfilled;

(d) the benefit to public health of the immediate availability on
the market of the medicinal product concerned outweighs
the risk inherent in the fact that additional data are still
required.

In emergency situations as referred to in Article 2(2), a condi-
tional marketing authorisation may be granted, subject to the
requirements set out in points (a) to (d) of this paragraph, also
where comprehensive pre-clinical or pharmaceutical data have
not been supplied.

For the purposes of paragraph 1(c), ‘unmet medical needs’
2.
means a condition for which there exists no satisfactory method
authorised in the
of diagnosis, prevention or
Community or, even if such a method exists,
in relation to
which the medicinal product concerned will be of major ther-
apeutic advantage to those affected.

treatment

2.
The application for renewal shall be submitted to the
Agency at least six months before the expiry of the conditional
marketing authorisation, together with an interim report on the
fulfilment of the specific obligations to which it is subject.

The Committee shall assess the application for a renewal,
3.
on the basis that the risk-benefit balance is to be confirmed,
taking into account the specific obligations contained in the
authorisation and the timeframe for their fulfilment, and shall
formulate an opinion as to whether the specific obligations or
their timeframes need to be retained or modified. The Agency
shall ensure that the opinion of the Committee is given within
90 days following receipt of a valid renewal application. That
opinion shall be made publicly available.

4.
Once a renewal application has been submitted in
accordance with paragraph 2, the conditional marketing author-
isation shall remain valid until a decision is adopted by the
Commission in accordance with Article 10 of Regulation (EC)
No 726/2004.

Article 7

Article 5

Marketing authorisation not subject to specific obligations

Specific obligations

1.
By way of specific obligations, the holder of a conditional
marketing authorisation shall be required to complete ongoing
studies, or to conduct new studies, with a view to confirming

Where the specific obligations laid down in accordance with
Article 5(1) have been fulfilled, the Committee may at any
time adopt an opinion in favour of
the granting of a
marketing authorisation in accordance with Article 14(1) of
Regulation (EC) No 726/2004.

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Article 8

Product Information

product being developed for a specific therapeutic indication
falls within one of the categories set out in Article 2 and
fulfils the requirement laid down in Article 4(1)(c).

Where a medicinal product has been granted conditional
marketing authorisation in accordance with this Regulation,
the information included in the summary of product character-
istics and package leaflet shall contain a clear mention of that
fact. The summary of product characteristics shall also contain
the date on which the conditional authorisation is due for
renewal.

Article 9

Periodic safety update reports

The periodic safety update reports provided for in Article 24(3)
of Regulation (EC) No 726/2004 shall be submitted to the
Agency and Member States immediately upon request or at
least every six months following the granting or renewal of a
conditional marketing authorisation.

Article 11

Guidelines

The Agency shall develop guidelines concerning the scientific
to
application and the practical
implement
this Regulation. The guidelines shall be adopted
after consultation with stakeholders and a favourable opinion
of the Commission.

arrangements necessary

Article 12

Transitional provision

This Regulation shall apply to applications pending at the time
of its entry into force.

Article 10

Article 13

Agency advice prior to marketing authorisation application

Entry into force

A potential applicant for a marketing authorisation may request
the Agency on whether a specific medicinal
the advice of

This Regulation shall enter into force on the third 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, 29 March 2006.

For the Commission

Günter VERHEUGEN
Vice-President